Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Pelvic Organ Prolapse; Stress Incontinence Female

Treatments: Procedure: Midurethral sling placed after robotic sacrocolpopexy; Procedure: Midurethral sling placed before robotic sacrocolpopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT07008898

300014707

Details and patient eligibility

About

This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place.

Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.

Full description

Investigators will conduct a prospective, randomized, noninferiority trial on patients undergoing retropubic midurethral sling (RP MUS) placement at the time of robotic-assisted sacrocolpopexy (RSC).

Patients scheduled to undergo retropubic midurethral sling placement at the time of robotic- assisted sacrocolpopexy will be invited to participate during regularly scheduled preoperative visits with their urogynecologic provider. Participants will be randomized to receive RP MUS before RSC or after RSC. Randomization will be conducted in RedCap. Randomization will be performed using a variable permutated block randomization scheme. The Randomization window will be +/- 4 days before their scheduled surgery, and patients will be blinded to sequence of MUS placement intraoperatively.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age

• Able to speak and read English and Spanish

  • Diagnosis of pelvic organ prolapse stage 2-4
  • Planning to undergo a robotic-assisted sacrocolpopexy
  • Demonstrable SUI (either by CST, with or without prolapse reduction, or UDS) within the year prior to enrollment
  • Planning to undergo concomitant SUI correction with MUS at the time of RSC

Exclusion criteria

• Less than 18 years of age
• Unable to speak and read English or Spanish
• No diagnosis of SUI (prophylactic slings)
• History of prior surgery for SUI
• Bladder capacity <200 mL or post-void residual (PVR) >150 mL
• Current genitourinary fistula or urethral diverticulum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Midurethral sling placed before robotic sacrocolpopexy

Active Comparator group

Description:

Midurethral sling placed after robotic sacrocolpopexy

Treatment:

Procedure: Midurethral sling placed before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy

Active Comparator group

Treatment:

Procedure: Midurethral sling placed after robotic sacrocolpopexy