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

Pelvic Organ Prolapse Clinical Trial

— Harmony 522  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02123992
• Other study ID #: PR1206
• Status: Terminated
• Phase: Phase 4
• First received: April 24, 2014
• Last updated: September 6, 2016
• Start date: April 2014
• Est. completion date: April 2019

Study information

• Verified date: September 2016
• Source: ASTORA Women's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Elevate Apical and Posterior

Procedure:
• Native Tissue Repair for pelvic organ prolapse

Locations

Country	Name	City	State
United States	The Institute for Female Pelvic Medicine - St. Luke's Hospital	Allentown	Pennsylvania
United States	The Womens Centre	Denton	Texas
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	University of Texas at Galveston	Galveston	Texas
United States	North Shore Women's Health Clinic	Great Neck	New York
United States	Athena Women's Health	Issaquah	Washington
United States	Center for Women's Health of Lansdale	Lansdale	Pennsylvania
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Delaware Valley Urology	Mt. Laurel	New Jersey
United States	Swan Urogynecology	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	The Clark Center for Urogynecology	Newport Beach	California
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	Female Pelvic Medicine Institute of Virginia	North Chesterfield	Virginia
United States	Adult & Pediatric Urology and Urogynecology	Omaha	Nebraska
United States	Premier Medical Group	Poughkeepsie	New York
United States	Princeton Medical Center	Princeton	New Jersey
United States	Lone Star Urogynecology and Continence Center	Round Rock	Texas
United States	University of Washington Pelvic Health Center	Seattle	Washington
United States	Urological Associates of Southern Arizona	Tucson	Arizona
United States	National Center for Advanced Pelvic Surgery	Washington	District of Columbia
United States	The Center for Specialized Women's Health	Whippany	New Jersey
United States	Metro Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
ASTORA Women's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjects experiencing adverse events related to device or procedure		36 months	Yes
Other	Subjects experiencing vaginal bulge		36 months	No
Other	Subjects experiencing prolapse at or beyond the hymenal ring [Time Frame: 36 months		36 months	No
Primary	Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures		36 months	No
Primary	Rate of device or procedure related serious adverse events		36 months	Yes
Secondary	Surgical success or failure through composite endpoint including anatomic, subjective and re-treatment measures		36 months	No
Secondary	Rate of repeat surgery/revision for prolapse arising from the same site/target compartment		36 months	No
Secondary	Changes in Quality of Life measured through the following questionaires: PFDI- 20,PFIQ-7, PISQ-12		36 months	No