NCT02162628

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
2 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

June 11, 2014

Last Update Submit

December 11, 2015

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Floor DisorderPelvic Organ ProlapseSexual DysfunctionMeshPOPTransvaginalTotal RepairUterine ProlapseCystoceleRectoceleEnteroceleVaginal Vault ProlapseNative Tissue RepairRepair Augmented with MeshPathological Conditions, AnatomicalExair Prolapse Repair SystemVaginal MeshTransvaginal Mesh

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Recurrence of prolapse

    36 Month

  • Rates of other adverse events

    36 months

Other Outcomes (3)

  • 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

Study Arms (2)

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

Interventions

Exair Prolapse Repair SystemDEVICE
Exair for Total Repair
Total Native Tissue RepairPROCEDURE
Total Native Tissue Repair

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Progressive GYN Center

Savannah, Georgia, 31405, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Advanced Urogynecology of Michigan

Dearborn, Michigan, 48124, United States

Location

Minnesota Women's Care

Maplewood, Minnesota, 55109, United States

Location

Atlantic Urogynecology Associates

Morristown, New Jersey, 07960, United States

Location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

United Health Services

Johnson City, New York, 13790, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Novant Health Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Vermont Urogynecology Associates, P.C.

Williston, Vermont, 05495, United States

Location

Carillion Clinic OB/GYN

Christiansburg, Virginia, 24073, United States

Location

CHUS-CRC

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Pelvic Organ ProlapsePelvic Floor DisordersSexual Dysfunction, PhysiologicalUterine ProlapseCystoceleRectoceleHerniaPathological Conditions, Anatomical

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, Signs and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesGenital DiseasesUterine DiseasesGenital Diseases, FemaleUrinary Bladder DiseasesUrologic DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • James Lukban, DO, FACOG

    The Pelvic Solutions Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 13, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(13)CA(1)