Back to resultsTVT-SECUR as an Office-based Procedure (TVTSOffice)
Primary Purpose
Urinary Incontinence, Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gynecare TVT-SECUR system
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping, TVT
Eligibility 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
Sites / Locations
- Advanced Urogynecology of Michigan PC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gynecare TVT-SECUR system
Arm Description
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Outcomes
Primary Outcome Measures
Treatment Success Based on Patient Report on Validated Questionnaire
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
Positive response to a satisfaction question
Full Information
NCT ID
NCT01137539
First Posted
May 24, 2010
Last Updated
May 25, 2017
Sponsor
Michigan Institution of Women's Health PC
Collaborators
Ethicon, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01137539
Brief Title
TVT-SECUR as an Office-based Procedure
Acronym
TVTSOffice
Official Title
TVT-SECUR as an Office-based Procedure - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan Institution of Women's Health PC
Collaborators
Ethicon, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Urinary Incontinence
Keywords
urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping, TVT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gynecare TVT-SECUR system
Arm Type
Experimental
Arm Description
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Intervention Type
Device
Intervention Name(s)
Gynecare TVT-SECUR system
Other Intervention Name(s)
TVT-S, Mid-urethral sling
Intervention Description
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Primary Outcome Measure Information:
Title
Treatment Success Based on Patient Report on Validated Questionnaire
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Positive response to a satisfaction question
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salil S Khandwala, MD
Organizational Affiliation
Michigan Institute of Women's Health PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Urogynecology of Michigan PC
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TVT-SECUR as an Office-based Procedure
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