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The aim of this study was to assess the 3-year objective and subjective outcomes of patients with complex anorectal fistula treated with Video-Assisted Anal Fistula Treatment (VAAFT). Furthermore, we evaluated the risk factors associated with recurrence. All consecutive patients with complex anorectal fistula who underwent VAAFT in Beata Vergine Hospital of Mendrisio, Switzerland, from January 2013 to January 2016, were enrolled. Patients with suspicion or diagnosis of Crohn’s disease, malignancy, previous history of radiotherapy or radical pelvic surgery were excluded. Preoperative clinical assessment based upon medical history, physical examination and endosonography, was performed in all patients. Data regarding subjective outcomes (the Patient Global Impression of Improvement, patient satisfaction scores and Wexner score), objective cure rate (absence of fistula at clinical examination), and adverse events were collected during follow-up. Uni and multivariate analysis were performed to investigate outcomes. One hundred and four patients had VAAFT. At 3-year follow-up, 96 patients (92.3%) were available for the evaluation. At 3 years after surgery, 81 of 96 patients (84.4%) declared themselves cured (p = 0.60). Similarly, at 3-year evaluation, 80 of 96 patients (83.3%) were objectively cured (p = 0.52). No serious intraoperative or postoperative complications were reported. All recurrences were treated with a repeat VAAFT procedure resulting in a complete healing. Uni and multivariate analysis of variables potentially involved in the failure of VAAFT showed that age ≥ 50 years was the only factor associated at risk of recurrence. VAAFT is a highly effective safe procedure for the treatment of anorectal fistula, with a low recurrence rate at 3-year follow-up. However, our study demonstrated that age ≥ 50 years is a risk factor for failure of VAAFT.

Introduction and hypothesis: Several studies have shown that immediate catheter removal following pelvic surgery is associated with several advantages. The aim of this case–control study is to compare immediate versus delayed catheter removal following mid-urethral sling surgery, to determine if indwelling catheterisation is necessary after this procedure. The secondary outcomes were subjective and objective cure rate after at least a 1-year follow-up. Methods: Cases were defined as all the women who underwent a TVT Abbrevo for urodynamically proven stress incontinence. In every case the Foley catheter was removed by the surgeon at the end of the procedure. A voided volume >200ml with a post-void residual of

The tension-free vaginal tape ABBREVO (TVT-A) is a new surgical procedure for the treatment of female stress urinary incontinence (SUI). However, data reporting medium- and long-term outcomes are lacking. The aim of the study was to assess the efficacy and safety of TVT-A in patients with at least a 3-year follow-up. All consecutive women who complained of pure SUI symptoms with urodynamically proven SUI undergoing a TVT-A procedure were prospectively enrolled. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement and patient satisfaction scores), objective cure (stress test) rates and adverse events were collected during follow-up. Univariate analysis was performed to investigate outcomes. A total of 41 women underwent TVT-A implantation. At 3-year follow-up, 40 women (97.5%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 3 years after surgery, 36 of 40 (90%) patients were subjectively cured (p for trend 0.18) and 37 out of 40 (92.5%) patients were objectively cured (p for trend 0.22). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. A significant trend of de novo overactive bladder (OAB) occurrence was registered at the 3-year follow-up (p for trend = 0.03). No serious late complications or groin-thigh pain were reported. TVT-A implantation is a highly effective option for the treatment of women with pure SUI.

Background: Neurogenic bowel dysfunctions (NBDs) in the form of both fecal incontinence (FI) and functional constipation (FC) are frequent in multiple sclerosis (MS) patients and significantly affect their quality of life. Therapeutic options are limited. Objective: To investigate effectiveness of percutaneous posterior tibial nerve stimulation (PTNS) in MS patients suffering from FI and FC. Methods: Prevalence and severity of FI and FC were prospectively collected among MS patients undergoing 12 weeks of PTNS for neurogenic bladder. The Cleveland Clinic Fecal Incontinence Score (CCFIS) and the Rome III criteria were used to define FI and FC, respectively. Subjective treatment satisfaction was estimated using the Benefit Satisfaction and Willingness to Continue (BSWC) questionnaire. Results: A total of 60 patients undergoing PTNS suffered from NBDs (25 FI+/FC+, 5 FI+/FC–, 30 FI–/FC+). Median CCFIS decreased after PTNS from 12.0 (11.0–13.0) to 8.5 (7.0–11.0, p Conclusion: PTNS represents a valid minimally invasive alternative treatment for MS patients suffering from NBDs.

Aim To assess the efficacy and safety of tension-free vaginal tape-obturator (TVT-O) 13 years after implantation for the treatment of female pure stress urinary incontinence (SUI). This is the longest-term evaluation available of TVT-O outcomes. Methods A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable and multivariate analyses was performed to investigate outcomes. Results One hundred sixty-eight women had TVT-O implantation. At 13 year after surgery, 150 of 157 patients (95%) declared themselves cured (P = .8). Similarly, at 10-year evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (P = .1). The multivariate analysis showed that previous anti-incontinence procedures and obesity independently predicted the subjective (odd ratio [OR]: 6.2 [95% confidence interval [CI], 1.8-13.6]; P = .02 and OR, 1.8 [95% CI, 1.3-3.0]; P = .03, respectively) and objective failure of TVT-O (OR, 5.8 [95% CI, 1.6-13.2]; P = .02 and OR, 1.6 [95% CI, 1.2-3.2]; P = .03, respectively). We found four cases of sling exposure; all of them occurred after the 10-year follow-up. Conclusions The 13-year results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. We found that there is a significantly higher risk of having a sling exposure over 10 years after the procedure; however, the incidence is very low.

Uterine-sparing prolapse surgery has been gaining back popularity with clinicians and patients. Although both prosthetic and native-tissue surgery procedures are described, the latter is progressively regaining a central role in pelvic reconstructive surgery, owing to a lack of mesh-related complications. Available native-tissue procedures have different advantages and pitfalls, as well as different evidence profiles. Most of them offer anatomical and subjective outcomes comparable with those of hysterectomy-based procedures. Moreover, native-tissue procedures in young women desiring childbearing allow to avoid synthetic material implantation, which may lead to potentially serious complications during pregnancy. As a consequence, we do think that offering a reconstructive native-tissue procedure for uterine preservation (with the exception of the Manchester procedure) is the safest option in women wishing for pregnancy. Sacrospinous ligament hysteropexy and high uterosacral ligament hysteropexy may be considered first-line options in consideration of the higher level of evidence and lack of adverse obstetrical outcomes.

Background Inside-out transobturator tape (tension-free vaginal tape–obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. Objective To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. Design, setting, and participants A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. Intervention TVT-O implantation. Outcome measurements and statistical analysis Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire–Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. Results and limitations One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured ( p =0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time ( p =0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61–11.9; p =0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. Conclusions The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. Patient summary At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence.

Introduction Pregnancy and childbirth are considered risk factors for the development of diastasis recti abdominis (DRA). This anatomical change could be on the basis of stress urinary incontinence (SUI). Aim of this study was to assess the relationship between the value of DRA and SUI, in order to understand, if a specific abdominal rehabilitation might be indicated. Methods All women with clinically and urodynamically proven SUI (group 1) 6 months after first childbirth, have been enrolled and compared with women without any symptoms of SUI (group 2). Exclusion criteria were age > 45 years, pelvic organ prolapse > II stage, previous abdominal surgery including cesarean section, BMI (Body Mass Index) > 30, previous weight loss > 10 kg, presence of abdominal hernia, and pathological connective tissue laxity. Physical examination and ultrasound measurement of DRA were performed. DRA in women with SUI were compared with DRA in continent women. Results During the study period, 35 (48 %) incontinent women were included in group 1 and 38 (52 %) continent women were included in group 2. The two groups did not differ in any characteristics. No statistically significant differences in the mean value of DRA, 1.76 cm (±0.81 DS) in group 1 versus 1.69 (±0.79 DS) in group 2 (p value = 0.91), were found. Conclusions DRA is not a risk factor for SUI. Therefore, an intervention on the abdominal muscles during pelvic floor rehabilitation for SUI does not seem to be justified.

Aim Vaginal paraurethral leiomyomas are uncommon benign tumors of the female genitourinary tract. We report a case of anterior vaginal paraurethral leiomyoma. Furthermore, we performed a systematic review of the literature to provide information that can help the physicians in the diagnosis and management of women with this rare pathology. Methods A case of anterior vaginal paraurethral leiomyoma in 53-year-old, primiparous, caucasian woman with history of pelvic pressure, vaginal bulging and overactive bladder symptoms, was described. Furthermore, a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement was performed between January 1, 2000 to Dec 30, 2019. Only articles that reported cases of vaginal or paraurethral leiomyoma (b) case series and case reports with literature review were included. Results we screened a total 2281 records; 70 articles published from 2000 to 2019 were included. Conclusion Vaginal paraurethral leiomyoma is a rare benign tumor of the vagina with a wide spectrum of symptoms and good prognosis. The recurrence and transformation into malignant condition are rare. Histopathological examination is the gold standard for diagnosis, but MRI and US can be help to define the size and localization of the tumor. Management requires surgical vaginal excision in the majority of cases; however, abdominal approach could be considered when it is large and located high in the vagina.

We present a case of a preoperatively unrecognized giant bladder diverticulum in a 63-year-old postmenopausal woman. We carried out preoperative ultrasonographic evaluation and suspected an ovarian cyst. We performed two transvaginal ultrasonography scans before surgery, asking the patient to totally empty her bladder. Consequently, we decided to subject the patient to laparoscopic cyst removal. However, during surgery, the presumed ovarian cyst was not found and a bladder diverticulum was suspected. To confirm our hypothesis, we filled the bladder with saline until the reappearance of giant swelling and we recognized a bladder diverticulum. This case shows that diagnosis based on imaging alone can reveal unpleasant pitfalls. It is important to integrate clinical information, and to consider other possible investigations in order to reduce the chances of a misdiagnosis.

Summary Background We previously reported the 5-year results of the phase 3 IBCSG 23-01 trial comparing disease-free survival in patients with breast cancer with one or more micrometastatic (≤2 mm) sentinel nodes randomly assigned to either axillary dissection or no axillary dissection. The results showed no difference in disease-free survival between the groups and showed non-inferiority of no axillary dissection relative to axillary dissection. The current analysis presents the results of the study after a median follow-up of 9·7 years (IQR 7·8–12·7). Methods In this multicentre, randomised, controlled, open-label, non-inferiority, phase 3 trial, participants were recruited from 27 hospitals and cancer centres in nine countries. Eligible women could be of any age with clinical, mammographic, ultrasonographic, or pathological diagnosis of breast cancer with largest lesion diameter of 5 cm or smaller, and one or more metastatic sentinel nodes, all of which were 2 mm or smaller and with no extracapsular extension. Patients were randomly assigned (1:1) before surgery (mastectomy or breast-conserving surgery) to no axillary dissection or axillary dissection using permuted blocks generated by a web-based congruence algorithm, with stratification by centre and menopausal status. The protocol-specified primary endpoint was disease-free survival, analysed in the intention-to-treat population (as randomly assigned). Safety was assessed in all randomly assigned patients who received their allocated treatment (as treated). We did a one-sided test for non-inferiority of no axillary dissection by comparing the observed hazard ratios (HRs) for disease-free survival with a margin of 1·25. This 10-year follow-up analysis was not prespecified in the trial's protocol and thus was not adjusted for multiple, sequential testing. This trial is registered with ClinicalTrials.gov, number NCT00072293. Findings Between April 1, 2001, and Feb 8, 2010, 6681 patients were screened and 934 randomly assigned to no axillary dissection (n=469) or axillary dissection (n=465). Three patients were ineligible and were excluded from the trial after randomisation. Disease-free survival at 10 years was 76·8% (95% CI 72·5–81·0) in the no axillary dissection group, compared with 74·9% (70·5–79·3) in the axillary dissection group (HR 0·85, 95% CI 0·65–1·11; log-rank p=0·24; p=0·0024 for non-inferiority). Long-term surgical complications included lymphoedema of any grade in 16 (4%) of 453 patients in the no axillary dissection group and 60 (13%) of 447 in the axillary dissection group, sensory neuropathy of any grade in 57 (13%) in the no axillary dissection group versus 85 (19%) in the axillary dissection group, and motor neuropathy of any grade (14 [3%] in the no axillary dissection group vs 40 [9%] in the axillary dissection group). One serious adverse event (postoperative infection and inflamed axilla requiring hospital admission) was attributed to axillary dissection; the event resolved without sequelae. Interpretation The findings of the IBCSG 23-01 trial after a median follow-up of 9·7 years (IQR 7·8–12·7) corroborate those obtained at 5 years and are consistent with those of the 10-year follow-up analysis of the Z0011 trial. Together, these findings support the current practice of not doing an axillary dissection when the tumour burden in the sentinel nodes is minimal or moderate in patients with early breast cancer. Funding International Breast Cancer Study Group.

Objective To assess the efficacy and safety of retropubic tension-free vaginal tape (TVT) 17 years after implantation for the treatment of female pure stress urinary incontinence (SUI). Patients and methods A prospective study was conducted in two urogynaecological units in two countries. All consecutive women with urodynamically proven pure SUI treated by TVT were included. Patients with mixed incontinence and/or anatomical evidence of pelvic organ prolapse were excluded. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. Results A total of 52 women underwent TVT implantation. At 17-year follow-up, 46 women (88.4%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 17 years after surgery, 41 of 46 women (89.1%) declared themselves cured (P = 0.98). Similarly, at 17-year evaluation, 42 of 46 women (91.4%) were objectively cured. No significant deterioration in objective cure rates was observed over time (P for trend 0.50). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. Of the 46 women, 15 (32.6%) reported the onset of de novo overactive bladder at 17-year follow-up. No other late complications were reported. Conclusions The 17-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI.

Aim To assess long-term subjective, objective, and urodynamic outcomes of retropubic mid-urethral slings at 13-year follow-up. Methods This was a prospective observational study. Consecutive women with proven urodynamic stress incontinence were treated with standard retropubic tension free vaginal tape (TVT). Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. All the included patients underwent preoperative clinical and urodynamic evaluations. During follow-up examinations, women were assessed for subjective satisfaction and objective cure rates. The Cox model was used in order to investigate factors predicting the risk of recurrent stress urinary incontinence (SUI), over the study period. Results Overall, 55 patients were suitable for the analysis. At 13-year follow-up, 47 out of 55 (85.5%) patients declared themselves cured (p-for-trend 0.02) and 48 out of 58 (87.2%) were at least improved (p-for-trend 0.07). No significant deterioration of objective cure rates was observed over time (P = 0.29). At the time of the last evaluation, 50 out of 55 (90.9%) women were objectively cured; urodynamic evaluation confirmed this finding in 49 (89.1%) patients. Considering factors predictive of SUI recurrence, we observed that, via multivariate analysis, obesity (HR 7.2; P = 0.01) and maximum detrusor pressure during the voiding phase ≤29 cmH2O (HR 8.0; P = 0.01) were the only independent predictors of recurrent SUI. Conclusion Our data confirmed that TVT is a highly effective and safe procedure also at 13-year follow-up. Interestingly, we observed a significant decrease of subjective satisfaction over time. Neurourol. Urodynam. © 2015 Wiley Periodicals, Inc.

The aim of this study was to assess the safety and efficacy of vaginal native tissue repair and uterine suspension after a follow-up of at least 1 year. We included all consecutive women with an anterior vaginal prolapse of stage II or higher and a concomitant uterine prolapse of stage II who underwent this surgical procedure. We considered women with a descensus with maximum point of less than −1 in any compartment as objectively cured. Overall success was defined as no prolapse symptoms, together with a Patient Global Impression of Improvement (PGI-I) score of 2 or less, prolapse of stage lower than II, and no need for other surgery. A total of 102 patients underwent this surgical procedure during the study period and met all the inclusion criteria for statistical analysis. The mean follow-up was 31 ± 8.2 months; no patient was lost to follow-up. Five patients (4.9%) showed postoperative complications. In terms of subjective outcomes, at the last available follow-up, failure of this surgical procedure was seen in 2% of patients. The objective cure rate and the overall cure rate were the 95.1%. No significant deterioration in objective cure rates was observed over time (p = 0.6). Vaginal repair and hysteropexy appear to be an effective and safe option for women with advanced uterovaginal prolapse.

Background and Aims: A gynaecological cream containing collagen, phytocollagen, hyaluronate and vitamins was investigated in women in menopause. Methods: The cream was daily applied to the vaginal mucosa and the perineal skin as well as to the abdominal skin (healthy skin used as control) for 1 week and then on alternate days for other 2 weeks. Skin hydration and viscoelasticity were measured at baseline and after 8 and 21 days by Corneometer® CM 825 and Cutometer® MPA 850, respectively. The product use comfort and the moisturising of the vaginal mucosa were evaluated by the volunteers through a questionnaire and a visual analogue scale, respectively. Results: The local tolerability was excellent for nearly all of the volunteers (90% - 95%) and according both to dermatologist’s and gynaecologist’s evaluation. Related adverse reactions had a frequency of 15% (10% vulvovaginal burning sensation and 5% vulvovaginal discomfort). The topical hydration increased both in the perineal and the abdominal skin. Hydration increase vs. baseline was more marked on day 8 than on day 21 and was significant in the abdominal skin (p-value

Background: Percutaneous tibial nerve stimulation (PTNS) has been proposed as a new, minimally invasive neuromodulation technique to treat lower urinary tract symptoms (LUTS). Objective: To evaluate efficacy, safety and impact on quality of life (QoL) of PTNS on patients with multiple sclerosis (MS) who have LUTS. Methods: 21 patients (5 men, 16 women) with MS and LUTS unresponsive to anticholinergics were treated with 12 sessions of PTNS. Assessment of LUTS was by validated, self-administered chart and questionnaires, testing the subjective and objective relevance of LUTS for patients and their impact on QoL before and after treatment; the mean post-micturition residual was assessed by trans-abdominal ultrasound scanning. Analysis was by intention to treat. Results: There was a significant reduction of daytime frequency (from 9 to 6, p = 0.04), nocturia (from 3 to 1, p = 0.002) and mean post-micturition residual (from 98 ± 124 ml to 43 ± 45 ml, p = 0.02). The mean voided volume increased from 182 ± 50 ml to 225 ± 50 ml ( p = 0.003). Eighty-nine percent of patients reported a treatment satisfaction of 70%. Significant improvement in QoL was seen in most domains of the King’s Health QoL questionnaire ( p Conclusions: PTNS is an effective, safe and well-tolerated treatment for LUTS in patients with MS.

Bacterial vaginosis (BV) is the most prevalent vaginal disorder in adult women worldwide. A number of clinical studies indicate that re-establishment of the physiological ecosystem by re-colonization of vaginal mucosa by lactobacilli may be an effective therapy for BV both after initial antimicrobial therapy or when given alone. A vaginal pH4.5 is considered physiological and its measurement has been reported as an objective parameter, very sensitive to alterations of vaginal microflora and correlated with clinically relevant BV.The aims of this work were to assess the effectiveness of a long-term (24 months) intravaginal treatment with Lactobacillus rhamnosus (NORMOGIN) on the vaginal pH and on the clinical symptoms in a group of 40 women affected by BV diagnosed by the Amsel criteria.A prospective open clinical trial was performed in 40 consecutive cases evaluated for B.V. by the Amsel criteria.Vaginal pH was above the physiological value of 4.5 in 36 out of 40 patients at the first visit. It returned under 4.5 value in 24/40 and 32/40 women after 12 and 24 months of treatment, respectively. pH values were significantly decreased at 12 month treatment (P0.001) and further reduction in pH values was found at 24 months of treatment (P0.02 vs. 12 months). The gradual return to a vaginal physiological pH was associated with a reduction of the intensity of symptoms as shown by the decrease in the symptoms score.The present study supports the use of pH measurement for sensitive, objective, and simple therapy follow-up in women with BV and shows that long-term administration of vaginal tablets containing Lactobacillus rhamnosus represents an effective and safe treatment for restoring the physiological vaginal pH and controlling BV symptoms.