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Clinical Trials in the USA / NCT04200937
Enrolling by invitation Observational

IT Matters: The Erectile Restoration Registry

NCT04200937 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2021-08-05
Last updated
2026-10-13

Condition(s) studied

Erectile Dysfunction

Investigational drug(s) / intervention(s)

Tactra MalleableSpectra™ Concealable Penile ProthesisAMS Ambicor™ Inflatable Penile ProsthesisAMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) PumpAMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump

Tactra Malleable: The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure.

Spectra™ Concealable Penile Prothesis: The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

AMS Ambicor™ Inflatable Penile Prosthesis: The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery.

AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump: The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump: The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

Study 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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

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

Trial sites (25)

FacilityCityRegionStatus
USC Medical Center Los Angeles California
Ronald Reagan UCLA Medical Center Los Angeles California
Tower Urology-Research Facility Los Angeles California
University of Miami Hospital Miami Florida
USF Health South Tampa Center for Advanced Healthcare Tampa Florida
University of Chicago Chicago Illinois
SIU School of Medicine Springfield Illinois
Indiana University Medical Center Indianapolis Indiana
Willis-Knighton Medical Center Bossier City Louisiana
Washington University in St. Louis St Louis Missouri
Duke University Medical Center Raleigh North Carolina
W.G. Hefner VA Medical Center Salisbury North Carolina
Wake Forest University Winston-Salem North Carolina
Cleveland Clinic Cleveland Ohio
Ohio State University Wexner Medical Center Columbus Ohio
Thomas Jefferson University Hospital Philadelphia Pennsylvania
Baylor College of Medicine Houston Texas
Houston Methodist Hospital Houston Texas
University of Utah Salt Lake City Utah
University of Washington Medical Center Seattle Washington
Medical College of Wisconsin Milwaukee Wisconsin
Peking University First Hospital Beijing China
Shanghai General Hospital Shanghai China
Shanghai Jiaotong University School of Medicine Renji Hospital Shanghai China
Johns Hopkins Aramco Healthcare Dhahran Saudi Arabia

More Boston Scientific Corporation trials in the USA

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Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device Active, not recruiting
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Active, not recruiting
Paresthesia-Free Fast-Acting Subperception (FAST) Study Active, not recruiting

Other trials for the same condition

Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants. Starting soon
Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED Active, not recruiting
Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject Starting soon
The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04200937 on ClinicalTrials.gov ↗ ← All trials in the USA