280
Participants
Start Date
December 12, 2018
Primary Completion Date
January 2, 2024
Study Completion Date
January 2, 2024
RP sling placement
A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
SIS placement
The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Northwell Health, Manhasset
MedStar Health/National Center for Advance Pelvic Surgery, Washington D.C.
Wake Forest Baptist Medical Center, Winston-Salem
Cleveland Clinic, Cleveland
Northwestern Medical Group, Chicago
Women & Infants Hospital of Rhode Island, Providence
Foundation for Female Health Awareness
OTHER
Wake Forest University Health Sciences
OTHER