This study is accepting new patients by invitation only

IT Matters: The Erectile Restoration Registry

a study on Erectile Dysfunction

Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jesse Mills (ucla)

Description

Summary

The primary objective of the It MATTERS registry is to assess erectile function at 6 months, post implantation of an It MATTERS Study Penile Prosthesis, demonstrating an improvement in quality of life from baseline.

Details

The study is a post-market study on a newly released device and is part of the planned postmarket clinical follow-up (PMCF) of the device. Adult males with moderate to severe erectile dysfunction (IIEF-EF domain score 1-16) who meet the indications for surgical correction of erectile dysfunction will be included. The purpose of this study will be to assess the impact of the Tactra malleable prosthesis on quality of life in men with erectile dysfunction through use of the International Index of Erectile Function, Erectile Function Score (IIEF-EF).

Keywords

Erectile Dysfunction, Tactra Malleable, Spectra Penile Prothesis, AMS Ambicor, BSC Penile Prothesis Recipients

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Males who are >/= 18 years of age.
  2. Males with chronic, organic, erectile dysfunction (impotence) who are determined to be suitable candidates for implantation surgery by their physician.
  3. Willing and able to undergo surgical implantation of a study BSC penile prothesis device.
  4. Willing and able to complete the informed consent process.
  5. Willing and able to comply with the follow-up requirement.

You CAN'T join if...

  1. Men who are deemed by their physician as not suitable for a penile prothesis will be excluded per the contraindications in each study device's Instructions for Use (IFU).

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • Tower Urology-Research Facility
    Los Angeles California 99048 United States

Lead Scientist at University of California Health

  • Jesse Mills (ucla)
    HS Clinical Professor, Urology, Medicine. Authored (or co-authored) 55 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT04200937
Study Type
Observational
Participants
Expecting 450 study participants
Last Updated