Status:
ACTIVE_NOT_RECRUITING
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
Lead Sponsor:
Michigan Institution of Women's Health PC
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-89 years
Phase:
NA
Brief Summary
This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, ...
Detailed Description
The single-incision midurethral sling (SIMUS) is a procedure where there are no exit incisions. There is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle...
Eligibility Criteria
Inclusion
- SUI with hypermobility of the urethrovesical (UV) junction
- American Society of Anesthesiologists (ASA) classes I or II
- Ages ranging 21-89 years
- Have the ability to stand for CST during the procedure
- Have failed behavioral therapy
- Completed childbearing
Exclusion
- ASA classes III or IV
- Need for concomitant surgery
- Poor compliance for office-based approach
- Demonstrate concomitant urgency incontinence on urodynamic testing
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03842410
Start Date
May 31 2019
End Date
March 1 2025
Last Update
January 22 2024
Active Locations (1)
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1
Advanced Urogynecology of Michigan P.C
Dearborn, Michigan, United States, 48124