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Procedure

AUS vs ATOMS for Urinary Incontinence

N/A
Recruiting
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult men (≥ 18 years of age) with moderate-to-severe post-prostatectomy urinary incontinence who are eligible and have consented to receive surgery as treatment. Determining patient eligibility for surgery is based on the AUA/SUFU Guidelines, published in 2019.
Be older than 18 years old
Must not have
Patients who suffer mild incontinence (less than 200g per day).
Patients with known allergies or sensitivity to rifampin or to minocycline HCl or other tetracyclines in InhibiZone implantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness of two treatments for post-prostatectomy incontinence: an artificial urinary sphincter (AUS) or an adjustable transobturator male sling (ATOMS).

Who is the study for?
Adult men over 18 with moderate-to-severe urinary incontinence after prostate surgery, who are fit for surgery based on AUA/SUFU Guidelines and agree to be randomly assigned to receive either ATOMS or AUS. Excludes those with poor manual dexterity, cognitive issues, unresolved urethral stenosis, mild incontinence, neurogenic incontinence, previous incontinence surgeries, rising PSA levels or allergies to certain antibiotics.
What is being tested?
This study is testing the effectiveness of two surgical devices for treating post-prostatectomy urinary incontinence: Artificial Urinary Sphincter (AUS) and Adjustable Transobturator Male System (ATOMS). It's a pilot randomized controlled trial aiming to see if ATOMS is not worse than AUS by more than 15% for this condition.
What are the potential side effects?
Potential side effects may include urethral erosion or atrophy which could be less common with ATOMS compared to AUS. Other risks typically associated with surgical procedures such as infection or reaction to anesthesia may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man over 18 with severe urinary issues after prostate surgery and have agreed to more surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I experience light incontinence, less than 200g per day.
Select...
I am allergic to rifampin, minocycline HCl, or other tetracyclines.
Select...
I have had surgery for incontinence before.
Select...
I have urinary incontinence caused by a permanent blockage in my lower urinary tract.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
Experimental Treatment
Active Control
Group I: Adjustable Transobturator Male SystemExperimental Treatment1 Intervention
Group II: Artificial Urinary SphincterActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
307 Previous Clinical Trials
77,564 Total Patients Enrolled

Media Library

Adjustable Transobturator Male System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05464316 — N/A
Incontinence Research Study Groups: Adjustable Transobturator Male System, Artificial Urinary Sphincter
Incontinence Clinical Trial 2023: Adjustable Transobturator Male System Highlights & Side Effects. Trial Name: NCT05464316 — N/A
Adjustable Transobturator Male System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464316 — N/A
~15 spots leftby Dec 2025
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