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

• Sponsor: Jewish General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01866085
• Collaborator: Center Hospitalier de Fleurimont,Sherbrooke University (Other), Sunnybrook Health Sciences Centre (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Procedure: AdVance® sling procedure; Procedure: ARGUS Sling procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
• Study Start Date: Jun 1, 2012
• Anticipated Primary Completion Date: Jun 1, 2014
• Anticipated Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AdVance sling procedure	Procedure: AdVance® sling procedure
Active Comparator: ARGUS sling procedure	Procedure: ARGUS Sling procedure

Outcome Measures

Primary Outcome Measures

1. 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

1. Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index. [12 months]

Other Outcome Measures

1. Summarize all cumulative device and procedure related adverse events [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

• Jewish General Hospital
• Center Hospitalier de Fleurimont,Sherbrooke University
• Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacques Corcos, MD. Professor of Urology, McGill University, Jewish General Hospital
• ClinicalTrials.gov Identifier: NCT01866085
• Other Study ID Numbers: 12-013; 12-013
• First Posted: May 31, 2013
• Last Update Posted: May 31, 2013
• Last Verified: May 1, 2013

• Keywords provided by Jacques Corcos, MD. Professor of Urology, McGill University, Jewish General Hospital: stress urinary incontinence; post prostatectomy
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of May 31, 2013