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

Stress Urinary Incontinence Clinical Trial

Official title:

Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866085
• Other study ID #: 12-013
• Secondary ID: 12-013
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2013
• Last updated: May 30, 2013
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2013
• Source: Jewish General Hospital
• Contact: Jacques Corcos, MD
• Phone: 1-514-340-8222
• Email: jcorcos[@]jgh.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• AdVance® sling procedure

• ARGUS Sling procedure

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Jewish General Hospital	Center Hospitalier de Fleurimont,Sherbrooke University, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summarize all cumulative device and procedure related adverse events		12 months	Yes
Primary	Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .		12 months	No
Secondary	Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.		12 months	No