Recruiting

AdVance® vs. ARGUS®

Sponsor:

Jewish General Hospital

Code:

NCT01866085

Conditions

Stress Urinary Incontinence

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AdVance® sling procedure

ARGUS Sling procedure

Study Details

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.

Conditions

Stress Urinary Incontinence

Study ID

NCT01866085

Start date

Jun, 2012

Status verified date

May, 2013

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: AdVance

sling procedure

active comparator: ARGUS

sling procedure

Interventions

AdVance® sling procedure

ARGUS Sling procedure

Primary outcome measure

  • Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight . [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jacques Corcos, MD

1-514-340-8222jcorcos@jgh.mcgill.ca

Oleg Loutochin

1-514-340-8222oloutochin@jgh.mcgill.ca

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Jacques Corcos, MD

1-514-340-8222jcorcos@jgh.mcgill.ca

1-514-340-8222oloutochin@jgh.mcgill.ca

Principal Investigator:

Jacques Corcos, MD

More Information

Sponsor

Jewish General Hospital

Last update posted

May 31, 2013

Last verified

May, 2013

Keywords

  • stress urinary incontinence
  • post prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2013-05-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.