Prostate Cancer
Conditions
Keywords
Urinary incontinence, Pelvic Floor Muscle Exercise
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.
Interventions
OTHERKegel exercises
Kegel exercises without any formal training
OTHERPelvic 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).
OTHERQuestionnaires
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.
OTHERInterviews
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a randomized controlled pilot study.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing rate of accrual | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Eastham, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed