Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006392

Trial Description

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Title

Virtue® Male Sling European Study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006392
  •   2014/08/22
  •   2012/05/28
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01608789  (ClinicalTrials.gov)
  •   SU012  (Coloplast A/S)
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Health Condition or Problem studied

  •   Stress Urinary Incontinence
  •   N39.3 -  Stress incontinence
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Interventions/Observational Groups

  •   Device: Virtue® Male Sling
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
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Primary Outcome

- Improvement of urinary incontinence based on 24-hour pad test; time frame: 1 year; The primary effectiveness end point will be improvement in pad weight defined as at least a 50% reduction in 24-hour pad weight from baseline to 12-months.
- Safety of the device characterized by reported adverse events; time frame: 1 year; Safety of the device, including the implant procedure.

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Secondary Outcome

- Improvement of urinary incontinence based on 24-hour pad test; time frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
- Improvement of urinary incontinence based on number of pad used; time frame: baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
- Subject reported improvement measured by the PGI-I; time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
- Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form; time frame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
- Patient satisfaction questionaire; time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
- Safety of the device characterized by reported adverse events; time frame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years; Safety of the device, including the implant procedure.

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Ireland
  •   Italy
  •   Netherlands
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/08/31
  •   121
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Coloplast A/S
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.