Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 24, 2010
October 5, 2012
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 ] [ Designated as safety issue: No ]
Negative response to question #3 on the UDI-6 questionnaire
Treatment Success based on patient report on validated questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Female
21 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01137539
MIWH08-001
No
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
October 2012

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