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

February 10, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Kegel exercises
Kegel exercises without any formal training
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.
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).
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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing rate of accrual
Time Frame: up to six months after surgery
Assess the feasibility of a comprehensive, physical therapist-instructed pre- and postoperative PFME program by determining rates of accrual
up to six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: James Eastham, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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