Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Pelvic Organ ProlapseUrinary Incontinence
Interventions
PROCEDURE

POP repair plus mini-sling

"For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum.~A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh."

PROCEDURE

POP repair

For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.

Trial Locations (1)

06100

Urology Dept. University of Perugia, Perugia

All Listed Sponsors
lead

University Of Perugia

OTHER

NCT01384084 - Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone | Biotech Hunter | Biotech Hunter