N/A
N=197
Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Urinary Incontinence · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01960998 ↗Enrolled (actual)
197
Serious AEs
0.5%
Results posted
Aug 2021
Primary outcome: Primary: Time to Continence — NA; NA weeks — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic Floor Muscle Training (Behavioral); Perioperative Care and Wetness Management (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Continence |
NA; NA | 0.22 |
| SECONDARY International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total Score |
7.1; 7.0; 6.2; 6.7; 5.9; 6.0 | 0.70 |
| SECONDARY Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI) |
63.9; 63.5; 67.7; 65.1; 70.4; 68.0 | 0.70 |
| SECONDARY Incontinence Impact Questionnaire - Short Form (IIQ-SF) |
19.4; 22.3; 15.2; 19.3; 13.5; 16.5 | 0.46 |
| SECONDARY International Prostate Symptom Scale - Quality of Life Question |
21; 30; 27; 21; 27; 18 | 0.63 |
| SECONDARY Patient Satisfaction Question (PSQ) |
35; 48; 61; 38; 5; 8 | 0.04 sig |
| SECONDARY Estimated Percent Improvement (EPI) |
69.6; 65.1; 76.0; 72.6; 77.4; 75.7 | 0.67 |
| SECONDARY Global Perception of Improvement (GPI) |
39; 43; 41; 29; 15; 16 | 0.65 |
| SECONDARY How Disturbing is Urine Leakage |
39; 41; 54; 42; 8; 11 | 0.37 |
| SECONDARY Activity Restriction |
57; 48; 34; 34; 4; 7 | 0.63 |
| SECONDARY Return to Work |
63; 49; 3; 5; 1; 2 | 0.71 |
| SECONDARY Resumption of Normal Activity |
5; 7; 23; 28; 73; 59 | 0.41 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01960998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.