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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Active, not recruiting

Conditions: Prolapse; Female; Prolapse Genital; Prolapse Uterovaginal

Treatments: Procedure: Laparoscopic colposacropexy with levator ani muscle mesh fixation; Procedure: Simplified modification of laparoscopic colposacropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT07194343

PI21/00852

Details and patient eligibility

About

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.

Full description

This study is a multicenter, randomized, controlled, evaluator-blinded, non-inferiority clinical trial. The null hypothesis is that colposacropexy with posterior mesh fixation to the vaginal vault (without rectovaginal dissection) is associated with an anatomical and/or functional failure rate that is equal to or more than 15% higher than colposacropexy with posterior mesh fixation to the levator ani muscle (deep rectovaginal dissection). A non-inferiority margin of 15% has been selected because smaller differences are not considered clinically relevant.

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.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

Group A: Standard laparoscopic colposacropexy

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopic colposacropexy with levator ani muscle mesh fixation

Group B: Simplified laparoscopic colposacropexy

Experimental group

Description:

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.

Treatment:

Procedure: Simplified modification of laparoscopic colposacropexy