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 June 2015 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01917968
First received: July 18, 2013
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Uphold Lightweight Vaginal Support System
Transvaginal repair with mesh (Uphold LITE)
Device: Uphold Lightweight Vaginal Support System
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
Other Name: Uphold LITE
Traditional native tissue repair
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Procedure: Traditional native tissue repair
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Detailed Description:

The primary objective is to evaluate clinical effectiveness of transvaginal repair with mesh (Uphold LITE) against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Uphold LITE-related complications and subject reported outcomes.

The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh (Uphold LITE) over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures.

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with mesh (Uphold LITE) 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.

The secondary endpoints of the study include assessments of complications and subject reported outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women 18 years or older with anterior and/or apical pelvic organ prolapse

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 (for prolapse of the anterior compartment alone) C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
  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

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 focal 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
  15. Subject is pregnant or intends to become pregnant during the study
  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

Contacts
Contact: Lisa LeBlanc lisa.leblanc@bsci.com

  Show 27 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Karen Noblett, MD UC Riverside, School of Medicine
  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: June 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
POP
Transvaginal
Native Tissue Repair
Repair Augmented with Mesh
Pelvic Organ Prolapse

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

ClinicalTrials.gov processed this record on August 27, 2015