Exair® Versus Native Tissue Repair for Prolapse

Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study

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.

Study Overview

• Status: Terminated
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Exair Prolapse Repair System; Procedure: Total Native Tissue Repair

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS-CRC
• United States
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Progressive GYN Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Advanced Urogynecology of Michigan
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Women's Care
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Urogynecology Associates
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Johnson City, New York, United States, 13790
      • United Health Services
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Clinical Research
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery
  • Vermont
    • Williston, Vermont, United States, 05495
      • Vermont Urogynecology Associates, P.C.
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Carillion Clinic OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Prolapse	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.	36 Month
Rate of device and procedure related adverse events		36 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of prolapse	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.	36 Month
Rates of other adverse events		36 months

Other Outcome Measures

Outcome Measure	Time Frame
Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7	36 months
Subjects experiencing vaginal bulge	36 months
Rates of revision and/or re-surgery	36 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: James Lukban, DO, FACOG, The Pelvic Solutions Center

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (ESTIMATE): June 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cystocele; Pelvic Organ Prolapse; Mesh; POP; Sexual Dysfunction; Transvaginal; Pathological Conditions, Anatomical; Rectocele; Native Tissue Repair; Repair Augmented with Mesh; Pelvic Floor Disorder; Uterine Prolapse; Enterocele; Vaginal Vault Prolapse; Vaginal Mesh; Transvaginal Mesh; Total Repair; Exair Prolapse Repair System
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: SU019