Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

January 15, 2025 updated by: Hospital Mutua de Terrassa

Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gerard Molina
  • Phone Number: +34937365050

Study Contact Backup

  • Name: Pilar Arcusa
  • Phone Number: +34937365050

Study Locations

  • Spain
      • Terrassa, Spain, 08221
        • Recruiting
        • Hospital Mútua de Terrassa
        • Contact:
          • Gerard Molina
          • Phone Number: 937365050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Vaginal hysterectomy plus anterior colporrhaphy
Procedure: Vaginal hysterectomy plus anterior colporrhaphy
Vaginal hysterectomy plus anterior colporrhaphy
Sham Comparator: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Procedure: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Experimental: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Procedure: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of anatomical anterior vaginal wall prolapse
Time Frame: 36 months
Defined as point Ba POP-Q stage ≥II by clinical examination
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between groups in anatomical prolapse
Time Frame: 36 moths
Defined as point C POP-Q stage ≥II by clinical examination
36 moths
Differences between groups in symptomatic recurrence
Time Frame: 36 months
Evaluated by Pelvic Floor Impact Questionnaire. Minimum value: 0. Maximum value: 300. The higher the value worse is the outcome
36 months
Differences between groups in quality of Life
Time Frame: 36 months
Evaluated by European Quality of Life-5 Dimensions Questionnaire. Minimum value: 0. Maximum value: 1. The higher the value the worse is the outcome
36 months
Differences between groups in sexual functioning.
Time Frame: 36 months
Evaluated by Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire. Minimum value: 0. Maximum value: 100. The higher the value the worse is the outcome
36 months
Differences between groups in hospital stay
Time Frame: 36 months
Evaluated by number of days of hospital stay
36 months
Differences between groups in operative time
Time Frame: 36 months
Evaluated by minutes of duration of surgery
36 months
Differences between groups in surgical complication rate.
Time Frame: 36 months
Monitoring of development of hematoma, urologic lesion, need for blood transfusion, suture dehiscence, pain, infection and mesh extrusion
36 months
Differences between groups in reintervention rate
Time Frame: 36 months
Reintervention will be done in cases of symptomatic recurrence of the compartment previously treated or development of another prolapse.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Mutua de Terrassa

Collaborators

Germans Trias i Pujol Hospital
Hospital Arnau de Vilanova
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mesh in prolapse treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in the publication

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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