• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Boston Scientific, PFDN collaborate on Uterine Prolapse treatment

Boston Scientific, PFDN collaborate on Uterine Prolapse treatment

June 7, 2013
CenterWatch Staff

Global medical technology company Boston Scientific provided a research and education grant of more than $1 million to the Pelvic Floor Disorders Network (PFDN) for the SUPeR clinical trial.  The SUPeR study will evaluate treatment outcomes of two different surgical options for women with uterine prolapse, a form of pelvic organ prolapse. PFDN is funded by the NIH.

An estimated 28 million women in the U.S. live with at least one pelvic floor disorder.  The two most common conditions are urinary incontinence, which is the inability to hold urine, and pelvic organ prolapse, a medical condition that occurs when the tissue and muscles of the pelvic floor no longer support the pelvic organs, resulting in "sagging" or dropping of organs such as the bladder, uterus or rectum. 

The SUPeR study anticipated enrollment of 180 women who are considering surgery for their uterine prolapse and do not plan to have additional children.  They will be randomly assigned to either a uterine-preserving transvaginal mesh repair using the Boston Scientific Uphold LITE Vaginal Support System or traditional surgery that will include a vaginal hysterectomy.

"The data for this study will give physicians reliable evidence from a randomized trial on surgical treatment for women with uterine prolapse," said Charles Nager, M.D., director of the Urogynecology and Reconstructive Pelvic Surgery Division at UC San Diego School of Medicine.  "That evidence will help inform clinicians as they make decisions in an effort to provide the best patient care possible."

After surgery, patients will be evaluated every six months for up to five years to determine surgical success, patient safety, cost-effectiveness, quality of life and body image.  Data are expected to be available in 2017 and the final results to follow approximately one year later.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing