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Sling
Urethral Sling Surgeries for Stress Urinary Incontinence
Phase 3
Waitlist Available
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with stress urinary incontinence with a positive cough test
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 & 2 years post surgery
Awards & highlights
Study Summary
This trial compares two surgeries for treating female stress urinary incontinence.
Who is the study for?
This trial is for women who have stress urinary incontinence confirmed by a cough test and want surgery. It's not suitable for those with mostly overactive bladder symptoms, past unsuccessful treatments, weak urethral closure pressure, significant vaginal prolapse beyond stage 1, or difficulty emptying their bladder fully.Check my eligibility
What is being tested?
The study is comparing two surgical procedures to treat female stress urinary incontinence: the Mini-Arc Precise Pro sling and the Trans Vaginal Obturator Tape (TVT-O). Women will be randomly assigned to one of these surgeries.See study design
What are the potential side effects?
Possible side effects from both surgeries may include pain at the incision site, bleeding, infection risk, temporary difficulty urinating post-surgery, and potential injury to surrounding organs during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with urine leakage when I cough.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cough test at one year from surgery
Secondary outcome measures
Subjective symptoms, QOL questionaires
Trial Design
1Treatment groups
Active Control
Group I: Precise sling vs TVT-O slingActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,522 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman with urine leakage when I cough.I have had a treatment or procedure that did not work.Your bladder pressure is less than 20 centimeters of water.I am choosing to have surgery for my condition.I have a vaginal prolapse more severe than stage 1.I have trouble emptying my bladder fully.I mainly have issues with bladder control.
Research Study Groups:
This trial has the following groups:- Group 1: Precise sling vs TVT-O sling
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Could you please compare and contrast the risks associated with Precise sling vs TVT-O sling?
"Precise sling vs TVT-O sling both have extensive safety data, thus they each received a score of 3."
Answered by AI
Who else is applying?
What site did they apply to?
Ken Maslow
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I am tired of not living my life to its fullest potential.
PatientReceived 2+ prior treatments
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