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Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

Pelvic Organ Prolapse Clinical Trial

Official title:
Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

Clinical Trial Summary

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. [describe participant population/health conditions]. The main question[s] it aims to answer are: - Is the leading edge of the prolapse above the hymen - Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

Clinical Trial Description

This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy. Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06263985
Study type Interventional
Source Michigan Institution of Women's Health PC
Contact
Status Active, not recruiting
Phase Phase 4
Start date November 2, 2021
Completion date May 30, 2025
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