NCT06671782

A Study of a Pelvic Floor Muscle Exercise Program Before and After Radical Prostatectomy

Improving Patient Involvement in Care-A Pilot Study of a Comprehensive Pelvic Floor Muscle Exercise Program Before and After Radical Prostatectomy to Prevent Urinary Leakage

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out if a PFME program to reduce urinary incontinence after radical prostatectomy is feasible for people with prostate cancer. The researchers will track how many participants join the study, follow the program, and stay in the study. They will also evaluate how people feel about their experience and satisfaction with participating in this program through interviews. They will also measure participants' quality of life by filling out questionnaires, and we will study whether the program shows promise in reducing urinary incontinence. Radical prostatectomy sometimes causes incontinence after the surgery. The researchers think that by teaching PFME and strengthening and improving control of the pelvic floor muscles, PFME training before and after radical prostatectomy may help reduce incontinence and/or reduce how long incontinence lasts.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Kegel exercises	Kegel exercises without any formal training
OTHER	Pelvic Floor Muscle Exercise Program with biofeedback	Patients in the intervention arm will undergo PFME training with a physical therapist 2 times before surgery (4-6 weeks \[in person\] and 3-4 weeks \[in person\], before surgery) (within ±1 week is considered acceptable to avoid protocol violations). Patients in the intervention group will also undergo 2 PFME training sessions after surgery (3 weeks and 1.5 months after surgery).
OTHER	Questionnaires	All patients will complete the Prostate Quality of Life Survey at baseline and at 1.5, 3, and 6 months after radical prostatectomy (within ±2 weeks is considered acceptable to avoid protocol violations). This is part of the standard of care for patients undergoing prostatectomy.
OTHER	Interviews	A qualitative interview with each of the 15 patients in the intervention group to obtain information about the patient's experience. The interview will last for 30-60 min and will be conducted at 3-6 months after prostatectomy, when the patient has completed all 4 physical therapy sessions. It will cover topics related to patient involvement, satisfaction, and activation.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-11-04
• Last updated: 2026-02-11

Locations

7 sites across 1 country: United States