The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.

ConditionsPelvic Organ Prolapse Vaginal Surgery Stress Urinary Incontinence in Women

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

AgeNot listed

SponsorHospital General de Agudos J. M. Penna

About this trial

This study evaluates the efficacy of adding a human amniotic membrane graft to polypropylene mesh surgery for pelvic prolapse and stress urinary incontinence. The goal is to assess improvements in tissue integration and the reduction of surgical complications

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pelvic organ prolapse (POP) stage II C or greater, defined as C ≥ +1, in women without prior hysterectomy and/or with a diagnosis of stress urinary incontinence seeking surgical treatment.

Ability to understand study information and provide written informed consent.

Availability for follow-up for a minimum of 12 months.

Disqualifiers

Previous surgery with synthetic mesh (via vaginal or abdominal approach) for POP repair.

Known adverse reaction to synthetic meshes.

Unresolved or active chronic pelvic pain.

History of prior abdominal or pelvic radiation.

Trial design

Design model

Parallel

Treatments tested in this trial

Sacrospinous Hysteropexy with Mesh
Procedure/Surgery
Sacrospinous Hysteropexy with polypropylene mesh
Retropubic Mid-urethral Sling (Bottom-Up)
Procedure/Surgery
Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.
Transobturator Mid-urethral Sling (Out-In)
Procedure/Surgery
Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.

Treatment groups

330 Participants

are divided into 2 treatment groups

Group A: With amniotic membraneExperimental treatment 3 interventions

Group B: without amniotic membrane, surgery aloneActive comparator 3 interventions

Trial outcomes

Primary outcomes

Number of Participants with Mesh exposure

Comparison of mesh exposure incidence between the control group and the amniotic membrane group through scheduled postoperative follow-up and self-administered questionnaires.

Time frame

From enrollment through the end of the 12-month follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital General de Agudos J. M. Penna

Lead sponsor

Source ClinicalTrials.gov

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