Physical Therapy for Men Undergoing Prostatectomy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02558946
• Other study ID #: 1501440753
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: Kim Smoot
• Phone: 317-962-688-3846
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Physical Therapy
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital and IU Health University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Comparison of post-op EPIC scores in the two study groups		4 to 8 weeks post-op
Secondary	Return to continence following surgery		Up to 12 months post-op