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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female at least 22 years old
Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will show whether the ACT is safe and effective in improving stress urinary incontinence.
Who is the study for?
This trial is for women over 22 who've unsuccessfully tried other treatments for stress urinary incontinence (SUI) for at least 6 months. They should have a significant degree of urine leakage, as shown by a pad test, and be able to follow the trial's procedures. Women can't join if they're pregnant, breastfeeding, have certain bladder issues or cancers, severe pelvic prolapse, uncontrolled diabetes, bleeding disorders or are undergoing radiation therapy.Check my eligibility
What is being tested?
The Adjustable Continence Therapy (ACT) is being tested to see if it can significantly improve SUI in women. This single-arm study involves multiple centers where all participants receive ACT without being compared to another group.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the implant site, infection risk from surgery, potential device malfunction or failure leading to persistent symptoms of SUI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 22 or older.
Select...
I have been diagnosed with stress urinary incontinence due to weak sphincter muscles.
Select...
I am eligible for surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Provocative pad weight
Secondary outcome measures
Incontinence Quality of Life Questionnaire (I-QOL)
Urogenital Distress Inventory (UDI)
Other outcome measures
Complete adverse event profile
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adjustable Continence Therapy for WomenExperimental Treatment1 Intervention
Implantation of the Adjustable Continence Therapy for the treatment of female SUI.
Find a Location
Who is running the clinical trial?
UromedicaLead Sponsor
3 Previous Clinical Trials
489 Total Patients Enrolled
Timothy C Cook, PhDStudy DirectorUromedica, Inc.
1 Previous Clinical Trials
145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried treatments for urinary incontinence for over 6 months without success.Your bladder does not stretch like it should, as shown by a test called a cystometrogram.I have or might have bladder cancer.My bladder muscle is overactive and medications haven't helped.I have had bladder stones in the past.My diabetes is not under control, with high HbA1c and blood sugar levels.I am currently receiving radiation therapy.You have leaked more than 11 grams of urine during a specific test.I have had radiation therapy to my pelvic area before.I have a bleeding disorder.Your cystourethroscopy results are normal.I currently have a urinary tract infection.You have previously had a device called an artificial urinary sphincter implanted.You are expected to live for less than 5 years.Your urine test results are normal.I have trouble fully emptying my bladder, leaving more than 100 ml.I have a narrowed urethra confirmed by a bladder scope test.I have a nerve condition that affects my bladder control.My bladder doesn't contract properly or has coordination issues.I am a woman aged 22 or older.You have an autoimmune disease.I have a significant pelvic organ prolapse.I have been diagnosed with stress urinary incontinence due to weak sphincter muscles.I am eligible for surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Adjustable Continence Therapy for Women
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 people have committed to participating in this research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which initially posted on January 26th 2021 is currently recruiting participants. Specifically, 167 individuals are sought from 6 different clinical sites."
Answered by AI
How many locales are facilitating this trial?
"There are 6 medical sites currently participating in this research, including Ochsner Health in New Orleans, Virtua Health Inc. in Moorestown and the Medical University of South carolina in Charleston. Additionally, there are 3 other establishments that have signed up for the project."
Answered by AI
Is there currently an enrollment period for this trial?
"As verified by clinicaltrials.gov, the recruitment process for this study is still underway. It was first announced on January 26th 2021 and has received subsequent updates as recently as May 2nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
What site did they apply to?
Ochsner Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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