Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse

Michigan Institution of Women's Health PC

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: Exair Transvaginal Mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03271294

20160000

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects desiring surgery for stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q) and symptoms specific to pelvic organ prolapse mainly bothersome perception of a vaginal bulge

Exclusion criteria

• any physical or mental limitation that precluded their participation or inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Exair transvaginal mesh surgery

Other group

Description:

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).

Treatment:

Device: Exair Transvaginal Mesh