Status:
COMPLETED
Program to Reduce Incontinence by Diet and Exercise
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
30+ years
Phase:
NA
Brief Summary
PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00091988
Start Date
July 1 2004
End Date
November 1 2007
Last Update
April 16 2020
Active Locations (4)
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1
University of Alabama
Birmingham, Alabama, United States, 35205
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
3
University of California at San Francisco
San Francisco, California, United States, 94110
4
Miriam Hospital/Brown University
Providence, Rhode Island, United States, 02903