Post-Prostatectomy IncontinenceNCT05464316
Prospective Pilot ATOMS vs AUS
A study testing Adjustable Transobturator Male System and Artificial Urinary Sphincter in people with Post-Prostatectomy Incontinence and Urinary Stress Incontinence, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Post-Prostatectomy Incontinence, Urinary Stress Incontinence, Urinary Incontinence
- What is being tested?
- Adjustable Transobturator Male System and Artificial Urinary Sphincter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2022to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients who consented to being randomised in receiving ATOMS and AUS.
Who cannot join
- Patients whom the physician determines to be poor candidates for surgical procedures and/or anesthesia due to; poor manual dexterity, poor cognitive function, and other physical or mental conditions.
- Patients who have unresolved urethral or urethral-vesical anastomose stenosis within the last 12 months.
- Patients who have undergone previous incontinence surgeries.
- Patients who suffer mild incontinence (less than 200g per day).
- Patients with primarily neurogenic incontinence.
- Patients with rising PSA levels within the previous 12 months.
- Patients with urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract"
- Patients with known allergies or sensitivity to rifampin or to minocycline HCl or other tetracyclines.", in InhibiZone implantation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Fleurimont- Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, J1E0G3
Le Mai Tu, MD, FRCSC, (819)346-1110 ext. 74595, Le.Mai.Tu@uSherbrooke.ca
About this study
Official title: Comparing the Effectiveness of the Adjustable Trans Obutator Male System (ATOMS) Versus the Artificial Urinary Sphincter (AUS) in Moderate to Severe Post-Prostatectomy Stress Urinary Incontinence
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.
- Conditions
- Post-Prostatectomy Incontinence, Urinary Stress Incontinence, Urinary Incontinence, Stress Incontinence, Male
- Being tested
- Adjustable Transobturator Male System, Artificial Urinary Sphincter
- Keywords
- ATOMS, AUS, Prospective
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable Transobturator Male SystemDevice
The ATOMS sling was developed in 2008 by Agency for Medical Innovations GmbH in Austria. It is a self-anchoring adjustable system which supports the bulbar urethra dorsally and uses the trans obturator approach. This device gained its fame in the male sling scene by being adjustable, which theoretically makes it more efficacious than its competitors.
Artificial Urinary SphincterDevice
The AMS800™, which is by far the most frequently implanted AUS, was first marketed in 1983 and was developed by America Medical Holdings in Minnesota. Today, the AUS has been given the title "gold standard" for surgical treatment for PPI. This device is an inflatable cuff which wraps around the urethra to supply circumferential pressure. It has a control pump, which is found in the scrotum and is operated by the patient. The patient can void simply by squeezing the pump, which brings the fluid from the cuff to a reservoir and release the pressure around the urethra. The cuff is then automatically refilled with fluid within a couple of minutes to close back the sphincter.
| Study group | Role | What they receive |
|---|---|---|
| Adjustable Transobturator Male System | Experimental | Not described Receives: Device: Adjustable Transobturator Male System |
| Artificial Urinary Sphincter | Active comparator | Not described Receives: Device: Artificial Urinary Sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare effectiveness of the ATOMS and AUS devices in patients using results from the Patient Global Impression of Improvement (PGI-I) questionnaire.
Measured: Three years
To compare effectiveness of the ATOMS and AUS devices in patients using results from the 24-hour pad test.
Measured: Three years
Secondary outcomes (14)
To compare complication rates of the AUS and ATOMS using the Clavien-Dindo Classification.
Measured: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-UI SF questionnaire.
Measured: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-OAB questionnaire.
Measured: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-MLUTS LF questionnaire.
Measured: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the IPSS-QoL questionnaire.
Measured: Three years
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.
Measured: 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.
Measured: Three years
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.
Measured: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-UI SF questionnaire.
Measured: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-OAB questionnaire.
Measured: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-MLUTS LF questionnaire.
Measured: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the IPSS-QoL questionnaire.
Measured: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the 24-hour pad-count.
Measured: Three years
To compare effectiveness rates of the AUS and ATOMS using the results of the 24-hour pad-counts.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start13 Jan 2022
- Primary completion13 Jan 2024 (estimated)
- Study completion13 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Prostatectomy IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Mai Tu, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464316
- Sponsor's protocol ID
- 2022-4477
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of the Adjustable Trans Obutator Male System (ATOMS) Versus the Artificial Urinary Sphincter (AUS) in Moderate to Severe Post-Prostatectomy Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05464316
- Acronym / sponsor ID
- 2022-4477
- Conditions
- Post-Prostatectomy Incontinence, Urinary Stress Incontinence, Urinary Incontinence, Stress Incontinence, Male
- Keywords
- ATOMS, AUS, Prospective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Jan 2024 (estimated)
- Study completion
- 13 Jan 2025 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjustable Transobturator Male System | Experimental | Device: Adjustable Transobturator Male System |
| Artificial Urinary Sphincter | Active comparator | Device: Artificial Urinary Sphincter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Patients who consented to being randomised in receiving ATOMS and AUS.
Key exclusion criteria (8 listed)
- Patients whom the physician determines to be poor candidates for surgical procedures and/or anesthesia due to; poor manual dexterity, poor cognitive function, and other physical or mental conditions.
- Patients who have unresolved urethral or urethral-vesical anastomose stenosis within the last 12 months.
- Patients who have undergone previous incontinence surgeries.
- Patients who suffer mild incontinence (less than 200g per day).
- Patients with primarily neurogenic incontinence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustable Transobturator Male SystemThe ATOMS sling was developed in 2008 by Agency for Medical Innovations GmbH in Austria. It is a self-anchoring adjustable system which supports the bulbar urethra dorsally and uses the trans obturator approach. This device gained its fame in the male sling scene by being adjustable, which theoretically makes it more efficacious than its competitors. | Device | Adjustable Transobturator Male System |
| Artificial Urinary SphincterThe AMS800™, which is by far the most frequently implanted AUS, was first marketed in 1983 and was developed by America Medical Holdings in Minnesota. Today, the AUS has been given the title "gold standard" for surgical treatment for PPI. This device is an inflatable cuff which wraps around the urethra to supply circumferential pressure. It has a control pump, which is found in the scrotum and is operated by the patient. The patient can void simply by squeezing the pump, which brings the fluid from the cuff to a reservoir and release the pressure around the urethra. The cuff is then automatically refilled with fluid within a couple of minutes to close back the sphincter. | Device | Artificial Urinary Sphincter |
Primary outcome
To compare effectiveness of the ATOMS and AUS devices in patients using results from the Patient Global Impression of Improvement (PGI-I) questionnaire.
Time frame: Three years
To compare effectiveness of the ATOMS and AUS devices in patients using results from the 24-hour pad test.
Time frame: Three years
14 secondary outcomes
To compare complication rates of the AUS and ATOMS using the Clavien-Dindo Classification.
Time frame: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-UI SF questionnaire.
Time frame: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-OAB questionnaire.
Time frame: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the ICIQ-MLUTS LF questionnaire.
Time frame: Three years
To compare effectiveness of the AUS and ATOMS devices in patients using results from the IPSS-QoL questionnaire.
Time frame: Three years
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.
Time frame: 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.
Time frame: Three years
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.
Time frame: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-UI SF questionnaire.
Time frame: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-OAB questionnaire.
Time frame: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the ICIQ-MLUTS LF questionnaire.
Time frame: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the IPSS-QoL questionnaire.
Time frame: Three years
To assess the impact of OAB and radiotherapy on the effectiveness of AUS and ATOMS using results from the 24-hour pad-count.
Time frame: Three years
To compare effectiveness rates of the AUS and ATOMS using the results of the 24-hour pad-counts.
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Transobturator Male System and Artificial Urinary Sphincter in people with Post-Prostatectomy Incontinence and Urinary Stress Incontinence, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Le Mai Tu, MD, FRCSC ((819) 346-1110 ext. 74595, Le.Mai.Tu@uSherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare effectiveness of the ATOMS and AUS devices in patients using results from the Patient Global Impression of Improvement (PGI-I) questionnaire. (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.