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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06263985
• Other study ID #: 20214133
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2, 2021
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Michigan Institution of Women's Health PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	Advanced Urogynecology of Michigan	Dearborn	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan Institution of Women's Health PC	Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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