Search

Introduction and hypothesis Few studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs). The aim of this study is to assess the efficacy and safety of retro-pubic tension-free vaginal tape (TVT) 20 years after implantation for the treatment of female stress urinary incontinence (SUI). Methods A prospective observational study was conducted in two urogynaecologic units in two countries. All the patients involved were consecutive women with urodynamically proven pure SUI treated by TVT. The patients underwent preoperative clinical and urodynamic evaluations. Subjective outcomes, objective outcomes and adverse events were recorded during the follow-up period. Results Fifty-two patients underwent a TVT surgical procedure. Twenty years after surgery, 32 out of 36 patients (88.8%) declared themselves cured (p = 0.98). Similarly, 33 out of these 36 patients (91.7%) were objectively cured (p = 0.98). No significant deterioration of subjective and objective cure rates was observed over time (p for trend 0.50 and 0.48). Fifteen of the 36 patients (41.6%) at the 20-year follow-up reported the onset of de novo overactive bladder (OAB) (p = 0.004). No significant vaginal bladder or urethral erosion or de novo dyspareunia was recorded and no patient required tape release or resection during this period. The cause of death of seven out of ten women who died in the last year of the follow-up period was coronavirus disease 19 (COVID 19). Conclusions The 20-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI. The impact of COVID 19 on the mortality rate of elderly women has drastically reduced the number of eligible patients for future evaluations in our region.

Although it is known that hysterectomy (HY) alone cannot resolve apical prolapse, vaginal hysterectomy (VH) remains the most common surgical procedure for this issue. In recent years, various procedures for uterine conservation have been proposed to avoid the surgical risks of HY. Furthermore, most women with symptomatic pelvic organ prolapse (POP) prefer uterine conservation in the absence of considerable benefit in uterine removal. In 2017, we proposed a new technique for hysteropexy and anterior vaginal native tissue repair (NTR) in women with cystocele and apical prolapse. The objective of this study is to assess the efficacy and safety of this new procedure after at least 5 years of follow-up. We included only patients with stage II or greater prolapse of the anterior vaginal wall and a concomitant stage II uterine prolapse in accordance with Pelvic Organ Prolapse Quantification (POP-Q) system. A Patient Global Impression of Improvement (PGI-I) score ≤ 2 in addition with the absence of POP symptoms was defined as subjective success. A descensus with a maximum point of less than −1 in any compartment was considered objective cure. A total of 102 patients who fulfilled the inclusion criteria were enrolled. At 60 months follow-up, 90 out of 102 patients (88%) were subjectively cured, whereas 88 out of the 102 (86%) patients were objectively cured. Subjective and objective cure rates persisted during the entire study period. Uni- and multivariate analysis of possible predictive factors associated with recurrence of prolapse showed that only a preoperative point C > 0 cm and BMI ≥ 25 kg/m2 were risk factors for failure. In conclusion, our study showed that hysteropexy with anterior vaginal native tissue repair may be an effective and safe option for the treatment of anterior vaginal prolapse and concomitant stage II uterine prolapse by at least 5 years of follow-up.

Objectives Pelvic floor disorders (PFDs), which include urinary incontinence, pelvic organ prolapse, sexual dysfunction and gastrointestinal disorders, affect over 20% of the adult population. Prevalence may also be underestimated, since a certain portion of patients may be reluctant to talk to physicians about PFDs due to embarassment. Consequently, there is a need for self-assessed diagnostic tools with the capability to screen population and collect clinical information. Symptom and quality of life (QoL) questionnaires - also identified as patient-reported outcomes (PROs) - have been developed with this purpose. Despite the large number of questionnaires available for the assessment of PFDs and QoL-related issues in the English language, few of them have been validated for the Italian language. The objective of this article is to update the list of Italian-validated PROs for PFDs along with practical information concerning literature references and suggestions on how to obtain every single questionnaire. Methods PubMed/MEDLINE databases and websites were used to update the list of available Italian-validated questionnaires about PFDs. Once identified, the possibility to get a copy of the questionnaire was verified and steps to obtain it are reported in the tables. Results eight additional questionnaires validated into the Italian language, for diagnosis and overall management of common urinary, vaginal, sexual and bowel conditions, were retrieved. The complete list of PFDs PROS is reported in a modular format for consultation. Conclusions This format is intended to serve as a tool to promote appropriateness in PROs adoption while investigating PFDs in Italian patients.

Functional magnetic stimulation (FMS) is a new technique for the conservative treatment of Urinary incontinence (UI), based on magnetic induction. It induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. The aim of this study was to assess the efficacy of the new 3 Tesla FMS chair, both in patients with pure stress urinary incontinence (SUI) and in women with pure overactive bladder (OAB) symptoms. A prospective observational study was conducted in our urogynaecologic unit. All the patients involved were consecutive women with pure SUI or pure OAB symptoms treated by a 3 Tesla electromagnetic chair. The primary outcome was a subjective outcome evaluation by the PGI-I Scale and a patient-satisfaction scale. The secondary outcome was the change score of the UDI-6, IIQ-7, ICIQ-SF and OAB-q SF questionnaires from baseline to final visit. At 2 months follow-up, 28 out of 60 patients (47%) with SUI symptoms and 20 out of 40 patients (50%) with OAB symptoms declared themselves cured. Considering cured and improved patients, the subjective cure rates were 68.3% (41/60) and 70% (28/40) for patients with SUI and OAB symptoms, respectively. The results of this study showed that the 3 Tesla electromagnetic chair may be an effective option for the treatment of UI.

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.

Recurrent stress urinary incontinence (rSUI) represents a major challenge for most clinicians as there is little evidence in the literature on the best option after sling failure. The objective of this study is to summarise the findings on the use of urethral bulking agents (UBAs) in the management of rSUI after the failure of a mid-urethral sling (MUSs). We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected eleven publications for inclusion in the analysis. We found that the overall cure and improvement rate ranged from 64% to 85% in the included studies, with a pooled value of 75%, compared with pooled failure and re-operation rates of 32% (95% CI: 22%-43%) and 25% (95% CI: 17%-34%), respectively. The I-2 test indicated significant statistical heterogeneity among the studies in relation to all the outcome measures; however, no risk of publication bias was found. To explore this heterogeneity in more depth, we performed a sub-group analysis of the two most commonly used bulking agents (Bulkamid and Macroplastique). The pooled values of the cure and improvement rate were 84% (95% CI: 77.0%-90.0%) and 80% (95% CI: 74.0%-85.0%) for Macroplastique and Bulkamid, respectively. We did not find significant heterogeneity or significant differences in the outcome measures in either group.For the first time in literature, our study provides an insight into the use of UBAs after failed MUSs. Although the results seem very promising, future studies with shared protocols are needed in order to recommend the use of UBAs in the treatment of recurrent cases.

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 The management of recurrent female stress urinary incontinence (SUI) still needs worldwide standardization. Few data on the role of urethral bulking agents (UBA) for the treatment of recurrent stress urinary incontinence exist. The aim of this study is to assess the efficacy and safety of urethral bulking agents for the treatment of recurrent SUI. Methods A multicenter, prospective study was conducted in four tertiary referral centers in two countries. All consecutive women with urodynamically proven recurrent SUI, and with a history of previous failed anti-incontinence surgical procedure (mid-urethral sling or single incision sling), treated by UBAs were included. We evaluated only patients who completed at least a 3yr follow up. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, Urogenital Distress Inventory score and patient satisfaction score), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable and multivariable analyses was performed to investigate outcomes. Results Forty-seven consecutive patients were enrolled. At 3-yr follow-up, all women were available for the evaluation. At 3 yr after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-yr evaluation, 39 of 47 patients (83%) were objectively cured. Only 5 patients (10.6 %) required reoperation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH2O (hazard ratio: 2.74; 95% CI, 1.64-10.7; p=0.009 and 1.62; 95% CI, 1.11-3.42; p=0.04, respectively) were the only predictors of failure. Only four complications were reported (8.5%). Conclusions The 3-yr results of this study showed that bulking agents is an appropriately effective and safe option for the treatment of recurrent SUI. The presence of preoperative concomitant detrusor overactivity is associated with a significant decrease of the efficacy of this procedure.

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.

The lifetime risk of women for undergoing surgery for pelvic organ prolapse (POP) is estimated to be 11-19%, and 30% of these women will require subsequent reoperation over time. Following hysterectomy, 3.6 per 1,000 person-years need surgical correction of prolapse, and in two-thirds of these cases multi-compartment prolapse is present. In the last decades, vaginally synthetic meshes were widely used in pelvic reconstructive surgery. However, after the decision of the Food and Drug Administration in 2019 to stop selling all surgical mesh devices for transvaginal prolapse repair, native tissue (NT) vaginal repair seems to regain an important role in pelvic reconstructive surgery. In the literature, various surgical techniques have been described for apical repair, but the best surgical approach is still to be proven. This paper analyzes the current evidence from recent literature on NT vaginal vault prolapse (VVP) repair, with special focus on the safety and efficacy of the various vaginal techniques.

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.

Purpose. A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women. Methods. The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications. Results. Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects’ evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples. Conclusion. The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.

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.

The pelvic floor is the bottom of the pelvic cavity. It consists of several components: peritoneum, pelvic viscera, endopelvic fascia, levator ani muscles, perineal membrane, and superficial genital muscles. The support for all these structures comes from connections to the bony pelvis and its attached muscles. Furthermore, viscera play an important role in forming the pelvic floor through their connections with structures, such as the cardinal and uterosacral ligaments [1]. For these reasons, it should not be considered as a single compartment but as a complex of structures in strong synergism, to ensure multiple functions. The interaction and integrity of muscular, connective, and nerve structures is essential to guarantee normal pelvic organ support. If one of these factors fails, the other might be able to compensate to a certain degree until pelvic organ prolapse occurs [2]. The International Urogynecological Association (IUGA) and International Continence Society (ICS), in their joint report, defined the prolapse as the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus (cervix), or the apex of the vagina (vaginal vault or cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. More commonly, this correlation would occur at the level of the hymen or beyond. Prolapse symptoms are vaginal bulging, pelvic pressure, bleeding, discharge, infection, splinting/digitation, and low back pain. These are generally worse at the times when gravity might make the prolapse worse (e.g. after long periods of standing or exercise) and better when gravity is not a factor, for example, lying supine.

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

In Switzerland, children are prescribed 7.5–12.5 μg per day of vitamin D3 dissolved in alcohol, but many families do not adhere to the recommendation. The aim of the trial was to compare the acceptance of vitamin D3 dissolved in alcohol or in medium-chain triglycerides among mothers of Swiss newborn infants. The acceptance was tested in 42 healthy newborn infants (20 girls and 22 boys) aged between 2 and 7 days. Their neonatal body weight ranged between 2.225 and 4.150 kg, and the gestational age between 36 1/7 and 41 3/7 weeks. The blinded mothers rated the facial reaction of their children by pointing on a facial hedonic scale. Thirty eight of the 41 mothers, who brought the comparison to completion, assigned a better score to the oily preparation with no difference in the remaining three cases (P < 0.0001). The acceptance for the oily preparation was significantly better both among mothers whose babies were initially presented the alcoholic preparation and among mothers whose babies were initially presented the oily preparation. Furthermore, the acceptance for the oily preparation was better irrespective of gender of the infant or parity of the mother. In conclusion, from the perspective of mothers, Swiss newborn infants prefer the taste of the oily vitamin D3 preparation over the alcoholic preparation.

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.

In Switzerland, children are prescribed 7.5-12.5 μg per day of vitamin D(3) dissolved in alcohol, but many families do not adhere to the recommendation. The aim of the trial was to compare the acceptance of vitamin D(3) dissolved in alcohol or in medium-chain triglycerides among mothers of Swiss newborn infants. The acceptance was tested in 42 healthy newborn infants (20 girls and 22 boys) aged between 2 and 7 days. Their neonatal body weight ranged between 2.225 and 4.150 kg, and the gestational age between 36 1/7 and 41 3/7 weeks. The blinded mothers rated the facial reaction of their children by pointing on a facial hedonic scale. Thirty eight of the 41 mothers, who brought the comparison to completion, assigned a better score to the oily preparation with no difference in the remaining three cases (P 0.0001). The acceptance for the oily preparation was significantly better both among mothers whose babies were initially presented the alcoholic preparation and among mothers whose babies were initially presented the oily preparation. Furthermore, the acceptance for the oily preparation was better irrespective of gender of the infant or parity of the mother. In conclusion, from the perspective of mothers, Swiss newborn infants prefer the taste of the oily vitamin D(3) preparation over the alcoholic preparation.

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.

Background and Objective Highly purified human menotrophin and urofollitrophin preparations obtained from human urine via a novel patented purification method have been tested over a timeframe of 14 years in the studies presented in this article. The objective of the studies was to investigate the pharmacokinetics and the pharmacodynamics of follicle-stimulating hormone (FSH) after single subcutaneous and intramuscular doses and multiple subcutaneous doses of the tested preparations in healthy fertile pituitary-suppressed women. Designs We performed five open, randomised, crossover, single-dose bioequivalence and/or bioavailability studies and one open, multiple-dose, pharmacokinetics and pharmacodynamics study. Study Subjects and Treatments The six studies included 121 healthy fertile women taking their usual combined oral contraceptives for 3 months before the study: Study 1: 300 international units (IU) of highly purified menotrophin as single subcutaneous and intramuscular doses. Study 2: 300 IU of highly purified menotrophin (test formulation vs. comparator) as single subcutaneous doses. Study 3: 300 IU of highly purified urofollitrophin (hp-FSH) (test formulation vs. comparator) as single subcutaneous doses. Study 4: 300 IU (2 × 150 IU vs. 4 × 75 IU) of hp-FSH as single subcutaneous doses. Study 5: 225 and 445 IU of hp-FSH as single subcutaneous doses. Study 6: daily 225 IU of hp-FSH as subcutaneous doses for 5 consecutive days. Main Outcome Measures The main outcome measures were the FSH pharmacokinetic parameters, estradiol concentrations, and the number and size of the follicles. Results FSH after single subcutaneous and intramuscular injections of menotrophin or urofollitrophin attained a systemic peak (maximum) concentration (C max) that was on average consistent throughout the first four studies and ranged from 4.98 to 7.50 IU/L. The area under the plasma concentration–time curve (AUC) from administration to the last observed concentration time t (AUCt) ranged from 409.71 to 486.16 IU/L·h and the elimination half-life (t ½) ranged from 39.02 to 53.63 h. After multiple doses of urofollitrophin (225 IU) for 5 days, FSH attained a mean C max of 14.93 ± 2.92 IU/L and had an AUC during the time interval τ between two consecutive doses at steady state (AUCτ) of 322.59 ± 57.92 IU/L·h, which was similar to the mean AUCt after a single subcutaneous dose of 225 IU of urofollitrophin in study 5 (306.82 ± 68.37 IU/L·h). Conclusions In our studies, the intramuscular and subcutaneous routes of menotrophin were equivalent; both menotrophin and urofollitrophin were bioequivalent to their marketed reference; FSH kinetic parameters following injection of urofollitrophin were dose proportional and independent from the administered concentration; and multiple doses of FSH increased estradiol levels and enhanced growth of follicles with a good dose–response correlation. Local tolerability was excellent throughout the six studies.