Program to Reduce Incontinence by Diet and Exercise

Urinary Incontinence Clinical Trial

— PRIDE  

Official title:

Program to Reduce Incontinence by Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091988
• Other study ID #: U01DK067860
• Secondary ID: U01DK067860
• Status: Completed
• Phase: N/A
• Start date: July 2004
• Est. completion date: November 2007

Study information

• Verified date: April 2020
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Description:

Three hundred and thirty overweight and obese women with urinary incontinence, 165 from each of two Clinical Centers, will be randomized to either a 6-month intensive behavioral weight control program or to usual care (no weight reduction intervention) and followed for 18 months. Efficacy of weight reduction as a treatment for urinary incontinence will be examined at 6 months following the intensive weight control program, and the sustained impact of the intervention will be examined at 18 months. To increase the maintenance of weight reduction and facilitate evaluation of the enduring impact of weight loss on urinary incontinence, we propose to study a motivation-based weight maintenance program. At the end of the intensive weight control program, women randomized to the weight loss program will be randomized to either a 12-month skill-based maintenance intervention or to a motivation-based maintenance intervention. The maintenance interventions maximize the potential for sustained weight loss and will allow us to determine if long-term weight reduction will produce continued improvement in urinary incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• aged = 30 years and not institutionalized

• body mass index 25 to 50 kg/m2

• urinary incontinence symptoms for > 3 months by self-report and record > 10 incontinent episodes per week on a 7-day urinary diary

• able to complete a behavioral run-in consisting of self-monitoring of food and activity

• report having a primary health care provider

• able to understand and sign informed consent and complete baseline questionnaires

• agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

Exclusion Criteria:

• current use, or use within the previous month of medical therapy for incontinence

• currently pregnant or gave birth in the previous 6 months

• current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having > 4 urinary tract infections in the preceding year

• incontinence of neurologic or functional origin (by history)

• self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation

• self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)

• report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure > 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician

• currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months

• report being unable to walk 2 blocks (1/4 mile) without stopping

• report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia

• participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Lifestyle & Behavioral Change Program
Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.
• Structured Education Program
Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Arkansas	Little Rock	Arkansas
United States	Miriam Hospital/Brown University	Providence	Rhode Island
United States	University of California at San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of incontinent episodes	Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months	6 months
Secondary	Change in body weight at 6 months	Change from baseline in body weight measured in kg	6 months
Secondary	Change in body weight at 12 months	Change from baseline in body weight measured in kg	12 months
Secondary	Change in body weight at 18 months	Change from baseline in body weight measured in kg	18 months

External Links

•   PRIDE Public Website