Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial.

Introduction: To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort. Materials and Methods: A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant. Results: Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ 2 2,n = 52  = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI. Conclusion: Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.

Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland.

INTRODUCTION AND HYPOTHESIS: Botulinum toxin (BoNT) is a widely used treatment for overactive bladder (OAB). Despite its common use, no standardized treatment regimen exists so far. The aim of this survey was to evaluate the variation in perioperative treatment strategies among members of the German-speaking urogynecologic societies. MATERIALS AND METHODS: A clinical practice online survey was carried out between May 2021 and May 2022, and all members of the German, Swiss, and Austrian urogynecologic societies were invited to participate. Participants were grouped in two ways. First, they were grouped into (1) urogynecologists with board certification and (2) non-board-certified general obstetricians and gynecologists (OBGYNs). Second, we set a cut-off at 20 transurethral BoNT procedures per year to differentiate between (1) high- and (2) low-volume surgeons. RESULTS: One hundred and six completed questionnaires were received. Our results demonstrated that BoNT is mostly used as a third-line treatment (93%, n = 98/106), while high-volume surgeons used it significantly more often as a first/second-line treatment (21% vs. 6%, p = 0.029). Large variations existed in the use of perioperative antibiotics, preferred sites of injection, the number of injections, and the timing of the measurement of the postvoid residual volume (PVRV). Forty percent of participants did not offer outpatient treatment to patients. Local anesthesia (LA) was mostly used by board-certified urogynecologists (49% vs. 10%, p < 0.001) and high-volume surgeons (58% vs. 27%, p = 0.002). Injections into the trigone were also more often performed by board-certified urogynecologists and high-volume surgeons (22% vs. 3% (p = 0.023) and 35% vs. 6% (p < 0.001), respectively). PVRV was controlled between weeks 1 and 4 by only 54% of participants (n = 57/106). Clean intermittent self-catheterization (CISC) was infrequently taught (26%). CONCLUSIONS: Our survey confirmed that BoNT is widely used by urogynecologists in the three German-speaking countries, but practice patterns vary widely, and no standardized method could be detected, despite interviewing urogynecologic experts. These results clearly demonstrate that there is a need for studies to define standardized treatment strategies for the best perioperative and surgical approach regarding the use of BoNT in patients with OAB.

Sexual Disorders in Women with Overactive Bladder and Urinary Stress Incontinence Compared to Controls: A Prospective Study.

Introduction and Hypothesis Female urinary incontinence (UI) has a negative impact on sexual function and sexual quality of life (QoL) in women. But there is still no consensus on the type of UI or the prevalence of sexual dysfunction (SD). The aim of the study was to evaluate sexual disorders in women with overactive bladder (OAB) compared to patients with urinary stress incontinence (SUI) and healthy controls. Materials and Methods 106 women presenting to a urogynecological outpatient clinic (referral clinic) were investigated using standardized questionnaires and the Female Sexual Function Index (FSFI-d). All 65 incontinent women underwent a full urodynamic examination; the controls (31) were non-incontinent women in the same age range who came for routine check-ups or minor disorders not involving micturition or pelvic floor function. Women with mixed urinary incontinence, a history of previous medical or surgical treatment for UI, recurrent urinary tract infections, previous radiation therapy or pelvic organ prolapse of more than stage 2 on the Pelvic Organ Prolapse Quantification (POP-Q) system were excluded. Results 100 questionnaires could be evaluated (94.3%). Thirty-four women had urinary stress incontinence, 35 had OAB, 31 were controls. Mean age was 56 years, with no significant differences between groups. The scores of the questionnaire ranged from 2 to 35.1 points. The median score of OAB patients was significantly lower (17.6) than the median score of the controls (26.5; p = 0,004). The stress-incontinent women had a score of 21.95, which was lower than that of the controls but statistically non-significant (p = 0.051). In all subdomains, the OAB patients had lower scores than the stress-incontinent women and significantly lower values than the control group. Most striking was the impairment of "sexual interest in the last 4 weeks". The figure for "none or almost no sexual activity" was 80% for the OAB group, 64.7% for the group of stress-incontinent women and 48% for the control group. Incontinence during intercourse was reported by one OAB patient and 4 stress-incontinent women but did not occur in the control group. Conclusions There is a high prevalence of SD in women with urinary incontinence. Patients with OAB reported a greater negative impact on sexual function and had significantly lower scores for the FSFI questionnaire than patients with stress incontinence or controls.

Short- and long-term efficacy and safety of duloxetine in women with predominant stress urinary incontinence.

OBJECTIVE: To evaluate short- and long-term safety and efficacy of duloxetine in women with predominant stress urinary incontinence (SUI). RESEARCH DESIGN AND METHODS: The study was a 6-week, double-blind, randomised, parallel, placebo-controlled study followed by an uncontrolled open-label extension (OLE) run in 342 study centres in 16 European countries. Women with predominant SUI were randomly assigned to placebo (n = 1380) or duloxetine 40 mg twice daily (n = 1378) for 6 weeks. Completers of the acute phase were enrolled in the OLE, which had a minimum duration of 6 weeks and ended, based on the approval status of duloxetine in the participating country. MAIN OUTCOME MEASURES: The primary outcome measure was the change in incontinence episode frequency (IEF) over 6 weeks. Secondary outcome measures were the long-term maintenance of effect on IEF and Patient Global Impression of Improvement (PGI-I), the short- and long-term impact on quality of life using the King's Health Questionnaire (KHQ), and the long-term safety of duloxetine. RESULTS: After 6 weeks, the decrease in weekly IEF was significantly greater with duloxetine treatment compared to placebo (-50.0 vs. -29.9%; p < 0.001). The percentage of responders (defined as > or =50% decrease in IEF) was significantly higher with duloxetine treatment than with placebo (50.6 vs. 31.2%; p < 0.001). Duloxetine treatment was associated with improvements in weekly pad use (-31.4%), PGI-I ratings (63.6%), and KHQ score (-6.25) compared to placebo (-12.5%, 48.5% and -3.13, respectively, all p < 0.001). Treatment-emergent adverse events were significantly more common during duloxetine treatment (48.3%) than placebo (33.3%), (p < 0.001). Of the 2290 patients continuing into the OLE, 1165 (42.2%) completed the available duration, and 592 (21.5%) discontinued because of an adverse event (percentages relative to total randomised patients). Long-term efficacy in the OLE was assessed over a 72-week period and was maintained over that time. However, the results should be interpreted within the context that better responding patients are more likely to remain on duloxetine, while patients responding poorly are more likely to discontinue over time. CONCLUSIONS: Duloxetine seems to be an efficacious treatment with an acceptable safety profile for women with SUI. Achieved improvement is maintained over the longer term in those women who remain on therapy.

Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence.

OBJECTIVES: To evaluate the efficacy and safety of duloxetine in community-dwelling women > or =65 years with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) versus placebo. METHODS: Patients were randomly assigned for 12 weeks to placebo (N=134) or duloxetine (N=131) (20mg twice daily [BID] for 2 weeks and 40 mg BID for an additional 10 weeks), followed by a double-blind 4-week dose de-escalation/discontinuation phase. The primary efficacy variable was the percent change in incontinence episode frequency (IEF) from baseline to endpoint. Other variables included absolute IEF change, responder rate, changes in mean time between voids (MTBV), weekly continence pad usage, the impact of treatment on quality of life, patient's global impression of improvement (PGI-I), and changes in depression and cognition. RESULTS: Duloxetine-treated patients had a significantly greater decrease from baseline to endpoint in mean IEF/week than placebo-treated patients (-52.47% vs. -36.70%, P<0.001). The IEF responder rate (> or =50% reduction in IEF/week) was 57.1% in the duloxetine group and 35.2% in the placebo group (P<0.001). Significant benefits of duloxetine were also demonstrated for weekly continence pad usage (P=0.011), MTBV (P<0.001), incontinence quality of life questionnaire (I-QOL) scores (P<0.001), and PGI-I ratings (P<0.001). Patients with depressive symptoms and cognitive impairments were few and changes were insignificant. The proportion of patients with > or =1 treatment-emergent adverse event (TEAE) was similar with both treatments, but dry mouth, fatigue, constipation, and hyperhidrosis were significantly more common in women taking duloxetine. CONCLUSIONS: Duloxetine is a safe and effective treatment for elderly women with symptoms of SUI or S-MUI.

Funneling before and after anti-incontinence surgery--a prognostic indicator? Part 2: tension-free vaginal tape.

Does the presence of pre- and postoperative funneling of the proximal urethra affect the outcome of tension-free vaginal tape (TVT)? This prospective study of 191 women with proven primary genuine stress urinary incontinence treated by TVT insertion and assessed by pre- and postoperative introital ultrasound aims to answer that question. At 36-month follow-up, the cure rate was 89.5% (Kaplan-Meier estimator). At 6-month follow-up, 6.3% of the women had urge symptoms and 0.5% de novo urge incontinence. The cure rate in preoperative funneling was 77.5% as opposed to 96.6% in the group without funneling (P<0.0001). The funneling rate significantly decreased from 37.2% preoperatively to 17.3% immediately postoperatively (P<0.0001). The continence rate was 57.5% in persistent postoperative funneling vs 96.2% in the group without postoperative funneling (P<0.0001). The complication rate was not higher in the group with persistent postoperative funneling. The TVT procedure significantly reduces bladder neck funneling. Both preoperative and persistent postoperative funneling are associated with an increased probability of therapeutic failure or recurrence.

Urethral hypermobility after anti-incontinence surgery - a prognostic indicator?

The aim of this study was to define the concept of hypermobility of the bladder neck and determine its effects on the cure rate and postoperative complications in patients undergoing colposuspension. In a retrospective study, 310 patients who underwent primary colposuspension for urodynamically proven genuine stress urinary incontinence were assessed by introital ultrasound before surgery and during follow-up for up to 48 months postoperatively. A total of 152 women completed 48 months of follow-up. Mobility of the bladder neck during straining was described as linear dorsocaudal movement (LDM) with LDM >15 mm being defined as hypermobility. The overall objective cure rate was 90.0% at 6-month follow-up vs 76.8% at 48-month follow-up (Kaplan-Meier estimators). Urge symptoms occurred in 12.6% (39/310) of the women and de novo urge incontinence in 2.3% (7/310). Bladder neck hypermobility was significantly reduced after anti-incontinence surgery, from 67.1% (208/310) before surgery to 5.5% (17/310) immediately after surgery (P<0.0001). Postoperative hypermobility was associated with a higher recurrence rate. In the hypermobility group, 52.9 and 34.0% of the patients were continent for up to 6 and 48 months, respectively, as opposed to 92.2 and 79.2% in the group without hypermobility (P<0.0001). Women with postoperative hypermobility had a 3.2-fold higher risk of recurrence within 48 months. Bladder neck hypermobility after surgery was also associated with postoperative voiding difficulty (P=0.0278). Patients in whom hypermobility of the bladder neck diagnosed before surgery persists after colposuspension have a higher risk of recurrence and are more likely to develop postoperative complications than those without this hypermobility.

Postoperative funneling after anti-incontinence surgery--a prognostic indicator?--Part 1: colposuspension.

AIMS: How does funneling of the bladder neck after open colposuspension affect the postoperative cure rate? METHODS: In a retrospective study, 310 patients who underwent primary colposuspension for urodynamically proven genuine stress urinary incontinence were assessed by introital ultrasound before and immediately after surgery as well as at 6, 12, 24, 36, and 48 months. A total of 152 women completed 48-month follow-up. Objective cure rates at the different follow-up times were calculated and correlated with the presence of postoperative bladder neck funneling. RESULTS: The objective cure rate up to 6 months after colposuspension was 90.0 versus 76.8% up to 48-month follow-up. Urge symptoms occurred in 11.6% (36/310) of the women and de novo urge incontinence in 1.6% (5/310). Bladder neck funneling was significantly reduced after anti-incontinence surgery, from 55.2% before surgery to 12.3% (38/310) at 6-month follow-up (P < 0.0001). Postoperative funneling was associated with a higher recurrence rate. In the funneling group, 58.8 and 40.6% of the patients were continent up to 6 and 48 months, respectively, as opposed to 93.8 and 81.3% in the group without funneling (P < 0.0001). Urgency and de novo urge incontinence were more common in the funneling group (23.5 and 28.3% up to 6 and 48 months, respectively, vs. 12.7 and 13.5%; P < 0.05). CONCLUSIONS: Patients in whom funneling of the bladder neck diagnosed before surgery persists after colposuspension have a higher risk of recurrence and are more likely to develop postoperative complications.

Duloxetine versus placebo in the treatment of European and Canadian women with stress urinary incontinence.

OBJECTIVE: To assess the efficacy and safety of duloxetine in women with stress urinary incontinence. DESIGN: Randomised double-blind, placebo-controlled clinical trial. SETTING: Fort-six centres in seven European countries and Canada. POPULATION: Four hundred and ninety-four women aged 24-83 years identified as having predominant symptoms of stress urinary incontinence using a clinical algorithm that was 100% predictive of urodynamic stress urinary incontinence in a subgroup of 34 women. METHODS: The case definition included a predominant symptom of stress urinary incontinence with a weekly incontinence episode frequency > or =7, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequencies, a bladder capacity > or =400 mL and both a positive cough stress test and positive stress pad test. Subjects completed two urinary diaries prior to randomisation and three diaries during the active treatment phase of the study, each completed during the week prior to monthly visits. Subjects also completed quality of life questionnaires at each visit. Safety was assessed by the evaluation of treatment-emergent adverse events, discontinuation of treatment because of adverse events, serious adverse events, vital sign measurements, electrocardiograms (ECG) and clinical laboratory tests. INTERVENTION: After a two-week placebo lead-in, women received placebo or duloxetine 40 mg BD for 12 weeks. MAIN OUTCOME MEASURES: The percentage decrease in incontinence episode frequency and the change in the Incontinence Quality of Life (I-QOL) questionnaire total score were prespecified as co-primary outcome variables in the protocol. RESULTS: Incontinence episode frequency decreased significantly with duloxetine compared with placebo (median decrease of 50%vs 29%; P= 0.002) with comparable improvements in the more severely incontinent subgroup (those experiencing at least 14 incontinence episodes per week at baseline; 56%vs 27% decreases; P < 0.001). The primary analysis of I-QOL scores did not reveal a significant difference between treatment groups, due primarily to the carrying forward of low scores from patients who discontinued treatment very early due to duloxetine-associated adverse events. The increase in I-QOL scores was significantly greater for duloxetine than for placebo at each of the three postrandomisation visits after 4, 8, and 12 weeks of treatment. Discontinuation rates for adverse events were higher for duloxetine (22%vs 5%; P < 0.001) with nausea being the most common reason for discontinuation (5.3%). Nausea tended to be mild to moderate, not progressive, and transient. CONCLUSIONS: The findings support duloxetine as a potential treatment for women with stress urinary incontinence.