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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
Patients who consented to being randomised in receiving ATOMS and AUS.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agreed to be randomly assigned to receive either ATOMS or AUS treatment.
Select...
I am a man over 18 with severe urinary issues after prostate surgery and have agreed to more surgery.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare effectiveness of the ATOMS and AUS devices in patients using results from the 24-hour pad test.
To compare effectiveness of the ATOMS and AUS devices in patients using results from the Patient Global Impression of Improvement (PGI-I) questionnaire.
Secondary outcome measures
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the 24-hour pad test.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the 24-hour pad-count.
Spectrophotometry, Atomic
+11 more

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
290 Previous Clinical Trials
68,885 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting participants at the present time?

"Indeed, the information hosted on clinicaltrials.gov corroborates that this research project is presently looking for participants. Initially posted on January 13th 2022, it has been updated as recently as July 14th 2022 and seeks to enroll 60 patients from a single centre."

Answered by AI

How many participants are currently signed up for this research study?

"Affirmative. Information found on clinicaltrials.gov indicates that this experiment, which went live in January 13th 2022, is actively pursuing participants for enrollment. Sixty individuals should be recruited from one site to complete the trial."

Answered by AI
~19 spots leftby Mar 2025