An interventional study of Exair Transvaginal Mesh in Pelvic Organ Prolapse, sponsored by Michigan Institution of Women's Health PC. Completed. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Michigan Institution of Women's Health PC · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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).
Device: Exair Transvaginal Mesh
Exair transvaginal mesh system for the treatment of pelvic organ prolapse
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.
Time frame: 1 year
No study locations are listed for this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Michigan Institution of Women's Health PC