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: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged ≥18 years with prostate cancer scheduled for radical prostatectomy at MSK

Locations
United States
New Jersey
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITING
Rockville Centre
Contact Information
Primary
James Eastham, MD
easthamj@mskcc.org
646-422-4322
Backup
Felix Cheung, MD
646-422-4318
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 33
Treatments
Active_comparator: control group (usual care)
Consented patients randomized to the control group will receive usual care at MSK. This will comprise standardized verbal (and sometimes also written) instructions about Kegel exercises from the nurse and/or urologist before the operation. 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.
Experimental: intervention group (PFME program with biofeedback)
Consented patients randomized to the intervention group will be referred to SPEAR Physical Therapy to undergo the study PFME training program. The team at SPEAR Physical Therapy regularly sees patients undergoing radical prostatectomy and is specially trained in PFME training for male patients. 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).
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov