Clinical trial NCT00856778: Virtue® Male Incontinence Sling Study
Official title: Virtue® Male Incontinence Sling Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Male sling
stress urinary incontinence
urinary incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 98
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.


Eligibility criteria: Inclusion Criteria:

* Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
* Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
* Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
* Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
* Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
* Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria:

* Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
* Subject has active urogenital infection or active skin infection in region of surgery
* Subject has serious bleeding disorders
* Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
* Subject has previous implant to treat SUI
* Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
* Subject has active urethral or bladder neck stricture disease requiring continued treatment
* Subject has urge predominant incontinence

Primary outcomes:
measure: Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
timeFrame: 12 months post implant
measure: Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
timeFrame: 12 months
Secondary outcomes:
measure: Assess Change in Subject Satisfaction Through ICIQ
timeFrame: Baseline
measure: Assess Change in Subject Satisfaction Through ICIQ
timeFrame: 12 months post implant
measure: Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
timeFrame: Baseline
measure: Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
timeFrame: 12 months post implant
measure: Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
timeFrame: Baseline
measure: Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
timeFrame: 12 months post implant
measure: Assess Change in Pad Use
timeFrame: Baseline
measure: Assess Change in Pad Use
timeFrame: 12 months post-implant
measure: Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
timeFrame: At implant
measure: Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
timeFrame: At implant
measure: Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
timeFrame: At implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Dearborn
country: United States
facility: Wayne State University
state: Michigan
city: New York
country: United States
facility: NYU Urology Associates
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Houston
country: United States
facility: University of Texas-M.D. Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Sunybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Mortimer S Davis Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Hopital Fleurimont
state: Quebec
Study officials:
affiliation: Stanford University
name: Craig Comiter, MD
role: PRINCIPAL_INVESTIGATOR
References: