Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Midurethral sling placed before robotic sacrocolpopexy, Midurethral sling placed after robotic sacrocolpopexy.
- Who it may be relevant to
- Registry conditions: Stress Incontinence Female, Pelvic Organ Prolapse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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. - 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.
Primary outcome measures
- Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative [Time frame: 3 months]
Secondary outcome measures (9)
- Provocative stress test results at 6 weeks postoperative [Time frame: 6 weeks]
- Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative [Time frame: 6 weeks]
- Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative [Time frame: 3 months]
- Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative [Time frame: 3 months]
- Complications (graded as Clavien Dindo) [Time frame: 6 weeks]
- Objective surgical data such as operative time [Time frame: 6 weeks]
- Objective surgical data such as estimated blood loss (EBL) [Time frame: 6 weeks]
- Patient satisfaction (a decision scale and decision regret scale) [Time frame: 3 months]
- Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence) [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Alabama at Birmingham — Birmingham
- Albany Medical Center — Albany
Identifiers
NCT: NCT07008898 · 300014707 · No funding