AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: AdVance® sling procedure; Procedure: ARGUS Sling procedure

• Registration Number: NCT01866085
• Lead Sponsor: Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Status Verified: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31
• Primary Completion: 2014-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AdVance	AdVance® sling procedure	sling procedure
ARGUS	ARGUS Sling procedure	sling procedure

Primary Outcome Measures

Name	Time	Method
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .	12 months

Secondary Outcome Measures

Name	Time	Method
Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.	12 months

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada