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Exair® Versus Native Tissue Repair for Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162628
Recruitment Status : Terminated (Device voluntarily withdrawn from commercial use by manufacturer)
First Posted : June 13, 2014
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Device: Exair Prolapse Repair System Procedure: Total Native Tissue Repair

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Exair for Total Repair
Total repair with Exair Prolapse Repair System alone or in combination with native tissue repair
Device: Exair Prolapse Repair System
Total Native Tissue Repair
Total repair with native tissue only
Procedure: Total Native Tissue Repair



Primary Outcome Measures :
  1. Recurrence of Prolapse [ Time Frame: 36 Month ]
    Recurrent prolapse is measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.

  2. Rate of device and procedure related adverse events [ Time Frame: 36 Month ]

Secondary Outcome Measures :
  1. Recurrence of prolapse [ Time Frame: 36 Month ]
    Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.

  2. Rates of other adverse events [ Time Frame: 36 months ]

Other Outcome Measures:
  1. Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 [ Time Frame: 36 months ]
  2. Subjects experiencing vaginal bulge [ Time Frame: 36 months ]
  3. Rates of revision and/or re-surgery [ Time Frame: 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
Criteria

Inclusion Criteria:

  • Female at least 18 years of age
  • Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and Bp ≥0 and C≥ -1/2 tvl
  • Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
  • Subject is willing to provide written informed consent
  • Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

  • Subject is pregnant or intends to become pregnant during the study
  • Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
  • Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
  • Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
  • Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  • Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
  • Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
  • Subject has uncontrolled diabetes mellitus (DM)
  • Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
  • Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
  • Subject is not able to conform to the modified dorsal lithotomy position
  • Subject is currently participating in or plans to participate in another device or drug study during this study
  • Subject has a known sensitivity to polypropylene
  • Subject has had previous prolapse repair with mesh in the target compartment(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162628


Locations
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United States, Georgia
Progressive GYN Center
Savannah, Georgia, United States, 31405
United States, Indiana
Women's Health Advantage
Fort Wayne, Indiana, United States, 46825
United States, Michigan
Advanced Urogynecology of Michigan
Dearborn, Michigan, United States, 48124
United States, Minnesota
Minnesota Women's Care
Maplewood, Minnesota, United States, 55109
United States, New Jersey
Atlantic Urogynecology Associates
Morristown, New Jersey, United States, 07960
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United Health Services
Johnson City, New York, United States, 13790
United States, North Carolina
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Novant Health Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
United States, Vermont
Vermont Urogynecology Associates, P.C.
Williston, Vermont, United States, 05495
United States, Virginia
Carillion Clinic OB/GYN
Christiansburg, Virginia, United States, 24073
Canada, Quebec
CHUS-CRC
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: James Lukban, DO, FACOG The Pelvic Solutions Center
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02162628    
Other Study ID Numbers: SU019
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Coloplast A/S:
Pelvic Floor Disorder
Pelvic Organ Prolapse
Sexual Dysfunction
Mesh
POP
Transvaginal
Total Repair
Uterine Prolapse
Cystocele
Rectocele
Enterocele
Vaginal Vault Prolapse
Native Tissue Repair
Repair Augmented with Mesh
Pathological Conditions, Anatomical
Exair Prolapse Repair System
Vaginal Mesh
Transvaginal Mesh
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical