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NCT01960998 · ClinicalTrials.gov registry record · NA
Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 245
- Enrollment target
NCT01960998: Completed NA study, sponsored by VA Office of Research and Development.
NCT01960998 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 245 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960998, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Pelvic Floor Muscle Training
- BEHAVIORAL Perioperative Care and Wetness Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2014-08-11 |
| Est. Completion | 2019-09-30 |
| Phase | NA |
What the finished NCT01960998 record still lists
NCT01960998 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Pelvic Floor Muscle Training is the first listed.
NCT01960998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960998 about?
NCT01960998 is a clinical study titled "Perioperative Post-Prostatectomy Incontinence Home Telehealth Program". 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 pr...
What is the current status of trial NCT01960998?
This trial is currently completed. It is a NA study. The enrollment target is 245 participants. The study started on 2014-08-11. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT01960998?
The interventions under investigation include: Pelvic Floor Muscle Training (BEHAVIORAL), Perioperative Care and Wetness Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT01960998?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960998's enrollment target sits among peer trials
245 436th of 2000 higher than 1,563 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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