Longitudinal Fluctuations in Treatment Response After OnabotulinumToxinA and Sacral Neuromodulation for Refractory Urgency Incontinence.

PURPOSE: We compared fluctuations in treatment response after onabotulinumtoxinA and sacral neuromodulation for urgency incontinence using Markov models. MATERIALS AND METHODS: We fit data from a randomized trial to Markov models to compare transitions of success/failure over 6 months between 200 U onabotulinumtoxinA and sacral neuromodulation. Objective failure was <50% reduction in urgency incontinence episodes from baseline; subjective failure "strongly disagree" to "neutral" to the Patient Global Symptom Control questionnaire. RESULTS: Of the 357 participants (median baseline daily urgency incontinence episodes 4.7 [IQR 3.7-6.0]) 61% vs 51% and 3.2% vs 6.1% reported persistent states of objective success and failure over 6 months after onabotulinumtoxinA vs sacral neuromodulation. Participants receiving onabotulinumtoxinA vs sacral neuromodulation had lower 30-day transition probabilities from objective and subjective success to failure (10% vs 14%, ratio 0.75 [95% CI 0.55-0.95]; 14% vs 21%, ratio 0.70 [95% CI 0.51-0.89]). The 30-day transition probability from objective and subjective failure to success did not differ between onabotulinumtoxinA and sacral neuromodulation (40% vs 36%, ratio 1.11 [95% CI 0.73-1.50]; 18% vs 17%, ratio 1.14 [95% CI 0.65-1.64]). CONCLUSIONS: Over 6 months after treatment, 2 in 5 women's symptoms fluctuate. Within these initial 6 months, women receiving onabotulinumtoxinA transitioned from success to failure over 30 days less often than sacral neuromodulation. For both treatments, there was an almost 20%-40% probability over 30 days that women returned to subjective and objective success after failure. Markov models add important information to longitudinal models on how symptoms fluctuate after urgency incontinence treatment.

Predicting success using response after lead implantation with sacral neuromodulation for urgency incontinence.

IMPORTANCE: Many women report inadequate symptom control after sacral neuromodulation (SNM), despite 50% reduction in urgency incontinence episodes (UUIE) after test stimulation. OBJECTIVE: To determine the ideal percent UUIE reduction after test stimulation that predicts 24-month success. STUDY DESIGN: Using data from a multicenter SNM trial, we constructed receiver operating characteristic curves to identify an ideal threshold of percent UUIE reduction after test stimulation. We defined 24-month success as Patient Global Impression of Improvement of "very much better" to "better." We compared predictive accuracy of two models predicting success: (1) percent UUIE reduction alone and (2) with baseline characteristics. RESULTS: Of 149 women (median [IQR] baseline daily UUIE 4.7 [3.7, 6.0]), the ideal threshold for 24-month success was 72% (95% confidence interval 64,76%) UUIE reduction with accuracy 0.54 (0.42, 0.66), sensitivity 0.71 (0.56, 0.86) and specificity 0.27 (0.05, 0.55). The accuracy of the 50% reduction threshold was 0.60 (0.49, 0.71), sensitivity 0.95 (0.88, 1.0) and specificity 0.04 (0.0, 0.12). Percent reduction in UUIE was not better than chance in predicting 24-month success (concordance index [c-index] 0.47 [0.46, 0.62]); adding age, body mass index, diabetes mellitus and visual or hearing impairment the c-index was 0.68 (0.61, 0.78). CONCLUSIONS: Among women who received an internal pulse generator (IPG) due to ≥50% UUIE reduction after test stimulation, we found no ideal threshold that better predicted 24-month success. Percent reduction in UUIE after test stimulation poorly predicts 24-month success with or without clinical factors. Given this, re-evaluating how we determine who should receive an IPG is needed.

Postpartum sedentary behaviour and pelvic floor support: A prospective cohort study.

We evaluated the association between sedentary time and pelvic floor support in primiparas delivered vaginally. The 532 participants (29.2 ± 4.9 years) wore wrist accelerometers 6 months postpartum to assess sedentary time, light physical activity (LPA) and moderate to vigorous physical activity (MVPA). We assessed pelvic floor support 1 year postpartum, considered worse if vaginal walls or apex prolapsed to or beyond the hymen. We used multivariable isotemporal substitution analyses to determine the prevalence of worse support when replacing sedentary time with equal time spent in either LPA or MVPA. In 1 year, 9.4% demonstrated worse pelvic floor support. Decreasing sedentary time by 30 min/day with a concomitant increase in MVPA, controlling for LPA, was associated with increased prevalence of worse support (PR 1.43 (95% CI 1.15, 1.77), P < 0.01). Decreasing the sedentary time by 30 min/day with a concomitant increase in LPA, controlling for MVPA, was not significant (PR 0.89 (95% CI 0.80, 0.99), P = 0.04, > pre-set alpha of 0.02). Increasing MVPA while decreasing LPA, controlling for sedentary time, also increased the prevalence of worse support (PR 1.66 (95% CI 1.28, 2.16), P < 0.001). In conclusion, decreasing sedentary time increased the prevalence of worse pelvic floor support when replaced by MVPA, but not LPA.

Early postpartum physical activity and pelvic floor support and symptoms 1 year postpartum.

BACKGROUND: Risks of pelvic organ prolapse and urinary incontinence increase after the first vaginal delivery. During the early postpartum period, a time of active regeneration and healing of the pelvic floor, women may be particularly vulnerable to greater pelvic floor loading. OBJECTIVE: This prospective cohort study aimed to determine whether objectively measured moderate to vigorous physical activity in the early postpartum period predicts pelvic floor support and symptoms 1 year after the first vaginal birth. STUDY DESIGN: We enrolled nulliparous women in the third trimester, later excluding those who had a cesarean or preterm delivery. Participants wore triaxial wrist accelerometers at 2 to 3 weeks and 5 to 6 weeks postpartum for ≥4 days. Primary outcomes, assessed 1 year postpartum, included (1) pelvic floor support on Pelvic Organ Prolapse Quantification examination, dichotomized as maximal vaginal descent of <0 cm (better support) vs ≥0 cm (worse support); and (2) pelvic floor symptom burden, considered positive with report of ≥1 bothersome symptom in ≥2 of 6 domains, assessed using the Epidemiology of Prolapse and Incontinence Questionnaire. The primary predictor was average daily moderate to vigorous physical activity. Because we could not eliminate women with pelvic floor changes before pregnancy, we modeled prevalence, rather than risk, ratios for each outcome using modified Poisson regression. RESULTS: Of 825 participants eligible after delivery, 611 completed accelerometry and 1-year follow-up; 562 completed in-person visits, and 609 completed questionnaires. The mean age was 28.9 years (standard deviation, 5.01). The mean for moderate to vigorous physical activity measured in minutes per day was 57.3 (standard deviation, 25.4) and 68.1 (standard deviation, 28.9) at 2 to 3 weeks and 5 to 6 weeks, respectively. One year postpartum, 53 of 562 participants (9.4%) demonstrated worse vaginal support and 330 of 609 participants (54.2%) met criteria for pelvic floor symptom burden. In addition, 324 (53.1%), 284 (46.6%), 144 (23.6%), and 25 (4.1%) reported secondary outcomes of stress urinary incontinence, overactive bladder, anal incontinence, and constipation, respectively, and 264 (43.4%), 250 (41.0%), and 89 (14.6%) reported no, mild, or moderate to severe urinary incontinence, respectively. The relationship between moderate to vigorous physical activity and outcomes was not linear. On the basis of plots, we grouped quintiles of moderate to vigorous physical activity into 3 categories: first and second quintiles combined, third and fourth quintiles combined, and fifth quintile. In final multivariable models, compared with women in moderate to vigorous physical activity quintiles 3 and 4, those in the lower 2 (prevalence ratio, 0.55; 95% confidence interval, 0.31-1.00) and upper quintile (prevalence ratio, 0.70; 95% confidence interval, 0.35-1.38)) trended toward lower prevalence of worse support. However, we observed the reverse for symptom burden: compared with women in quintiles 3 and 4, those in the lower 2 (prevalence ratio, 1.20; 95% confidence interval, 1.02-1.41) and upper quintile prevalence ratio 1.34 (95% confidence interval, 1.11-1.61) demonstrated higher prevalence of symptom burden. Moderate to vigorous physical activity did not predict any of the secondary outcomes. The presence of a delivery factor with potential to increase risk for levator ani muscle injury did not modify the effect of moderate to vigorous physical activity on outcomes. CONCLUSION: Except for support, which was worse in women with moderately high levels of activity, early postpartum moderate to vigorous physical activity was either protective or had no effect on other parameters of pelvic floor health. Few women performed substantial vigorous activity, and thus, these results do not apply to women performing strenuous exercise shortly after delivery.

Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence.

BACKGROUND: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. OBJECTIVE: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. STUDY DESIGN: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain. CONCLUSION: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

Development of a novel intra-abdominal pressure transducer for large scale clinical studies.

Intra-abdominal pressure may be one of the few modifiable risk factors associated with developing a pelvic floor disorder. With one in eight women having surgery to correct a pelvic floor disorder in their lifetimes, intra-abdominal pressure may be a key to understanding the disease etiology and how to mitigate its occurrence and progression. Many traditional methods of intra-abdominal pressure measurement have limitations in data quality, environment of use, and patient comfort. We have modified a previously reported intravaginal pressure transducer that has been shown to overcome other intra-abdominal pressure measurement technique limitations (Coleman et al. 2012). Our modifications to the intravaginal pressure transducer make it easier to use, less costly, and more reliable than previous designs, while maintaining accuracy, integrity, and quality of data. This device has been used in over 400 participants to date as part of one of the most comprehensive studies examining the relationship between intra-abdominal pressure and pelvic floor disorders.

Longitudinal associations between mental health conditions and overactive bladder in women veterans.

BACKGROUND: One in 5 recently deployed US women veterans report overactive bladder symptoms. Mental health conditions such as depression and anxiety commonly co-occur in women with overactive bladder, but temporal relationships between these outcomes have not been well studied, and the mechanism behind this association is unknown. The Women Veterans Urinary Health Study, a nationwide longitudinal study in recently deployed women veterans, was designed to better understand relationships between overactive bladder and mental health conditions. OBJECTIVE: We sought to estimate the 1-year incidence and remission of overactive bladder and to identify the impact of depression, anxiety, posttraumatic stress disorder, and prior sexual assault on 1-year overactive bladder incidence and remission rates. STUDY DESIGN: Participants of this 1-year prospective cohort study were female veterans separated from military service who had returned from Iraq or Afghanistan deployment within the previous 2 years. Eligible women were identified through the Defense Manpower Data Center and recruited by mail and telephone. Telephone screening confirmed participants were ambulatory, community-dwelling veterans and excluded those with urinary tract fistula, congenital abnormality, or cancer; pelvic radiation; spinal cord injury; multiple sclerosis; Parkinson disease; stroke; or current/recent pregnancy. Data collection included computer-assisted telephone interviews performed at enrollment and 1 year later. The interview assessed demographic and military service characteristics; urinary symptoms and treatment; depression, anxiety, and posttraumatic stress disorder symptoms and treatment; and a lifetime history of sexual assault. Overactive bladder was identified if at least moderately bothersome urgency urinary incontinence and/or urinary frequency symptoms were reported on Urogenital Distress Inventory items. Exposures included depression, anxiety, posttraumatic stress disorder, and lifetime sexual assault, assessed at baseline using validated questionnaires (including the Patient Health Questionnaire and Posttraumatic Stress Disorder Checklist). Associations between exposures and overactive bladder incidence and remission were estimated using propensity score adjusted logistic regression models. RESULTS: In all, 1107 (88.0%) of 1258 eligible participants completed 1-year interviews. Median age was 29 (range 20-67) years and 53% were nulliparous. Overactive bladder was identified at baseline in 242 (22%), and 102 (9.2%), 218 (19.7%), 188 (17.0%), and 287 (25.9%) met criteria for baseline depression, anxiety, posttraumatic stress disorder, and lifetime sexual assault, respectively. At 1 year, overactive bladder incidence was 10.5% (95% confidence interval, 8.6-12.8%), and remission of overactive bladder was 36.9% (95% confidence interval, 30.8-43.4%). New overactive bladder occurred more often in women with baseline anxiety (21% vs 9%), posttraumatic stress disorder (19% vs 9%) and lifetime sexual assault (16% vs 9%) (all: P < .01). After adjustment, anxiety (odds ratio, 2.4; 95% confidence interval, 1.4-4.1) and lifetime sexual assault (odds ratio, 1.7; 95% confidence interval, 1.0-2.8) predicted 1-year incident overactive bladder. Overactive bladder remission occurred less often in those with baseline depression (19% vs 41%, P < .01) and anxiety (29% vs 42%, P = .03). After adjustment, depression decreased 1-year overactive bladder remission risk (odds ratio, 0.37; 95% confidence interval, 0.16-0.83). Overactive bladder treatment was uncommon and not associated with remission. CONCLUSION: Anxiety, depression, and prior sexual assault-common postdeployment problems for women veterans-influence the natural history of overactive bladder. Providers should screen for mental health conditions and sexual assault in women with newly diagnosed or persistent overactive bladder.

Role of chronic exercise on pelvic floor support and function.

PURPOSE OF REVIEW: To summarize recent literature about the potential role of chronic exercise on pelvic floor support and function. RECENT FINDINGS: Stress urinary incontinence is common during physical activity. Scant evidence suggests a dose-response association between higher volumes of exercise and urinary incontinence. Athletes do not appear to have greater pelvic floor muscle strength or worse pelvic floor support compared to nonathletes. Pelvic floor muscle electromyographic activity increases substantially as running speeds increase. SUMMARY: Based on the current literature, no strong conclusions can be drawn about whether chronic exercise exerts a positive or negative influence on pelvic floor support and function. Adopting longitudinal research methodology that prospectively monitors exercise exposure and subsequent changes in pelvic floor support and function would help to reduce selection bias associated with cross sectional studies on groups of athletes.

Physical activity and the pelvic floor.

Pelvic floor disorders are common, with 1 in 4 US women reporting moderate to severe symptoms of urinary incontinence, pelvic organ prolapse, or fecal incontinence. Given the high societal burden of these disorders, identifying potentially modifiable risk factors is crucial. Physical activity is one such potentially modifiable risk factor; the large number of girls and women participating in sport and strenuous training regimens increases the need to understand associated risks and benefits of these exposures. The aim of this review was to summarize studies reporting the association between physical activity and pelvic floor disorders. Most studies are cross-sectional and most include small numbers of participants. The primary findings of this review include that urinary incontinence during exercise is common and is more prevalent in women during high-impact sports. Mild to moderate physical activity, such as brisk walking, decreases both the odds of having and the risk of developing urinary incontinence. In older women, mild to moderate activity also decreases the odds of having fecal incontinence; however, young women participating in high-intensity activity are more likely to report anal incontinence than less active women. Scant data suggest that in middle-aged women, lifetime physical activity increases the odds of stress urinary incontinence slightly and does not increase the odds of pelvic organ prolapse. Women undergoing surgery for pelvic organ prolapse are more likely to report a history of heavy work than controls; however, women recruited from the community with pelvic organ prolapse on examination report similar lifetime levels of strenuous activity as women without this examination finding. Data are insufficient to determine whether strenuous activity while young predisposes to pelvic floor disorders later in life. The existing literature suggests that most physical activity does not harm the pelvic floor and does provide numerous health benefits for women. However, future research is needed to fill the many gaps in our knowledge. Prospective studies are needed in all populations, including potentially vulnerable women, such as those with high genetic risk, levator ani muscle injury, or asymptomatic pelvic organ prolapse, and on women during potentially vulnerable life periods, such as the early postpartum or postoperative periods.

The impact of acute and chronic strenuous exercise on pelvic floor muscle strength and support in nulliparous healthy women.

BACKGROUND: Strenuous physical activity, which is known to increase intraabdominal pressure and theoretically places stress on the pelvic floor, may affect pelvic support in nulliparous women. OBJECTIVE: The aims of this study were to: (1) examine the differences in maximal vaginal descent (MVD), vaginal resting pressure (VRP), and pelvic floor muscle strength (PFMS) between women who habitually perform strenuous exercise vs women who refrain from performing strenuous exercise; and (2) compare MVD, VRP, and PFMS before and immediately following physical activity in the strenuous and nonstrenuous groups separately. STUDY DESIGN: Participants were healthy nulliparous women ages 18-35 years who were habitual strenuous or nonstrenuous exercisers. Women in the strenuous group participated in CrossFit (CrossFit, Inc., Washington, DC) at least 3 days per week for at least 6 months. We assessed anthropometric and body composition values using standardized procedures. Participants completed the Pelvic Organ Prolapse Quantification examination and pelvic muscle strength assessment before and again within 15 minutes of completing exercise (CrossFit for the strenuous group and self-paced walking for the nonstrenuous). A research nurse masked to study group assignment recorded MVD, defined as the greatest value of anterior, posterior, or apical support, and VRP and PFMS using a perineometer. Maximal PFMS was recorded as the highest pressure measured in 3 vaginal contraction trials. Data were analyzed using parametric and nonparametric tests as appropriate. P < .05 was considered significant. RESULTS: Seventy nulliparous women participated in the study, 35 in each group. The mean age was 24.77 ± 4.3 years. Compared to the nonstrenuous group, strenuous participants were heavier (64.70 ± 7.78 kg vs 60.6 ± 8.99 kg, P = .027), had lower percent body fat (23.36 ± 5.88% vs 27.55 ± 7.07%, P = .003), and had higher handgrip strength (20.78 ± 5.97 kg vs 16.04 ± 11.04 kg, P = .001). Before exercise, there were no significant differences in VRP (P = .167), MVD (P = .49), or maximal PFMS (P = .773) between the strenuous and nonstrenuous groups. Immediately following exercise, we observed significant increases in MVD in both the strenuous (P = .008) and nonstrenuous (P = .025) groups, indicating marginal decreases in support. VRP significantly decreased in both groups after exercise. Maximal PFMS did not change significantly in either group after exercise. CONCLUSION: After an exercise bout typical for each group, vaginal support and VRP decreased slightly in both groups. Based on preexercise measures, chronic strenuous exercise demonstrated neither beneficial nor deleterious effects on pelvic floor strength or support. While strenuous women had greater grip strength than nonstrenuous women, PFMS was not significantly greater, suggesting that targeted pelvic floor muscle strengthening, rather than general muscle fitness, is needed to maximize PFMS.

Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 2-the effect of exercise on the fetus, labour and birth.

This is Part 2 of 5 in the series of evidence statements from the IOC expert committee on exercise and pregnancy in recreational and elite athletes. Part 1 focused on the effects of training during pregnancy and on the management of common pregnancy-related symptoms experienced by athletes. In Part 2, we focus on maternal and fetal perinatal outcomes.

Physical activity patterns in healthy middle-aged women.

Exercise in healthy female adults around the menopausal transition has been routinely examined in leisure activities alone, potentially discounting the physical activity (PA) that is accumulated in household and outdoor domains. The purpose of this study was to quantify PA in healthy middle-aged women and to examine the extent to which the Center for Disease Control (CDC) PA guidelines were met through leisure, household, and outdoor activities. METHODS: 440 healthy women, 51-64 years old, BMI ≥18.5 or < 40 kg/m2, participated in the study using the Lifetime Physical Activity Questionnaire (LPAQ) to quantify PA. RESULTS: 25.91% met the CDC PA guidelines if leisure time alone was examined. When multiple domains were included, 73.41% of the women met the PA guidelines. This percentage is much higher than the reported 20.6% of U.S. adults who met the guidelines in 2011. PA in women may be underrepresented in data limited to leisure time PA.

A midurethral sling to reduce incontinence after vaginal prolapse repair.

BACKGROUND: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS: We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS: Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS: A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Lifetime physical activity and female stress urinary incontinence.

OBJECTIVE: We sought to estimate whether moderate/severe stress urinary incontinence (SUI) in middle-aged women is associated with overall lifetime physical activity (including leisure, household, outdoor, and occupational), as well as lifetime leisure (recreational), lifetime strenuous, and strenuous activity during the teen years. STUDY DESIGN: Recruitment for this case-control study was conducted in primary-care-level family medicine and gynecology clinics. A total of 1538 enrolled women ages 39-65 years underwent a Pelvic Organ Prolapse Quantification examination to assess vaginal support. Based on Incontinence Severity Index scores, cases had moderate/severe and controls had no/mild SUI. We excluded 349 with vaginal descent at/below the hymen (pelvic organ prolapse), 194 who did not return questionnaires, and 110 with insufficient activity data for analysis. In all, 213 cases were frequency matched 1:1 by age group to controls. Physical activity was measured using the Lifetime Physical Activity Questionnaire, in which women recall activity from menarche to present. We created separate multivariable logistic regression models for activity measures. RESULTS: SUI odds increased slightly with overall lifetime activity (odds ratio [OR], 1.20 per 70 additional metabolic equivalent of task-h/wk; 95% confidence interval [CI], 1.02-1.41), and were not associated with lifetime strenuous activity (OR, 1.11; 95% CI, 0.99-1.25). In quintile analysis of lifetime leisure activity, which demonstrated a nonlinear pattern, all quintiles incurred about half the odds of SUI compared to reference (second quintile; P = .009). Greater strenuous activity in teen years modestly increased SUI odds (OR, 1.37 per 7 additional h/wk; 95% CI, 1.09-1.71); OR, 1.75; 95% CI, 1.15-2.66 in sensitivity analysis adjusting for measurement error. The predicted probability of SUI rose linearly in women exceeding 7.5 hours of strenuous activity/wk during teen years. Teen strenuous activity had a similar effect on SUI odds when adjusted for subsequent strenuous activity during ages 21-65 years. CONCLUSION: In middle-aged women, a slight increased odds of SUI was noted only after substantially increased overall lifetime physical activity. Increased lifetime leisure activity decreased and lifetime strenuous activity appeared unrelated to SUI odds. Greater strenuous activity during teen years modestly increased SUI odds.