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Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

NCT01029106 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2011-07-28

No results posted yet for this study

Summary

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.

The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.

Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.

To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

Gynecare TVT Secur

Implant of the Gynecare TVT Secur

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Sender Herschorn, MD · Sunnybrook Health Sciences Centre

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029106 on ClinicalTrials.gov