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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Pelvic Floor Muscle Exercise Program with biofeedback; Other: Questionnaires; Other: Interviews; Other: Kegel exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06671782

24-212

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

control group (usual care)

Active Comparator group

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.

Treatment:

Other: Kegel exercises

Other: Questionnaires

intervention group (PFME program with biofeedback)

Experimental group

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).

Treatment:

Other: Interviews

Other: Questionnaires

Other: Pelvic Floor Muscle Exercise Program with biofeedback