Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse (Harmony 522)

A Prospective, Safety and Efficacy Cohort Study of Elevate® Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.

Study Overview

• Status: Terminated
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Elevate Apical and Posterior; Procedure: Native Tissue Repair for pelvic organ prolapse

Detailed Description

The Harmony 522 study has been terminated due to the closing of the Astora Women's Health business. No other entity will be taking responsibility for this study. The study was terminated with partial subject enrollment complete and therefore no primary or secondary data analysis can be performed. The data from this study resides in a national data base which Astora no longer has access and therefore is another reason why no data analysis can be performed. The national database is owned and managed by the American Urogynecology Society (AUGS). AUGS has access to Astora's data and will at some time in the near future publish results to physicians who are active participants in the registry. Full public disclosure of this data may not occur for a number of years and will be aggregated with data from other study sponsors.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85941
      • Urological Associates of Southern Arizona
  • California
    • Newport Beach, California, United States, 92663
      • The Clark Center for Urogynecology
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • National Center for Advanced Pelvic Surgery
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Metro Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology and Urogynecology
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Women's Cancer Center of Nevada
  • New Jersey
    • Mt. Laurel, New Jersey, United States, 08054
      • Delaware Valley Urology
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Center
    • Whippany, New Jersey, United States, 07981
      • The Center for Specialized Women's Health
  • New York
    • Great Neck, New York, United States, 11021
      • North Shore Women's Health Clinic
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine - St. Luke's Hospital
    • Lansdale, Pennsylvania, United States, 19446
      • Center for Women's Health of Lansdale
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Swan Urogynecology
  • Texas
    • Denton, Texas, United States, 76210
      • The Womens Centre
    • Galveston, Texas, United States, 77555
      • University of Texas at Galveston
    • Round Rock, Texas, United States, 78665
      • Lone Star Urogynecology and Continence Center
  • Virginia
    • North Chesterfield, Virginia, United States, 23235
      • Female Pelvic Medicine Institute of Virginia
  • Washington
    • Issaquah, Washington, United States, 98027
      • Athena Women's Health
    • Seattle, Washington, United States, 98195
      • University of Washington Pelvic Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Subject is female

Subject is at least 18 years of age

Subject must have documented diagnosis of posterior or posterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment posterior prolapse that includes the apical compartment)

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 or subject's legally authorized representative 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 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 systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, 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

Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elevate Apical and Posterior; The experimental arm of the study will include the implantation of the Elevate Posterior surgical mesh for the treatment of posterior vaginal prolapse	Device: Elevate Apical and Posterior
Active Comparator: Native Tissue Repair; The control arm of the study will include the treatment of posterior vaginal prolapse using standard surgical sutures	Procedure: Native Tissue Repair for pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures	36 months
Rate of device or procedure related serious adverse events	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures	36 months
Rate of repeat surgery/revision for prolapse arising from the same site/target compartment	36 months
Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12	36 months

Other Outcome Measures

Outcome Measure	Time Frame
Subjects experiencing vaginal bulge	36 months
Subjects experiencing adverse events related to device or procedure	36 months
Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months	36 months

Collaborators and Investigators

• Sponsor: ASTORA Women's Health
• Investigators: Principal Investigator: Eric R Sokol, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PR1206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.