Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

NCT ID: NCT07008898

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2027-06-30

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.

Conditions

Stress Incontinence Female; Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Midurethral sling placed before robotic sacrocolpopexy

Midurethral sling placed after robotic sacrocolpopexy

Group Type: ACTIVE_COMPARATOR

Midurethral sling placed before robotic sacrocolpopexy

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Midurethral sling placed after robotic sacrocolpopexy

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Halder

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriela E Halder, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martha K Coghlan, MD

Role: CONTACT

mkcoghlan@uabmc.edu

6019883613

Gabriela E Halder, MD, MPH

Role: CONTACT

gehalder@uabmc.edu

205-975-0304

Facility Contacts

Martha K Coghlan, MD

Role: primary

mkcoghlan@uabmc.edu

205-934-1777

Gabriela E Halder, MD, MPH

Role: backup

gehalder@uabmc.edu

205-975-0304

Other Identifiers

300014707

Identifier Type: -

Identifier Source: org_study_id