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Recruiting NCT07008898

NCT07008898 Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

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Clinical Trial Summary
NCT ID NCT07008898
Status Recruiting
Phase
Sponsor University of Alabama at Birmingham
Condition Stress Incontinence Female
Study Type INTERVENTIONAL
Enrollment 110 participants
Start Date 2025-07-08
Primary Completion 2027-05

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Midurethral sling placed before robotic sacrocolpopexyMidurethral sling placed after robotic sacrocolpopexy

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 110 participants in total. It began in 2025-07-08 with a primary completion date of 2027-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Martha K Coghlan, MD

✉ mkcoghlan@uabmc.edu

📞 6019883613

Principal Investigator

Gabriela E Halder, MD, MPH

PRINCIPAL INVESTIGATOR

University of Alabama at Birmingham

Frequently Asked Questions

Who can join the NCT07008898 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Stress Incontinence Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07008898 currently recruiting?

Yes, NCT07008898 is actively recruiting participants. Contact the research team at mkcoghlan@uabmc.edu for enrollment information.

Where is the NCT07008898 trial being conducted?

This trial is being conducted at Birmingham, United States, Albany, United States.

Who is sponsoring the NCT07008898 clinical trial?

NCT07008898 is sponsored by University of Alabama at Birmingham. The principal investigator is Gabriela E Halder, MD, MPH at University of Alabama at Birmingham. The trial plans to enroll 110 participants.

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