Recruiting

MUS vs. Timing

Sponsor:

University of Alabama at Birmingham

Code:

NCT07008898

Conditions

Stress Incontinence Female

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Midurethral sling placed before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy

Study Details

Brief summary:

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.

Conditions

Stress Incontinence Female

Pelvic Organ Prolapse

Study ID

NCT07008898

Start date

Jul 8, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Midurethral sling placed before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy

active comparator: Midurethral sling placed after robotic sacrocolpopexy

Interventions

Midurethral sling placed before robotic sacrocolpopexy

Sequence of midurethral sling placement (before or after suspension of the vaginal apex) during robotic sacrocolpopexy is largely surgeon-dependent and dictated by training and experience. This study will examine whether there are any differences in continence and patient satisfaction between patients in whom slings are placed prior to suspension of the vaginal apex during robotic sacrocolpopexy versus after.

Midurethral sling placed after robotic sacrocolpopexy

Sequence of midurethral sling placement (before or after suspension of the vaginal apex) during robotic sacrocolpopexy is largely surgeon-dependent and dictated by training and experience. This study will examine whether there are any differences in continence and patient satisfaction between patients in whom slings are placed prior to suspension of the vaginal apex during robotic sacrocolpopexy versus after.

Primary outcome measure

  • Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Martha K Coghlan, MD

6019883613mkcoghlan@uabmc.edu

Gabriela E Halder, MD, MPH

205-975-0304gehalder@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Martha K Coghlan, MD

205-934-1777mkcoghlan@uabmc.edu

Gabriela E Halder, MD, MPH

205-975-0304gehalder@uabmc.edu

Principal Investigator:

Gabriela E Halder, MD, MPH

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Karissa Leong Fellow, MD

518-262-5013leongk9@amc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Stress incontinence
  • Pelvic organ prolapse
  • Midurethral sling
  • Sucess rates
  • Complication rates
  • Patient satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-17.