By InvitationNot Applicable

IT Matters: The Erectile Restoration Registry

United States450 participantsStarted 2021-08-05

Plain-language summary

The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. ≥ 18 years of age.
✓. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
✓. Willing and able to complete the informed consent process.
✓. Willing and able to comply with the follow-up requirements.

Exclusion criteria

✕. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
✕. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.

What they're measuring

Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT04200937

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-01

View on ClinicalTrials.gov More Erectile Dysfunction trials