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Adjustable Continence Device
ProACT Therapy for Stress Urinary Incontinence
N/A
Recruiting
Research Sponsored by Uromedica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery
Subject demonstrates stress urinary incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will help to assess the long-term risks and benefits of the ProACT implant for treating stress urinary incontinence.
Who is the study for?
Men over 50 with stress urinary incontinence post-prostate surgery can join this study. They must be able to undergo ProACT device implantation, follow a 5-year study plan including phone interviews, and have no untreated urogenital cancers or bladder conditions. Men with severe allergies, uncontrolled diabetes (A1c >6.5%), recent prostate/anti-incontinence surgeries, or radiation therapy are excluded.Check my eligibility
What is being tested?
The trial is testing the long-term safety of ProACT Adjustable Continence Therapy for men with urinary incontinence after prostate surgery. It focuses on risks like urethral stricture and device erosion over five years and how it affects future treatments for stress urinary incontinence.See study design
What are the potential side effects?
Potential side effects may include complications such as urethral stricture (narrowing of the urethra) and device erosion into surrounding tissues which could require additional medical attention or surgical intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery for prostate cancer.
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I experience urine leakage when I cough, sneeze, or exercise.
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I am willing and able to have surgery to implant ProACT devices.
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I have no urogenital cancer except for treated prostate cancer.
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I have no urogenital cancer except for treated prostate cancer.
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I experience urine leakage when I cough, sneeze, or exercise.
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You have a low level of a specific protein in your blood called PSA, or if your PSA level is higher, your doctor thinks you are a good candidate for surgery.
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I am a man aged 50 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Erosions
Incontinence Quality of Life Questionnaire (I-QoL)
Urethral Strictures
Other outcome measures
Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: ProACT Adjustable Continence Therapy for MenExperimental Treatment1 Intervention
Patients implanted with ProACT Adjustable Continence Therapy for Men
Find a Location
Who is running the clinical trial?
UromedicaLead Sponsor
3 Previous Clinical Trials
511 Total Patients Enrolled
Timothy C Cook, PhDStudy DirectorUromedica, Inc.
1 Previous Clinical Trials
167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery for prostate cancer.My diabetes is not under control, with an A1c level of 6.5% or higher.I experience urine leakage when I cough, sneeze, or exercise.I am willing and able to have surgery to implant ProACT devices.I have no urogenital cancer except for treated prostate cancer.I have no urogenital cancer except for treated prostate cancer.I have bladder control issues that haven't improved with treatment.I experience urine leakage when I cough, sneeze, or exercise.I have bladder and sphincter muscle coordination issues.You have a low level of a specific protein in your blood called PSA, or if your PSA level is higher, your doctor thinks you are a good candidate for surgery.I have or might have bladder cancer.Your urine test does not show any signs of infection.I have bladder stones that haven't been treated or treatments failed.You have shown an increase of at least 8 grams in your pad weight during two 24-hour tests.I have a bladder that cannot contract.I am a man aged 50 or older.You have a device called an artificial urinary sphincter or any parts of it inside your body.I had prostate or anti-incontinence surgery in the last year.I have had radiation therapy in the prostate area within the last year.I have or had a narrowed urethra or underwent a procedure to widen it.I have hemophilia or another bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: ProACT Adjustable Continence Therapy for Men
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.
Is there an opportunity for individuals to join this research project at present?
"Affirmative, the clinicaltrials.gov page discloses that this experiment is presently recruiting applicants. First posted on February 19th 2019 and last amended April 19th 2022, it seeks to enroll 145 individuals at 3 distinct locations."
Answered by AI
What is the capacity of participants for this trial?
"This experiment necessitates 145 suitably qualified individuals to take part. Potential participants are able to join at a selection of sites, such as the University of Michigan in Ann Arbor or the University of Florida in Gainesville."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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