Virtue® European Study

Coloplast

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Virtue® Male Sling

Study type: Interventional

Funder types: Industry

Identifiers

NCT01608789

SU012

Details and patient eligibility

About

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

Full description

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Enrollment: 123 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 radical prostatectomy completed at least 1 year prior to implantation date
  • The subject has a good bladder function
  • The subject has failed non-invasive therapies, eg. Pelvic Floor/Kegel exercises, behavioral modification, or biofeedback, for at least 6 months
  • The subject is willing to have the Virtue® Male Sling implanted
  • The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol

Exclusion criteria

• The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol

  • The subject has an active urinary tract infection or active skin infection in region of surgery (temporary exclusion)
  • The subject has compromised immune systems or any other conditions that affect healing
  • The subject has serious bleeding disorders
  • The subject has an urinary incontinence that is not mainly a stress urinary incontinence
  • The subject has a stress urinary incontinence due to TransUrethral Resection or laser surgery of the Prostate (TURP)
  • 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 (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agents are allowed)
  • 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 3 months
  • The subject has a postvoid residual (PVR) > or = 150mL
  • The subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months
  • The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without the sponsors' approval
  • The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Virtue® Male Sling

Experimental group

Description:

Patient implanted Virtue® Male Sling

Treatment:

Device: Virtue® Male Sling