Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interviews | Other | — | UNRESOLVED |
| Kegel exercises | Other | — | UNRESOLVED |
| Pelvic Floor Muscle Exercise Program with biofeedback | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group (usual care)
- description
- 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.
- interventionNames
- Other: Kegel exercises
- Other: Questionnaires
- type
- EXPERIMENTAL
- label
- intervention group (PFME program with biofeedback)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years with prostate cancer scheduled for radical prostatectomy at MSK Exclusion Criteria: * Previous radiotherapy for prostate cancer * Urinary incontinence at baseline before radical prostatectomy * Inability to participate in study activities (exercise program, imaging, and questionnaires) because of: * Comorbidity(-ies) and/or * Geographic location and/or * Communication barrier(s)
References
Publications (0)
Data not yet available