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

NCT ID: NCT03271294

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-19
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Exair Transvaginal Mesh

Intervention Type: DEVICE

Exair transvaginal mesh system for the treatment of pelvic organ prolapse

Interventions

Exair Transvaginal Mesh

Exair transvaginal mesh system for the treatment of pelvic organ prolapse

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: collaborator

Michigan Institution of Women's Health PC

OTHER

Sponsor Role: lead

Responsible Party

Salil Khandwala MD

Director of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20160000

Identifier Type: -

Identifier Source: org_study_id