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TVT-SECUR as an Office-based Procedure (TVTSOffice)

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier:
NCT01137539
First received: May 24, 2010
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 20 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 1 year.


Condition Intervention
Urinary Incontinence
Stress Urinary Incontinence
 Device: Gynecare TVT-SECUR system

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TVT-SECUR as an Office-based Procedure - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Michigan Institution of Women's Health PC:

Primary Outcome Measures:
  • Treatment Success based on patient report on validated questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Negative response to question #3 on the UDI-6 questionnaire


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Positive response to a satisfaction question


Enrollment: 50
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gynecare TVT-SECUR system
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
 Device: Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Other Names:
  • TVT-S
  • Mid-urethral sling

Detailed Description:

The study will include 20 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

  Eligibility

Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stress urinary incontinence with hypermobility of the UV junction
  • ASA I or II
  • Age 21-89

Exclusion Criteria:

  • Prior anti-incontinence surgery
  • Not completed childbearing
  • ASA III or higher
  • Need concomitant surgery
  • Poor compliance for office based approach
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137539

Locations
United States, Michigan
Advanced Urogynecology of Michigan PC
Dearborn, Michigan, United States, 48124
Sponsors and Collaborators
Michigan Institution of Women's Health PC
Ethicon, Inc.
Investigators
Principal Investigator: Salil S Khandwala, MD Michigan Institute of Women's Health PC
  More Information

No publications provided

Responsible Party: Salil Khandwala MD, President, Michigan Institution of Women's Health PC, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT01137539     History of Changes
Other Study ID Numbers: MIWH08-001
Study First Received: May 24, 2010
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan Institution of Women's Health PC:
urinary incontinence
stress urinary incontinence
mid-urethral slings
Tension-free vaginal taping
TVT

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013