Clinical trial NCT07008898: Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
Official title: Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Incontinence Female
Pelvic Organ Prolapse
Keywords: Stress incontinence
Pelvic organ prolapse
Midurethral sling
Sucess rates
Complication rates
Patient satisfaction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Distress Index, Short Form (UDI-6) scores at 6 months postoperative
timeFrame: 6 months
Secondary outcomes:
measure: Provocative stress test results at 6 weeks postoperative
timeFrame: 6 weeks
measure: Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative
timeFrame: 6 weeks
measure: Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 6 months postoperative
timeFrame: 6 months
measure: Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 6 months postoperative
timeFrame: 6 months
measure: Complications (graded as Clavien Dindo)
timeFrame: 6 weeks
measure: Objective surgical data such as operative time
timeFrame: 6 weeks
measure: Objective surgical data such as estimated blood loss (EBL)
timeFrame: 6 weeks
measure: Patient satisfaction (a decision scale and decision regret scale)
timeFrame: 6 months
measure: Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence)
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gabriela E Halder, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: