Virtue® Male Incontinence Sling Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

NCT04098822

Urinary Incontinence, Stress

RECRUITING

Virtue® Male Sling Fixation Study

NCT01170728

Stress Urinary Incontinence

TERMINATED

Virtue® European Study

NCT01608789

Stress Urinary Incontinence

COMPLETED NA

A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

NCT00998790

Stress Urinary Incontinence

COMPLETED NA

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

NCT04115605

Urinary Incontinence, Stress

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtue® Male Sling

Subjects implanted with Virtue® Male Sling

Group Type OTHER

Virtue® Male Incontinence Sling

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No