Clinical Trials /

Physical Therapy for Men Undergoing Prostatectomy

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

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

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.

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

NameTypeDescriptionInterventions
Physical Therapy Treatment GroupActive ComparatorWritten 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 GroupActive ComparatorWritten 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:Recruiting
      Lead Sponsor:Indiana University

      Last Updated

      February 10, 2017