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Physical Therapy for Men Undergoing Prostatectomy

Primary Purpose

Prostate Cancer, Urinary Incontinence, Pelvic Floor Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic Floor Muscle Physical Therapy
Control Group
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • IU Health Methodist Hospital and IU Health University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Physical Therapy Treatment Group

Control Group

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Return to continence following surgery

Full Information

First Posted
September 18, 2015
Last Updated
May 19, 2023
Sponsor
Indiana University
Collaborators
Indiana University Health
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1. Study Identification

Unique Protocol Identification Number
NCT02558946
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana University Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Urinary Incontinence, Pelvic Floor Physical Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy Treatment Group
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Muscle Physical Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
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 Measure Information:
Title
• Comparison of post-op EPIC scores in the two study groups
Time Frame
4 to 8 weeks post-op
Secondary Outcome Measure Information:
Title
Return to continence following surgery
Time Frame
Up to 12 months post-op

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Smoot
Phone
317-962-688-3846
Facility Information:
Facility Name
IU Health Methodist Hospital and IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Smoot
Phone
317-688-3846
First Name & Middle Initial & Last Name & Degree
Ronald Boris, MD

12. IPD Sharing Statement

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Physical Therapy for Men Undergoing Prostatectomy

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