Deborah L. Myers

Dietary caffeine intake and the risk for detrusor instability: a case-control study

Objective To determine whether there is an association in women between caffeine intake and risk for detrusor instability. Methods Women were included if they had symptoms of urinary incontinence, completed a 48-hour voiding diary detailing fluid and caffeine intake, and had undergone standardized multichannel urodynamics. The study group had 131 women with detrusor instability on provocative cystometry and maximum urethral closure pressure greater than 20 cm of water. The control group had 128 women without detrusor instability on provocative cystometry and maximum urethral closure pressure greater than 20 cm of water. For statistical comparison, women were divided into the following three groups on the basis of caffeine intake: minimal (< 100 mg/day), moderate (100–400 mg/day), and high (> 400 mg/day). Results The mean caffeine intake of women with detrusor instability (484 ± 123 mg/day) was significantly higher than that of controls (194 ± 84 mg/day, P = .002). On univariate analysis, significant risk factors for detrusor instability were age, smoking status, and caffeine intake. On multivariate analysis, the statistically significant association between high caffeine intake and detrusor instability persisted after controlling for age and smoking (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1, 6.5, P = .018). When women with moderate caffeine intake were compared with those with minimal caffeine intake, the risk for detrusor instability was lower and did not reach significant levels (OR 1.5, 95% CI 0.1, 7.2, P = .093). Conclusion An association between high caffeine intake and detrusor instability was seen in this population. Larger studies are required to determine whether the association is causal.

Risk factors for bladder injury during cesarean delivery.

OBJECTIVE: During the period of this research, M.G.P. was supported by the Building Interdisciplinary Research Careers in Womens Health (BIRCWH) program (K12 HD43447-01) of the National Institutes of Health. To identify risk factors for bladder injury during cesarean delivery so as to inform patients and practitioners of these risks. METHODS: We conducted a case-control study of women undergoing cesarean delivery at Women and Infants Hospital between January 1995 and December 2002. Cases were women with bladder injuries at the time of cesarean delivery. Two controls per case were selected randomly. Medical records were reviewed for demographic and clinical data to compare cases and controls. RESULTS: Forty-two bladder injuries were identified among 14,757 cesarean deliveries (incidence of 0.28%). Prior cesarean delivery was more prevalent among cases than controls (67% versus 32%, P < .01). The adjusted risk for bladder injury associated with prior cesarean delivery was 3.82 (95% confidence interval 1.62–8.97). Statistically significant differences (P values ≤ .01) between cases and controls were found in emergent timing of delivery (31% versus 11%), labor before cesarean (83% versus 61%), attempted vaginal birth after cesarean (64% versus 22%), concurrent uterine rupture (14% versus 0%), adhesions (60% versus 10%), age (33.6 versus 29.3 years), and body mass index (29.9 versus 33.0 kg/m2). No differences were found among type of uterine incision, labor induction, chorioamnionitis, fetal position, gestational age, or maternal illnesses. CONCLUSION: Prior cesarean delivery is a risk factor for bladder injury at the time of repeat cesarean delivery. Patients should be counseled regarding this risk, particularly in the setting of increasing rates of elective primary cesarean delivery. LEVEL OF EVIDENCE: II-2

Vaginal paravaginal repair with an AlloDerm graft

OBJECTIVE This study was undertaken to describe outcomes of a technique of vaginal paravaginal repair that used AlloDerm graft (LifeCell, Branchburg, NJ) in women with recurrent stage II or with primary or recurrent stage III/IV anterior vaginal wall prolapse. STUDY DESIGN This was an observational study. Thirty-three women underwent a vaginal paravaginal repair using AlloDerm graft. Anterior vaginal wall prolapse was staged using the pelvic organ prolapse quantification system preoperatively and every 6 months after surgery. Recurrence of prolapse, changes in functional status (urinary symptoms, prolapse symptoms, and sexual activity), and complications were recorded. Objective failure was defined as recurrent anterior vaginal wall prolapse, stage II or greater, and subjective failure as symptomatic recurrent anterior vaginal wall prolapse. Life-table analysis evaluated objective and subjective failure. Risk factors for recurrent anterior vaginal wall prolapse were evaluated. RESULTS The mean age was 65.2 years and 93% of the women were white. Preoperatively, 6 women had recurrent stage II, 24 women had stage III, and 3 women had stage IV anterior vaginal wall prolapse. The median length of follow-up was 18 months. Postoperatively, 12 women had asymptomatic stage II anterior vaginal wall prolapse (not beyond the hymen) develop, and 1 woman had symptomatic stage II prolapse develop. Thus, there were 13 (41%) objective failures and 1 (3%) subjective failure. Life-table analysis demonstrated the cumulative probability of an objective failure was 0.24 at 1 year and 0.50 at 2, 3, and 4 years. The cumulative probability of a subjective failure was 0.00 at 1 and 2 years and 0.11 at 3 and 4 years. No risk factors for objective failure were identified. Voiding complaints resolved in 11 of 14 (79%) women (P=.004), incontinence symptoms resolved in 17 of 19 (89%) women (P<.001), and urgency symptoms resolved in 20 of 23 (87%) women (P<.001) (all two-tailed Fisher exact test). Twenty-one women (64%) were sexually active, and none complained of postoperative dyspareunia. Complications included 1 case of febrile morbidity, 1 cystotomy, and 1 anterior wall breakdown secondary to hematoma formation caused by heparin therapy. No other erosions or rejections were seen. CONCLUSION Vaginal paravaginal repair with AlloDerm graft in women with recurrent stage II or stage III/IV anterior vaginal wall prolapse is safe and has good subjective but only fair objective success within the first 2 years.

Effect of weight loss on urinary incontinence in overweight and obese women: results at 12 and 18 months.

PURPOSE Initial weight loss improves urinary incontinence in overweight and obese women. In this study we examined the longer term effects of a weight loss intervention on urinary incontinence. MATERIALS AND METHODS Overweight and obese women (mean +/- SD age 53 +/- 10 years) with 10 or more urinary incontinence episodes weekly were randomized to an 18-month behavioral weight loss intervention (226) or control group (112). Outcome measures were collected at 12 and 18 months. RESULTS At baseline women had a mean body mass index of 36 +/- 6 kg/m(2) and reported a mean of 24 +/- 18 incontinence episodes weekly. Of the patients 86% completed 18-month measurements. The percent weight loss in the intervention group averaged 8.0%, 7.5% and 5.5% at 6, 12 and 18 months, respectively, vs approximately 1.5% in the control group (all values p <0.001). Compared with controls at 12 months the intervention group reported a greater percent reduction in weekly stress urinary incontinence episodes (65% vs 47%, p <0.001), and a greater proportion achieved at least a 70% decrease in weekly total and stress urinary incontinence episodes. At 18 months a greater proportion of women in the weight loss intervention group had more than 70% improvement in urge incontinence episodes but there were no significant differences between the groups for stress or total urinary incontinence. The intervention group also reported greater satisfaction with changes in urinary incontinence than the control group at 6, 12 and 18 months. CONCLUSIONS Weight loss intervention reduced the frequency of stress incontinence episodes through 12 months and improved patient satisfaction with changes in incontinence through 18 months. Improving weight loss maintenance may provide longer term benefits for urinary incontinence.

Improving urinary incontinence in overweight and obese women through modest weight loss.

OBJECTIVE: To examine the relationship between magnitude of weight loss and changes in urinary incontinence frequency. METHODS: Overweight and obese women (N=338) with 10 or more urinary incontinence episodes per week were assigned randomly to an intensive 6-month behavioral weight loss program followed immediately by a 12-month weight maintenance program (intervention; n=226) or to a structured education program (control; n=112). The intervention and control groups were combined to examine the effects of the magnitude of weight loss on changes in urinary incontinence assessed by 7-day voiding diary, pad test, and self-reported satisfaction with change in urinary incontinence. RESULTS: Compared with participants who gained weight (reference), those who lost 5% to less than 10% or 10% or more of their body weight had significantly greater percent reductions in urinary incontinence episodes and were more likely to achieve at least a 70% reduction in the frequency of total and urge urinary incontinence episodes at 6, 12, and 18 months. Satisfaction was also related to magnitude of weight loss; approximately 75% of women who lost 5% to less than 10% of their body weight reported being moderately or very satisfied with their changes in urine leakage. CONCLUSION: Weight losses between 5% and 10% of body weight were sufficient for significant urinary incontinence benefits. Thus, weight loss should be considered as initial treatment for incontinence in overweight and obese women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00091988. LEVEL OF EVIDENCE: II

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Effect of body mass index on the risk of anal incontinence and defecatory dysfunction in women

OBJECTIVE The primary objective was to estimate the effect of body mass index on the risk of anal incontinence and defecatory dysfunction in a tertiary referral urogynecologic population. STUDY DESIGN This was a cross-sectional study, including 519 new patients. Exposure was defined as body mass index. The primary outcome was any reported anal incontinence. The secondary outcome was any defecatory dysfunction. We used multiple logistic regression to estimate odds ratios and 95% confidence intervals for the effect of body mass index on anal incontinence and defecatory dysfunction. RESULTS After adjusting for confounders, every 5 unit increase in body mass index was associated with a significantly increased odds of anal incontinence (odds ratio 1.25; 95% confidence interval, 1.09 to 1.44) and a trend toward an increased odds of defecatory dysfunction (odds ratio 1.13; 95% confidence interval, 0.98 to 1.31), although this was not statistically significant. CONCLUSION Increasing body mass index is significantly associated with anal incontinence, but not defecatory dysfunction in women.

Association between urinary incontinence and depressive symptoms in overweight and obese women.

OBJECTIVE The objective of the study was to determine the association between urinary incontinence (UI) and depressive symptoms. STUDY DESIGN The study was a cross-sectional study of 338 incontinent and overweight women at baseline in the Program to Reduce Incontinence by Diet and Exercise trial. Depressive symptoms were defined as a Beck Depression Inventory score of 10 or greater. UI frequency was determined by a 7-day voiding diary. Symptom bother and quality of life were determined using the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). Multivariable regression was used to estimate the association between UI and depressive symptoms. RESULTS Women with depressive symptoms (n = 101) reported a higher mean number of UI episodes per week (28 vs 23; P = .005) and higher (worse) mean scores on the UDI (176 vs 162; P = .02) and IIQ (136 vs 97; P < .001) compared with women without depressive symptoms. The risk of having depressive symptoms increased with each 7-episode increase in UI per week (adjusted odds ratio [AOR], 1.10; 95% confidence interval [CI], 1.01-1.21), each 50-point increase in UDI (AOR, 1.27; 95% CI, 1.01-1.60), and each 50-point increase in IIQ (AOR, 1.44; 95% CI, 1.22-1.71). CONCLUSION Urinary incontinence frequency, symptom bother, and quality of life are independently associated with depressive symptoms in overweight and obese women.

Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial.

OBJECTIVE: To estimate the effect of porcine subintestinal submucosal graft augmentation on improving anatomic and subjective rectocele repair outcomes compared with native tissue repair. METHODS: We conducted a randomized controlled trial at two sites, including women with at least stage 2 symptomatic rectocele. Anatomic and subjective outcomes (vaginal bulge and defecatory) were collected 12 months postoperatively, including blinded Pelvic Organ Prolapse Quantification (POP-Q) examinations. Anatomic failure was defined as points Ap or Bp −1 or greater on POP-Q. Subjective failure was defined as no improvement or worsening of symptoms. We estimated number needed to treat and adjusted odds ratios (ORs). Assuming graft use is associated with 93% anatomic success, 63 women per group would be needed to detect a 20% difference at &agr;=.05 and &bgr;=.20. RESULTS: One hundred sixty women were randomized; 137 had 12-month anatomic data (67 graft; 70 control). There was no difference in anatomic failure (12% compared with 9%, P=.5), vaginal bulge symptom failure (3% compared with 7%, P=.4, number needed to treat=26) or defecatory symptom failure (44% compared with 45%, P=.9, number needed to treat=91) for graft compared with control, respectively. Both groups reported improvement in vaginal bulge and defecatory symptoms (P<.05 for all). On multiple logistic regression, graft use was not associated with a decreased odds of anatomic failure (adjusted OR 1.36, 95% confidence interval [CI] 0.44–4.25), vaginal bulge symptoms (adjusted OR 0.46, 95% CI 0.08–2.68), or defecatory symptoms (adjusted OR 0.98, 95% CI 0.48–2.03). CONCLUSION: Although rectocele repair by either approach is associated with improved symptoms, subintestinal submucosal graft augmentation was not superior to native tissue for anatomic or subjective outcomes at 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00321867. LEVEL OF EVIDENCE: I

The Effect of Posterior Wall Support Defects on Urodynamic Indices in Stress Urinary Incontinence

Objective To determine if posterior vaginal wall defects affect urodynamic indices and mask stress urinary incontinence. Methods Ninety women with grade 0, 1, 2, or 3 posterior wall defects were evaluated prospectively by complete urodynamics to assess their urinary complaints. None had severe anterior or apical support defects. Urethral pressure profilometry and cough stress test were performed with the posterior wall in the unretracted position and then with the posterior wall retracted using a split speculum. Analysis of covariance was used to compare adjusted mean differences in maximum urethral closure pressure, functional urethral length, and units of leakage volume during the cough stress test in the unretracted and retracted positions among the posterior wall grade groups. Results In women with grade 3 posterior wall defects, there were significant changes from the unretracted to the retracted position in maximum urethral closure pressure of −7.0 cm H2O, (99% confidence interval [CI] −12.4, −1.6), functional urethral length of −0.3 cm (99% CI −0.5, −0.1), and leak volume units of +0.7 (99% CI 0.4, 1.0) during the cough stress test. There were four women with grade 3 posterior wall defects who demonstrated potential stress incontinence when their posterior wall was retracted. Conclusion A grade 3 posterior wall defect may artificially raise maximum urethral closure pressure, increase functional urethral length, and mask urinary stress incontinence during a cough stress test. Women with grade 3 posterior wall defects should be tested with the posterior wall retracted during urodynamic evaluation.