Stress Urinary IncontinenceNCT01866085
AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
A study testing AdVance® sling procedure and ARGUS Sling procedure in people with Stress Urinary Incontinence, run by Jewish General Hospital at 1 site in Canada.
Trial summary
The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- AdVance® sling procedure and ARGUS Sling procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2015
- 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
- The subject is male
- The subject is at least 18 years of age
- The subject has an estimated life expectancy of more than 5 years
- The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
- The subject has intrinsic sphincter deficiency due to one of the following:
- post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
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- Positive Cough Stress Test (CST):
- Positive 24-hours Pad Test (PT):
- A positive PT is confirmed with leakage of >8.O g/24h and < 400 g
- The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant
- The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol
- The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics commit-tee of the respective site
Who cannot join
- Subjects who meet any of the following criteria are excluded from entry into the study
- The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol
- The subject has an active urogenital infection or active skin infection in region of surgery
- The subject has serious bleeding disorders
- The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
- The subject had a previous implant to treat stress urinary incontinence
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- The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
- The subject is likely to undergo radiation therapy within the next 6 months
- The subject has active urethral or bladder neck stricture disease, requiring continued treatment
- The subject has urge predominant incontinence
- The subject has an atonic bladder or a postvoid residual (PVR) ≥150mL
- The subject has a condition or disorder likely to require future transurethral procedure
- The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval
- Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Jacques Corcos, MD, 1-514-340-8222 ext. 5166, jcorcos@jgh.mcgill.ca
1-514-340-8222 ext. 1627, oloutochin@jgh.mcgill.ca
About this study
Official title: Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.
- Conditions
- Stress Urinary Incontinence
- Being tested
- AdVance® sling procedure, ARGUS Sling procedure
- Keywords
- stress urinary incontinence, post prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdVance® sling procedureProcedure or surgery
ARGUS Sling procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AdVance | Active comparator | sling procedure Receives: Procedure: AdVance® sling procedure |
| ARGUS | Active comparator | sling procedure Receives: Procedure: ARGUS Sling procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
Measured: 12 months
Secondary outcomes (1)
Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke, Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Jacques Corcos, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866085
- Sponsor's protocol ID
- 12-013
- Other IDs
- 12-013
- Status last verified
- May 2013
- First submitted
- 28 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01866085
- Acronym / sponsor ID
- 12-013
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, post prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Université de Sherbrooke, Sunnybrook Health Sciences Centre
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 31 May 2013 (estimated)
- 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.
The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdVance | Active comparator | Procedure: AdVance® sling proceduresling procedure |
| ARGUS | Active comparator | Procedure: ARGUS Sling proceduresling procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject is male
- The subject is at least 18 years of age
- The subject has an estimated life expectancy of more than 5 years
- The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
- The subject has intrinsic sphincter deficiency due to one of the following:
Key exclusion criteria (14 listed)
- Subjects who meet any of the following criteria are excluded from entry into the study
- The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol
- The subject has an active urogenital infection or active skin infection in region of surgery
- The subject has serious bleeding disorders
- The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
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 |
|---|---|---|
| AdVance® sling procedure | Procedure or surgery | AdVance |
| ARGUS Sling procedure | Procedure or surgery | ARGUS |
Primary outcome
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
Time frame: 12 months
1 secondary outcome
Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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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 AdVance® sling procedure and ARGUS Sling procedure in people with Stress Urinary Incontinence, run by Jewish General Hospital 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 12 inclusion and 14 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 31 May 2013. 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 Jacques Corcos, MD (1-514-340-8222 ext. 5166, jcorcos@jgh.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight . (time frame: 12 months). 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 31 May 2013.