Exair® Versus Native Tissue Repair for Prolapse | NCT02162628

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exair Prolapse Repair System	Device		Exair for Total Repair
Total Native Tissue Repair

Outcomes Module

Primary Outcomes

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 Outcomes

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

Measure	Description	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

Eligibility Module

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)

Name	Affiliation	Role
James Lukban, DO, FACOG	The Pelvic Solutions Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Progressive GYN Center		Savannah	Georgia	31405	United States
Women's Health Advantage

ID	Term
D056887	Pelvic Organ Prolapse
D059952	Pelvic Floor Disorders
D012735	Sexual Dysfunction, Physiological
D014596	Uterine Prolapse
D052858	Cystocele
D020047	Rectocele
D006547	Hernia
D020763	Pathological Conditions, Anatomical

Ancestor Terms

ID	Term
D011391	Prolapse
D013568	Pathological Conditions, Signs and Symptoms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D011248	Pregnancy Complications
D052801	Male Urogenital Diseases
D000091662	Genital Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases