Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01917968
First received: July 18, 2013
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele.


Condition Intervention
Anterior/Apical Pelvic Organ Prolapse
Device: Uphold Lightweight Vaginal Support System
Procedure: Traditional native repair

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • The primary endpoint will be based on anatomic success measured by Pelvic Organ Prolapse Quantification System (POP-Q) for the target compartment at 36 months. [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    Success will be based on a composite of objective and subjective measures. Also, a co-primary endpoint of the study is to achieve non-inferiority of mesh to native tissue repair for safety by comparing rates of serious device or serious procedure-related complications between baseline and the 36 month time point.


Estimated Enrollment: 414
Study Start Date: October 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Uphold Lightweight Vaginal Support System Device: Uphold Lightweight Vaginal Support System
Active Comparator: Traditional native repair Procedure: Traditional native repair

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is female
  2. Subject is ≥18 years of age
  3. Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL (for a multi-compartment prolapse that includes the apical compartment).
  4. Subject reports of 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")
  5. Subject or subject's legally authorized representative must be willing to provide written informed consent
  6. Subject is willing and able to comply with the follow-up regimen
  7. Subject has had a total hysterectomy

Exclusion Criteria:

  1. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
  2. Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
  3. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
  4. Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  5. Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos collagenosis, polymyositis polymyalgia rheumatica)
  6. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
  7. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
  8. Subject has a previous prolapse repair with mesh in the target compartment
  9. Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
  10. Subject is not able to conform to the modified dorsal lithotomy position
  11. Subject has chronic systemic pain that includes the pelvic area or chronic pain that includes the pelvis
  12. Subject has uncontrolled diabetes mellitus (DM)
  13. Subject is currently participating in or plans to participate in another device or drug study during this study
  14. Subject has a known hypersensitivity to polypropylene mesh
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917968

  Show 27 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01917968     History of Changes
Other Study ID Numbers: U8090
Study First Received: July 18, 2013
Last Updated: April 13, 2014
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014