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临床试验/NCT01365182
NCT01365182已完成不适用

Improving Urinary Continence and Quality of Life in Prostate Cancer Patients

Case Western Reserve University0 个研究点目标入组 279 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
279
主要终点
Amount of Urinary Leakage

研究概览

简要总结

This intervention program combines biofeedback PFME with a telephone or support group intervention to treat persistent urinary incontinence (UI). The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of incontinence symptoms. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions.

详细描述

This is a randomized, controlled longitudinal study. Patients with early-stage prostate cancer and UI for more than six months were randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+SUPPORT); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+SUPPORT and BF+PHONE participants learned PFME through computerized biofeedback. Thereafter, the BF+SUPPORT participants attended six group meetings and the BF+PHONE participants had six phone contacts every other week for three months. The UC participants did not receive biofeedback PFME or telephone/group intervention but continued receiving usual medical care. All subjects were assessed blind at baseline, 3 months (post intervention) and 6 months (follow-up). In addition, 49 moderately to severely incontinent patients were recruited from the three study groups to undergo urodynamic testing at baseline and 3 months for the evaluation of physiological changes. Data of the costs for the interventions and the participants' medical care were collected for a cost-effectiveness analysis.

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
21 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Have been diagnosed with early stage (I-III) prostate cancer.
  • Have completed cancer treatments six months prior.
  • Presence of incontinence symptoms

排除标准

  • Receiving hormonal treatment.
  • Urinary tract infection or urinary retention.
  • Cognitive impairment.
  • Having an implant

结局指标

主要结局

Amount of Urinary Leakage

时间窗: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment

Amount of leakage measured on 1-hour pad test

Frequency of Daily Urinary Leakage

时间窗: Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment

Average times of daily leakage measured on a 3-day diary

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Zhang

Associate Professor

Case Western Reserve University

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