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

NCT07414849 | Not Yet Recruiting

• 1 other identifier: 18099
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse Vaginal Surgery; Stress Urinary Incontinence in Women

Keywords

amniotic membrane graft; polypropylene mesh

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

With amniotic membrane

EXPERIMENTAL

Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.

Procedure: Sacrospinous Hysteropexy with Mesh; Procedure: Retropubic Mid-urethral Sling (Bottom-Up); Procedure: Transobturator Mid-urethral Sling (Out-In)

without amniotic membrane, surgery alone

ACTIVE COMPARATOR

Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch

Procedure: Sacrospinous Hysteropexy with Mesh; Procedure: Retropubic Mid-urethral Sling (Bottom-Up); Procedure: Transobturator Mid-urethral Sling (Out-In)

Interventions

Sacrospinous Hysteropexy with Mesh PROCEDURE

Sacrospinous Hysteropexy with polypropylene mesh

With amniotic membrane; without amniotic membrane, surgery alone

Retropubic Mid-urethral Sling (Bottom-Up) PROCEDURE

Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.

With amniotic membrane; without amniotic membrane, surgery alone

Transobturator Mid-urethral Sling (Out-In) PROCEDURE

Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.

With amniotic membrane; without amniotic membrane, surgery alone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Contraindication to the planned surgical procedure.
• Current pregnancy.

Sponsors & Collaborators

• Hospital General de Agudos J. M. Penna: lead

Study Sites (1)

Hospital J M Penna

Buenos Aires, Argentina

Location

Related Publications (17)

• Jacquetin B, Hinoul P, Gauld J, Fatton B, Rosenthal C, Clave H, Garbin O, Berrocal J, Villet R, Salet-Lizee D, Debodinance P, Cosson M. Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study. Int Urogynecol J. 2013 Oct;24(10):1679-86. doi: 10.1007/s00192-013-2080-4. Epub 2013 Apr 6.

  PMID: 23563891 BACKGROUND

• Willison N, McPhail C, Seman E, Taheri M, Aryan P, Nguyen T, Yi J, Abbott D, Dune T, Behnia-Willison F. Platelet-Rich Plasma and Fractional CO2 Laser Therapy to Reduce Surgical Intervention for Symptomatic Vaginal Mesh-Related Complications. Int Urogynecol J. 2025 Apr;36(4):903-912. doi: 10.1007/s00192-025-06123-z. Epub 2025 Apr 3.

  PMID: 40178545 BACKGROUND

• Meutia AP, Budinurdjaja P, Fauzi A, Boediono A, Djusad S, Prihartono J, Wuyung PE, Hestiantoro A, Santoso BI. Enhancing Mesh-Tissue Integration in Menopausal Models Using a Platelet-Rich Plasma-Decellularized Amnion Scaffold Sandwich: A Study on Mesh Contraction, Inflammatory Infiltrate, IL-17, CD31, and Collagen Deposition. Int Urogynecol J. 2025 May;36(5):1045-1052. doi: 10.1007/s00192-025-06084-3. Epub 2025 Mar 5.

  PMID: 40042603 BACKGROUND

• Lau HH, Jou QB, Huang WC, Su TH. Amniotic Membrane Graft in the Management of Complex Vaginal Mesh Erosion. J Clin Med. 2020 Jan 28;9(2):356. doi: 10.3390/jcm9020356.

  PMID: 32012905 BACKGROUND

• Dibb B, Woodgate F, Taylor L. When things go wrong: experiences of vaginal mesh complications. Int Urogynecol J. 2023 Jul;34(7):1575-1581. doi: 10.1007/s00192-022-05422-z. Epub 2023 Jan 6.

  PMID: 36607398 BACKGROUND

• Siblini T, Baracy M, Kulkarni S, Mabis C, Hagglund K, Aslam M. Midurethral Sling Mesh Exposure Confers a High Risk of Persistent Stress Urinary Incontinence. Int Urogynecol J. 2024 Jun;35(6):1177-1182. doi: 10.1007/s00192-024-05762-y. Epub 2024 May 4.

  PMID: 38703222 BACKGROUND

• Six JC, Pinsard M, Guerin S, Gasmi A, Coiffic J, Richard C, Haudebert C, Nyangoh Timoh K, Hascoet J, Peyronnet B. Risk factors for stress urinary incontinence recurrence after midurethral sling revision. Int J Urol. 2023 Nov;30(11):1008-1013. doi: 10.1111/iju.15248. Epub 2023 Jul 13.

  PMID: 37439555 BACKGROUND

• Maher CF, Yeung E, Chen Z, Masel A, Smith D, Lourie R, Devan SM, Rasch R, Uwins P, Blakey I, Boyle GM, Jones L. Pathogenesis of polypropylene mesh complications in female pelvic floor surgery. Am J Obstet Gynecol. 2025 Oct;233(4):309.e1-309.e11. doi: 10.1016/j.ajog.2025.03.009. Epub 2025 Mar 10.

  PMID: 40073920 BACKGROUND

• Liang R, Knight K, Abramowitch S, Moalli PA. Exploring the basic science of prolapse meshes. Curr Opin Obstet Gynecol. 2016 Oct;28(5):413-9. doi: 10.1097/GCO.0000000000000313.

  PMID: 27517341 BACKGROUND

• Page AS, Cattani L, Pacquee S, Claerhout F, Callewaert G, Housmans S, Van der Aa F, D'Hoore A, Deprest J. Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh. Obstet Gynecol. 2023 Jan 1;141(1):189-198. doi: 10.1097/AOG.0000000000005021. Epub 2022 Nov 30.

  PMID: 36701619 BACKGROUND

• Hofmann N, Rennekampff HO, Salz AK, Borgel M. Preparation of human amniotic membrane for transplantation in different application areas. Front Transplant. 2023 May 5;2:1152068. doi: 10.3389/frtra.2023.1152068. eCollection 2023.

  PMID: 38993896 BACKGROUND

• Jahanafrooz Z, Bakhshandeh B, Behnam Abdollahi S, Seyedjafari E. Human amniotic membrane as a multifunctional biomaterial: recent advances and applications. J Biomater Appl. 2023 Mar;37(8):1341-1354. doi: 10.1177/08853282221137609. Epub 2022 Nov 4.

  PMID: 36331116 BACKGROUND

• Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014 Feb;210(2):163.e1-8. doi: 10.1016/j.ajog.2013.10.012. Epub 2013 Oct 11.

  PMID: 24126300 BACKGROUND

• Giusto LL, Zahner PM, Goldman HB. Management of the Exposed or Perforated Midurethral Sling. Urol Clin North Am. 2019 Feb;46(1):31-40. doi: 10.1016/j.ucl.2018.08.003.

  PMID: 30466700 BACKGROUND

• Mao J, Chughtai B, Ibrahim S, Sedrakyan A. Food and Drug Administration Safety Communication on the Use of Transvaginal Mesh in Pelvic Organ Prolapse Repair Surgery: The Impact of Social Determinants of Health. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e133-e138. doi: 10.1097/SPV.0000000000000863.

  PMID: 32453208 BACKGROUND

• Guler Sonmez T, Ugras E, Gul Sahin E, Fidanci I, Aksoy H, Ayhan Baser D. The prevalence of incontinence and its impact on quality of life. Medicine (Baltimore). 2024 Dec 27;103(52):e41108. doi: 10.1097/MD.0000000000041108.

  PMID: 39969293 BACKGROUND

• de Tayrac R, Antosh DD, Baessler K, Cheon C, Deffieux X, Gutman R, Lee J, Nager C, Schizas A, Sung V, Maher C. Summary: 2021 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse. J Clin Med. 2022 Oct 17;11(20):6106. doi: 10.3390/jcm11206106.

  PMID: 36294427 BACKGROUND

MeSH Terms

Interventions

Melanocyte-Stimulating Hormones

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Ileana Sanger, MD

CONTACT

5491149113030; ilesaenger@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

AR (1)