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NCT Number: NCT07008898

Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 3 months

    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.

Secondary outcomes

  1. Provocative stress test results at 6 weeks postoperative

    Time frame: 6 weeks

    Patients will be examined in the office during 6-week postoperative visit as is routine practice and assess for leakage of urine during empty supine provocative cough stress test.

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

    Time frame: 6 weeks

    If recurrent stress urinary incontinence is noted to be present at 6-weeks postoperative, whether or not patients elect to proceed with additional treatment will be assessed.

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

    Time frame: 3 months

    PISQ-IR will be administered at enrollment and at 3 months postoperative, and scores will be compared.

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

    Time frame: 3 months

    IIQ-7 will be administered to patients at enrollment and at 3 months postoperative, and scores at these two time points will be compared.

  5. Complications (graded as Clavien Dindo)

    Time frame: 6 weeks

    Complications occurring during or after concomitant RSC and RP MUS will be recorded between both groups and compared.

  6. Objective surgical data such as operative time

    Time frame: 6 weeks

    Objective surgical data such as operative time will be recorded between both groups and compared.

  7. Objective surgical data such as estimated blood loss (EBL)

    Time frame: 6 weeks

    Objective surgical data such as estimated blood loss (EBL) will be recorded between both groups and compared.

  8. Patient satisfaction (a decision scale and decision regret scale)

    Time frame: 3 months

    A decision regret scale will be administered to patients at 3 months postoperative, and scores will be compared between the two groups to assess if any difference in patient satisfaction exists.

  9. Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence)

    Time frame: 3 months

    The PGI-I will be administered to all patients at 3 months to assess patient satisfaction with the procedure performed; any differences between groups in patient satisfaction will be assessed with this outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela E Halder, MD, MPH

CONTACT

[email protected]

205-975-0304

Martha K Coghlan, MD

CONTACT

[email protected]

6019883613

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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