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

August 30, 2017 updated by: Salil Khandwala MD, Michigan Institution of Women's Health PC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exair transvaginal mesh surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exair transvaginal mesh procedure success in anatomy and function at 1 year
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan Institution of Women's Health PC

Collaborators

Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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