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.).

Burch colposuspension versus fascial sling to reduce urinary stress incontinence.

BACKGROUND: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. METHODS: We performed a multicenter, randomized clinical trial comparing two procedures--the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension--among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events. RESULTS: A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence. CONCLUSIONS: The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .).

Patient satisfaction with stress incontinence surgery.

AIMS: To identify predictors and correlates of patient satisfaction 24 months after Burch colpopexy or autologous fascial sling for treatment of stress urinary incontinence (SUI). METHODS: Participants were the 655 randomized subjects in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Variables potentially associated with satisfaction were tested in bivariate analysis, including demographics, baseline clinical characteristics of incontinence, and outcomes on validated subjective and objective measures. Satisfaction with treatment was defined as a response of "completely satisfied" or "mostly satisfied" on the Patient Satisfaction Questionnaire (PSQ) at 24 months. Variables significantly related to satisfaction were entered into multivariable regression models to test their independent association with satisfaction. RESULTS: At 24 months post-surgery, 480 (73%) participants completed the PSQ. Mean (±SD) age of the sample was 52 (±10) years and 77% were white. Most (82%) were completely or mostly satisfied with their surgery related to urine leakage. In the final multivariable model, patient satisfaction was associated with greater reduction in SUI symptoms (from baseline to 24 months; OR = 1.17, 95% CI: 1.10, 1.24) and greater reductions in symptom distress (OR = 1.16; CI: 1.08, 1.24). Lower odds of satisfaction were associated with greater urge incontinence symptoms at baseline (OR = 0.09, CI: 0.04, 0.22), detrusor overactivity at 24 months (OR = 0.29, CI: 0.12, 0.69), and a positive stress test at 24 months (OR = 0.45, CI: 0.22, 0.91). CONCLUSIONS: Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact.

Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial.

BACKGROUND: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING: 9 university-affiliated outpatient clinics. PATIENTS: 307 women with urge-predominant incontinence. INTERVENTION: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

Factors associated with incontinence frequency in a surgical cohort of stress incontinent women.

OBJECTIVE: The aim of this study was to identify factors associated with urinary incontinence severity at baseline in women undergoing surgery for stress incontinence. STUDY DESIGN: Baseline data were obtained from 650 women (age 28 to 81 years) with stress incontinence participating in a randomized surgical trial. Severity of incontinence was defined by the mean number of incontinence episodes per day recorded in a 3-day bladder diary. The relationships between severity and several baseline variables were examined, including demographics, medical, obstetric, and gynecologic history, body mass index, smoking status, Q-tip displacement, and Pelvic Organ Prolapse Quantification stage (POP-Q). RESULTS: In a multivariable model, severity of incontinence was positively associated with body mass index (P = .0003) and current smoking (P = .01), and negatively associated with prolapse stage (P < .0001) and Q-tip displacement (P = .042). CONCLUSION: Incontinence severity in a surgical population was independently associated with 2 modifiable factors, obesity and tobacco use, as well as pelvic support.

Radiologic images of retrograde ureterography before and after release of bilateral sacrospinous ligament fixation sutures.

Ureteral injury or compromise can occur after pelvic floor reconstruction for prolapse. Therefore, it is routine to perform intraoperative urethrocystoscopy at end of the operative case to confirm ureteral patency. We show retrograde ureterogram before and after release of fixation sutures from bilateral sacrospinous ligament fixation performed for stage III vaginal prolapse. The fluoroscopic images presented are intended to help pelvic surgeons visualize what could occur during sacrospinous ligament fixation. Furthermore, this case report illustrates how angulation of the distal ureter, without complete obstruction, may result in renal compromise.

Patient expectations did not predict outcome of drug and behavioral treatment of urgency urinary incontinence.

OBJECTIVES: : This study aimed to determine whether expectations of treatment outcomes in women participating in a drug and behavioral treatment trial for urge urinary incontinence are related to patient factors, demographics, health-related locus of control, and treatment outcomes. METHODS: : Baseline assessments included expectations (improvement in bladder condition, time to improvement in bladder condition, and duration of improvement) and the Medical Health Locus of Control (MHLC) scale. Outcomes were measured by the Patient Global Impression of Improvement scale (PGI-I) at the end of active treatment (10 weeks) and 8 months after trial start. RESULTS: : At baseline among 173 subjects, 114 (66%) believed their incontinence would get "very much better," 94 (55%) expected improvement by 1 month, and 111 (66%) expected improvement would last for the rest of their lives. There were no significant associations between baseline expectations or MHLC with the Patient Global Impression of Improvement scale at 10 weeks or 8 months. CONCLUSIONS: : Expectations of treatment outcome and MHLC did not predict eventual patient-reported treatment outcome in this sample of women with urge-predominant urinary incontinence participating in a trial of drug and behavioral therapy.

Estrogen stimulates the human endometrium to express a factor(s) that promotes vascular smooth muscle cell migration as an early step in microvessel remodeling.

Vascular smooth muscle cell (VSMC) migration is a pivotal early step in blood vessel remodeling; however, very little is known about the regulation of this process in the human endometrium during the menstrual cycle. In this study, explants of human endometrium were incubated with estradiol and/or progesterone and the conditioned medium (CM) applied to cultures of VSMC to test the hypothesis that estrogen and progesterone stimulate endometrial cells to secrete a factor(s) that promotes VSMC migration. Endometrial explants were composed of highly organized glands and stroma. VSMC migration (cells migrated in 21 h/mm(2) fibronectin-coated semipermeable membrane) in the presence of CM from human endometrial explants obtained in the proliferative phase of the menstrual cycle and incubated for 24 h with estradiol was approximately threefold greater (P < 0.001) than with medium alone and greater (P < 0.05) than with CM from explants treated with estradiol plus progesterone or progesterone. It is concluded, therefore, that estrogen stimulates endometrial secretion of a factor(s) that promotes VSMC migration as an early step in vessel remodeling within the endometrium.