Physical Therapy for Men Undergoing Prostatectomy

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Urinary Incontinence; Pelvic Floor Physical Therapy
• Interventions: Behavioral: Control Group; Behavioral: Pelvic Floor Muscle Physical Therapy

• Registration Number: NCT02558946
• Lead Sponsor: Indiana University

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?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06-29
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 113

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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.
Physical Therapy Treatment Group	Pelvic Floor Muscle Physical Therapy	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 .

Primary Outcome Measures

Name	Time	Method
• Comparison of post-op EPIC scores in the two study groups	4 to 8 weeks post-op

Secondary Outcome Measures

Name	Time	Method
Return to continence following surgery	Up to 12 months post-op

Trial Locations

Locations (1)

IU Health Methodist Hospital and IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States