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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Jewish General Hospital
Sponsor:
Collaborators:
Center Hospitalier de Fleurimont,Sherbrooke University
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Jacques Corcos, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01866085
First received: May 28, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Stress Urinary Incontinence
Procedure: AdVance® sling procedure
Procedure: ARGUS Sling procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight . [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Summarize all cumulative device and procedure related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AdVance
sling procedure
Procedure: AdVance® sling procedure
Active Comparator: ARGUS
sling procedure
Procedure: ARGUS Sling procedure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866085

Contacts
Contact: Jacques Corcos, MD 1-514-340-8222 ext 5166 jcorcos@jgh.mcgill.ca
Contact: Oleg Loutochin 1-514-340-8222 ext 1627 oloutochin@jgh.mcgill.ca

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Jacques Corcos, MD    1-514-340-8222 ext 5166    jcorcos@jgh.mcgill.ca   
Contact    1-514-340-8222 ext 1627    oloutochin@jgh.mcgill.ca   
Principal Investigator: Jacques Corcos, MD         
Sponsors and Collaborators
Jewish General Hospital
Center Hospitalier de Fleurimont,Sherbrooke University
Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Jacques Corcos, MD. Professor of Urology, McGill University, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01866085     History of Changes
Other Study ID Numbers: 12-013, 12-013
Study First Received: May 28, 2013
Last Updated: May 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by Jewish General Hospital:
stress urinary incontinence
post prostatectomy

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014