A Phase 4 interventional study of Elevate Apical and Posterior and Native Tissue Repair for pelvic organ prolapse in Pelvic Organ Prolapse, sponsored by ASTORA Women's Health. Terminated at 23 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by ASTORA Women's Health · Phase 4, Interventional, and Treatment
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.
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.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 99 is above the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →ASTORA Women's Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
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
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
Time frame: 36 months
Rate of device or procedure related serious adverse events
Time frame: 36 months
Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
Time frame: 36 months
Rate of repeat surgery/revision for prolapse arising from the same site/target compartment
Time frame: 36 months
Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12
Time frame: 36 months
Subjects experiencing adverse events related to device or procedure
Time frame: 36 months
Subjects experiencing vaginal bulge
Time frame: 36 months
Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months
Time frame: 36 months
Plan to share: Yes — Data will be shared at a later data by the American Urogynecology Society aggregated with other data extracted from a national registry database.
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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ASTORA Women's Health