ИТ имеет значение: Реестр восстановления эрекции
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Beijing, Китай, 100034
- Peking University First Hospital
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Shanghai, Китай, 200080
- Shanghai General Hospital
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Shanghai, Китай, 200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
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Dhahran, Саудовская Аравия, 34465
- Johns Hopkins Aramco Healthcare
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California
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Los Angeles, California, Соединенные Штаты, 90095
- Ronald Reagan UCLA Medical Center
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Los Angeles, California, Соединенные Штаты, 90033
- USC Medical Center
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Los Angeles, California, Соединенные Штаты, 99048
- Tower Urology-Research Facility
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Florida
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Hospital
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Tampa, Florida, Соединенные Штаты, 33606
- USF Health South Tampa Center for Advanced Healthcare
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60637
- University of Chicago
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Springfield, Illinois, Соединенные Штаты, 62702
- SIU School of Medicine
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
- Indiana University Medical Center
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Louisiana
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Bossier City, Louisiana, Соединенные Штаты, 71111
- Willis-Knighton Medical Center
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63110
- Washington University in St. Louis
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North Carolina
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Raleigh, North Carolina, Соединенные Штаты, 27609
- Duke University Medical Center
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Salisbury, North Carolina, Соединенные Штаты, 28144
- W.G. Hefner VA Medical Center
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Wake Forest University
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44195
- Cleveland Clinic
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Columbus, Ohio, Соединенные Штаты, 43212
- Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Thomas Jefferson University Hospital
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- Baylor College of Medicine
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Houston, Texas, Соединенные Штаты, 77030
- Houston Methodist Hospital
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84132
- University of Utah
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Washington
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Seattle, Washington, Соединенные Штаты, 98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Medical College of Wisconsin
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended. |
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. 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. 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. The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Временное ограничение: 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). |
Baseline to 6 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, and 12 months post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.
Временное ограничение: Post-Surgery, 6 months, and 12 months
|
The Patient Health Questionnaire (PHQ) is a diagnostic tool for mental health disorders used by health care professionals. The PHQ contains: mood anxiety, alcohol, eating, and somatoform modules. The PHQ-9, is a validated tool specific to depression, scoring each of the 9 DSM-IV criteria. Scored from 0-27, the PHQ-9 is separated into five different diagnoses: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), and severe depression (20-27). |
Post-Surgery, 6 months, and 12 months
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Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
Временное ограничение: 6 months, and 12 months
|
The WPAI:GH (Work Productivity and Activity Impairment Questionnaire: General Health) is a validated tool that asks a series of questions about the effect of subject health problems, both physical and emotional, on their ability to work and perform regular activities. The WPAI:GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as following 6 questions: 1 = currently employed, 2 = hours missed due to health problems, 3 = hours missed other reasons, 4 = hours actually worked, 5 = degree health affected productivity while working, 6 = degree health affected regular activities. Scores are then multiplied by 100 to be expressed in percentages. |
6 months, and 12 months
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Change in erectile function at post-surgery, and 12 months post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).
Временное ограничение: Post-Surgery, and 12 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). |
Post-Surgery, and 12 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Временное ограничение: Post-surgery, 6 months, and 12 months
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The Likert scale has the options of Very Satisfied, Dissatisfied, Neither Satisfied nor Dissatisfied, Satisfied and Very Satisfied. Responses will be evaluated categorically. |
Post-surgery, 6 months, and 12 months
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Assess for outcomes and adverse events on AMS Tools at Post Procedure.
Временное ограничение: Collected only at Post-Procedure
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AMS tools will be assess by a physician survey as part of the post-procedure case report form. |
Collected only at Post-Procedure
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Mohit Khera, MD, Baylor College of Medicine
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- U0670
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .