Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse

NCT07194343 | Completed

• 1 other identifier: PI21/00852
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Participants will be randomized into two groups: Group A: laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle. Group B: laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff/cervix, without dissection of the rectovaginal space. The objective of the study is to determine whether a simplified colposacropexy technique is non-inferior to the standard procedure in terms of anatomical and functional outcomes. The primary outcome is anatomical success, defined as a postoperative POP-Q stage 0-I. Secondary outcomes include functional status and sexual function, evaluated using the PFDI-20 and PISQ-12 questionnaires. Data on prolapse anatomy, related symptoms, and sexual function will be collected at baseline and during follow-up visits at 1, 6, and 12 months after surgery. This study is supported by a national health research grant from the Instituto de Salud Carlos III (ISCIII), Ministry of Science and Innovation, Spain.

Conditions

Prolapse; Female; Prolapse Genital; Prolapse Uterovaginal

Keywords

pelvic organ prolapse; apical prolapse; laparoscopic colposacropexy; mesh fixation; levator ani muscle; surgical outcomes; functional outcomes; anatomical outcomes; sexual function

Outcome Measures

Primary Outcomes (1)

• Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.

  Proportion of participants achieving anatomical success, defined as postoperative POP-Q stage 0-I. The primary analysis will test non-inferiority of the simplified technique (Group B) versus the standard technique (Group A). Non-inferiority will be concluded if the lower bound of the two-sided 95% confidence interval for (Success\_B - Success\_A) is greater than 15% (non-inferiority margin = 15%). POP-Q assessment will be performed using standardized technique by an evaluator blinded to surgical assignment.

  12 months after surgery

Secondary Outcomes (2)

• Difference in functional outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.

  12 months after surgery

• Difference in sexual outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.

  12 months after surgery

Study Arms (2)

Group A: Standard laparoscopic colposacropexy

ACTIVE COMPARATOR

The procedure is based on the laparoscopic colposacropexy technique described by Wattiez in 2001 (Clermont-Ferrand group). The standard technique includes dissection of the sacral promontory, the vesicovaginal space, and the rectovaginal space with bilateral pararectal fossae. In the vesicovaginal space, the mesh is anchored deeply at the level of the vesical neck, and posteriorly, in the rectovaginal and pararectal spaces, at the level of the levator ani muscle.

Procedure: Laparoscopic colposacropexy with levator ani muscle mesh fixation

Group B: Simplified laparoscopic colposacropexy

EXPERIMENTAL

The simplified technique includes dissection of the sacral promontory and the vesicovaginal space, but does not involve dissection of the rectovaginal space or the pararectal fossae. In this technique, the posterior mesh is anchored to the posterior aspect of the vaginal vault or cervix. Mesh fixation at the sacral promontory and in the vesicovaginal space is performed within the same anatomical boundaries as in the standard technique.

Procedure: Simplified modification of laparoscopic colposacropexy

Interventions

Simplified modification of laparoscopic colposacropexy PROCEDURE

Rectovaginal dissection is avoided, and the mesh is anchored to the posterior aspect of the cervix or vaginal vault rather than to the levator ani muscle, representing the specific modification from the standard technique.

Group B: Simplified laparoscopic colposacropexy

Laparoscopic colposacropexy with levator ani muscle mesh fixation PROCEDURE

The standard technique includes dissection of the rectovaginal space and bilateral mesh fixation to the levator ani muscle at the deep limit of the pararectal fossae dissection.

Group A: Standard laparoscopic colposacropexy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female participants are eligible, as the condition under study (apical pelvic organ prolapse) occurs exclusively in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification.
• Women with symptomatic POP with indication of reconstructive POP surgery.
• Agreement to comply with all scheduled visits and assessments through 12 months post-surgery.
• Understand and accept the study procedures and sign the informed consent.

You may not qualify if:

• History of abdominal reconstructive surgery for pelvic organ prolapse.
• History of vaginal reconstructive surgery for prolapse using mesh.
• Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse.
• Medical contraindication to general anesthesia.
• Patient preference for vaginal surgical treatment.
• Declines participation in the study.
• Patients with disabilities or unable to understand the terms of the study.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Carlos III Health Institute: collaborator
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (6)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

Location

Hospital Universitari d'Igualada

Igualada, Barcelona, Spain

Location

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Madrid, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Related Publications (9)

• Kuroda K, Hamamoto K, Kawamura K, Masunaga A, Horiguchi A, Ito K. Device Selection Contributes to Operative Time Reduction in Laparoscopic Sacrocolpopexy. Gynecol Minim Invasive Ther. 2025 Mar 15;14(2):157-164. doi: 10.4103/gmit.gmit_155_23. eCollection 2025 Apr-Jun.

  PMID: 40521574 BACKGROUND

• Schaub M, Lecointre L, Faller E, Boisrame T, Baldauf JJ, Wattiez A, Akladios CY. Laparoscopic Sacral Colpopexy: The "6-Points" Technique. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1081-1082. doi: 10.1016/j.jmig.2017.04.003. Epub 2017 Apr 18.

  PMID: 28435129 BACKGROUND

• 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

• Habib N, Centini G, Pizzoferrato AC, Bui C, Argay I, Bader G. Laparoscopic promontofixation: Where to stop the anterior dissection? Med Hypotheses. 2019 Mar;124:60-63. doi: 10.1016/j.mehy.2019.02.006. Epub 2019 Feb 2.

  PMID: 30798918 BACKGROUND

• Cosma S, Petruzzelli P, Chiado Fiorio Tin M, Parisi S, Olearo E, Fassio F, Zizzo R, Danese S, Benedetto C. Simplified laparoscopic sacropexy avoiding deep vaginal dissection. Int J Gynaecol Obstet. 2018 Nov;143(2):239-245. doi: 10.1002/ijgo.12632. Epub 2018 Aug 24.

  PMID: 30076597 BACKGROUND

• Moroni RM, Juliato CRT, Cosson M, Giraudet G, Brito LGO. Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review. Neurourol Urodyn. 2018 Nov;37(8):2335-2345. doi: 10.1002/nau.23764. Epub 2018 Jul 19.

  PMID: 30024069 BACKGROUND

• Gluck O, Blaganje M, Veit-Rubin N, Phillips C, Deprest J, O'reilly B, But I, Moore R, Jeffery S, Haddad JM, Deval B. Laparoscopic sacrocolpopexy: A comprehensive literature review on current practice. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:94-101. doi: 10.1016/j.ejogrb.2019.12.029. Epub 2019 Dec 26.

  PMID: 31891897 BACKGROUND

• Costantini E, Brubaker L, Cervigni M, Matthews CA, O'Reilly BA, Rizk D, Giannitsas K, Maher CF. Sacrocolpopexy for pelvic organ prolapse: evidence-based review and recommendations. Eur J Obstet Gynecol Reprod Biol. 2016 Oct;205:60-5. doi: 10.1016/j.ejogrb.2016.07.503. Epub 2016 Aug 3.

  PMID: 27566224 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

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the surgical intervention, a double-blind design is not feasible. However, the assessment of anatomical and functional outcomes during follow-up will be performed by an evaluator who is blinded to the type of surgical technique used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Pelvic Floor Functional Unit at the Hospital de la Santa Creu i Sant Pau

Model Details: Group A: Laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle (standard technique). Group B: Laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff or cervix, without rectovaginal space dissection (simplified technique).

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: October 6, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)