Clinical trial NCT01866085: AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
Official title: Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
post prostatectomy
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Center Hospitalier de Fleurimont,Sherbrooke University
name: Sunnybrook Health Sciences Centre
First posted: 2013-05-31
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
timeFrame: 12 months
Secondary outcomes:
measure: Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.
timeFrame: 12 months
Other outcomes:
measure: Summarize all cumulative device and procedure related adverse events
timeFrame: 12 months
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: