Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence.
ABSTRACT The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI).
Change in symptom and condition-specific health-related quality-of-life (HRQOL) measures were compared between pessary and behavioral groups 3 months after randomization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial. Four hundred forty-six women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary, prolapse, and colorectal scales of the Pelvic Floor Distress Inventory; urinary, prolapse, and colorectal scales of the Pelvic Floor Impact Questionnaire; and Stress and Urge scales of the Questionnaire for Urinary Incontinence Diagnosis. Student t test and analysis of variance were used to compare scores within and between groups.
Mean age of participants was 49.8 (SD, 11.9) years; 84% were white, and 10% were African American. One hundred forty-nine were randomized to pessary, and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after randomization, but there was no statistically significant difference between groups.
There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI.
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ABSTRACT: Mixed urinary incontinence (MUI) is a common, bothersome condition in women. In MUI, the two subtypes of urinary incontinence that coexist are treated differently; stress urinary incontinence (SUI) is primarily treated surgically while urge urinary incontinence (UUI) is primarily treated medically. There is no evidence to guide the treatment for women with significant bother from both incontinence subtypes. Therefore, investigators of the Urinary Incontinence Treatment Network (UITN) designed and initiated a randomized clinical trial comparing outcomes for two distinct initial treatment approaches for women with mixed urinary incontinence (MUI): therapy initiated with surgery versus therapy initiated with nonsurgical treatment. The aim of this manuscript is to describe the challenges in planning and implementing this randomized clinical trial. The mixed incontinence: medical or surgical approach (MIMOSA) trial was designed as a practical or pragmatic clinical trial to establish the relative efficacy of two specific treatment approaches. The design presented many challenging decisions including: (1) selection of practical paradigm; (2) refining inclusion/ exclusion criteria to offer equipoise; (3) selection of feasibility sample size; (4) recruitment challenges for two divergent treatment approaches (medical vs. surgical), and (5) resolution of ethical and methodological issues. MIMOSA recruitment was planned in two phases, starting with a 5-month pilot and feasibility phase followed by a full trial contingent on the outcome of the first phase. The feasibility portion of the MIMOSA trial started in November 2008. 1198 subjects were screened and approached for study enrollment, but only 27 consented to randomization. The feasibility study was halted due to lack of enrollment in March 2009. The challenges of this trial included a lack of information from subjects who did not enroll, increasing the difficulty of interpreting the feasibility phase. Successful recruitment to a randomized trial that compares significantly different treatment approaches poses a challenge.Clinical Trials 08/2009; 6(4):355-64. · 2.20 Impact Factor
- Journal of Clinical Epidemiology 01/2006; 58(12):1217-9. · 5.33 Impact Factor
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ABSTRACT: We sought to estimate the minimum important difference (MID) for the Urinary Distress Inventory (UDI), UDI-stress subscale of the Pelvic Floor Distress Inventory, and Urinary Impact Questionnaire (UIQ) of the Pelvic Floor Impact Questionnaire. We calculated MID using anchor- and distribution-based approaches from a randomized trial for nonsurgical stress incontinence treatment. Anchors included a global impression of change, incontinence episodes from a urinary diary, and the Incontinence Severity Index. Effect size and standard error of measurement were the distribution methods used. Anchor-based MIDs ranged from -22.4 to -6.4 points for the UDI, -16.5 to -4.6 points for the UDI-stress, and -17.0 to -6.5 points for the UIQ. These data were supported by 2 distribution-based estimates. Reasonable estimates of MID are 11, 8, and 16 points for the UDI, UDI-stress subscale, and UIQ, respectively. Statistically significant improvements that meet these thresholds should be considered clinically important.American journal of obstetrics and gynecology 06/2009; 200(5):580.e1-7. · 3.28 Impact Factor