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Pelvic Floor Physical Therapy for Prostate Cancer
N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients scheduling to undergo robot-assisted radical prostatectomy
Be older than 18 years old
Must not have
Previous prostate surgery
Radiation treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if pre- and post-operative pelvic floor exercises can improve quality of life after prostate surgery.
Who is the study for?
This trial is for men who are planning to have robot-assisted surgery to remove the prostate due to cancer. They must be able to understand and agree to the study's process, and willing to fill out a health questionnaire. Men who've had radiation treatments, previous prostate surgeries, or any urinary leakage requiring pads in the last 6 months cannot participate.
What is being tested?
The study is testing if special exercises for pelvic floor muscles taught by a physical therapist can improve life quality after prostate removal surgery. Participants will either receive this therapy or be placed in a control group without it.
What are the potential side effects?
Since this intervention involves physical therapy exercises, potential side effects may include muscle soreness or strain. However, these activities are generally considered safe and side effects should be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a robotic surgery to remove my prostate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my prostate before.
Select...
I am undergoing or have undergone radiation treatment.
Select...
I have used pads for urinary leakage in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Control GroupActive Control1 Intervention
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.
Group II: Physical Therapy Treatment GroupActive Control1 Intervention
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 .
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,945 Total Patients Enrolled
2 Trials studying Urinary Incontinence
20 Patients Enrolled for Urinary Incontinence
Indiana University HealthOTHER
31 Previous Clinical Trials
16,028 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my prostate before.I am scheduled for a robotic surgery to remove my prostate.I am undergoing or have undergone radiation treatment.I have used pads for urinary leakage in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Physical Therapy Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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