Recruiting NCT07414849
The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up), Transobturator Mid-urethral Sling (Out-In).
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
Overview
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
Interventions
- Procedure Sacrospinous Hysteropexy with Mesh
Sacrospinous Hysteropexy with polypropylene mesh - Procedure Retropubic Mid-urethral Sling (Bottom-Up)
Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence. - Procedure Transobturator Mid-urethral Sling (Out-In)
Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.
Primary outcome measures
- Number of Participants with Mesh exposure [Time frame: From enrollment through the end of the 12-month follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Argentina · 1 center
- Hospital J M Penna — Buenos Aires
Publications
- 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
- 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
- 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 PMID 40042603
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07414849 · 18099