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

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: AdVance® sling procedure; Procedure: ARGUS Sling procedure

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Jacques Corcos, MD; Phone Number: 5166 1-514-340-8222; Email: jcorcos@jgh.mcgill.ca
      • Contact: Phone Number: 1627 1-514-340-8222; Email: oloutochin@jgh.mcgill.ca
      • Principal Investigator: Jacques Corcos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AdVance; sling procedure	Procedure: AdVance® sling procedure
ACTIVE_COMPARATOR: ARGUS; sling procedure	Procedure: ARGUS Sling procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Summarize all cumulative device and procedure related adverse events	12 months

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Collaborators: Sunnybrook Health Sciences Centre; Center Hospitalier de Fleurimont,Sherbrooke University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (ESTIMATE): May 31, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: stress urinary incontinence; post prostatectomy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 12-013 (Research Ethics Board,JGH)