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临床试验/NCT01960998
NCT01960998已完成不适用

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2014年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
245
试验地点
6
主要终点
Time to Continence

研究概览

简要总结

Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.

详细描述

Many men develop urine leakage after radical prostatectomy. Usually it is temporary, but pelvic floor muscle training including bladder control strategies has been shown to reduce the severity of incontinence and reduce the time to regaining continence. This study will test an evidence-based pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves.

This study is a randomized, controlled trial of the telehealth-delivered, evidence-based, intervention developed in the pilot/developmental study. Participants will be randomized 1:1 to treatment or to a control group. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.

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 (Care Provider)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Scheduled to undergo a radical prostatectomy for treatment of prostate cancer and enrolled at the Birmingham, Philadelphia, or Atlanta VA Medical Centers or the affiliated University Medical Centers
  • Ability to read English.
  • Internet access

排除标准

  • Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling)
  • Less than 1 week before surgery

结局指标

主要结局

Time to Continence

时间窗: 6 months

Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; higher scores indicate worse condition.

次要结局

  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score(6 months, 9 months, 12 months)
  • Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)(6 months, 9 months, 12 months)
  • Estimated Percent Improvement (EPI)(6 months, 9 months, 12 months)
  • Return to Work(6 months, 9 months, 12 months)
  • Incontinence Impact Questionnaire - Short Form (IIQ-SF)(6 months, 9 months, 12 months)
  • International Prostate Symptom Scale - Quality of Life Question(6 months, 9 months, 12 months)
  • Patient Satisfaction Question (PSQ)(6 months, 9 months, 12 months)
  • Global Perception of Improvement (GPI)(6 months, 9 months, 12 months)
  • How Disturbing is Urine Leakage(6 months, 9 months, 12 months)
  • Activity Restriction(6 months, 9 months, 12 months)
  • Resumption of Normal Activity(6 months, 9 months, 12 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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