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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Axis Dermis biologic mesh repair for pelvic organ prolapse

Detailed 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Advanced Urogynecology of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh; 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.	Device: Axis Dermis biologic mesh repair for pelvic organ prolapse; Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in function	Determine improvement in function based on questionnaire Pelvic Floor Distress Inventory Q#3 "Do you usually have a bulge or something falling out that you can see or fell in the vaginal area?" Answered No, or if Yes: Not at all bothersome.	Preoperative to 3 years postoperative.
Improvement in Anatomy	To assess improvement in anatomy with success defined as the leading edge of the prolapse is above the hymen, and no reintervention (surgery or pessary) for pelvic organ prolapse.	Preoperative to 3 years postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess complications or untoward side effects.	Assessment of intraoperative complications (such as bleeding and injuries) and post operative complications (such as de novo incontinence, de novo dyspareunia, recurrent urinary tract infections, voiding dysfunction and effect on untreated vaginal wall).	intraoperative to 3 years postoperative

Collaborators and Investigators

• Sponsor: Michigan Institution of Women's Health PC
• Collaborators: Coloplast A/S
• Investigators: Principal Investigator: Salil Khandwala, MD, Michigan Institution of Women's Health PC

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 20214133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No