Harmony 522: Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Subjects experiencing adverse events related to device or procedure [36 months]
- Subjects experiencing vaginal bulge [36 months]
- Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months [36 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urological Associates of Southern Arizona | Tucson | Arizona | United States | 85941 |
| 2 | The Clark Center for Urogynecology | Newport Beach | California | United States | 92663 |
| 3 | Yale School of Medicine | New Haven | Connecticut | United States | 06520 |
| 4 | National Center for Advanced Pelvic Surgery | Washington | District of Columbia | United States | 20010 |
| 5 | Women's Health Advantage | Fort Wayne | Indiana | United States | 46825 |
| 6 | Metro Urology | Woodbury | Minnesota | United States | 55125 |
| 7 | Adult & Pediatric Urology and Urogynecology | Omaha | Nebraska | United States | 68114 |
| 8 | Women's Cancer Center of Nevada | Las Vegas | Nevada | United States | 89169 |
| 9 | Delaware Valley Urology | Mt. Laurel | New Jersey | United States | 08054 |
| 10 | Princeton Medical Center | Princeton | New Jersey | United States | 08540 |
| 11 | The Center for Specialized Women's Health | Whippany | New Jersey | United States | 07981 |
| 12 | North Shore Women's Health Clinic | Great Neck | New York | United States | 11021 |
| 13 | Premier Medical Group | Poughkeepsie | New York | United States | 12601 |
| 14 | The Institute for Female Pelvic Medicine - St. Luke's Hospital | Allentown | Pennsylvania | United States | 18103 |
| 15 | Center for Women's Health of Lansdale | Lansdale | Pennsylvania | United States | 19446 |
| 16 | The Female Pelvic Health Center | Newtown | Pennsylvania | United States | 18940 |
| 17 | Swan Urogynecology | Nashville | Tennessee | United States | 37203 |
| 18 | The Womens Centre | Denton | Texas | United States | 76210 |
| 19 | University of Texas at Galveston | Galveston | Texas | United States | 77555 |
| 20 | Lone Star Urogynecology and Continence Center | Round Rock | Texas | United States | 78665 |
| 21 | Female Pelvic Medicine Institute of Virginia | North Chesterfield | Virginia | United States | 23235 |
| 22 | Athena Women's Health | Issaquah | Washington | United States | 98027 |
| 23 | University of Washington Pelvic Health Center | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- ASTORA Women's Health
Investigators
- Principal Investigator: Eric R Sokol, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PR1206