This randomized clinical trial studies how well pelvic floor muscle training works in improving continence recovery in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body who are undergoing surgery. Pelvic floor muscle training may help to provide a quicker return to urinary continence (ability to hold urine in) and improve health-related quality of life in patients with prostate cancer who are undergoing surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT02558946.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine if preoperative pelvic floor muscle training as directed by a physical therapist lessens the expected postoperative drop off (from baseline to 4 to 8 weeks post-op) in urinary related quality of life as measured in the urinary domain score from the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
II. To determine if preoperative pelvic floor muscle training as directed by a physical therapist impacts patients’ recovery of continence following surgery as measured by the EPIC questionnaire.
SECONDARY OBJECTIVES:
I. To determine if preoperative pelvic floor muscle training as directed by a physical therapist impacts the total EPIC score.
II. To determine if preoperative pelvic floor muscle training as directed by a physical therapist impacts time to continence.
III. To determine if preoperative pelvic floor muscle training as directed by a physical therapist impacts overall continence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo pelvic floor muscle training with a physical therapist over 1 hour at 1-6 weeks pre-operatively, and at 7-10 days and 4-8 weeks post-operatively. Patients also receive standard of care written and verbal information on performing Kegel exercises before undergoing robot-assisted radical prostatectomy.
GROUP II: Patients receive standard of care written and verbal information on performing Kegel exercises before undergoing robot-assisted radical prostatectomy.
After completion of study, patients are followed up at 4-8 weeks, and then every 3 months for 1 year.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorRonald S Boris
