Идёт набор NCT07008898

Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy

Без фазы С лечением Stress Incontinence Female Pelvic Organ Prolapse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Midurethral sling placed before robotic sacrocolpopexy, Midurethral sling placed after robotic sacrocolpopexy.
Кому может быть актуально: Состояния в реестре: Stress Incontinence Female, Pelvic Organ Prolapse. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Процедура 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.
Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

Provocative stress test results at 6 weeks postoperative [Срок оценки: 6 weeks]
Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative [Срок оценки: 6 weeks]
Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative [Срок оценки: 3 months]
Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative [Срок оценки: 3 months]
Complications (graded as Clavien Dindo) [Срок оценки: 6 weeks]
Objective surgical data such as operative time [Срок оценки: 6 weeks]
Objective surgical data such as estimated blood loss (EBL) [Срок оценки: 6 weeks]
Patient satisfaction (a decision scale and decision regret scale) [Срок оценки: 3 months]
Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence) [Срок оценки: 3 months]

Критерии участия

Критерии включения

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