N/A
Completed N=50
TVT-SECUR as an Office-based Procedure
Source: ClinicalTrials.gov NCT01137539 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Treatment Success Based on Patient Report on Validated Questionnaire — 42 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Based on Patient Report on Validated Questionnaire |
42 | — |
| SECONDARY Patient Satisfaction |
47 | — |
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
Data sourced from ClinicalTrials.gov (NCT01137539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.