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

NCT03271294 | Completed

• 1 other identifier: 20160000
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pelvic organ prolapse; Exair; Transvaginal mesh

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Exair transvaginal mesh surgery

OTHER

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

Interventions

Exair Transvaginal Mesh DEVICE

Exair transvaginal mesh system for the treatment of pelvic organ prolapse

Exair transvaginal mesh surgery

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michigan Institution of Women's Health PC: lead
• Coloplast A/S: collaborator

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urogynecology

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: April 19, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 5, 2017

Record last verified: 2017-08