Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial
Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss.
The increased venous outflow from the corpora cavernosa can be illustrated as a so called 'venous leakage' by cavernosography being responsible for the therapeutical failure of intracavernously applied vasoactive substances. Cavernous smooth muscle pathology proven in some of the patients with venous leakage gave little hope to reconstructive surgery.
However, own examinations let assume that the etiology of 'venous leakage' is caused by endogenic and exogenic factors. Furthermore, reversible venous leakage was observed. Any therapeutic option of the veno-occlusive dysfunction showed disappointing results with a respective success rate of 20% in the long-term follow-up (surgical venous resection, percutaneous transpenile venous embolisms).
Finally the vacuum device or penile prosthetics are the only therapeutical option for the patients. Physiologically, bulbocavernous and ischiocavernous muscles increase the intracavernous pressure of the tumescent penis.
Regular pelvic floor exercise can be achieved by a physiotherapist which seems to be a time-consuming and expensive procedure, or an advantageous transcutaneous electrical stimulation which is the standard therapy for the treatment of posttraumatic atrophy of the striated muscular system.
Thus an external stimulator device has been developed to evaluate the therapeutical potency of striated muscle exercise in patients with erectile dysfunction. The present clinical study documents the first experiences with this EIS device and outlines its potency for the treatment of erectile dysfunction.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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-
Menoufia
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Shebin El-Kom, Menoufia, Египет, 32511
- Menoufia Faculty of Medicine
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound
Exclusion Criteria:
- Patients with history of cardiovascular disease, contraindication for phosphodiesterase type 5 inhibitor, implanted cardiac pacemakers or defibrillators, anatomically significant penile deformities, active skin lesions at the electrode placement sites or any untreated endocrinal disorder that could affect the erectile function
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Sham-placebo
This group will receive Sham stimulation along with Placebo similar to tadalafil
|
Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero. |
|
Другой: Active-Placebo
This group will receive active stimulation along with Placebo similar to tadalafil
|
Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents.
The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow.
Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa.
2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles.
Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months.
Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
|
|
Другой: Sham-Tadalafil
This group will receive Sham stimulation along with tadalafil
|
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero.
Tadalafil 5 mg oral tablet to be given once daily for 3 months
|
|
Другой: Active-Tadalafil
This group will receive active stimulation along with tadalafil
|
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents.
The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow.
Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa.
2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles.
Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months.
Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
Tadalafil 5 mg oral tablet to be given once daily for 3 months
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peak systolic volume
Временное ограничение: 3 months
|
Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound
|
3 months
|
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End diastolic volume
Временное ограничение: 3 months
|
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
|
3 months
|
|
Resistive index
Временное ограничение: 3 months
|
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
|
3 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Erection Hardness Score
Временное ограничение: 3 months
|
a Doppler-related erection grading system with the following Grades: Grade0: Lack of response, Grade1: Mild tumescence, Grade2: Tumescence insufficient for penetration, Grade3: Rigidity sufficient for penetration and Grade4: Complete rigidity.
via Penile Color Doppler Ultrasound
|
3 months
|
|
IIEF-5 score
Временное ограничение: 3 months
|
The IIEF-5 questionnaire (International Index of Erectile Function) is a 5-item, validated tool used to diagnose the presence and severity of erectile dysfunction (ED) where Scores range from 5-25, with lower scores indicating more severe dysfunction
|
3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Mohamed Alhefnawy, Urology Department, Benha University, Benha, Qalubia, Egypt
- Главный следователь: Islam Said, Urology Department, Benha University, Benha, Qalubia, Egypt
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
- Урогенитальные заболевания
- Генитальные заболевания
- Психические расстройства
- Заболевания половых органов, мужчины
- Мужские мочеполовые заболевания
- Сексуальная дисфункция, физиологическая
- Сексуальные дисфункции, психологические
- Эректильная дисфункция
- Пиридины
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Индолы
- Индольные алкалоиды
- Гетероциклические соединения, 3-кольцо
- Карболины
- Тадалафил
Другие идентификационные номера исследования
- TENS and Tadalafil in ED
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.
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