48
Participants
Start Date
January 31, 2007
Primary Completion Date
March 31, 2009
Study Completion Date
March 31, 2009
TVT-SECUR - 'Hammock' technique
The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.
TVT-SECUR - 'U-Method'
The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.
Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).
Local anesthesia consisted of 30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%. Sedation was used in association with local anesthesia, including 1 mg of lorazepam sublingual as well as a combination of 0.5 to 2 mg intravenous (IV) of midazolam and 50 to 200 ug IV of fentanyl. Postoperative analgesia consisted of a prescription of 30 tablets of morphine 5 mg.
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke
Ethicon, Inc.
INDUSTRY
Université de Sherbrooke
OTHER