Phase 2
Completed N=48
Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia
Urinary Stress Incontinence
Source: ClinicalTrials.gov NCT00904618 ↗
Enrolled (actual)
48
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Local Anesthesia Satisfaction — 43; 3 participants
Summary
The objective was to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR for the treatment of stress urinary incontinence, with the use of questionnaires completed by the patients, and to evaluate the short-term efficacy and safety of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Anesthesia Satisfaction |
43; 3 | — |
| SECONDARY Improvement in Stress Urinary Symptoms. |
11; 22; 5; 0 | 0.0087 sig |
| SECONDARY Safety of the Sling. |
0; 1; 6; 0; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence
- Acceptance of local anesthesia
Data sourced from ClinicalTrials.gov (NCT00904618). 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.