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OpenTrials
Active, Not Recruiting

NCT Number: NCT02558946

Physical Therapy for Men Undergoing 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Pelvic Floor Physical Therapy Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital and IU Health University Hospital

Indianapolis, Indiana, 46202, United States

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 4 to 8 weeks post-op

Secondary outcomes

  1. Return to continence following surgery

    Time frame: Up to 12 months post-op

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2015
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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