Clinical Trial: NCT02558946 - My Cancer Genome

NCT02558946

Description:

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.

Related Conditions:

Prostate Carcinoma

Recruiting Status:

Unknown status

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02558946

Trial Eligibility

Document

Title

Brief Title: Physical Therapy for Men Undergoing Prostatectomy
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 IDs

ORG STUDY ID: 1501440753
NCT ID: NCT02558946

Conditions

Prostate Cancer
Urinary Incontinence
Pelvic Floor Physical Therapy

Purpose

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?

Trial Arms

Name	Type	Description	Interventions
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 .
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.

Eligibility Criteria

        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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Male
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	• Comparison of post-op EPIC scores in the two study groups
Time Frame:	4 to 8 weeks post-op
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Return to continence following surgery
Time Frame:	Up to 12 months post-op
Safety Issue:
Description:

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Unknown status
Lead Sponsor:	Indiana University

Last Updated

February 13, 2017

Clinical Trials /

Physical Therapy for Men Undergoing Prostatectomy