Physical Therapy for Men Undergoing Prostatectomy

Indiana University

Status: Active, not recruiting

Conditions: Pelvic Floor Physical Therapy; Prostate Cancer; Urinary Incontinence

Treatments: Behavioral: Control Group; Behavioral: Pelvic Floor Muscle Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02558946

1501440753

Details and patient eligibility

About

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.

Full 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?

Enrollment: 113 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Physical Therapy Treatment Group

Active Comparator group

Description:

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 .

Treatment:

Behavioral: Pelvic Floor Muscle Physical Therapy

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Group