155 results on '"Kluivers KB"'
Search Results
2. External validation of the paediatric risk of malignancy index
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Hermans, AJ, primary, Kluivers, KB, additional, Massuger, LF, additional, and Coppus, SF, additional
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- 2015
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3. The natural history of levator avulsion one year following childbirth: a prospective study
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van Delft, KWM, primary, Thakar, R, additional, Sultan, AH, additional, IntHout, J, additional, and Kluivers, KB, additional
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- 2014
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4. External validation of the paediatric risk of malignancy index.
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Hermans, AJ, Kluivers, KB, Massuger, LF, Coppus, SF, Hermans, A J, Kluivers, K B, Massuger, L F, and Coppus, S F
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CHILDHOOD cancer , *ADNEXA uteri , *DISEASES in girls , *HISTOLOGY , *ADNEXAL diseases , *IMAGING of cancer , *RECEIVER operating characteristic curves , *DIAGNOSIS , *CANCER , *CANCER risk factors , *COMPARATIVE studies , *FEMALE reproductive organs , *FEMALE reproductive organ tumors , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *RISK assessment , *EVALUATION research , *RETROSPECTIVE studies - Abstract
Objective: This study aimed to validate the paediatric risk of malignancy index (PRMI), as previously published.Design: External validation study.Setting: Academic hospital: Radboud University Medical Center.Population: Female paediatric patients under the age of 18 years diagnosed with, or treated for, an adnexal mass between January 1999 and October 2013.Methods: Information was collected on diagnosis, presenting symptoms, and signs and imaging characteristics. The PRMI was calculated for each patient. Sensitivity, specificity, and positive and negative predictive values were calculated, and the results were visualised using a receiver operating characteristic curve (ROC curve).Main Outcome Measures: Histological diagnosis, discriminative performance using the area under the curve (AUC) of the ROC curve and sensitivity and specificity.Results: Seventy-eight patients were included, with a median age of 12 years. A malignant mass was found in 17 patients (21.8%). The PRMI with a cut-off value of 7 resulted in a sensitivity of 70.1% (95% CI 44.1-89.6%) and a specificity of 85.3% (95% CI 73.8-93.0%). The area under the ROC curve was 0.868 (95% CI 0.756-0.980).Conclusions: The PRMI showed less discriminative capacity than originally published, but its performance was still good; however, further prospective validation studies are needed to define whether the model is useful in daily clinical practice. [ABSTRACT FROM AUTHOR]- Published
- 2016
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5. The natural history of levator avulsion one year following childbirth: a prospective study.
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Delft, KWM, Thakar, R, Sultan, AH, IntHout, J, and Kluivers, KB
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AVULSION fractures ,PELVIC floor injuries ,CHILDBIRTH ,PUERPERAL disorders ,COHORT analysis ,LONGITUDINAL method - Abstract
Objective To explore the natural history of levator avulsion in primipara 1 year postpartum and correlate this to pelvic floor dysfunction ( PFD). Design Observational longitudinal cohort study. Setting District General University Hospital. Population or sample Nullipara at 36 weeks of gestation, 3 months and 1 year postpartum. Methods Validated methods assessed muscle strength, prolapse, ultrasound measurements of levator hiatus and avulsion, and questionnaires for sexual function, and urinary and anal incontinence. Pattern differences over time were evaluated using linear mixed models. Main outcome measures Natural history of levator avulsion and relationship with PFD. Results Of the 269 nullipara, 191 returned at 3 months and 147 (55%) at 1 year postpartum; 109 had a vaginal delivery and 38 had a caesarean delivery. Sixty-two percent ( n = 13/21; 95% CI 41-79%) of levator avulsions diagnosed 3 months postpartum were no longer evident at 1 year. Following vaginal delivery, nine women (8%, 95% CI 4.2-15.1%) had persistent levator avulsion. Most changes in PFD occurred between the antenatal and first postnatal visit, without improvement at 1 year. Women with persistent levator avulsion had significantly worse deterioration patterns of muscle strength, hiatus measurements and vaginal symptoms (loose vagina/lump sensation). However, evidence of PFD was also related to no longer evident levator avulsion. Conclusions Sixty-two percent of levator avulsions were no longer evident 1 year postpartum. Partial avulsion has a tendency to improve over time, which seems to be less common for complete levator avulsions. Women with no longer evident and persistent levator avulsion had PFD, with worse patterns in presence of persistent avulsion. [ABSTRACT FROM AUTHOR]
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- 2015
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6. The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.
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Dancet EA, Apers S, Kluivers KB, Kremer JA, Sermeus W, Devriendt C, Nelen WL, and D'Hooghe TM
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- 2012
7. Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial.
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Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, and Kluivers KB
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- 2012
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8. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure.
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Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL, Withagen, Mariëlla I, Vierhout, Mark E, Hendriks, Jan C, Kluivers, Kirsten B, and Milani, Alfredo L
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- 2011
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9. Evaluation of adnexal masses with three-dimensional ultrasonography.
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Geomini PMA, Kluivers KB, Moret E, Bremer GL, Kruitwagen RFP, Mol BWJ, Geomini, Peggy M A J, Kluivers, Kirsten B, Moret, Evelien, Bremer, Gérard L, Kruitwagen, Roy F P M, and Mol, Ben Willem J
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Objective: To estimate whether three-dimensional ultrasonography and three-dimensional power Doppler investigation can contribute to the differentiation between benign and malignant ovarian masses.Methods: Women scheduled for surgical treatment of an adnexal mass were included in a multicenter prospective study. All women underwent two-dimensional and three-dimensional ultrasonographic examination in the week before surgery. All parameters were compared in women with benign tumors, borderline tumors, and malignant tumors using receiver operating characteristic analysis and likelihood ratios.Results: We included 181 women; 144 had a benign mass, 26 had a malignancy, and 11 had a borderline tumor. At three-dimensional ultrasonography, the most striking difference was found in the presence of central vessels in an adnexal mass. Central vessels assessed by three-dimensional ultrasonography were present in 15% (21 of 144) of the benign masses, 69% (18 of 26) of the malignant masses, and 27% (3 of 11) of the masses of borderline malignancy. The likelihood ratios for presence of central vessels for a mass being malignant and/or borderline was 4.9 (95% confidence interval 2.1-12). Mean gray index and flow index were also significantly different between the groups, but other features were not.Conclusion: The central localization of vessels in an adnexal mass, as observed by three-dimensional ultrasonography, the mean gray index, and the flow index are potentially important parameters for distinguishing benign from malignant adnexal masses.Level Of Evidence: II-2. [ABSTRACT FROM AUTHOR]- Published
- 2006
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10. Science. Reliable identification of the type III collagen gene polymorphism rsl800255 with the use of high resolution melting analysis.
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Lince SL, Kluivers KB, Dijkstra JR, Janssen MJW, Vierhout ME, and van Kempen LCL
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Background: We have recently identified a homozygous nucleotide substitution in exon 30 of type III collagen (COL3A1 2209G>A, rs1800255) as a risk factor for the development of pelvic organ prolapse. This polymorphism is also associated with mitral valve prolapse. Patients could benefit from preventive actions when identified prior to clinical evidence of the disease. High resolution melting (HRM) analysis is a low-cost, high-throughput technique to identify DNA polymorphisms. The purpose of this study was to investigate whether HRM is an accurate method to detect the above mentioned polymorphism in DNA from blood samples Methods: A total of 36 randomly selected DNA samples from pelvic organ prolapse patients were analyzed in duplicate using polymerase chain reaction (PCR)-based restriction fragment length polymorphism (PCR-RFLP) and sequence analysis. Using the latter as the gold standard, all samples were subjected to HRM analysis with the use of specific primers and an unlabelled probe. Results: Compared to sequence analysis, PCR-RFLP resulted in 2 incorrect diagnoses. High resolution melting analysis demonstrated unique melting profiles for wild-type, as well as heterozygous and homozygous polymorphisms, with 100% accuracy. Conclusion: High resolution melting is a fast, cost-effective, and sensitive screening method to detect the rs1800255 polymorphism. [ABSTRACT FROM AUTHOR]
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- 2009
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11. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.
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van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brölmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME, van Leijsen, Sanne A L, and Kluivers, Kirsten B
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Background: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.Methods/design: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.Trial Registration: Clinical Trials NCT00814749. [ABSTRACT FROM AUTHOR]- Published
- 2009
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12. The use of synthetic mesh in vaginal prolapse surgery: a survey of Dutch urogynaecologists.
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Lensen EJ, Withagen MI, Stoutjesdijk JA, Kluivers KB, and Vierhout ME
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- 2012
13. Sexual function after surgically corrected menstrual outflow obstruction due to congenital anomalies.
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Martens L, Spath MA, van Beek MA, Willemsen WNP, and Kluivers KB
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Objectives: To enhance evidence-based knowledge about sexual function and the prevalence of sexual dysfunction after surgical therapy for congenital anomalies with menstrual outflow obstruction., Materials and Methods: In this long-term case-control study, all patients underwent surgical correction of an obstructive Müllerian anomaly between 1980 and 2013. At the start of the case-control study, patients were at least 18 years old and were two years post their initial operation. The control group were women without current gynaecological problems. 38 patients (response rate 48.7%) and 54 controls were included. Chi-square test linear-by-linear Association, Fisher's Exact Test, Mann-Whitney U test and the unpaired sample t-test were used for statistical analysis., Main Outcome Measures: The following questionnaires were used: the Female Sexual Function Index (FSFI), the Body Exposure during Sexual Activities Questionnaire (BESAQ), and the Endometriosis Health Profile Questionnaire (EHP-30)., Results: The mean FSFI score in patients was 27.8 (SD5.4) versus 27.4 (SD6.8) in controls (p=0.858). A total FSFI score ≥26.55, indicating no sexual dysfunction was present in 70.6% of patients and 69.2% of controls (p=1.000). The mean BESAQ score in patients was 30.4 (18.5), compared to 38.3 (SD21.4) in controls (p=0.261), where lower scores denote better body image during intimate sessions. In the EHP-30, a statistically significant difference between patients and controls was found in all items on sexual intercourse. The subscale score of patients was 31.1 (SD26.2) versus 7.0 (SD11.1) in controls (p=<0.001), indicating better sexual functioning in controls., What Is New?: The study showed that a history of menstrual outflow obstruction had a negative influence on several domains of sexual function, yet the patients total scores on sexual function remained in the normal range. The FSFI score of patients' post-surgical treatment of obstructive congenital anomalies is similar to the control group.
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- 2024
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14. Supporting the Choice for Conservative and Surgical Treatment in Female Stress Urinary Incontinence: Development and Evaluation of a Patient Decision Aid.
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Gerritse MBE, de Vries M, The R, Heesakkers JPFA, Lagro-Janssen ALM, Huub van der Vaart C, and Kluivers KB
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- Humans, Female, Middle Aged, Patient Participation, Urologic Surgical Procedures, Adult, Suburethral Slings, Netherlands, Urinary Incontinence, Stress surgery, Decision Support Techniques, Conservative Treatment
- Abstract
Introduction: Making a treatment decision for female stress urinary incontinence (SUI) can be challenging for patients and healthcare providers. Dutch guidelines advise to counsel both pelvic floor muscle therapy and midurethral sling surgery as primary treatment options in uncomplicated moderate to severe cases. The use of a patient decision aid (PDA) can support decision-making, reduce decisional conflict and decisional regret, and increase knowledge. The aim of this study was to develop and evaluate an online PDA for females (SUI)., Methods: This mixed-methods study was performed in consecutive stages by a multidisciplinary working group. PDA design was based on the International Patient Decision Aids Standards (IPDAS) and on outcomes of needs assessments amongst patients and healthcare providers. Content was based on Dutch guidelines, targeted literature searches and patient information from the Dutch scientific society for gynecology. The concept version was evaluated by patients, patients' advocates, and healthcare providers., Results: Using the nominal group technique, the working group established the design and format of the PDA. Fifty-six out of 58 applicable items of the IPDAS were met. The PDA contains information on the condition, advice on lifestyle adaptations, and describes surgical and nonsurgical treatment options. The option grid contains comparisons of the primary treatment options. Furthermore, value clarification exercises and narratives were included. Acceptability and usability evaluation of the concept version was performed by 15 healthcare providers, three patients, and two patients' advocates. Comments were processed in the working group, resulting in the final version of the PDA, which was supported by all assessors., Conclusion: Our multidisciplinary working group developed an online PDA for women with moderate to severe SUI including conservative and surgical treatment options, based on IPDAS criteria, guidelines, scientific evidence, and needs assessments from patients and healthcare providers. This PDA is supported by patients, healthcare providers, scientific societies, and the Dutch patients' association. The next step is to evaluate and implement this PDA in daily practice., Trial Registration: ID 2014-308., (© 2024 The Author(s). Neurourology and Urodynamics published by Wiley Periodicals LLC.)
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- 2024
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15. Multidisciplinary healthcare for women with Mayer-Rokitansky-Küster-Hauser syndrome.
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Martens L, Lodewijk SJ, Leuning E, Oerlemans AJM, Verhaak CM, and Kluivers KB
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- 2024
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16. Social media recruitment of participants in a female stress urinary incontinence trial: A feasibility study.
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de Graaf BC, Gerritse MBE, Michiels KCJ, Kluivers KB, and van de Belt TH
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- Humans, Female, Middle Aged, Adult, Advertising methods, Aged, Social Media, Feasibility Studies, Urinary Incontinence, Stress therapy, Patient Selection
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Objective: This study explores the opportunities of social media advertisements as a recruitment strategy in women with stress urinary incontinence (SUI)., Study Design: This feasibility study was part of a larger clinical trial on the effects of a patient decision aid for SUI treatment. We started a 61-day social media advertisement campaign to recruit women for the trial. The primary outcome of our study was enrolment pace. Secondary outcomes involved cost per participant, baseline demographic comparison and ad campaign performance metrics. Additionally, we interviewed recruited participants to identify the facilitators and barriers of our approach., Results: Ten participants were recruited, of whom 8 completed the full study protocol (2 questionnaires 6 months apart). The enrolment pace, 4.0 study participants per month, was faster compared to the average of 2.7 participants per month through conventional methods. The campaign reached 87 clicks on the advertisement per day and 1 % of these women showed interest in our study by contacting us. The overall conversion rate from click to full participation was 0.2 %. The costs per participant were €112. Besides higher age, the demographics of the social media recruited participants were comparable to the conventional inclusions. Qualitative analysis identified more user-oriented enrolment procedures and potential participant benefit as facilitators of social media recruitment., Conclusion: This study shows that social media recruitment can be feasible in trials for women with SUI. It can accelerate recruitment of eligible participants. Optimising the enrolment procedure to better meet participants' needs and recruitment benefits may improve participation and cost-effectiveness. Trial registration ID 2017-3540., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kirsten Kluivers reports financial support was provided by Netherlands Organisation for Health Research and Development. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)
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- 2024
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17. Response to letter to "Patient Impression of Improvement 1 year After Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Pelvic Organ Prolapse Stage 2 or Higher".
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Stoter LM, Notten KJB, and Kluivers KB
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- Humans, Female, Gynecologic Surgical Procedures methods, Patient Satisfaction, Severity of Illness Index, Pelvic Organ Prolapse surgery, Hysterectomy, Vaginal methods
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- 2024
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18. Lessons learned from the experiences of patients with chronic pelvic pain syndrome (CPP syndrome) with a multidisciplinary consultation: a qualitative study.
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Wissing MC, van der Net L, Engels Y, Vissers KCP, Kluivers KB, Wal SV, and Notten KJB
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Introduction: Chronic pelvic pain syndrome is a complex multifactorial condition with an increasing prevalence probably due to a rising awareness. Chronic pelvic pain syndrome is pain in the pelvic area and often accompanied with complaints in other organ systems of the lesser pelvis. Patients with chronic pelvic pain syndrome who present at our center are evaluated in a standardized care pathway with an integrated multidisciplinary consultation. The team works in a single center and consists of gynecologists, pain specialists, urologists, a pelvic floor physiotherapist and a psychologist. The aim of this interview study is to evaluate the value of the multidisciplinary consultation from the patient's perspectives., Methods: In a qualitative study, we evaluated the experiences and perspectives of patients with chronic pelvic pain syndrome concerning the multidisciplinary consultation at the Radboud University Medical Center. Semistructured interviews were conducted with patients with chronic pelvic pain syndrome who attended a multidisciplinary consultation between 2019 and 2022. All interviews were transcribed verbatim, coded and analyzed via ATLAS.ti with the conventional content analysis., Results: Data saturation was reached after seven interviews, followed by three confirmative interviews. In total, 10 patients (22-76 years) participated in the study. Three relevant themes were identified in the interviews: the deleterious effects of pain on overall health, the importance of the design of the multidisciplinary consultation, and the performance of healthcare professionals (knowledge, skills and interaction with patients and colleagues). Participants suggested that although the consultation did not improve their pain experience, there was value in having a comprehensive assessment of their disease. Patients preferred the consultation to occur at the beginning of the care. Additionally, they acknowledged the performance of healthcare providers and having their complaints recognized. However, some participants suggested the need for additional attention to mental health issues during the multidisciplinary consultation., Discussion: Even though patients did not perceive the multidisciplinary consultation to improve their pain experience, they appreciated the sense of recognition by this team., Conclusion: A multidisciplinary consultation is of value from the patients' perspective. A suggestion for improvement emerged where the multidisciplinary consultation should occur at the beginning of the patient journey., Competing Interests: Competing interests: None declared., (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
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- 2024
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19. Patient Impression of Improvement 1 year After Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Pelvic Organ Prolapse Stage 2 or Higher.
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Stoter LM, Notten KJB, Claas M, Tijsseling D, Ruefli M, van den Tillaart F, van Kuijk SMJ, Milani AL, and Kluivers KB
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- Humans, Female, Middle Aged, Aged, Treatment Outcome, Prospective Studies, Gynecologic Surgical Procedures methods, Severity of Illness Index, Hysterectomy, Vaginal methods, Pelvic Organ Prolapse surgery, Patient Reported Outcome Measures
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Introduction and Hypothesis: Patient-reported outcomes are relevant outcomes in studies on pelvic organ prolapse (POP) surgery, as anatomical recurrence alone does not have a significant correlation with perceived improvement. In the present study, the patient's impression of improvement after 1 year is studied after vaginal hysterectomy (VH) versus sacrospinous hysteropexy (SSH) in large cohorts from daily clinical practice. We hypothesize that there is no difference between the groups., Methods: This is a secondary analysis on prospectively collected data in a multicenter cohort of patients who underwent VH or SSH for symptomatic POP. All patients had a POP-Q stage ≥ 2 in at least one compartment at baseline and were treated with VH or SSH between 2002 and 2019. The primary outcome was the patient-reported score on the patient global impression of improvement index (PGI-I) 1 year after surgery. The secondary outcome was a composite outcome of surgical success, defined as the absence of recurrent POP beyond the hymen with bothersome bulge symptoms and/or repeat surgery., Results: A total of 378 women (196 VH and 182 SSH) were included. The median score on the PGI-I did not differ between VH and SSH. At 1 year post-operatively, 77 women after VH (73%) and 77 women after SSH (75%) considered their condition (very) much improved (p = 0.86). There was no difference in composite outcome of surgical success (126 out of 137 women [92%] after VH, 118 out of 125 women [94%] after SSH; p = 0.44)., Conclusions: Our study shows that there was no difference in the type of surgery, VH or SSH, with regard to the patient's impression of improvement 1 year postoperatively in a large cohort from daily clinical practice., (© 2024. The Author(s).)
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- 2024
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20. Long-term effects of surgically corrected menstrual outflow obstruction: A case-control study.
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Martens L, Spath MA, van Beek MA, Willemsen WNP, and Kluivers KB
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- Humans, Female, Adolescent, Case-Control Studies, Surveys and Questionnaires, Abdominal Pain, Health Status, Quality of Life, Endometriosis
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Objective: To enhance evidence-based knowledge on long-term sequalae in patients with surgically corrected obstructing Müllerian anomalies., Methods: This long-term case-control study included patients with menstrual outflow obstruction due to congenital anomalies of the uterus or vagina, who were at least 18 years old, and for whom 2 years had elapsed since the first surgery at the start of this study. The control group consisted of women without current gynecological problems. Patients underwent a surgical correction at the Radboud University Medical Center Nijmegen between 1980 and 2013. Of 78 patients approached, 38 (49%) were included in this study. The control group consisted of 54 females. The main outcome measures were pain and health state. The following questionnaires were used: Visual Analogue Scale pain scores, European Quality of Life-5 Dimensions questionnaire (EQ-5D-3L) and the adapted Endometriosis Health Profile questionnaire (EHP-30)., Results: Patients had higher actual and maximum abdominal pain scores compared with controls (11 vs 0 [P = 0.007] and 48 vs 21 [P = 0.035], respectively). Based on the EQ-5D-3L scores, patients had more pain and discomfort (P = 0.005), more mood problems (P = 0.023), and a poorer subjective health state (P = 0.002) and self-rated health state (P = 0.031). Based on the EHP-30, patients had a significant poorer self-rated health state on four out of five subscales., Conclusion: In this study, following surgically corrected menstrual obstruction, patients had statistically significant higher abdominal pain scores and a poorer self-rated health state compared with controls., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)
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- 2024
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21. Laparoscopic Davydov vs. laparoscopic Vecchietti neovaginoplasty in women with Mayer-Rokitansky-Küster-Hauser syndrome; a systematic review and meta-analysis.
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Martens L, Tannenbaum L, Van Kuijk SMJ, Notten KJB, and Kluivers KB
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- Adult, Female, Humans, Gynecologic Surgical Procedures methods, Gynecologic Surgical Procedures adverse effects, Surgically-Created Structures adverse effects, Treatment Outcome, 46, XX Disorders of Sex Development surgery, Congenital Abnormalities surgery, Laparoscopy methods, Laparoscopy adverse effects, Mullerian Ducts abnormalities, Mullerian Ducts surgery, Plastic Surgery Procedures methods, Plastic Surgery Procedures adverse effects, Vagina surgery, Vagina abnormalities
- Abstract
Objective: To summarize the available evidence on the laparoscopic Davydov and Vecchietti methods to create a neovagina and to compare these techniques with a focus on neovaginal length, sexual function, operative time, and complications., Design: A systematic electronic search up to August 2022 using PubMed and Embase is performed., Setting: Not applicable., Patients: Women with Mayer-Rokistansky-Küster-Hauser syndrome., Interventions: All published clinical studies concerning the laparoscopic Davydov and laparoscopic Vecchietti procedures as a surgical technique to create a neovagina in women with Mayer-Rokistansky-Küster-Hauser syndrome were obtained. The guidelines for the preferred reporting items for systematic reviews and meta-analysis were followed. The following data were extracted: operative time, hospital stay, major early complications (within 3 months postsurgery), dilation therapy, neovaginal length, vaginal discharge, vaginal stenosis, time to sexual activity, sexual satisfaction, penetrative sexual activity, dyspareunia, score on the Female Sexual Function Index (FSFI), and duration of follow-up. The Newcastle Ottawa Scale was used to assess the quality of articles., Main Outcome Measures: Neovaginal length, FSFI scores, operative time, and complications., Results: A total of 1,163 articles were identified, of which 33 studies were included in this systematic review. Of these, 12 studies (380 patients) are related to the Davydov method, 19 studies (1,126 patients) to the Vecchietti method, and 2 articles concern both. There is clinical heterogeneity and variety in the quality of the studies. Eighteen studies were included in the meta-analyses. The mean neovaginal length 12 months after the Davydov method is 8.3 cm (95% confidence interval [CI] 8.1-8.6), vs. 8.7 cm (95% CI 7.2-10.3) after the Vecchietti method. The mean FSFI score after the Davydov method is 28.9 (95% CI 26.8-31.1), compared with 27.5 (95% CI 25.0-30.1) after the Vecchietti method. The operative time of the Davydov method is 126 minutes (95% CI 109-143), compared with 40 minutes (95% CI 35-45) of the Vecchietti method., Conclusions: The operations yield comparable neovaginal length, sexual function, and complication rates. The mean FSFI scores indicate no sexual dysfunction in either group. The operative time of the Davydov method is significantly longer. There is no superiority shown for one of the surgical techniques in functional terms., Competing Interests: Declaration of Interests L.M. has nothing to disclose. L.T. has nothing to disclose. S.M.J.V.K. has nothing to disclose. K.J.B.N. has nothing to disclose. K.B.K. has nothing to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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22. Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).
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van Oudheusden AMJ, van IJsselmuiden MN, Menge LF, Coolen AWM, Veen J, van Eijndhoven HWF, Dietz V, Kluivers KB, Spaans WA, Vollebregt A, van de Pol G, Radder CM, van der Ploeg JM, van Kuijk SMJ, and Bongers MY
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- Female, Humans, Gynecologic Surgical Procedures adverse effects, Vagina surgery, Hysterectomy adverse effects, Treatment Outcome, Surgical Mesh adverse effects, Pelvic Organ Prolapse surgery, Pelvic Organ Prolapse etiology, Laparoscopy adverse effects
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Objective: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP)., Design: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside., Setting: Seven non-university teaching hospitals and two university hospitals in the Netherlands., Population: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment., Methods: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively., Main Outcome Measures: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function., Results: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129)., Conclusions: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
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- 2023
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23. Location and motion of vaginal pessaries in situ in women with successful and unsuccessful pessary treatment for pelvic organ prolapse.
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Boogaard LL, Triepels CPR, Verhamme LM, van Kuijk SMJ, Donners JJAE, Kluivers KB, Maal TJJ, Weemhoff M, and Notten KJB
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- Female, Humans, Pessaries, Cross-Sectional Studies, Vagina diagnostic imaging, Pelvic Organ Prolapse diagnostic imaging, Pelvic Organ Prolapse therapy, Urinary Bladder Diseases
- Abstract
Introduction and Hypothesis: The objective was to compare the location and motion of pessaries between women with pelvic organ prolapse (POP) with a successful (fitting) and unsuccessful (non-fitting) pessary treatment on dynamic magnetic resonance imaging (dMRI)., Methods: A cross-sectional exploratory study of 15 women who underwent a mid-sagittal dMRI of the pelvic floor at rest, during contraction and during Valsalva with three different types of pessaries. The coordinates of the pessaries cross section, inferior pubic point (IPP) and sacrococcygeal junction (SCJ) were obtained and the location (position, orientation) and the motion (translation and rotation) were calculated. Differences between the groups and between the pessaries within the groups were compared., Results: Nine women with a fitting pessary and 6 women with a non-fitting pessary were selected. In the non-fitting group, the pessaries were positioned more caudally and rotated more in clockwise direction and descended more, but not significantly, during Valsalva compared with the fitting group. The Falk pessary was positioned more anteriorly in the fitting group and more cranially in the non-fitting group compared with the ring and ring with support pessary., Conclusions: A non-fitting pessary was positioned more caudally at rest; on Valsalva, it rotated more clockwise and moved more caudally, suggesting that the dynamic characteristics of the pessary might play an important role in its effectiveness. Findings of this study serve as a basis for the development of new pessary designs., (© 2023. The Author(s).)
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- 2023
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24. Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial.
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Enklaar RA, Schulten SFM, van Eijndhoven HWF, Weemhoff M, van Leijsen SAL, van der Weide MC, van Bavel J, Verkleij-Hagoort AC, Adang EMM, and Kluivers KB
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- Female, Humans, Middle Aged, Gynecologic Surgical Procedures methods, Treatment Outcome, Uterus surgery, Aged, Pelvic Organ Prolapse surgery, Uterine Prolapse surgery
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Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure., Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent., Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen., Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217)., Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications., Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups., Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure., Trial Registration: TrialRegister.nl Identifier: NTR 6978.
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- 2023
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25. Identifying Womens' Needs in Making a Treatment Decision for Stress Urinary Incontinence: A Qualitative Study.
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Gerritse MBE, de Swart E, de Vries M, and Kluivers KB
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Background: Choosing a treatment option for female stress urinary incontinence (SUI) is a preference-sensitive decision. Nowadays, shared decision making (SDM) is the preferred way of decision making. SDM considers the needs patients have regarding the decision-making process. The aim of this study was to identify decisional needs of women who are making a treatment decision for SUI., Materials and Methods: Semistructured interviews were planned with women who had been seeking treatment for SUI. Patients were recruited in two teaching hospitals in the Netherlands. Interviewers used a topic list based on the Ottawa decision support framework. The interviews were transcribed and coded. Themes and subthemes of factors relating to the treatment decision-making process were identified and described., Results: We interviewed a total of 16 women. Four major themes of SUI patients' needs were identified: information on disorder and treatment, SDM, personalized health care, and consideration for social context. Within these themes, specific needs varied between individuals. In addition to the provision of objective information, other important identified needs were subjective, such as acknowledgment of symptoms and feeling understood by a physician. It was important for patients that they had a sufficient amount of time to make their decision., Conclusions: To ensure a good quality treatment decision in female SUI, several topics need to be addressed in an SDM process. The themes of decisional needs identified in this study can help improve the decision-making process., Competing Interests: No competing financial interests exist., (© Maria B.E. Gerritse et al., 2023; Published by Mary Ann Liebert, Inc.)
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- 2023
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26. Subjective outcomes 12 years after transvaginal mesh versus native tissue repair in women with recurrent pelvic organ prolapse; a randomized controlled trial.
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Kluivers KB, Kamping M, Milani AL, IntHout J, and Withagen MI
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- Female, Humans, Follow-Up Studies, Surgical Mesh, Gynecologic Surgical Procedures, Treatment Outcome, Pelvic Organ Prolapse surgery, Urinary Incontinence, Stress surgery
- Abstract
Introduction and Hypothesis: The present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study., Methods: One hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome., Results: At 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03)., Conclusions: There was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse., (© 2023. The Author(s).)
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- 2023
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27. Physicians' perspectives on using a patient decision aid in female stress urinary incontinence.
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Gerritse MBE, Smeets CFA, Heesakkers JPFA, Lagro-Janssen ALM, van der Vaart CH, de Vries M, and Kluivers KB
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- Humans, Female, Decision Support Techniques, Decision Making, Patient Participation, Urinary Incontinence, Stress therapy, General Practitioners
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Introduction and Hypothesis: A treatment choice for female stress urinary incontinence (SUI) is preference sensitive for both patients and physicians. Multiple treatment options are available, with none being superior to any other. The decision-making process can be supported by a patient decision aid (PDA). We aimed to assess physicians' perceptions concerning the use of a PDA., Methods: In a mixed methods study, urologists, gynecologists and general practitioners in the Netherlands were asked to fill out a web-based questionnaire. Questions were based on the Tailored Implementation for Chronic Diseases checklist using the following domains: guideline factors, individual health professional factors, professional interactions, incentives and resources, and capacity for organizational change. Participants were asked to grade statements using a five-point Likert scale and to answer open questions on facilitators of and barriers to implementation of a PDA. Outcomes of statement rating were quantitatively analyzed and thematic analysis was performed on the outcomes regarding facilitators and barriers., Results: The response rate was 11%, with a total of 120 participants completing the questionnaire. Ninety-two of the physicians (77%) would use a PDA in female SUI. Evidence-based and unbiased content, the ability to support shared decision making, and patient empowerment are identified as main facilitators. Barriers are the expected prolonged time investment and the possible difficulty using the PDA in less health-literate patient populations., Conclusions: The majority of physicians would use a PDA for female SUI. We identified facilitators and barriers that can be used when developing and implementing such a PDA., (© 2022. The Author(s).)
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- 2023
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28. Molecular Landscape of Pelvic Organ Prolapse Provides Insights into Disease Etiology.
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Kluivers KB, Lince SL, Ruiz-Zapata AM, Post WM, Cartwright R, Kerkhof MH, Widomska J, De Witte W, Pecanka J, Kiemeney LA, Vermeulen SH, Goeman JJ, Allen-Brady K, Oosterwijk E, and Poelmans G
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- Female, Humans, Vagina metabolism, Causality, Pelvic Organ Prolapse genetics, Pelvic Organ Prolapse metabolism
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Pelvic organ prolapse (POP) represents a major health care burden in women, but its underlying pathophysiological mechanisms have not been elucidated. We first used a case-control design to perform an exome chip study in 526 women with POP and 960 control women to identify single nucleotide variants (SNVs) associated with the disease. We then integrated the functional interactions between the POP candidate proteins derived from the exome chip study and other POP candidate molecules into a molecular landscape. We found significant associations between POP and SNVs in 54 genes. The proteins encoded by 26 of these genes fit into the molecular landscape, together with 43 other POP candidate molecules. The POP landscape is located in and around epithelial cells and fibroblasts of the urogenital tract and harbors four interacting biological processes-epithelial-mesenchymal transition, immune response, modulation of the extracellular matrix, and fibroblast function-that are regulated by sex hormones and TGFB1. Our findings were corroborated by enrichment analyses of differential gene expression data from an independent POP cohort. Lastly, based on the landscape and using vaginal fibroblasts from women with POP, we predicted and showed that metformin alters gene expression in these fibroblasts in a beneficial direction. In conclusion, our integrated molecular landscape of POP provides insights into the biological processes underlying the disease and clues towards novel treatments.
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- 2023
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29. Patient's preference for sacrospinous hysteropexy or modified Manchester operation: A discrete choice experiment.
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Schulten SFM, Essers B, Notten KJB, Enklaar RA, van Leijsen SAL, van Eijndhoven HWF, Kluivers KB, and Weemhoff M
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- Female, Humans, Patient Preference, Uterus surgery, Surveys and Questionnaires, Treatment Outcome, Choice Behavior, Uterine Prolapse surgery, Dyspareunia etiology
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Objective: To investigate women's preference for modified Manchester (MM) or sacrospinous hysteropexy (SH) as surgery for uterine prolapse., Design: Labelled discrete choice experiment (DCE)., Setting: Eight Dutch hospitals., Population: Women with uterine prolapse, eligible for primary surgery and preference for uterus preservation., Methods: DCEs are attribute-based surveys. The two treatment options were labelled as MM and SH. Attributes in this survey were treatment success ( levels SH: 84%, 89%, 94%; levels MM: 89%, 93%, 96%), dyspareunia (levels: 0%, 5%, 10%), cervical stenosis (levels: 1%, 6%, 11%) and severe buttock pain (levels: 0%, 1%). A different combination of attribute levels was used in each choice set. Women completed nine choice sets, making a choice based on attribute levels. Data were analysed in multinomial logit models., Main Outcome Measures: Women's preference for MM or SH., Results: 137 DCEs were completed (1233 choice sets). SH was chosen in 49% of the choice sets, MM in 51%. Of all women, 39 (28%) always chose the same surgery. After exclusion of this group, 882 choice sets were analysed, in which women preferred MM, likely associated with a labelling effect, i.e. description of the procedure, rather than the tested attributes. In that group, MM was chosen in 53% of the choice sets and SH in 47%. When choosing MM, next to the label, dyspareunia was relevant for decision-making. For SH, all attributes were relevant for decision-making., Conclusions: The preference of women for MM or SH seems almost equally divided. The variety in preference supports the importance of individualised healthcare., (© 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
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- 2023
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30. The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.
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Spruijt MA, Klerkx WM, Kelder JC, Kluivers KB, and Kerkhof MH
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- Female, Humans, Pelvic Floor, Pelvic Pain drug therapy, Quality of Life, Botulinum Toxins, Type A therapeutic use, Chronic Pain drug therapy, Dyspareunia, Neuromuscular Agents therapeutic use
- Abstract
Introduction and Hypothesis: Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6 to 27% of women aged 18-50 years worldwide. This study was conducted to review and meta-analyse the current literature on the reduction of chronic pelvic pain after botulinum toxin A (BTA) injection., Method: In July 2021 we performed a systematic search in PubMed and EMBASE to assess the benefits of BTA injection in pelvic floor muscles in women with chronic pelvic pain. Primary outcome was reduction in visual analogue scale (VAS) after treatment. Secondary outcomes evaluated were: reduction of dyspareunia, pelvic floor resting pressure and quality of life. Identified reports were assessed on quality of reporting and risk of bias. Standardized mean difference (SMD) was used to combine and analyse outcomes of the included studies., Results: Eight studies with 289 participants were considered eligible to be included in this systematic review and meta-analysis. After recalculating SMD into VAS scores (0-100), long-term follow-up (24-26 weeks) showed a significant 15-point improvement in VAS scores (95% CI: 8.8-21.5) for non-menstrual pelvic pain and a 13-point improvement (95% CI: 2.1-24.0) for dyspareunia. BTA injection had a significant effect on pelvic floor resting pressure and quality of life., Conclusion: There is limited scientific evidence on the effectiveness of BTA injections in pelvic floor muscles in women with chronic pelvic pain. The available studies show that BTA injections significantly reduce pain levels and improve quality of life at 6 months follow-up., Prospero Id: CRD42018105204., (© 2022. The Author(s).)
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- 2022
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31. Risk factors for primary pelvic organ prolapse and prolapse recurrence: an updated systematic review and meta-analysis.
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Schulten SFM, Claas-Quax MJ, Weemhoff M, van Eijndhoven HW, van Leijsen SA, Vergeldt TF, IntHout J, and Kluivers KB
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- Birth Weight, Cross-Sectional Studies, Delivery, Obstetric adverse effects, Female, Humans, Pregnancy, Risk Factors, Pelvic Organ Prolapse epidemiology, Pelvic Organ Prolapse etiology, Pelvic Organ Prolapse surgery
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Objective: To update a previously published systematic review and perform a meta-analysis on the risk factors for primary pelvic organ prolapse and prolapse recurrence., Data Sources: PubMed and Embase were systematically searched. We searched from July 1, 2014 until July 5, 2021. The previous search was from inception until August 4, 2014., Study Eligibility Criteria: Randomized controlled trials and cross-sectional and cohort studies conducted in the Western developed countries that reported on multivariable analysis of risk factors for primary prolapse or prolapse recurrence were included. The definition of prolapse was based on anatomic references, and prolapse recurrence was defined as anatomic recurrence after native tissue repair. Studies on prolapse recurrence with a median follow-up of ≥1 year after surgery were included., Methods: Quality assessment was performed with the Newcastle-Ottawa Scale. Data from the previous review and this review were combined into forest plots, and meta-analyses were performed where possible. If the data could not be pooled, "confirmed risk factors" were identified if ≥2 studies reported a significant association in multivariable analysis., Results: After screening, 14 additional studies were selected-8 on the risk factors for primary prolapse and 6 on prolapse recurrence. Combined with the results from the previous review, 27 studies met the inclusion criteria, representing the data of 47,429 women. Not all studies could be pooled because of heterogeneity. Meta-analyses showed that birthweight (n=3, odds ratio, 1.04; 95% confidence interval, 1.02-1.06), age (n=3, odds ratio, 1.34; 95% confidence interval, 1.23-1.47), body mass index (n=2, odds ratio, 1.75; 95% confidence interval, 1.17-2.62), and levator defect (n=2, odds ratio, 3.99; 95% confidence interval, 2.57-6.18) are statistically significant risk factors, and cesarean delivery (n=2, pooled odds ratio, 0.08; 95% confidence interval, 0.03-0.20) and smoking (n=3, odds ratio, 0.59; 95% confidence interval, 0.46-0.75) are protective factors for primary prolapse. Parity, vaginal delivery, and levator hiatal area are identified as "confirmed risk factors." For prolapse recurrence, preoperative prolapse stage (n=5, odds ratio, 2.68; 95% confidence interval, 1.93-3.73) and age (n=2, odds ratio, 3.48; 95% confidence interval, 1.99-6.08) are statistically significant risk factors., Conclusion: Vaginal delivery, parity, birthweight, age, body mass index, levator defect, and levator hiatal area are risk factors, and cesarean delivery and smoking are protective factors for primary prolapse. Preoperative prolapse stage and younger age are risk factors for prolapse recurrence after native tissue surgery., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2022
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32. Risk factors for pelvic organ prolapse recurrence after sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension.
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Schulten SF, Detollenaere RJ, IntHout J, Kluivers KB, and Van Eijndhoven HW
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- Female, Gynecologic Surgical Procedures, Humans, Ligaments surgery, Recurrence, Risk Factors, Treatment Outcome, Hysterectomy, Vaginal adverse effects, Pelvic Organ Prolapse etiology, Pelvic Organ Prolapse surgery
- Abstract
Background: Given that the number of surgeries for pelvic organ prolapse is expected to increase worldwide, knowledge on risk factors for prolapse recurrence is of importance for developing preventive strategies and shared decision-making., Objective: To identify risk factors for subjective and objective failure after either sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension over a period of 5 years after surgery., Study Design: This was a secondary analysis of the 5-year follow-up of the SAVE-U trial. The SAVE-U trial was conducted in 4 Dutch hospitals. A total of 208 women with uterine prolapse stage ≥2 were randomized to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. For the current analysis, available annual 5-year follow-up data of 207 women were analyzed. Without missing values this analysis would have included 1035 measurements in total over the 5-year follow-up. Recurrences were analyzed as "events" using generalized linear mixed models because recurrences of anatomic failure and bothersome vaginal bulge symptoms fluctuated over time. The primary outcome was the composite outcome of failure defined as prolapse beyond the hymen, bothersome bulge symptoms, repeated surgery, or pessary use for recurrent prolapse. Secondary outcome measures were bothersome vaginal bulge symptoms, overall anatomic failure (Pelvic Organ Prolapse Quantification stage ≥2 in any compartment), apical compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2), anterior compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2), and posterior compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2)., Results: For the composite outcome of failure (164 events in 66 different women), statistically significant risk factors were: body mass index (odds ratio, 1.10 [per 1 kg/m
2 ]; 95% confidence interval, 1.02-1.19; P=.02), smoking (odds ratio, 2.88; 95% confidence interval, 1.12-7.40; P=.03), and preoperative Pelvic Organ Prolapse Quantification point Ba (odds ratio, 1.23 [per 1 cm]; 95% confidence interval, 1.01-1.50; P=.04). When analyzing each surgical outcome measure separately, body mass index and Pelvic Organ Prolapse Quantification point Ba were risk factors for overall anatomic failure (462 events in 147 women; odds ratio, 1.15; 95% confidence interval, 1.07-1.25; P<.01 and odds ratio, 1.14; 95% confidence interval, 1.00-1.30; P=.05, respectively) and anterior compartment recurrence (385 events in 128 women; odds ratio, 1.11; 95% confidence interval, 1.02-1.22; P=.02 and odds ratio, 1.17; 95% confidence interval, 1.02-1.34; P=.02, respectively). Vaginal hysterectomy was a risk factor for posterior compartment recurrence when compared with sacrospinous hysteropexy (93 events in 40 women; odds ratio, 5.21; 95% confidence interval, 2.05-13.27; P<.01). Smoking was a risk factor for bothersome vaginal bulge symptoms (70 events in 41 women; odds ratio, 3.80; 95% confidence interval, 1.48-9.75; P=.01), and preoperative Pelvic Organ Prolapse Quantification stage 3 or 4 was significantly protective against bothersome bulge symptoms (odds ratio, 0.32; 95% confidence interval, 0.11-0.89; P=.03)., Conclusion: Body mass index, smoking, and Pelvic Organ Prolapse Quantification point Ba were statistically significant risk factors for the composite outcome of failure (prolapse beyond the hymen, bothersome bulge symptoms, repeated surgery, or pessary use for recurrent prolapse) in the period of 5 years after surgery., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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33. Molecular Processes in Stress Urinary Incontinence: A Systematic Review of Human and Animal Studies.
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Post WM, Widomska J, Grens H, Coenen MJH, Martens FMJ, Janssen DAW, IntHout J, Poelmans G, Oosterwijk E, and Kluivers KB
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- Animals, Humans, Mice, Rats, Urinary Incontinence, Stress genetics
- Abstract
Stress urinary incontinence (SUI) is a common and burdensome condition. Because of the large knowledge gap around the molecular processes involved in its pathophysiology, the aim of this review was to provide a systematic overview of genetic variants, gene and protein expression changes related to SUI in human and animal studies. On 5 January 2021, a systematic search was performed in Pubmed, Embase, Web of Science, and the Cochrane library. The screening process and quality assessment were performed in duplicate, using predefined inclusion criteria and different quality assessment tools for human and animal studies respectively. The extracted data were grouped in themes per outcome measure, according to their functions in cellular processes, and synthesized in a narrative review. Finally, 107 studies were included, of which 35 used animal models (rats and mice). Resulting from the most examined processes, the evidence suggests that SUI is associated with altered extracellular matrix metabolism, estrogen receptors, oxidative stress, apoptosis, inflammation, neurodegenerative processes, and muscle cell differentiation and contractility. Due to heterogeneity in the studies (e.g., in examined tissues), the precise contribution of the associated genes and proteins in relation to SUI pathophysiology remained unclear. Future research should focus on possible contributors to these alterations.
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- 2022
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34. Gynecologists' perspectives on two types of uterus-preserving surgical repair of uterine descent; sacrospinous hysteropexy versus modified Manchester.
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Enklaar RA, Essers BAB, Ter Horst L, Kluivers KB, and Weemhoff M
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- Female, Humans, Treatment Outcome, Uterus surgery, Vagina, Gynecologic Surgical Procedures, Uterine Prolapse
- Abstract
Introduction and Hypothesis: The modified Manchester (MM) and sacrospinous hysteropexy (SSH) are the most common uterus-preserving surgical procedures for uterine descent. Little is known about gynecologists' preferences regarding the two interventions. The study's aim was to identify which factors influence Dutch (uro)gynecologists when choosing one of these techniques., Methods: This qualitative study consists of ten semi-structured interviews with Dutch (uro)gynecologists using predetermined, open explorative questions, based on a structured topic list. An inductive content analysis was performed using Atlas.ti., Results: For SSH, the majority (6/10 gynecologists) reported the more dorsal change of direction of the vaginal axis as a disadvantage and expected more cystocele recurrences (7/10). The most reported disadvantage of MM was the risk of cervical stenosis (7/10). Four gynecologists found MM not to be appropriate for patients with higher stage uterine prolapse. The quality of the uterosacral ligaments was related to the chance of recurrence according to five gynecologists. Patient counseling was biased toward one of the uterus-preserving operations (7/10). Four gynecologists stated they make the final decision while two let patient-preference lead the final decision., Conclusions: Preference for one of the uterus-preserving interventions is mainly based on the gynecologist's own experience and background. The lack of information regarding these two uterus-preserving procedures hampers evidence-based decision making, which explains the practice pattern variation. In conclusion, further research is needed to improve evidence-based counseling and shared decision making regarding the choice of procedure.
- Published
- 2021
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35. Pain after midurethral sling; the underestimated role of mesh removal.
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Mengerink BB, Aourag N, Kluivers KB, Notten KJB, Heesakkers JPFA, and Martens FMJ
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Introduction: The primary aim of this study was to evaluate the results of midurethral sling (MUS) removal in women who have pain as their single complication of MUS., Material and Methods: We performed a retrospective chart study supplemented with a cross sectional questionnaire. Women who underwent MUS removal for pain as the solitary reason for removal between 2004 and 2018 were included. Primary outcome was change in pain levels assessed by the visual analogue scale (VAS) pain score (range 0-10). Secondary outcome was the recurrence of stress urinary incontinence (SUI)., Results: Twenty-six of 31 patients returned the questionnaire. Median medical file follow-up was 12 months (range 2-66) and 25 months (range 5-104) regarding questionnaires. VAS pain score dropped from 7.8 (SD 1.9) at baseline to 4.5 (SD 3.2) at follow-up (p <.00). Seven (23%) patients were pain-free. Patients undergoing partial vaginal resection (n = 6) had a VAS pain score decrease of 4.7 (p = .02) versus 2.7 (p = .02) for complete vaginal removal (n = 14). Twenty-three (89%) patients experienced SUI at follow-up, whereof 10 (45%) reported (almost) no incidents of SUI., Conclusions: MUS removal is a viable and safe option with a significant drop in VAS pain score in patients with chronic pain after MUS placement. A post-operative increase of SUI and a possible renewed wish for SUI treatment have to be considered. This should not be a reason to refrain from information and/or referral for surgical removal., Competing Interests: The authors declare no conflicts of interest., (Copyright by Polish Urological Association.)
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- 2021
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36. Genetic variants and expression changes in urgency urinary incontinence: A systematic review.
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Post WM, Ruiz-Zapata AM, Grens H, de Vries RBM, Poelmans G, Coenen MJH, Janssen DAW, Heesakkers JPFA, Oosterwijk E, and Kluivers KB
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- Dysuria genetics, Dysuria urine, Genome-Wide Association Study, Humans, Nerve Growth Factor urine, Urinary Incontinence, Urge urine, Genetic Variation, Urinary Incontinence, Urge genetics
- Abstract
Aim: To perform a systematic review summarizing the knowledge of genetic variants, gene, and protein expression changes in humans and animals associated with urgency urinary incontinence (UUI) and to provide an overview of the known molecular mechanisms related to UUI., Methods: A systematic search was performed on March 2, 2020, in PubMed, Embase, Web of Science, and the Cochrane library. Retrieved studies were screened for eligibility. The risk of bias was assessed using the ROBINS-I (human) and SYRCLE (animal) tool. Data were presented in a structured manner and in the case of greater than five studies on a homogeneous outcome, a meta-analysis was performed., Results: Altogether, a total of 10,785 records were screened of which 37 studies met the inclusion criteria. Notably, 24/37 studies scored medium-high to high on risk of bias, affecting the value of the included studies. The analysis of 70 unique genes and proteins and three genome-wide association studies showed that specific signal transduction pathways and inflammation are associated with UUI. A meta-analysis on the predictive value of urinary nerve growth factor (NGF) levels showed that increased urinary NGF levels correlate with UUI., Conclusion: The collective evidence showed the involvement of two molecular mechanisms (signal transduction and inflammation) and NGF in UUI, enhancing our understanding of the pathophysiology of UUI. Unfortunately, the risk of bias was medium-high to high for most studies and the value of many observations remains unclear. Future studies should focus on elucidating how deficits in the two identified molecular mechanisms contribute to UUI and should avoid bias., (© 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)
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- 2020
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37. Long-term safety, objective and subjective outcomes of laparoscopic sacrocolpopexy without peritoneal closure.
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van den Akker CM, Klerkx WM, Kluivers KB, van Eijndhoven HWF, Withagen MIJ, and Scholten PC
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- Female, Follow-Up Studies, Humans, Retrospective Studies, Surgical Mesh adverse effects, Treatment Outcome, Vagina surgery, Laparoscopy adverse effects, Pelvic Organ Prolapse surgery
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Introduction and Hypothesis: The laparoscopic sacrocolpopexy (LSC) is performed to support DeLancey's level I in patients with pelvic organ prolapse (POP). Although several studies have been conducted on the safety, objective and subjective outcomes of LSC, the specific effect of retroperitonealisation of mesh is unknown. This study is aimed at analysing the safety, objective and subjective outcomes of the LSC without peritoneal closure of mesh., Methods: The patients included have undergone an LSC for POP between 2004 and 2014. Retrospectively, a cohort of n = 178 was identified and asked to participate in a follow-up study. Chart research was performed. When informed consent was obtained, questionnaires were sent and the patients underwent a physical examination, including a POP-Q assessment. Each complication was scored by four reviewers for possibly being related to the non-peritonealisation of mesh., Results: The data on the outcome cohorts were complete for safety n = 178, objective n = 124, and subjective n = 61. The Patient Global Impression of Improvement (PGI-I) score is provided in 106 questionnaires. In this study, 77 complications were observed in 49 different patients. The total success rate (no reoperation, no descent beyond the hymen and no bulging symptoms) is 59.0% with a median follow-up (IQR) of 35 months (18-51). Seventy-six patients (71.7%) described their condition as being (much) improved after LSC., Conclusions: Three serious complications observed during the 178 LSCs were, by full consensus, thought to be possibly related to the non-peritonealisation of mesh. More than 70% of the patients found their condition to be (much) improved after the procedure.
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- 2020
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38. Extracellular Matrix Stiffness and Composition Regulate the Myofibroblast Differentiation of Vaginal Fibroblasts.
- Author
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Ruiz-Zapata AM, Heinz A, Kerkhof MH, van de Westerlo-van Rijt C, Schmelzer CEH, Stoop R, Kluivers KB, and Oosterwijk E
- Subjects
- Actins metabolism, Cells, Cultured, Collagen metabolism, Elastin metabolism, Extracellular Matrix metabolism, Female, Fibroblasts metabolism, Gene Expression physiology, Humans, Myofibroblasts metabolism, Pelvic Organ Prolapse metabolism, Pelvic Organ Prolapse pathology, Vagina metabolism, Cell Differentiation physiology, Extracellular Matrix physiology, Fibroblasts physiology, Myofibroblasts physiology, Vagina physiology
- Abstract
Fibroblast to myofibroblast differentiation is a key feature of wound-healing in soft tissues, including the vagina. Vaginal fibroblasts maintain the integrity of the vaginal wall tissues, essential to keep pelvic organs in place and avoid pelvic organ prolapse (POP). The micro-environment of vaginal tissues in POP patients is stiffer and has different extracellular matrix (ECM) composition than healthy vaginal tissues. In this study, we employed a series of matrices with known stiffnesses, as well as vaginal ECMs, in combination with vaginal fibroblasts from POP and healthy tissues to investigate how matrix stiffness and composition regulate myofibroblast differentiation in vaginal fibroblasts. Stiffness was positively correlated to production of α-smooth muscle actin (α-SMA). Vaginal ECMs induced myofibroblast differentiation as both α-SMA and collagen gene expressions were increased. This differentiation was more pronounced in cells seeded on POP-ECMs that were stiffer than those derived from healthy tissues and had higher collagen and elastin protein content. We showed that stiffness and ECM content regulate vaginal myofibroblast differentiation. We provide preliminary evidence that vaginal fibroblasts might recognize POP-ECMs as scar tissues that need to be remodeled. This is fundamentally important for tissue repair, and provides a rational basis for POP disease modelling and therapeutic innovations in vaginal reconstruction.
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- 2020
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39. [Urethral coitus due to congenital abnormality of the genitalia].
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Martens L and Kluivers KB
- Subjects
- Adolescent, Dilatation, Female, Humans, Urinary Incontinence, 46, XX Disorders of Sex Development diagnosis, Coitus, Congenital Abnormalities diagnosis, Dyspareunia diagnosis, Mullerian Ducts abnormalities, Urethra physiopathology, Vagina abnormalities
- Abstract
Background: Urethral coitus is rare and can arise in women who were born without a vagina, for instance in the context of Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome., Case Description: A 16-year-old girl presented at the general practitioner's surgery with primary amenorrhoea. After a long diagnostic process she was diagnosed with MRKH syndrome and treatment with a vaginal dilator was started. During follow-up the patient reported pain on coitus and that she sometimes lost a lot of fluid during intercourse. It appeared that the patient had dilated her urethra, not her vagina, and that she had had urethral coitus. The patient underwent Davydovvaginoplasty without complications., Conclusion: In patients with MRKH syndrome who experience urinary incontinence (particularly during and after coitus), recurrent urinary tract infections and dyspareunia urethral coitus should be suspected.
- Published
- 2020
40. Sexual functioning, sexual esteem, genital self-image and psychological and relational functioning in women with Mayer-Rokitansky-Küster-Hauser syndrome: a case-control study.
- Author
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Weijenborg PTM, Kluivers KB, Dessens AB, Kate-Booij MJ, and Both S
- Subjects
- 46, XX Disorders of Sex Development physiopathology, Adult, Anxiety, Case-Control Studies, Congenital Abnormalities physiopathology, Depression, Dyspareunia, Female, Humans, Middle Aged, Mullerian Ducts physiopathology, Netherlands, Surveys and Questionnaires, Vagina physiopathology, 46, XX Disorders of Sex Development psychology, Body Image psychology, Coitus, Congenital Abnormalities psychology, Interpersonal Relations, Mullerian Ducts abnormalities, Self Concept, Sexual Dysfunction, Physiological psychology, Sexuality psychology
- Abstract
Study Question: Do sexual functioning, sexual esteem, genital self-image and psychological and relational functioning in women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome differ from a comparison group of women without the condition?, Summary Answer: In comparison to controls, women with MRKH with a non-surgically or surgically created neovagina did not differ in psychological and relational functioning but reported lower sexual esteem and more negative genital self-image, intercourse-related pain, clinically relevant sexual distress and sexual dysfunction, with sexual esteem levels strongly associated with sexual distress and sexual dysfunction., What Is Known Already: Studies on sexual functioning measured with standardized questionnaires in women with MRKH syndrome compared with women without the condition have yielded contradictory results. Factors associated with sexual functioning in this patient population have rarely been investigated., Study Design, Size, Duration: Between November 2015 and May 2017, 54 women with MRKH syndrome with a neovagina and 79 age-matched healthy women without the condition were enrolled in this case-control study., Participants/materials, Setting, Methods: All participants had to be at least 18-years old and had to live in a steady heterosexual relationship. Women with MRKH syndrome were asked to participate by their (former) gynecologists at three university hospitals and by MRKH peer support group. Controls were recruited via advertisement in local newspapers and social media. Standardized questionnaires were administered to assess sexual functioning, sexual esteem, genital self-image and psychological and relational functioning., Main Results and the Role of Chance: Women with MRKH syndrome with a surgically or non-surgically created neovagina reported significantly more pain during intercourse (P < 0.05, d = 0.5), but did not differ in overall sexual functioning from control women. More women with MRKH syndrome reported clinically relevant sexuality-related distress (P < 0.05, odds ratio (OR): 2.756, 95% CI 1.219-6.232) and suffered a sexual dysfunction (P < 0.05, OR: 2.654, 95% CI: 1.088-6.471) in comparison with controls. MRKH women scored significantly lower on the sexual esteem scale (SES) (P < 0.01, d = 0.5) and the female genital self-image scale (FGSIS) (P < 0.01, d = 0.6) than controls. No significant differences were found between the two groups regarding psychological distress, anxiety and depression, global self-esteem and relational dissatisfaction. Sexual esteem was significantly associated with the presence of clinically relevant sexual distress (ß = 0.455, P = 0.001) and suffering a sexual dysfunction (ß = 0.554, P = 0.001) and explained, respectively, 40% and 28% of the variance., Limitations, Reasons for Caution: Given the nature of the study focusing on sexual functioning, a potential selection bias cannot be excluded. It is possible that those women with the most severe sexual and/or psychological disturbances did or did not choose to participate in our study., Wider Implications of the Findings: The study results add new data to the very limited knowledge about psychosexual functioning of women with MRKH syndrome and are of importance for more adequate counseling and treatment of these women., Study Funding/competing Interest(s): The research was financially supported by the Dutch Scientific Society of Sexology (Nederlandse wetenschappelijke Vereniging Voor Seksuologie). The funding was unrestricted, and there was no involvement in the conduct of the research. There are no conflicts of interest to declare., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2019
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41. Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).
- Author
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Schulten SFM, Enklaar RA, Kluivers KB, van Leijsen SAL, Jansen-van der Weide MC, Adang EMM, van Bavel J, van Dongen H, Gerritse MBE, van Gestel I, Malmberg GGA, Mouw RJC, van Rumpt-van de Geest DA, Spaans WA, van der Steen A, Stekelenburg J, Tiersma ESM, Verkleij-Hagoort AC, Vollebregt A, Wingen CBM, Weemhoff M, and van Eijndhoven HWF
- Subjects
- Adult, Female, Gynecologic Surgical Procedures methods, Humans, Middle Aged, Netherlands, Pelvic Organ Prolapse psychology, Quality of Life, Severity of Illness Index, Surgical Mesh, Surveys and Questionnaires, Treatment Outcome, Pelvic Organ Prolapse surgery, Round Ligament of Uterus surgery, Uterus surgery, Vagina surgery
- Abstract
Background: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed., Methods: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%., Discussion: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed., Trial Registration: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.
- Published
- 2019
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42. Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial.
- Author
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Steures P, Milani AL, van Rumpt-van de Geest DA, Kluivers KB, and Withagen MIJ
- Subjects
- Aged, Female, Follow-Up Studies, Gynecologic Surgical Procedures adverse effects, Gynecologic Surgical Procedures methods, Humans, Middle Aged, Postoperative Complications etiology, Reoperation, Sexual Behavior, Sutures, Treatment Outcome, Absorbable Implants adverse effects, Pelvic Organ Prolapse surgery, Surgical Mesh adverse effects, Vagina surgery
- Abstract
Introduction and Hypothesis: The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP)., Materials and Methods: Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events., Results: Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%)., Conclusion: At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.
- Published
- 2019
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- View/download PDF
43. Dutch translation and validation of the pelvic organ prolapse/incontinence sexual questionnaire-IUGA revised (PISQ-IR).
- Author
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van Dongen H, van der Vaart H, Kluivers KB, Elzevier H, Roovers JP, and Milani AL
- Subjects
- Adult, Aged, Female, Humans, Middle Aged, Netherlands epidemiology, Pelvic Floor Disorders diagnosis, Pelvic Floor Disorders epidemiology, Pelvic Organ Prolapse diagnosis, Pelvic Organ Prolapse epidemiology, Translating, Urinary Incontinence diagnosis, Urinary Incontinence epidemiology, Urinary Incontinence psychology, Pelvic Floor Disorders psychology, Pelvic Organ Prolapse psychology, Sexual Behavior, Surveys and Questionnaires
- Abstract
Introduction and Hypothesis: Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Dutch., Methods: The translated PISQ-IR was linguistically validated, followed by psychometrical validation among women presenting with symptoms of pelvic floor dysfunction in urogynecology clinics. For analysis of the criterion validity, the Pelvic Floor Dysfunction Inventory-20 (PFDI-20) and Female Sexual Function Index (FSFI) were used. Descriptive statistics, floor and ceiling effects, internal consistency using Cronbach's alpha coefficient and Pearson's and Spearman's correlations were calculated for all PISQ-IR subscales., Results: The PISQ-IR was completed by 220 women, of whom 61 (27.7%) considered themselves not sexually active (NSA) and 159 (72.3%) sexually active (SA). The mean age of participating women was 57 years; 49.5% reported symptoms of pelvic organ prolapse (POP), 66.8% urinary incontinence and 2.3% anal incontinence. The PISQ-IR subscales were analyzed separately for SA and NSA women with Cronbach's alpha coefficient ranging from 0.61 to 0.87. Moderate to high correlations were observed between PISQ-IR subscales and corresponding FSFI subscales and a moderate correlation between urinary distress and the condition impact (CI) subscale among NSA subjects., Conclusions: The Dutch PISQ-IR demonstrated a good internal consistency and criterion validity compared with the FSFI, but criterion validity compared with the PFDI-20 was poor except for urinary distress in NSA women and needs further attention.
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- 2019
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44. De-implementation of urodynamics in The Netherlands after the VALUE/VUSIS-2 results: a nationwide survey.
- Author
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Mengerink BB, Nelen WLDM, van Leijsen SAL, Heesakkers JPFA, and Kluivers KB
- Subjects
- Cross-Sectional Studies, Female, Humans, Netherlands, Surveys and Questionnaires, Treatment Outcome, Gynecology, Physicians, Suburethral Slings, Urinary Incontinence, Stress surgery, Urodynamics
- Abstract
Introduction and Hypothesis: We aimed to estimate the level of de-implementation of preoperative routine urodynamics (UDS) before stress urinary incontinence (SUI) surgery in The Netherlands and to analyze facilitators and barriers. Routine UDS was performed by 37% of the medical specialists in 2010. We hypothesized that the recommendations from the recent Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) and Value of Urodynamic Evaluation (ValUE) studies would have been followed by a reduction of routine UDS., Methods: A national survey was performed among all Dutch gynecologists and urologists dealing with SUI in daily practice. The questionnaire contained two parts: (1) respondents' characteristics and their actual care concerning preoperative UDS, and (2) facilitators and barriers., Results: The response rate was 41% (127/308). Of the respondents, 93% (n = 118) did not perform routine UDS in the preoperative workup for women in this group. Professional characteristics associated with not following the recommendations were profession urologist, academic hospital, and a lower number of midurethral sling (MUS) placed yearly. Facilitators to follow the recommendation not to perform routine UDS were adequate design of the VUSIS-II study and outcome and recommendations from the studies. Barriers not to follow the recommendation were believe in the additional value of UDS, especially the pressure transmission ratio, and the presence of detrusor overactivity., Conclusion: According to respondents to this questionnaire, VUSIS-II and ValUE study results are well implemented in The Netherlands. The vast majority of respondents replied as not performing routine preoperative UDS in women with primary, uncomplicated (predominant) SUI. Therefore, there is no need for a further de-implementation strategy.
- Published
- 2018
- Full Text
- View/download PDF
45. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial.
- Author
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Milani AL, Damoiseaux A, IntHout J, Kluivers KB, and Withagen MIJ
- Subjects
- Adult, Female, Follow-Up Studies, Gynecologic Surgical Procedures methods, Humans, Middle Aged, Postoperative Complications etiology, Plastic Surgery Procedures statistics & numerical data, Recurrence, Retrospective Studies, Time Factors, Treatment Outcome, Gynecologic Surgical Procedures statistics & numerical data, Pelvic Organ Prolapse surgery, Plastic Surgery Procedures methods, Surgical Mesh adverse effects, Surgical Mesh statistics & numerical data, Uterine Prolapse surgery, Vagina surgery
- Abstract
Introduction and Hypothesis: Our aim was to evaluate clinically relevant long-term outcomes of transvaginal mesh or native tissue repair in women with recurrent pelvic organ prolapse (POP)., Methods: We performed a 7-year follow-up of a randomized controlled trial on trocar-guided mesh placement or native tissue repair in women with recurrent POP. Primary outcome was composite success, defined as absence of POP beyond the hymen, absence of bulge symptoms, and absence of retreatment for POP. Secondary outcomes were adverse events, pain, and dyspareunia. Multiple imputation was used for missing data of composite success and pain; estimates are presented with 95% confidence intervals (CI)., Results: Between August 2006 and July 2008, 194 women were randomized; 190 underwent surgery. At 7 years, 142 (75%) were available for analysis, of whom, the primary outcome could be calculated in 127. Composite success was 53% (95% CI 41, 66) for mesh and 54% (95% CI 42, 65) for native tissue. Repeat surgery for POP was 25% for mesh and 16% for native tissue (difference 9%; 95% CI -5, 23) and occurred in untreated compartments in the mesh group and treated compartments in the native tissue group. Mesh exposure rate was 42%; pain with mesh 39% and native tissue 50% (difference - 11%, 95% CI -27, 6); dyspareunia with mesh 20% and native tissue 17% (difference 3%, 95% CI -9, 17)., Conclusions: Seven-year composite success rates appeared similar for mesh and native tissue. Mesh did not reduce long-term repeat surgery rates due to de novo POP in nonmesh-treated vaginal compartments. Mesh exposure rates were high, though significant differences in pain and dyspareunia were not detected., Clinical Trial Registration: ClinicalTrials.gov , NCT00372190.
- Published
- 2018
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46. The association between experiences with patient-centred care and health-related quality of life in women with endometriosis.
- Author
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Apers S, Dancet EAF, Aarts JWM, Kluivers KB, D'Hooghe TM, and Nelen WLDM
- Subjects
- Adult, Cross-Sectional Studies, Endometriosis psychology, Female, Humans, Quality of Life, Endometriosis therapy, Patient-Centered Care
- Abstract
In this cross-sectional study, we investigated whether patient-centred endometriosis care (PCEC) is associated with health-related quality of life (HRQOL). Dutch-speaking women with endometriosis, treated by laparoscopy in a university clinic between 2009 and 2010, were eligible (n = 194). Endometriosis Health Profile-30 and ENDOCARE questionnaire were used to assess HRQOL and PCEC, respectively. Overall and subscale scores were converted to a scale from 0 (best score) to 100 (worst score). Linear regression analyses were conducted while controlling for confounders. Participants (n = 109) had a mean age of 35.4 years; 79.6% had moderate-severe endometriosis. Mean scores for overall HRQOL and PCEC were 29.3/100 and 38.0/100, respectively. The PCEC-subscale 'continuity' was significantly associated with overall HRQOL (P = 0.029). A significant association was found between overall PCEC and the HRQOL-subscale 'social support' (P = 0.026). The PCEC-subscales 'information' and 'continuity' were significantly associated with the HRQOL-subscales 'emotional wellbeing' and 'social support' (P < 0.05). The PCEC-subscale 'respect' was significantly associated with the HRQOL-subscale 'emotional wellbeing' (P = 0.023). Multivariable regression analyses produced no significant associations, including all subscales of PCEC. Providing PCEC could lead to better HRQOL, especially if paying attention to 'continuity', 'respect' and 'information'. Large-scale longitudinal research is needed., (Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2018
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47. [Severe vaginal discharge following rectal surgery].
- Author
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Burg LC, Bremers AJA, Heesakkers JPFA, and Kluivers KB
- Subjects
- Aged, Female, Humans, Middle Aged, Vagina physiopathology, Digestive System Surgical Procedures adverse effects, Postoperative Complications etiology, Rectum surgery, Vaginal Discharge etiology
- Abstract
Background: Almost 50% of women who have had rectal surgery subsequently develop vaginal discharge. Due to the recurrent and unexpected nature of this heavy discharge, they often experience it as very distressing. Many of these women undergo extensive diagnostic tests that are mainly focused on identifying fistula formation. If no fistula is found, in most cases no other cause for severe vaginal discharge can be demonstrated., Case Description: In our practice, we saw three patients (49-, 54- and 74-years-old, respectively) with similar severe vaginal discharge after rectal surgery and in whom no explanation for the vaginal discharge could be found. For this reason we conducted a literature search into this condition., Conclusion: Anatomical changes appear to be responsible for heavy vaginal discharge following rectal surgery. Changes in pelvic floor muscles and compression of the distal part of the vagina may lead to pooling of fluid in the proximal part of the vagina, resulting in severe discharge. Symptomatic treatment may reduce the symptoms.
- Published
- 2018
48. Management of Gonads in Adults with Androgen Insensitivity: An International Survey.
- Author
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Tack LJW, Maris E, Looijenga LHJ, Hannema SE, Audi L, Köhler B, Holterhus PM, Riedl S, Wisniewski A, Flück CE, Davies JH, T'Sjoen G, Lucas-Herald AK, Evliyaoglu O, Krone N, Iotova V, Marginean O, Balsamo A, Verkauskas G, Weintrob N, Ellaithi M, Nordenström A, Verrijn Stuart A, Kluivers KB, Wolffenbuttel KP, Ahmed SF, and Cools M
- Subjects
- Adolescent, Adult, Androgen-Insensitivity Syndrome surgery, Female, Humans, Male, Neoplasms, Germ Cell and Embryonal pathology, Neoplasms, Germ Cell and Embryonal prevention & control, Orchiectomy, Ovarian Neoplasms pathology, Ovarian Neoplasms prevention & control, Ovariectomy, Ovary surgery, Testicular Neoplasms pathology, Testicular Neoplasms prevention & control, Testis surgery, Androgen-Insensitivity Syndrome pathology, Ovary pathology, Registries, Testis pathology
- Abstract
Background: Complete and partial androgen insensitivity syndrome (CAIS, PAIS) are associated with an increased risk of gonadal germ cell cancer (GGCC). Recent guidelines recommend gonadectomy in women with CAIS in late adolescence. Nevertheless, many adult women prefer to retain their gonads., Aims: This study aims to explore attitudes towards gonadectomy in AIS in centres around the world, estimate the proportion of adults with retained gonads and/or who developed GGCC, and explore reasons for declining gonadectomy., Methods: A survey was performed among health care professionals who use the International DSD Registry (I-DSD)., Results: Data were provided from 22 centres in 16 countries on 166 women (CAIS) and 26 men (PAIS). In CAIS, gonadectomy was recommended in early adulthood in 67% of centres; 19/166 (11.4%) women refused gonadectomy. Among 142 women who had gonadectomy, evidence of germ cell neoplasm in situ (GCNIS), the precursor of GGCC, was reported in 2 (1.4%) out of 8 from whom pathology results were formally provided. Nine out of 26 men with PAIS (34.6%) had retained gonads; 11% of centres recommended routine gonadectomy in PAIS., Conclusion: Although development of GGCC seems rare, gonadectomy after puberty is broadly recommended in CAIS; in PAIS this is more variable. Overall, our data reflect the need for evidence-based guidelines regarding prophylactic gonadectomy in AIS., (© 2018 S. Karger AG, Basel.)
- Published
- 2018
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49. Dutch women's attitudes towards hysterectomy and uterus preservation in surgical treatment of pelvic organ prolapse.
- Author
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van IJsselmuiden MN, Detollenaere RJ, Gerritse MBE, Kluivers KB, Bongers MY, and van Eijndhoven HWF
- Subjects
- Adult, Aged, Female, Humans, Middle Aged, Netherlands, Quality of Life, Surveys and Questionnaires, Attitude, Hysterectomy, Organ Sparing Treatments methods, Pelvic Organ Prolapse surgery, Uterus surgery
- Abstract
Objective: To investigate Dutch women's attitudes and preferences towards hysterectomy or uterus preservation in surgical treatment of pelvic organ prolapse., Study Design: Women's attitude was assessed by a structured questionnaire in one university hospital and one non-university teaching hospital in the Netherlands. Between December 2013 and November 2014, 102 women referred with prolapse complaints, without previous prolapse surgery, responded to the questionnaire received by mail prior to gynaecological consultation. Main outcome was the preference for uterus preserving surgery versus hysterectomy. Furthermore we studied the impact of uterus preservation and hysterectomy on body image and sexual function and the importance of treatment success, risk of urinary incontinence after surgery, complication risk, recovery time, length of hospital stay, costs and the risk of developing endometrial cancer., Results: Assuming that functional and anatomical outcomes after hysterectomy and uterus preserving surgery were equal, more women expressed preference for uterus preservation (43%, 44 out of 102 women) compared to hysterectomy (27%, 27 out of 102 women). The majority of women expected a similar improvement in sexuality and body image after the two treatment modalities. Treatment success, risk for urinary incontinence after surgery and complication risk were the most important factors. Taken the future risk of endometrial cancer into account, 18% of the women preferred hysterectomy because of this risk., Conclusions: This study demonstrated that women referred with prolapse complaints have a preference for uterus preservation in case outcomes after both interventions are expected to be equal. The majority of women expected that body image and sexual function would equally improve after both interventions., (Copyright © 2017 Elsevier B.V. All rights reserved.)
- Published
- 2018
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50. Choice of mode of delivery in a subsequent pregnancy after OASI: a survey among Dutch gynecologists.
- Author
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Donners JJAE, Kluivers KB, de Leeuw JW, van Dillen J, van Kuijk SMJ, and Weemhoff M
- Subjects
- Anal Canal injuries, Delivery, Obstetric adverse effects, Female, Humans, Male, Netherlands, Pregnancy, Surveys and Questionnaires, Delivery, Obstetric psychology, Gynecology statistics & numerical data, Obstetrics statistics & numerical data
- Abstract
Introduction and Hypothesis: National and international guidelines do not provide clear recommendations on the mode of delivery in a subsequent pregnancy after obstetric anal sphincter injury (OASI). The aim of this study was to investigate the opinion of gynecologists in The Netherlands on this choice and the extent to which this choice is affected by the gynecologist's characteristics., Methods: Of 973 gynecologists sent a questionnaire seeking their opinion on the mode of delivery in 16 different case descriptions, 234 (24%) responded. Factors influencing the opinion of the respondents on the mode of delivery, the presence of anal symptoms, the degree of OASI and the characteristics of the respondents were analyzed by univariate and multivariate logistic regression analysis., Results: Recommendations on the mode of delivery in a subsequent pregnancy after OASI showed considerable variation. The recommendations depended on (previous) symptoms and the degree of OASI. For gynecologists who based their recommendations on endoanal ultrasonography outcomes (7-20% depending on the case), the degree of OASI and severity of (previous) symptoms were less important. Gynecologists basing their recommendations on endoanal ultrasonography recommended a primary cesarean section less often. Gynecologist's characteristics (including years of experience, type of hospital and subspecialty) had a small effect on their recommendations on the mode of delivery., Conclusions: Due to lack of evidence, recommendations of gynecologists in The Netherlands on the mode of delivery in a subsequent pregnancy after OASI vary widely and depend on (previous) symptoms and the degree of OASI. Gynecologists who based their recommendations on endoanal ultrasonography outcomes recommended cesarean section less often.
- Published
- 2017
- Full Text
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