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

NCT07359755 | Recruiting DMC

• 2 other identifiers: 7.815.54586242424.1.0000.0068
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pelvic Organ Prolapse (POP); Pelvic Organ Prolapse Vaginal Surgery; Mesh Reinforcement; Vaginal Apex/Uterine Prolapse

Keywords

Pelvic organ prolapse; Vaginal prolapse; Vaginal mesh; Robotic-assisted sacrocolpopexy; Sacrocolpopexy; Uterine prolapse

Outcome Measures

Primary Outcomes (1)

• Objective Cure Rate

  The criteria for objective cure will be defined according to the Pelvic Organ Prolapse Quantification (POP-Q) system, with point C positioned at -6 cm or higher (proximal), corresponding to stage 0 or I genital prolapse.

  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.

Secondary Outcomes (1)

• Surgical complication

  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.

Study Arms (2)

Vaginal mesh surgery

EXPERIMENTAL

Vaginal mesh surgery for apical prolapse

Procedure: Vaginal mesh surgery for apical prolapse

Robotic-assited abdominal sacrocolpopexy

ACTIVE COMPARATOR

Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse

Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse

Interventions

Vaginal mesh surgery for apical prolapse PROCEDURE

Cirurgia com tela vaginal para prolapso apical.

Vaginal mesh surgery

Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse PROCEDURE

Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.

Robotic-assited abdominal sacrocolpopexy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina de Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Kisby CK, Occhino JA, Bews KA, Habermann EB, Linder BJ. Perioperative Complications in Minimally Invasive Sacrocolpopexy Versus Transvaginal Mesh in the Management of Pelvic Organ Prolapse: Analysis of a National Multi-institutional Dataset. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):72-77. doi: 10.1097/SPV.0000000000000738.

  PMID: 31094716 BACKGROUND

• Maher CF, Baessler KK, Barber MD, Cheong C, Consten ECJ, Cooper KG, Deffieux X, Dietz V, Gutman RE, van Iersel JJ, Nager CW, Sung VW, de Tayrac R. Surgical management of pelvic organ prolapse. Climacteric. 2019 Jun;22(3):229-235. doi: 10.1080/13697137.2018.1551348. Epub 2018 Dec 21.

  PMID: 30572743 BACKGROUND

• Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA) / International Continence Society (ICS) Joint Report on the Terminology for Female Pelvic Organ Prolapse (POP). Neurourol Urodyn. 2016 Feb;35(2):137-68. doi: 10.1002/nau.22922. Epub 2016 Jan 7.

  PMID: 26749391 BACKGROUND

• Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.

  PMID: 37493538 BACKGROUND

• Zhang CY, Sun ZJ, Yang J, Xu T, Zhu L, Lang JH. Sacrocolpopexy compared with transvaginal mesh surgery: a systematic review and meta-analysis. BJOG. 2021 Jan;128(1):14-23. doi: 10.1111/1471-0528.16324. Epub 2020 Jun 15.

  PMID: 32426903 BACKGROUND

• Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.

  PMID: 15339758 BACKGROUND

• Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.

  PMID: 12066091 BACKGROUND

• Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. Am J Obstet Gynecol. 2004 Jan;190(1):27-32. doi: 10.1016/j.ajog.2003.07.017.

  PMID: 14749630 BACKGROUND

• Bradley CS, Zimmerman MB, Qi Y, Nygaard IE. Natural history of pelvic organ prolapse in postmenopausal women. Obstet Gynecol. 2007 Apr;109(4):848-54. doi: 10.1097/01.AOG.0000255977.91296.5d.

  PMID: 17400845 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Marcelo Hisano, MD PhD

CONTACT

551126618080; m.hisano@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This prospective, randomized trial is designed to evaluate the treatment of apical vaginal prolapse, with the objective of demonstrating the non-inferiority of vaginal mesh repair compared to robotic-assisted abdominal sacral colpopexy. The assessment will focus on objective cure rates as well as secondary outcomes, including clinical complications, mesh erosion, and patient-reported clinical improvements measured through validated questionnaires.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 22, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

BR (1)