Enrolling by invitation NCT04200937
IT Matters: The Erectile Restoration Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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. - Device 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. - Device 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. - Device 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). - Device 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).
Primary outcome measures
- Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra [Time frame: Baseline to 6 months]
Secondary outcome measures (3)
- 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. [Time frame: Post-Surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years]
- 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. [Time frame: 6 months, 12 months and 24 months]
- 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). [Time frame: Post-Surgery, 12 months and annually thereafter through study completion, an average of 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 21 centers
- USC Medical Center — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- Tower Urology-Research Facility — Los Angeles
- University of Miami Hospital — Miami
- USF Health South Tampa Center for Advanced Healthcare — Tampa
- University of Chicago — Chicago
- SIU School of Medicine — Springfield
- Indiana University Medical Center — Indianapolis
- … and 13 more centers
China · 3 centers
- Peking University First Hospital — Beijing
- Shanghai General Hospital — Shanghai
- Shanghai Jiaotong University School of Medicine Renji Hospital — Shanghai
Saudi Arabia · 1 center
- Johns Hopkins Aramco Healthcare — Dhahran
Identifiers
NCT: NCT04200937 · U0670