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Completed

NCT Number: NCT00856778

Virtue® Male Incontinence Sling Study

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunybrook Health Sciences Centre, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtue® Male Incontinence Sling

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.

Primary outcomes

  1. Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)

    Time frame: 12 months post implant

    Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".

  2. Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).

    Time frame: 12 months

    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".

Secondary outcomes

  1. Assess Change in Subject Satisfaction Through ICIQ

    Time frame: Baseline

    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.

  2. Assess Change in Subject Satisfaction Through ICIQ

    Time frame: 12 months post implant

    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.

  3. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother

    Time frame: Baseline

    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.

  4. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother

    Time frame: 12 months post implant

    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.

  5. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function

    Time frame: Baseline

    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.

  6. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function

    Time frame: 12 months post implant

    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.

  7. Assess Change in Pad Use

    Time frame: Baseline

    Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.

  8. Assess Change in Pad Use

    Time frame: 12 months post-implant

  9. Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward

    Time frame: At implant

  10. Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies

    Time frame: At implant

  11. Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra

    Time frame: At implant

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2009
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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