IT Matters: The Erectile Restoration Registry for Erectile Dysfunction
This study, called IT Matters, is an observational registry designed to monitor the safe and effective use of several penile prostheses (implants) for men with chronic erectile dysfunction (impotence). These devices include Tactra Malleable, Spectra Concealable, AMS Ambicor Inflatable, and two types of AMS 700 Inflatable Penile Prostheses. The study aims to see how well these devices improve erectile function by tracking changes in a specific questionnaire (IIEF-EF) over six months. You may be able to join if you are an adult male (18 years or older) who is scheduled to receive one of these implants and are willing to complete follow-up requirements. The study plans to enroll 450 participants.
- Study design
- This is an observational study that will follow 450 adult male participants. It is not a randomized or blinded study.
- What's involved
- You would need to complete the informed consent process and comply with follow-up requirements. The primary endpoint is measured at six months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least six months after their implant surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
IT Matters: The Erectile Restoration Registry
At a glance
Conditions
Where it's being run
25 sites across 15 statesStudy leadership
- Mohit Khera, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for TactraBaseline to 6 months
The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains. The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30).