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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
May 24, 2010
June 4, 2010
April 12, 2017
June 28, 2017
June 28, 2017
October 2008
October 2012   (Final data collection date for primary outcome measure)
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.
Treatment Success Based on Patient Report on Validated Questionnaire [ Time Frame: 12 months ]
Negative response to question #3 on the UDI-6 questionnaire
Complete list of historical versions of study NCT01137539 on ClinicalTrials.gov Archive Site
Patient Satisfaction [ Time Frame: 12 months ]
Positive response to a satisfaction question
Same as current
Not Provided
Not Provided
 
TVT-SECUR as an Office-based Procedure
TVT-SECUR as an Office-based Procedure - A Pilot Study

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Urinary Incontinence
  • 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
Experimental: Gynecare TVT-SECUR system
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Intervention: Device: Gynecare TVT-SECUR system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01137539
MIWH08-001
No
Not Provided
Not Provided
Salil Khandwala MD, Michigan Institution of Women's Health PC
Michigan Institution of Women's Health PC
Ethicon, Inc.
Principal Investigator: Salil S Khandwala, MD Michigan Institute of Women's Health PC
Michigan Institution of Women's Health PC
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP