Virtue® Male Incontinence Sling Study

Coloplast A/S98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Virtue® Male Incontinence SlingDEVICE

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Kaiser Permanente

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Winter Park Urology Associates

Orlando, Florida, United States

Outcomes

Primary Outcomes

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".

Time frame: 12 months post implant

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".

Time frame: 12 months

Secondary Outcomes

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.

Time frame: Baseline

Assess Change in Subject Satisfaction Through ICIQ

Time frame: 12 months post implant

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.

Data from ClinicalTrials.gov

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