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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137539
First Posted: June 4, 2010
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC
  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 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TVT-SECUR as an Office-based Procedure - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Salil Khandwala MD, Michigan Institution of Women's Health PC:

Primary Outcome Measures:
  • Treatment Success Based on Patient Report on Validated Questionnaire [ Time Frame: 24 months ]
    Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 12 months ]
    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 50 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 24, 2010
First Posted: June 4, 2010
Results First Submitted: April 12, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017

Keywords provided by Salil Khandwala MD, 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
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders