60 Participants Needed

AUS vs ATOMS for Urinary Incontinence

LM
Overseen ByLe Mai Tu, MD, FRCSC
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Université de Sherbrooke
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Post-Prostatectomy Incontinence (PPI) is a common complication affecting 1% to 40% of patients after surgery. When conservative treatments fail, the installation of an artificial urinary sphincter (AUS) has been the treatment of choice for PPI since its introduction more than 50 years ago. Although small studies suggest inferior success rate of male slings compare to the AUS in moderate to severe male incontinence; recent studies, one prospective and one Canadian multicenter cohort study, have demonstrated adjustable transobturator male sling (ATOMS) as a safe and efficient alternative to treat PPI. Interestingly, the ATOMS does not required any operation manipulation from the user in order to void and it causes potentially less urethral erosion and less urethral atrophy than the AUS; although those findings were never compared head to head with the AUS. Therefore, we believe that a thorough prospective non-inferiority study comparing the outcomes and effectiveness of the ATOMS device versus the AUS in treating moderate to severe PPI could prove itself useful in guiding urologists and patients to choose their best treatment of male incontinence. The null hypothesis posed for the present study is that ATOMS is non inferior to AUS for the treatment of moderate to severe PPI using the non-inferiority margin of 15% to be of acceptable lower effectiveness.With regards to study methods, this will be a pilot prospective, randomized controlled trial, non-blinded with a non-inferiority design. This pilot study will take place at the CIUSSS de l'Estrie, in Sherbrooke, Quebec, Canada, with two surgeons. All male patients with moderate to severe incontinence after their prostate surgery, who are suitable for incontinence surgery will be screened for study eligibility respecting the exclusion and inclusion criteria. After written informed consent, enrolled patients will be randomized assigned (1:1) to one of the two interventions' arms (AUS or ATOMS). Sixty patients are estimated to be randomized in the two arms the day of their surgery with a computer-based algorithm sequence.By completing this pilot prospective study, we hope to provide concrete and scientifically significant evidence on the effectiveness of ATOMS in the treatment of moderate to severe PPI comparing with the AUS. Although both treatments are commonly used today, there has been little evidence comparing both devices side by side with more severe PPI. We therefore hope to make a global impact with said project.

Eligibility Criteria

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.

Inclusion Criteria

I agreed to be randomly assigned to receive either ATOMS or AUS treatment.

Exclusion Criteria

You have incontinence caused by a nerve-related issue.
My doctor thinks surgery or anesthesia is risky for me due to my physical or mental condition.
I experience light incontinence, less than 200g per day.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the ATOMS or AUS device for the treatment of moderate to severe post-prostatectomy incontinence

Immediate post-surgery
1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after the surgical intervention

12 months
Regular follow-up visits (in-person)

Treatment Details

Interventions

  • Adjustable Transobturator Male System
  • Artificial Urinary Sphincter
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Adjustable Transobturator Male SystemExperimental Treatment1 Intervention
Group II: Artificial Urinary SphincterActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+
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