Clinical trial NCT02123992: Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
timeFrame: 36 months
measure: Rate of device or procedure related serious adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures
timeFrame: 36 months
measure: Rate of repeat surgery/revision for prolapse arising from the same site/target compartment
timeFrame: 36 months
measure: Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12
timeFrame: 36 months
Other outcomes:
measure: Subjects experiencing adverse events related to device or procedure
timeFrame: 36 months
measure: Subjects experiencing vaginal bulge
timeFrame: 36 months
measure: Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months
timeFrame: 36 months
Locations:
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Newport Beach
country: United States
facility: The Clark Center for Urogynecology
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Washington
country: United States
facility: National Center for Advanced Pelvic Surgery
state: District of Columbia
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Omaha
country: United States
facility: Adult & Pediatric Urology and Urogynecology
state: Nebraska
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Mt. Laurel
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Center
state: New Jersey
city: Whippany
country: United States
facility: The Center for Specialized Women's Health
state: New Jersey
city: Great Neck
country: United States
facility: North Shore Women's Health Clinic
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine - St. Luke's Hospital
state: Pennsylvania
city: Lansdale
country: United States
facility: Center for Women's Health of Lansdale
state: Pennsylvania
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Nashville
country: United States
facility: Swan Urogynecology
state: Tennessee
city: Denton
country: United States
facility: The Womens Centre
state: Texas
city: Galveston
country: United States
facility: University of Texas at Galveston
state: Texas
city: Round Rock
country: United States
facility: Lone Star Urogynecology and Continence Center
state: Texas
city: North Chesterfield
country: United States
facility: Female Pelvic Medicine Institute of Virginia
state: Virginia
city: Issaquah
country: United States
facility: Athena Women's Health
state: Washington
city: Seattle
country: United States
facility: University of Washington Pelvic Health Center
state: Washington
Study officials:
affiliation: Stanford University
name: Eric R Sokol, MD
role: PRINCIPAL_INVESTIGATOR
References: