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Pelvic Floor Exercises

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06671782

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Kegel exercises

Pelvic Floor Muscle Exercise Program with biofeedback

Questionnaires

Interviews

Study Details

Brief 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

Study ID

NCT06671782

Start date

Nov 1, 2024

Status verified date

Jan, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

Interventions

Kegel exercises

Kegel exercises without any formal training

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).

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.

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.

Primary outcome measure

  • Assessing rate of accrual [ Time Frame: up to six months after surgery ]

Central Contacts and Locations

Central contacts

James Eastham, MD

646-422-4322easthamj@mskcc.org

Felix Cheung, MD

646-422-4318

Locations

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

James Eastham, MD

646-422-4322

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

James Eastham, MD

646-422-4322

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

James Eastham, MD

646-422-4322

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

James Eastham, MD

646-422-4322

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

James Eastham, MD

646-422-4322

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

James Eastham, MD

646-422-4322

Felix Cheung, MD

646-422-4318

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Urinary incontinence
  • Pelvic Floor Muscle Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-01-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.