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NCT03271294 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03271294
Other study ID # 20160000
Secondary ID
Status Completed
Phase N/A
First received August 29, 2017
Last updated August 30, 2017
Start date April 19, 2013
Est. completion date August 2015

Study information
Verified date August 2017
Source Michigan Institution of Women's Health PC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Exair Transvaginal Mesh
Exair transvaginal mesh system for the treatment of pelvic organ prolapse

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Michigan Institution of Women's Health PC Coloplast A/S

Outcome
Type Measure Description Time frame Safety issue
Primary 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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