NCT03271294

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Michigan Institution of Women's Health PC · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Exair Transvaginal Mesh	Exair transvaginal mesh system for the treatment of pelvic organ prolapse

Timeline

• Start date: 2013-04-19
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2017-09-05
• Last updated: 2017-09-05