CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 245 enrolled
Drug / intervention
Pelvic Floor Muscle Training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01960998
NCT01960998N/ACompleted

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

VA Office of Research and Development·interventional·Posted Oct 11, 2013·Updated Aug 9, 2021

In Brief

A clinical study evaluating Pelvic Floor Muscle Training and Perioperative Care and Wetness Management for Urinary Incontinence and Prostate Cancer. Completed, enrolled 245 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 11, 2013
Enrollment StartAug 11, 2014
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.7 years ago

Interventions

Pelvic Floor Muscle Trainingbehavioral

Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 2-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website

Perioperative Care and Wetness Managementbehavioral

Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.