Adjustable Transobturator Male System for Urinary Incontinence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hôpital Fleurimont- Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Canada
Urinary Incontinence+5 More
Adjustable Transobturator Male System - Device
Eligibility
18+
Male
What conditions do you have?
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Study Summary

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.

Eligible Conditions

  • Urinary Incontinence
  • Post-Prostatectomy Incontinence
  • Suid Herpesvirus 1
  • Incontinence pads

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Three years

Three years
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.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-MLUTS LF questionnaire.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-OAB questionnaire.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-UI SF questionnaire.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the IPSS-QoL questionnaire.
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the Patient Global Impression of Improvement (PGI-I) questionnaire.
To assess the impact of OAB and radiotherapy on the safety of AUS and ATOMS using Clavien-Dindo Classification to report adverse event frequency and severity.
To compare complication rates of the AUS and ATOMS using the Clavien-Dindo Classification.
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.
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-MLUTS LF questionnaire.
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-OAB questionnaire.
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-UI SF questionnaire.
To compare effectiveness of the AUS and ATOMS devices in patients using results from the IPSS-QoL questionnaire.
To compare effectiveness rates of the AUS and ATOMS using the results of the 24-hour pad-counts.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Artificial Urinary Sphincter
1 of 2
Adjustable Transobturator Male System
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Adjustable Transobturator Male System · No Placebo Group · N/A

Adjustable Transobturator Male System
Device
Experimental Group · 1 Intervention: Adjustable Transobturator Male System · Intervention Types: Device
Artificial Urinary Sphincter
Device
ActiveComparator Group · 1 Intervention: Artificial Urinary Sphincter · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: three years
Closest Location: Hôpital Fleurimont- Centre Hospitalier de l'Université de Sherbrooke · Sherbrooke, Canada
Photo of quebec 1Photo of quebec 2Photo of quebec 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Urinary Incontinence
0 CompletedClinical Trials

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
257 Previous Clinical Trials
68,870 Total Patients Enrolled
2 Trials studying Urinary Incontinence
204 Patients Enrolled for Urinary Incontinence

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are an adult male (≥ 18 years of age) with moderate-to-severe post-prostatectomy urinary incontinence who is eligible and has consented to receive surgery as treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.