Physical Therapy for Men Undergoing Prostatectomy

May 19, 2023 updated by: Clinton Bahler, Indiana University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kim Smoot
  • Phone Number: 317-962-688-3846

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Health Methodist Hospital and IU Health University Hospital
        • Principal Investigator:
          • Ronald Boris, MD
        • Contact:
          • Kim Smoot
          • Phone Number: 317-688-3846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Therapy Treatment Group
Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 7-10 days postoperative, and 4-8 weeks postoperative .
Behavioral: Pelvic Floor Muscle Physical Therapy
The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 1 week postoperative, and 4-6 weeks postoperative and will be coordinated with surgeon appointments to minimize any inconvenience and travel time.
Active Comparator: Control Group
Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit.
Behavioral: Control Group
At the cancer consultation visit, subjects will be educated by the urologist or urology team member regarding surgical and postoperative expectations. At this time, subjects will be provided verbal instruction and written information regarding Kegel exercises. Subjects in the control group may decide the duration and frequency of home exercise performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Comparison of post-op EPIC scores in the two study groups
Time Frame: 4 to 8 weeks post-op
4 to 8 weeks post-op

Secondary Outcome Measures

Outcome Measure
Time Frame
Return to continence following surgery
Time Frame: Up to 12 months post-op
Up to 12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Indiana University Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1501440753

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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