Improving Urinary Continence and Quality of Life in Prostate Cancer Patients
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
- 否
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
Amy Zhang
Associate Professor
Case Western Reserve University
