Clinical trial NCT06671782: A Study of a Pelvic Floor Muscle Exercise Program Before and After Radical Prostatectomy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Urinary incontinence
Pelvic Floor Muscle Exercise
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled pilot study.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessing rate of accrual
timeFrame: up to six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: