Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

NCT07008898 | Recruiting DMC

• 2 other identifiers: 300014707No funding
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative

  The primary outcome will be change between baseline and 3 months stress urinary incontinence symptoms as measured by the UDI-6. Scores for the UDI-6 range from 0 to 100 has an MCID of 5.8, with higher scores indicating worse symptoms.

  3 months

Secondary Outcomes (9)

• Provocative stress test results at 6 weeks postoperative

  6 weeks

• Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative

  6 weeks

• Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative

  3 months

• Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative

  3 months

• Complications (graded as Clavien Dindo)

  6 weeks

Study Arms (2)

Midurethral sling placed before robotic sacrocolpopexy

ACTIVE COMPARATOR

Midurethral sling placed after robotic sacrocolpopexy

Procedure: Midurethral sling placed before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy

ACTIVE COMPARATOR

Procedure: Midurethral sling placed after robotic sacrocolpopexy

Interventions

Midurethral sling placed before robotic sacrocolpopexy PROCEDURE

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 before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Patient Satisfaction

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gabriela E Halder, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha K Coghlan, MD

CONTACT

6019883613; mkcoghlan@uabmc.edu

Gabriela E Halder, MD, MPH

CONTACT

205-975-0304; gehalder@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 6, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

US (2)