Skip to main content
Clinical Trials/NCT02558946
NCT02558946
Active, not recruiting
Not Applicable

Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men with Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy

Indiana University1 site in 1 country113 target enrollmentJune 29, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Indiana University
Enrollment
113
Locations
1
Primary Endpoint
• Comparison of post-op EPIC scores in the two study groups
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.

Detailed Description

Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery. In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?

Registry
clinicaltrials.gov
Start Date
June 29, 2015
End Date
January 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronald Boris

Associate Professor, Urology

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Patients scheduling to undergo robot-assisted radical prostatectomy
  • Patients willing and able to complete the EPIC questionnaire in its entirety
  • Ability to provide informed consent

Exclusion Criteria

  • Previous prostate surgery
  • Radiation treatment
  • History of incontinence defined as any pad use for urinary leakage in the past 6 months

Outcomes

Primary Outcomes

• Comparison of post-op EPIC scores in the two study groups

Time Frame: 4 to 8 weeks post-op

Secondary Outcomes

  • Return to continence following surgery(Up to 12 months post-op)

Study Sites (1)

Loading locations...

Similar Trials