Clinical trial NCT04200937: IT Matters: The Erectile Restoration Registry
Official title: IT Matters: The Erectile Restoration Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Erectile Dysfunction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.

Brief 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

Detailed description: IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.

The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.

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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, 12 months and annually thereafter post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.
timeFrame: Post-Surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years
measure: Change in quality of life at 6 months, 12 months, and 24 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
timeFrame: 6 months, 12 months and 24 months
measure: Change in erectile function at post-surgery, 12 months and annually post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).
timeFrame: Post-Surgery, 12 months and annually thereafter through study completion, an average of 10 years
Other outcomes:
measure: Device satisfaction at post-surgery, 6 months, 12 months and annually thereafter measured by the Likert scale.
timeFrame: Post-surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years
measure: Assess for outcomes and adverse events on AMS Tools at Post Procedure.
timeFrame: Collected only at Post-Procedure
Locations:
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology-Research Facility
state: California
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Bossier City
country: United States
facility: Willis-Knighton Medical Center
state: Louisiana
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Raleigh
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Salisbury
country: United States
facility: W.G. Hefner VA Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Beijing
country: China
facility: Peking University First Hospital
city: Dhahran
country: Saudi Arabia
facility: Johns Hopkins Aramco Healthcare
Study officials:
affiliation: Baylor College of Medicine
name: Mohit Khera, MD
role: PRINCIPAL_INVESTIGATOR
References: