Physical Therapy for Men Undergoing Prostatectomy

NCT02558946 | Active Not Recruiting

• 1 other identifier: 1501440753
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urinary Incontinence; Pelvic Floor Physical Therapy

Outcome Measures

Primary Outcomes (1)

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

  4 to 8 weeks post-op

Secondary Outcomes (1)

• Return to continence following surgery

  Up to 12 months post-op

Study Arms (2)

Physical Therapy Treatment Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Pelvic Floor Muscle Physical Therapy BEHAVIORAL

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.

Physical Therapy Treatment Group

Control Group BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

IU Health Methodist Hospital and IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Urology

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 24, 2015
• Study Start: June 29, 2015
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-07

Locations

US (1)