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Physical Therapy for Men Undergoing Prostatectomy

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ClinicalTrials.gov Identifier: NCT02558946
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Indiana University Health
Information provided by (Responsible Party):
Ronald Boris, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Incontinence Pelvic Floor Physical Therapy Behavioral: Pelvic Floor Muscle Physical Therapy Behavioral: Control Group Not Applicable

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?


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men With Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: Physical Therapy Treatment Group
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 .
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.

Active Comparator: Control Group
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.
Behavioral: 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.




Primary Outcome Measures :
  1. • Comparison of post-op EPIC scores in the two study groups [ Time Frame: 4 to 8 weeks post-op ]

Secondary Outcome Measures :
  1. Return to continence following surgery [ Time Frame: Up to 12 months post-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558946


Contacts
Contact: Kim Smoot 317-962-0869

Locations
United States, Indiana
IU Health Methodist Hospital and IU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kim Smoot    317-962-0869      
Principal Investigator: Ronald Boris, MD         
Sponsors and Collaborators
Indiana University
Indiana University Health

Responsible Party: Ronald Boris, Physician, Indiana University
ClinicalTrials.gov Identifier: NCT02558946     History of Changes
Other Study ID Numbers: 1501440753
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Enuresis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders