Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
NCT ID: NCT07194343
Last Updated: 2025-09-26
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
190 participants
INTERVENTIONAL
2022-10-06
2025-12-31
Brief Summary
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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.
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Detailed Description
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With this project, the investigators aim to evaluate the outcomes of a simplified colposacropexy technique that avoids dissection of the rectovaginal space and deep pelvic mesh fixation. Demonstrating non-inferiority would imply rejecting the null hypothesis.
The procedure is indicated for women with stage II-IV uterine or vault prolapse according to the POP-Q classification, with or without associated anterior and/or posterior vaginal wall defects. The decision to perform surgery will be made by the gynecologists, independent of trial participation, to ensure that study enrollment does not influence standard surgical indications. Exclusion criteria include previous abdominal or vaginal mesh prolapse reconstructive surgery or POP-Q stage I or asymptomatic prolapse.
Sample size calculations assume a 91% success rate for the standardized procedure (Lee 2014), a non-inferiority margin of 15%, a 95% confidence interval, and 80% statistical power. A total of 166 patients (83 per group) are required, accounting for a 10% dropout rate.
DESCRIPTION OF THE SURGICAL TECHNIQUE
The vesicovaginal dissection and exposure of the sacral promontory will be performed identically in both groups. A predesigned polypropylene mesh will be used, consisting of:
* an apical end for fixation to the sacral promontory,
* two lateral arms shaped like "butterfly wings" to cover and support the anterior and lateral vaginal walls,
* and two lower arms designed for fixation to the levator ani muscle.
Fixation of the mesh to the vagina, sacral promontory, and (when applicable) the levator ani muscle will be performed using nitinol helical mechanical sutures (Spire'it). At the vesicovaginal space, the mesh will be anchored at the anatomical depth corresponding to the vesical neck level in both groups.
The only difference between groups involves the posterior compartment dissection and mesh fixation:
* Group A (standard technique): the posterior arms of the mesh are anchored bilaterally to the levator ani muscle with mechanical sutures.
* Group B (simplified technique): the posterior arms are removed, and the mesh is anchored only to the vaginal vault or cervix with mechanical sutures, without rectovaginal dissection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group B: Laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff or cervix, without rectovaginal space dissection (simplified technique).
TREATMENT
DOUBLE
Study Groups
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Group A: Standard laparoscopic colposacropexy
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.
Laparoscopic colposacropexy with levator ani muscle mesh fixation
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 B: Simplified laparoscopic colposacropexy
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.
Simplified modification of laparoscopic colposacropexy
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.
Interventions
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Laparoscopic colposacropexy with levator ani muscle mesh fixation
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.
Simplified modification of laparoscopic colposacropexy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Ministry of Science and Innovation, Spain
OTHER_GOV
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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IRENE MORA HERVAS
Coordinator of the Pelvic Floor Functional Unit at the Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Hospital Universitari d'Igualada
Igualada, Barcelona, Spain
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PI21/00852
Identifier Type: -
Identifier Source: org_study_id
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