Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

NACompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

January 2, 2024

Study Completion Date

January 2, 2024

Conditions
Stress Urinary IncontinencePelvic Floor Disorders
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (6)

11030

Northwell Health, Manhasset

20010

MedStar Health/National Center for Advance Pelvic Surgery, Washington D.C.

27157

Wake Forest Baptist Medical Center, Winston-Salem

44195

Cleveland Clinic, Cleveland

60611

Northwestern Medical Group, Chicago

02903

Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

Foundation for Female Health Awareness

OTHER

lead

Wake Forest University Health Sciences

OTHER

NCT03520114 - Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter