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

2026-09-14

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)

Facility	City	Region
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

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort Active, not recruiting

RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain Recruiting

Deep Brain Stimulation (DBS) Retrospective Outcomes Study Recruiting

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure Recruiting

Patient Retrospective Outcomes (PRO) Recruiting

Other trials for the same condition

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

Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject Starting soon

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED Active, not recruiting

Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants. Starting soon

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