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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Menoufia
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Shebin El-Kom, Menoufia, Egypt, 32511
- Menoufia Faculty of Medicine
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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. |
|
Jiný: 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.
|
|
Jiný: 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
|
|
Jiný: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Peak systolic volume
Časové okno: 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
Časové okno: 3 months
|
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
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3 months
|
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Resistive index
Časové okno: 3 months
|
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
|
3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Erection Hardness Score
Časové okno: 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
|
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IIEF-5 score
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Mohamed Alhefnawy, Urology Department, Benha University, Benha, Qalubia, Egypt
- Vrchní vyšetřovatel: Islam Said, Urology Department, Benha University, Benha, Qalubia, Egypt
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Duševní poruchy
- Onemocnění pohlavních orgánů, muž
- Mužská urogenitální onemocnění
- Sexuální dysfunkce, fyziologické
- Sexuální dysfunkce, psychologické
- Erektilní dysfunkce
- Pyridiny
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Indoly
- Indolské alkaloidy
- Heterocyklické sloučeniny, 3-kroužek
- Karboliny
- Tadalafil
Další identifikační čísla studie
- TENS and Tadalafil in ED
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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