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
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
Treatments tested in this trial
- Sacrospinous Hysteropexy with Mesh
- Retropubic Mid-urethral Sling (Bottom-Up)
- Transobturator Mid-urethral Sling (Out-In)