Female Sling Procedure

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Urinary Incontinence,Stress
Interventions
PROCEDURE

trans-obturator procedure

TOT procedure will be done using silicon-coated polypropylene tape that will be inserted at the mid-urethral portion. In group 1, a classical vertical vaginal incision will be done proximal to the external urethral meatus with dissection along the axis of the urethra till the mid-urethral zone that is identified by palpating the urethral catheter balloon through the vaginal at the bladder neck, while in group 2, two paramedian incisions will be done 1cm long in the anterior vaginal wall 2 cm apart parallel to the urethra till identification of the mid-urethral portion, communication will be done between the two incisions 1 cm wide in this area creating a tunnel where the tape will be placed, this technique provides healthy tissues proximal and distal to the tape that allows more stabilization and less migration. The rest of the procedure is the same as the standard procedure of Trans-obturator outside-in tension-free technique.

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT04571346 - Female Sling Procedure | Biotech Hunter | Biotech Hunter