Pelvic Organ Prolapse Vaginal SurgeryAMPERNCT07414849
The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
A study testing Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up) and Transobturator Mid-urethral Sling (Out-In) in people with Pelvic Organ Prolapse Vaginal Surgery and Stress Urinary Incontinence in Women, run by Hospital General de Agudos J. M. Penna at 1 site in Argentina.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women
- What is being tested?
- Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up) and Transobturator Mid-urethral Sling (Out-In)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital J M Penna
Buenos Aires
Ileana Sanger, MD, 549114911-5555, Ilesaenger@gmail.com
Ileana Sanger, MD
About this study
Official title: The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
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
- Being tested
- Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up), Transobturator Mid-urethral Sling (Out-In)
- Keywords
- amniotic membrane graft, polypropylene mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacrospinous Hysteropexy with MeshProcedure or surgery
Sacrospinous Hysteropexy with polypropylene mesh
Retropubic Mid-urethral Sling (Bottom-Up)Procedure or 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 or surgery
Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Sacrospinous Hysteropexy with Mesh; Procedure: Retropubic Mid-urethral Sling (Bottom-Up); Procedure: Transobturator Mid-urethral Sling (Out-In) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through the end of the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse Vaginal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Agudos J. M. Penna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ileana Sänger, Hospital General de Agudos J. M. Penna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414849
- Sponsor's protocol ID
- 18099
- Acronym
- AMPER
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23563891Willison 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.
PubMed 40178545Meutia 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.
PubMed 40042603Lau 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.
PubMed 32012905Dibb 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.
PubMed 36607398Siblini 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.
PubMed 38703222Six 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.
PubMed 37439555Maher 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.
PubMed 40073920Liang 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.
PubMed 27517341Page 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.
PubMed 36701619Hofmann 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.
PubMed 38993896Jahanafrooz 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.
PubMed 36331116Abbott 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.
PubMed 24126300Giusto 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.
PubMed 30466700Mao 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.
PubMed 32453208
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT07414849
- Acronym / sponsor ID
- AMPER / 18099
- Keywords
- amniotic membrane graft, polypropylene mesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hospital General de Agudos J. M. PennaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With amniotic membrane | Experimental | Procedure: Sacrospinous Hysteropexy with Mesh, Procedure: Retropubic Mid-urethral Sling (Bottom-Up), Procedure: Transobturator Mid-urethral Sling (Out-In)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. |
| without amniotic membrane, surgery alone | Active comparator | Procedure: Sacrospinous Hysteropexy with Mesh, Procedure: Retropubic Mid-urethral Sling (Bottom-Up), Procedure: Transobturator Mid-urethral Sling (Out-In)Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacrospinous Hysteropexy with MeshSacrospinous Hysteropexy with polypropylene mesh | Procedure or surgery | With amniotic membrane, without amniotic membrane, surgery alone |
| Retropubic Mid-urethral Sling (Bottom-Up)Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence. | Procedure or surgery | With amniotic membrane, without amniotic membrane, surgery alone |
| Transobturator Mid-urethral Sling (Out-In)Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence. | Procedure or surgery | With amniotic membrane, without amniotic membrane, surgery alone |
Primary outcome
Number of Participants with Mesh exposure
Time frame: From enrollment through the end of the 12-month follow-up
Comparison of mesh exposure incidence between the control group and the amniotic membrane group through scheduled postoperative follow-up and self-administered questionnaires.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 23563891Jacquetin 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.
- Background: PubMed 40178545Willison 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.
- Background: PubMed 40042603Meutia 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.
- Background: PubMed 32012905Lau 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.
- Background: PubMed 36607398Dibb 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.
- Background: PubMed 38703222Siblini 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.
- Background: PubMed 37439555Six 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.
- Background: PubMed 40073920Maher 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.
- Background: PubMed 27517341Liang 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.
- Background: PubMed 36701619Page 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.
- Background: PubMed 38993896Hofmann 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.
- Background: PubMed 36331116Jahanafrooz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacrospinous Hysteropexy with Mesh, Retropubic Mid-urethral Sling (Bottom-Up) and Transobturator Mid-urethral Sling (Out-In) in people with Pelvic Organ Prolapse Vaginal Surgery and Stress Urinary Incontinence in Women, run by Hospital General de Agudos J. M. Penna at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ileana Sanger, MD (5491149113030, ilesaenger@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Mesh exposure (time frame: From enrollment through the end of the 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414849, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.