Program to Reduce Incontinence by Diet and Exercise (PRIDE)

General Description

Epidemiological studies suggest that obesity is a strong risk factor for urinary incontinence (UI), and preliminary studies have suggested that weight loss may have a beneficial effect on urinary incontinence in obese women. The Program to Reduce Incontinence by Diet and Exercise (PRIDE) study was a multi-center (2 sites) randomized clinical trial conducted to examine the long term effects of a weight loss intervention on urinary incontinence in overweight and obese women.

A total of 338 women with at least UI episodes per week and a body-mass index (BMI) between 25 and 50 were enrolled in the study. Participants were randomly assigned to an intensive 6-month behavioral weight-loss program (intervention group) or to a structured four-session education program (control group) and followed for 18 months. Following completion of the 6-month weight loss intervention, participants in the intervention group underwent a second randomization to a motivationally focused weight loss maintenance program or a standard skills-based maintenance approach. The secondary randomization allowed the comparison of two approaches to weight loss maintenance. Urinary incontinence was assessed with a 7-day voiding diary. Assessments were completed at 6, 12, and 18 months, and information was collected on height, weight, demographics, and medical history, including urinary incontinence history. The primary outcome measure was the percentage change in the number of urinary incontinence episodes reported in the 7-day voiding diary at 6 months after randomization. Secondary outcome measures included the change in number of episodes of urge and stress urinary incontinence, participant satisfaction with incontinence treatment, and a standardized pad test to measure 24-hour involuntary urine loss. Longer term effects of the behavioral weight-loss program on UI were assessed at 12 and 18 months.

Results showed that the comprehensive behavioral weight-loss program resulted in a significantly greater reduction in the frequency of self-reported UI episodes (mean weekly number of incontinence episodes) at 6 months as compared with the structured education program. Additionally, decreased stress incontinence episode frequency was maintained at 12 months with a trend toward continued reduction in total incontinence episode frequency. At 18 months, there were no statistically significant differences in the reduction of weekly incontinence episode frequency for stress or total urinary incontinence between the groups, despite a substantial difference in greater weight loss and participant satisfaction with improvements in UI in the intervention group. The study concluded that the behavioral weight loss intervention was more effective than an educational control program in decreasing stress-related UI through 12 months, although the benefits at 18 months were more limited.

Objectives

The PRIDE study sought to determine whether a behavioral weight-reduction intervention for overweight and obese women with UI would result in greater reductions in the frequency of incontinence episodes as compared with a control group. A secondary aim was to compare the effects of motivation and skills based maintenance programs on changes in continence.

Outcome Measure

The primary outcome measure was the percentage change in the number of incontinence episodes reported in the 7-day voiding diary at 6 months after randomization. Secondary outcome measures included the percentage change in the number of episodes of urge and stress incontinence; the proportion of women in whom the frequency of incontinence decreased by at least 50%, 70%, or 100%; and change in a validated measure of participant satisfaction with incontinence treatment. A standardized pad test was also conducted to measure 24-hour involuntary urine loss.

Criteria

Women of at least 30 years of age were eligible for the study if they had a body-mass index (BMI) of 25 to 50 and at baseline reported 10 or more urinary-incontinence episodes in a 7-day diary of voiding. The participants were required to monitor their food intake and physical activity for 1 week, to be able to walk unassisted for two blocks (approximately 270 m) without stopping, and to agree not to initiate new treatments for incontinence or weight reduction for the duration of the study. Previous medical therapy for incontinence or obesity did not affect eligibility.

Exclusion criteria are documented in the study protocol.

Outcome

Results showed that the comprehensive behavioral weight-loss program resulted in a significantly greater reduction in the frequency of self-reported urinary-incontinence episodes at 6 months as compared with the structured education program. Additionally, decreased stress incontinence episode frequency was maintained at 12 months with a trend toward continued reduction in total incontinence episode frequency. At 18 months, there were no statistically significant differences in the reduction of weekly incontinence episode frequency for stress or total urinary incontinence between the groups, despite a substantial difference in greater weight loss and participant satisfaction with improvements in UI in the intervention group. The study concluded that the behavioral weight loss intervention was more effective than an educational control program in decreasing stress-related UI through 12 months, although the benefits at 18 months were more limited.