Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

Conditions

• Pelvic Organ Prolapse
• Stress Incontinence Female

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 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.

Study Details

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.

Key Dates

Start date

Jul 8, 2025

Status verified

Feb 2026

Primary completion

May 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Midurethral sling placed before robotic sacrocolpopexy
  Midurethral sling placed after robotic sacrocolpopexy
• Active Comparator: Midurethral sling placed after robotic sacrocolpopexy

Primary Outcome Measure

Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative [ Time Frame: 3 months ]

Central Contacts

• Martha K Coghlan, MD
  6019883613
  [email protected]
• Gabriela E Halder, MD, MPH
  205-975-0304
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

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