Clinical trial NCT01608789: Virtue® European Study
Official title: Virtue® Male Sling European Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Male sling
Stress Urinary Incontinence
Urination Disorders
Urologic Diseases
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 123
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of urinary incontinence based on 24-hour pad test
timeFrame: 1 year
measure: Safety of the device characterized by reported adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Improvement of urinary incontinence based on 24-hour pad test
timeFrame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
measure: Improvement of urinary incontinence based on number of pad used
timeFrame: baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
measure: Improvement of urinary incontinence based on PGI-I
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
measure: Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form
timeFrame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
measure: Patient satisfaction questionaire
timeFrame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
measure: Safety of the device characterized by reported adverse events
timeFrame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Créteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Nîmes
country: France
facility: Groupe Hospitalo Universitaire Carémeau
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Köln
country: Germany
facility: Heilig Geist Krankenhaus
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Milan
country: Italy
facility: Istituto europeo di Oncologia
city: Udine
country: Italy
facility: Hospital Santa Maria della Misericordia
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Barcelona
country: Spain
facility: Fundacio Puigvert - Universitat Autonoma de Barcelona
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
References: