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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Menoufia
-
Shebin El-Kom, Menoufia, Egypte, 32511
- Menoufia Faculty of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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. |
|
Autre: 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.
|
|
Autre: 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
|
|
Autre: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak systolic volume
Délai: 3 months
|
Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound
|
3 months
|
|
End diastolic volume
Délai: 3 months
|
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
|
3 months
|
|
Resistive index
Délai: 3 months
|
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Erection Hardness Score
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Mohamed Alhefnawy, Urology Department, Benha University, Benha, Qalubia, Egypt
- Chercheur principal: Islam Said, Urology Department, Benha University, Benha, Qalubia, Egypt
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Les troubles mentaux
- Maladies génitales, sexe masculin
- Maladies urogénitales masculines
- Dysfonction sexuelle, physiologique
- Dysfonctions sexuelles, psychologiques
- Dysérection
- Pyridines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Indoles
- Alcaloïdes indole
- Composés hétérocycliques, 3 ring
- Carbolines
- Tadalafil
Autres numéros d'identification d'étude
- TENS and Tadalafil in ED
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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