The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Argentina
Hospital J M Penna
RECRUITING
Buenos Aires
Contact Information
Primary
Ileana Sanger, MD
ilesaenger@me.com
5491149113030
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 330
Treatments
Experimental: With amniotic membrane
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.
Active_comparator: without amniotic membrane, surgery alone
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch
Related Therapeutic Areas
Sponsors
Leads: Hospital General de Agudos J. M. Penna