Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- VA Office of Research and Development
- Enrollment
- 245
- Locations
- 3
- Primary Endpoint
- Time to Continence
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling)
- •Less than 1 week before surgery
Outcomes
Primary Outcomes
Time to Continence
Time Frame: 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.
Secondary Outcomes
- 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)