Exair® Versus Native Tissue Repair for Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02162628
• Other study ID #: SU019
• Status: Terminated
• Phase: N/A
• First received: June 11, 2014
• Last updated: December 11, 2015
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Exair Prolapse Repair System

Procedure:
• Total Native Tissue Repair

Locations

Country	Name	City	State
Canada	CHUS-CRC	Sherbrooke	Quebec
United States	Albany Medical Center	Albany	New York
United States	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Carillion Clinic OB/GYN	Christiansburg	Virginia
United States	Advanced Urogynecology of Michigan	Dearborn	Michigan
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	United Health Services	Johnson City	New York
United States	Minnesota Women's Care	Maplewood	Minnesota
United States	Atlantic Urogynecology Associates	Morristown	New Jersey
United States	Princeton Urogynecology	Princeton	New Jersey
United States	Progressive GYN Center	Savannah	Georgia
United States	Vermont Urogynecology Associates, P.C.	Williston	Vermont
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina
United States	Novant Health Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7		36 months	No
Other	Subjects experiencing vaginal bulge		36 months	No
Other	Rates of revision and/or re-surgery		36 months	No
Primary	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	No
Primary	Rate of device and procedure related adverse events		36 Month	Yes
Secondary	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	No
Secondary	Rates of other adverse events		36 months	Yes