Clinical trial NCT02162628: Exair® Versus Native Tissue Repair for Prolapse
Official title: Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pelvic Organ Prolapse
Keywords: 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
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.

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.


Eligibility 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)

Primary outcomes:
measure: Recurrence of Prolapse
timeFrame: 36 Month
measure: Rate of device and procedure related adverse events
timeFrame: 36 Month
Secondary outcomes:
measure: Recurrence of prolapse
timeFrame: 36 Month
measure: Rates of other adverse events
timeFrame: 36 months
Other outcomes:
measure: Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7
timeFrame: 36 months
measure: Subjects experiencing vaginal bulge
timeFrame: 36 months
measure: Rates of revision and/or re-surgery
timeFrame: 36 months
Locations:
city: Savannah
country: United States
facility: Progressive GYN Center
state: Georgia
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan
state: Michigan
city: Maplewood
country: United States
facility: Minnesota Women's Care
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Urogynecology Associates
state: New Jersey
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Johnson City
country: United States
facility: United Health Services
state: New York
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Clinical Research
state: North Carolina
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Williston
country: United States
facility: Vermont Urogynecology Associates, P.C.
state: Vermont
city: Christiansburg
country: United States
facility: Carillion Clinic OB/GYN
state: Virginia
city: Sherbrooke
country: Canada
facility: CHUS-CRC
state: Quebec
Study officials:
affiliation: The Pelvic Solutions Center
name: James Lukban, DO, FACOG
role: PRINCIPAL_INVESTIGATOR
References: