IT Matters: The Erectile Restoration Registry

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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).
• Устройство 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).

Первичные конечные точки

• Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: Post-Surgery, 12 months and annually thereafter through study completion, an average of 10 years]

Критерии участия

Критерии включения

• ≥ 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 21 центр

• 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
• … и ещё 13 центров

Китай · 3 центра

• Peking University First Hospital — Пекин
• Shanghai General Hospital — Шанхай
• Shanghai Jiaotong University School of Medicine Renji Hospital — Шанхай

Саудовская Аравия · 1 центр

• Johns Hopkins Aramco Healthcare — Dhahran

Идентификаторы

NCT: NCT04200937 · U0670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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