Exair® Versus Native Tissue Repair for Prolapse

Sponsor

Coloplast A/S (Industry)

Overall Status

Terminated

CT.gov ID

NCT02162628

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Pelvic Organ Prolapse	Device: Exair Prolapse Repair System Procedure: Total Native Tissue Repair

Study Design

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 :

Aug 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Recurrence of Prolapse [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.
Rate of device and procedure related adverse events [36 Month]

Secondary Outcome Measures

Recurrence of prolapse [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.
Rates of other adverse events [36 months]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

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