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

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.
 
ClinicalTrials.gov Identifier: NCT01137539
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Urinary Incontinence Stress Urinary Incontinence Device: Gynecare TVT-SECUR system Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TVT-SECUR as an Office-based Procedure - A Pilot Study
Study Start Date : October 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Patient Satisfaction [ Time Frame: 12 months ]
    Positive response to a satisfaction question


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Salil S Khandwala, MD Michigan Institute of Women's Health PC
More Information
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Responsible Party: Salil Khandwala MD, President, Michigan Institution of Women's Health PC, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT01137539    
Other Study ID Numbers: MIWH08-001
First Posted: June 4, 2010    Key Record Dates
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:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders