Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

NCT ID: NCT06404931

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-01-01

Brief Summary

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.

They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .

Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.

Detailed Description

Eligible patients will be women with symptomatic anterior and apical prolapse with hiatal ballooning or levator ani injury eligible for vaginal surgical treatment.

At the time of the indication for surgery, anatomical severity of the prolapse (according to the Pelvic Organ Prolapse Quantification System (POP-Q) scale) and the symptoms of prolapse and sexual function, as well as their impact on the quality of life of the patient, are evaluated using validated questionnaires "Pelvic Floor Impact Questionnaire (PFIQ)", "Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"and "European Quality of Life-5 Dimensions Questionnaire (EQ5D)". Anatomical severity of the prolapse will be also evaluated by ecography described as follows.

Three-dimensional 3D/4D transperineal ultrasound (TPS) will be performed using a GE Voluson® ultrasound system (GE Medical Systems) with a RAB 8-4-MHz transducer at an acquisition angle of 85°.

TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure. Volumes are acquired at rest, on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver. Patients perform Valsalva for at least 5 s, and the best of three volumes is used for analysis. Using visual biofeedback, an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers.

3D volumes are measured offline using GE 4 Dimension View (GE Medical Systems). Using the best Valsalva maneuver, pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis. Levator hiatal area is assessed in the plane of minimal hiatal dimensions.

Surgical indication will be determined by gynaecologists and the decision will be clearly dissociated from the decision of study inclusion. Therefore, the performance of the study should not modify the habits of surgical indication by the doctors.

The study will be a single-blinded study, as it is impossible to blind the health care workers involved for the surgical procedure to which the woman is randomized. The physician evaluating the patients during the follow-up will be blinded about the group the patients were randomized to.

Women will be randomly assigned after consenting for participation in the study, by means of an interactive response technology system in a 1:1:1 ratio to receive surgical treatment with vaginal hysterectomy followed by hADM anterior reinforcement and sacrospinous fixation with Anchorsure® device (NeomedicTM International, Spain), vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone or classic vaginal hysterectomy with anterior colporrhaphy. A sacrospinous fixation-alone group was included to assess the impact of this technique in the principal surgery group. Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months.

Anatomical results will be evaluated by a member of the team blinded to the surgery performed during follow-up visits after surgery and by 3D ultrasound of the pelvic floor. Functional results are evaluated using the validated questionnaires performed prior to surgery done by the patients during follow-up visits after surgery.

Conditions

Prolapse; Female; Prolapse Genital; Prolapse Uterovaginal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus anterior colporrhaphy

Group Type: SHAM_COMPARATOR

Vaginal hysterectomy plus anterior colporrhaphy

Intervention Type: PROCEDURE

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Group Type: SHAM_COMPARATOR

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Intervention Type: PROCEDURE

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Group Type: EXPERIMENTAL

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Intervention Type: PROCEDURE

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Interventions

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Intervention Type: PROCEDURE

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus anterior colporrhaphy

Intervention Type: PROCEDURE

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with symptomatic POP with indication of vaginal surgery.
• Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
• Women ≥18 years old.
• Women wishing to complete a 36-month follow-up.
• Understand and accept the study procedures and sign the informed consent.

Exclusion Criteria

• Women with previous pelvic floor or prolapse surgery
• Women with POP grade IV
• Women with chronic pelvic pain.
• Not being able to understand the nature of the study and/or the procedures to be followed.
• Not signing the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role: collaborator

Hospital Mutua de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Mutua de Terrassa

Terrassa, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gerard Molina

Role: CONTACT

+34937365050

Pilar Arcusa

Role: CONTACT

+34937365050

Facility Contacts

Gerard Molina

Role: primary

937365050

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Other Identifiers

Mesh in prolapse treatment

Identifier Type: -

Identifier Source: org_study_id