Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

July 31, 2014

Conditions
Injury Due to Sling-shot
Interventions
DEVICE

Ophira

The procedure will be perfomed with a single incision in anterior wall vagina

DEVICE

Transobturator sling

Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.

Trial Locations (1)

09060-650

Faculty of Medicine of ABC, Santo André

All Listed Sponsors
lead

Faculdade de Medicina do ABC

OTHER

NCT02540525 - Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter