Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study

Официальное название

A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.

Обзор

The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are: * Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach? * Is the use of vaginal mesh as safe as abdominal mesh?

Подробное описание

This is a prospective, randomized non-inferiority study designed to compare the objective outcomes of treating apical compartment pelvic organ prolapse (POP) using robot-assisted abdominal mesh surgery versus vaginal mesh surgery. Additionally, clinical parameters such as mesh erosion, pain, and symptom-specific quality of life will be assessed utilizing an internationally validated instrument adapted for Portuguese-speaking populations.

Patients diagnosed with stage II or higher apical compartment pelvic organ prolapse (POP), with or without a uterus, who require surgical intervention and provide informed consent will be randomized through REDCap® software to determine the surgical approach.

The interventions under investigation include: vaginal prolapse repair with placement of the Splentis® mesh (Promedon®, Córdoba, Argentina) - not FDA approved, comprising anterior colporrhaphy combined with suspension of the cervix or vaginal vault, with bilateral anchoring of the mesh to the sacrospinous ligaments; and robot-assisted laparoscopic abdominal repair employing the Upsylon® mesh (Boston Scientific®, USA) - FDA approved - via colpocervicopexy, involving mesh fixation to the anterior and superior vaginal walls as well as the sacral promontory.

The sample size was calculated to assess the non-inferiority of the vaginal approach compared with the abdominal approach. Assuming an objective cure rate (stage 0 or I) of 90% for the abdominal group and 80% for the vaginal group, with a two-sided significance level of p \< 0.05 and an anticipated loss to follow-up of up to 10% in each group, a minimum of 43 participants per arm (total of 86 patients) was required. The calculation was based on detecting a non-inferiority margin considered clinically acceptable for the primary outcome.

Вмешательства

• Процедура Vaginal mesh surgery for apical prolapse
  Cirurgia com tela vaginal para prolapso apical.
• Процедура Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
  Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.

Первичные конечные точки

• Objective Cure Rate [Срок оценки: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.]

Вторичные конечные точки (1)

• Surgical complication [Срок оценки: Patients will undergo evaluations at 1 month postoperatively and subsequently at 6-month intervals from the date of surgery, continuing until 24 months of follow-up have been completed.]

Критерии участия

Критерии включения

• The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.

Критерии исключения

• The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);
• individuals with a prior history of pelvic radiotherapy;
• patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;
• and those with medical conditions that constitute a contraindication to elective surgical intervention.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital das Clinicas da Faculdade de Medicina de Sao Paulo — São Paulo

Публикации

• Bataller E, Ros C, Angles S, Gallego M, Espuna-Pons M, Carmona F. Anatomical outcomes 1 year after pelvic organ prolapse surgery in patients with and without a uterus at a high risk of recurrence: a randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy and anterior vaginal mesh. Int Urogynecol J. 2019 Apr;30(4):545-555. doi: 10.1007/s00192-018-3702-7. Epub 2018 Jul 9. PMID 29987345
• Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8. PMID 24433811
• Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16. PMID 29038834
• Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016. PMID 21306698
• Hudson CO, Northington GM, Lyles RH, Karp DR. Outcomes of robotic sacrocolpopexy: a systematic review and meta-analysis. Female Pelvic Med Reconstr Surg. 2014 Sep-Oct;20(5):252-60. doi: 10.1097/SPV.0000000000000070. PMID 25181374
• Rovner E, Chermansky C, Costantini E, Dmochowski R, Enemchukwu E, Ginsberg DA, Heesakkers J, Menefee S, Nadeau G, Rardin C, Zimmern P. Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A common standard minimum data set for the literature. Neurourol Urodyn. 2024 Nov;43(8):1753-1764. doi: 10.1002/nau.25445. Epub 2024 Jun 5. PMID 38837735
• Peterson TV, Pinto RA, Davila GW, Nahas SC, Baracat EC, Haddad JM. Validation of the Brazilian Portuguese version of the pelvic floor bother questionnaire. Int Urogynecol J. 2019 Jan;30(1):81-88. doi: 10.1007/s00192-018-3627-1. Epub 2018 Mar 16. PMID 29549393
• Angelo PH, de Queiroz NA, Leitao ACR, Marini G, Micussi MT. Validation of the international consultation on incontinence modular questionnaire - female lower urinary tract symptoms (ICIQ-FLUTS) into brazilian portuguese. Int Braz J Urol. 2020 Jan-Feb;46(1):53-59. doi: 10.1590/S1677-5538.IBJU.2019.0234. PMID 31851458

Идентификаторы

NCT: NCT07359755 · 7.815.545 · 86242424.1.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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