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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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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:
This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axisâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axis Dermis biologic mesh repair for pelvic organ prolapse | Device | Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salil Khandwala, MD | Michigan Institution of Women's Health PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Urogynecology of Michigan | Dearborn | Michigan | 48124 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh.
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