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

NCT02123992 | Terminated Phase 4

• 1 other identifier: PR1206
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 23

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Elevate Apical and Posterior

ACTIVE COMPARATOR

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

Native Tissue Repair

ACTIVE COMPARATOR

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

Interventions

Elevate Apical and Posterior DEVICE

Elevate Apical and Posterior

Native Tissue Repair for pelvic organ prolapse PROCEDURE

Native Tissue Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (23)

Urological Associates of Southern Arizona

Tucson, Arizona, 85941, United States

Location

The Clark Center for Urogynecology

Newport Beach, California, 92663, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

National Center for Advanced Pelvic Surgery

Washington D.C., District of Columbia, 20010, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Adult & Pediatric Urology and Urogynecology

Omaha, Nebraska, 68114, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Delaware Valley Urology

Mount Laurel, New Jersey, 08054, United States

Location

Princeton Medical Center

Princeton, New Jersey, 08540, United States

Location

The Center for Specialized Women's Health

Whippany, New Jersey, 07981, United States

Location

North Shore Women's Health Clinic

Great Neck, New York, 11021, United States

Location

Premier Medical Group

Poughkeepsie, New York, 12601, United States

Location

The Institute for Female Pelvic Medicine - St. Luke's Hospital

Allentown, Pennsylvania, 18103, United States

Location

Center for Women's Health of Lansdale

Lansdale, Pennsylvania, 19446, United States

Location

The Female Pelvic Health Center

Newtown, Pennsylvania, 18940, United States

Location

Swan Urogynecology

Nashville, Tennessee, 37203, United States

Location

The Womens Centre

Denton, Texas, 76210, United States

Location

University of Texas at Galveston

Galveston, Texas, 77555, United States

Location

Lone Star Urogynecology and Continence Center

Round Rock, Texas, 78665, United States

Location

Female Pelvic Medicine Institute of Virginia

North Chesterfield, Virginia, 23235, United States

Location

Athena Women's Health

Issaquah, Washington, 98027, United States

Location

University of Washington Pelvic Health Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric R Sokol, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (23)