IT Matters: The Erectile Restoration Registry

Launched by BOSTON SCIENTIFIC CORPORATION · Dec 13, 2019

Keywords

ClinConnect Summary

It MATTERS: The Erectile Restoration Registry is a prospective, real-world study funded by Boston Scientific to monitor how well Boston Scientific penile prostheses work and stay safe after they are on the market. It follows adult men who are having a market-approved BSC penile prosthesis implanted for erectile dysfunction. The study includes several device models (Tactra, Spectra, Ambicor, and AMS 700 series) and is happening at many centers in the U.S. and around the world. About 450 men are expected to join, and participation is by invitation.

Participants will be followed for up to about 10 years after surgery. The study collects information on how well the implant improves erectile function (measured with a standard questionnaire called IIEF-EF), mood and overall sexual function (PHQ-9 and IIEF total score), and quality of life and work impact (WPAI:GH). It also looks at device satisfaction and any adverse events after implantation. This is an observational registry, not a randomized trial, and there is no individual data sharing. The study aims to help doctors and patients understand real-world use of these devices over time. Enrollment is currently ongoing by invitation, with sites across the U.S. and several international centers. Primary insights are expected around 6 months after implantation, with long-term follow-up through about 2031.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥ 18 years of age.
• • 2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
• • 3. Willing and able to complete the informed consent process.
• • 4. Willing and able to comply with the follow-up requirements.
• Exclusion Criteria:
• • 1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
• • 2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.