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

Michigan Institution of Women's Health PC50 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Axis Dermis biologic mesh repair for pelvic organ prolapseDEVICE

Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Advanced Urogynecology of Michigan

Dearborn, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Preoperative to 3 years postoperative.

Secondary Outcomes

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).

Time frame: intraoperative to 3 years postoperative

Data from ClinicalTrials.gov

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