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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done for uterine prolapse in this study. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of large uterine prolapses precluding the need for a hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exair transvaginal mesh surgery | Other | This is a prospective study done in 80 consecutive subjects who underwent the Exair transvaginal mesh surgery from June 2013 to August 2015. The subjects were followed at 4 weeks, 6 months and 12 months post-operatively. All eligible subjects underwent a detailed urogynecologic history and examination including a Pelvic Organ Prolapse Quantification system assessment (POP-Q). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exair Transvaginal Mesh | Device | Exair transvaginal mesh system for the treatment of pelvic organ prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exair transvaginal mesh procedure success in anatomy and function at 1 year | Subjects who underwent the Exair transvaginal mesh surgery were followed post-operatively to determine mesh procedure success at 12 months. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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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