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

NCT01866085 | Unknown DMC

• 1 other identifier: 12-013
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

stress urinary incontinence; post prostatectomy

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .

  12 months

Secondary Outcomes (1)

• Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index.

  12 months

Other Outcomes (1)

• Summarize all cumulative device and procedure related adverse events

  12 months

Study Arms (2)

AdVance

ACTIVE COMPARATOR

sling procedure

Procedure: AdVance® sling procedure

ARGUS

ACTIVE COMPARATOR

sling procedure

Procedure: ARGUS Sling procedure

Interventions

AdVance® sling procedure PROCEDURE

AdVance

ARGUS Sling procedure PROCEDURE

ARGUS

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jacques Corcos, MD

CONTACT

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

Oleg Loutochin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Professor of Urology, McGill University

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

CA (1)