NCT05464316

Prospective Pilot ATOMS vs AUS

Status unknown NA Last updated 19 July 2022

What this trial tests

NA trial testing Adjustable Transobturator Male System in Post-Prostatectomy Incontinence in 60 participants. Status unknown.

Timeline

13 January 2022

Primary endpoint
13 January 2024

13 January 2025

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	13 January 2022
Primary completion	13 January 2024
Estimated completion	13 January 2025
Sites	1 location across Canada

Drugs / interventions tested

• Adjustable Transobturator Male System
• Artificial Urinary Sphincter

Conditions studied

• Post-Prostatectomy Incontinence — all drugs for Post-Prostatectomy Incontinence →
• Urinary Stress Incontinence — all drugs for Urinary Stress Incontinence →
• Urinary Incontinence — all drugs for Urinary Incontinence →
• Stress Incontinence, Male — all drugs for Stress Incontinence, Male →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

18 and older, male only, with Post-Prostatectomy Incontinence or Urinary Stress Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.