Pelvic Organ Prolapse
Conditions
Brief 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.
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.
Interventions
DEVICEAxis 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.
Sponsors
Coloplast A/S
Michigan Institution of Women's Health PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in function | Preoperative to 3 years postoperative. | 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. |
| Improvement in Anatomy | Preoperative to 3 years postoperative. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess complications or untoward side effects. | intraoperative to 3 years postoperative | 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). |
Countries
United States
Outcome results
None listed