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Pelvic Floor Physical Therapy for Prostate Cancer
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-op
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
• Comparison of post-op EPIC scores in the two study groups
Secondary outcome measures
Return to continence following surgery
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
980 Previous Clinical Trials
981,602 Total Patients Enrolled
2 Trials studying Urinary Incontinence
146 Patients Enrolled for Urinary Incontinence
Indiana University HealthOTHER
30 Previous Clinical Trials
15,873 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this medical experiment?
"Affirmative. According to information on clinicaltrials.gov, this medical study is still accepting volunteers. The trial was initially launched in May of 2015 and has been recently modified as of May 19th 2023; it requires 160 participants from a single site."
Answered by AI
Are there any opportunities available to join this experiment?
"Affirmative, the records hosted on clinicaltrials.gov indicate that this trial is actively looking for participants. It was first posted on May 1st 2015 and has been recently updated as of May 19th 2023. The experiment needs 160 volunteers from a single location."
Answered by AI
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