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Trial record 11 of 626 for:    transvaginal

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

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ClinicalTrials.gov Identifier: NCT03271294
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Coloplast A/S
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: Exair Transvaginal Mesh Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse
Actual Study Start Date : April 19, 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Salil Khandwala MD, Director of Urogynecology, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT03271294     History of Changes
Other Study ID Numbers: 20160000
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

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

Keywords provided by Salil Khandwala MD, Michigan Institution of Women's Health PC:
pelvic organ prolapse
Exair
Transvaginal mesh

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical