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NCT Number: NCT06671782

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kegel exercises

Other

Kegel exercises without any formal training

Pelvic Floor Muscle Exercise Program with biofeedback

Other

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

Other

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

Other

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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