drugset / Trial / NCT00904618

Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia

NCT00904618

Phase 2 Completed 48 enrolled University of Sherbrooke Ethicon, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-01
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Background Lidocaine Other / unclassified 35 ml Other
Background bicarbonate Small molecule 5 ml Other