Program to Reduce Incontinence by Diet and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 4
- 主要终点
- Change in the number of incontinent episodes
研究概览
简要总结
PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lifestyle & Behavioral Change Program
干预措施: Lifestyle & Behavioral Change Program (Behavioral)
Structured Education Program
干预措施: Structured Education Program (Behavioral)
结局指标
主要结局
Change in the number of incontinent episodes
时间窗: 6 months
Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months
次要结局
- Change in body weight at 6 months(6 months)
- Change in body weight at 12 months(12 months)
- Change in body weight at 18 months(18 months)