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

Michigan Institution of Women's Health PC

Status and phase: Active, not recruiting; Phase 4

Conditions: Pelvic Organ Prolapse

Treatments: Device: Axis Dermis biologic mesh repair for pelvic organ prolapse

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06263985

20214133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 21 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)
• Subjects who have bothersome vaginal bulge based upon symptoms.
• Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus).

Exclusion criteria

• Subjects who are unable to follow-up.
• Subjects who cannot complete the validated questionnaires.
• Subjects that lack competency of the English language.
• Subjects who decline to be part of the clinical trial.
• Subjects who do not sign an informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh

Other group

Description:

This is a single are which will be composed of subjects with Stage II or greater pelvic organ prolapse who have agreed to undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh. They will undergo the procedure and be followed for a period of 3 years.

Treatment:

Device: Axis Dermis biologic mesh repair for pelvic organ prolapse