TVT-SECUR as an Office-based Procedure

Urinary Incontinence Clinical Trial

— TVTSOffice  

Official title:

TVT-SECUR as an Office-based Procedure - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137539
• Other study ID #: MIWH08-001
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: October 5, 2012
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Michigan Institution of Women's Health PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 89 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence

Locations

Country	Name	City	State
United States	Advanced Urogynecology of Michigan PC	Dearborn	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan Institution of Women's Health PC	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success based on patient report on validated questionnaire	Negative response to question #3 on the UDI-6 questionnaire	24 months	No
Secondary	Patient satisfaction	Positive response to a satisfaction question	12 months	No