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NCT00856778 · ClinicalTrials.gov registry record · NA

Virtue® Male Incontinence Sling Study

A NA study of Stress Urinary Incontinence, sponsored by Coloplast A/S.

Completed
Registry status
NA
Development phase
98
Enrollment target
11
Study locations

NCT00856778: Completed NA study of Stress Urinary Incontinence, sponsored by Coloplast A/S.

NCT00856778 is a NA study of Stress Urinary Incontinence that has completed, run by Coloplast A/S. The registered enrollment target is 98 participants, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (39% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856778, a NA study of Stress Urinary Incontinence, has completed, sponsored by Coloplast A/S.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target
11
Study locations

Study Summary

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.

Primary Outcome

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

Interventions

  • DEVICE Virtue® Male Incontinence Sling

Study Locations (11)

California

  • Kaiser Permanente - Los Angeles
  • Stanford University Medical Center - Stanford

Quebec

  • Mortimer S Davis Jewish General Hospital - Montreal
  • CHUS Hopital Fleurimont - Sherbrooke

Florida

  • Winter Park Urology Associates - Orlando

Indiana

  • Northeast Indiana Research - Fort Wayne

Michigan

  • Wayne State University - Dearborn

New York

  • NYU Urology Associates - New York

North Carolina

  • McKay Urology - Charlotte

Texas

  • University of Texas-M.D. Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2009-01
Est. Completion 2011-01
Phase NA
Coloplast A/S

21 total trials

What the finished NCT00856778 record still lists

NCT00856778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (39% lower).

The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Virtue® Male Incontinence Sling is the first listed.

NCT00856778 lists 11 locations in 9 states (California, Quebec, Florida).

Frequently Asked Questions

What is clinical trial NCT00856778 about?

NCT00856778 is a clinical study titled "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.

What is the current status of trial NCT00856778?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2009-01. Estimated completion is 2011-01.

What conditions does trial NCT00856778 study?

This clinical trial studies the following conditions: Stress Urinary Incontinence.

What interventions are being tested in trial NCT00856778?

The interventions under investigation include: Virtue® Male Incontinence Sling (DEVICE).

Who is sponsoring clinical trial NCT00856778?

This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00856778 being conducted?

This trial has 11 study locations across California, Florida, Indiana, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stress Urinary Incontinence

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00856778's enrollment target sits among peer trials

98 17th of 35 higher than 19 of 35 other Stress Urinary Incontinence trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00856778, the US trial registry maintained by the National Library of Medicine. NCT00856778 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.