Virtue® Male Incontinence Sling Study

Stress Urinary Incontinence Clinical Trial

Official title:

Virtue® Male Incontinence Sling Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856778
• Other study ID #: CP001SU
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: April 11, 2014
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health CanadaNetherlands: Dutch Health Care InspectorateItaly: Ministry of HealthDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Virtue® Male Incontinence Sling
The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.

Locations

Country	Name	City	State
Canada	Mortimer S Davis Jewish General Hospital	Montreal	Quebec
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec
Canada	Sunybrook Health Sciences Centre	Toronto	Ontario
United States	McKay Urology	Charlotte	North Carolina
United States	Wayne State University	Dearborn	Michigan
United States	Northeast Indiana Research	Fort Wayne	Indiana
United States	University of Texas-M.D. Anderson Cancer Center	Houston	Texas
United States	Kaiser Permanente	Los Angeles	California
United States	NYU Urology Associates	New York	New York
United States	Winter Park Urology Associates	Orlando	Florida
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)	Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".	12 months post implant	No
Primary	Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).	Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding "very much better" or "much better".	12 months	No
Secondary	Assess Change in Subject Satisfaction Through ICIQ	The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.	Baseline	No
Secondary	Assess Change in Subject Satisfaction Through ICIQ	The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.	12 months post implant	No
Secondary	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	Baseline	No
Secondary	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	12 months post implant	No
Secondary	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	Baseline	No
Secondary	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	12 months post implant	No
Secondary	Assess Change in Pad Use	Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.	Baseline	No
Secondary	Assess Change in Pad Use		12 months post-implant	No
Secondary	Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward		At implant	No
Secondary	Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies		At implant	No
Secondary	Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra		At implant	No