Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Официальное название

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction Not Responding to Approved Oral or Intracorporeal Vasoactive Treatments.

Обзор

Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.

Подробное описание

Total of (32) male patients will be included in this study and will be recruited from the Andrology, Sexology \& STDs outpatient clinics- Faculty of medicine -Cairo and Aswan Universities. All those patients are complaining of erectile dysfunction Unresponsive to Approved Pharmacological Treatments. Each patient will have an informed consent obtained prior to conducting the study.

All patients will be subjected to the following:

* History taking. * Clinical examination (general and local genital examination). * International Index of Erectile Function (IIEF-5) before and after treatment (Rosen et al., 2002). * Erection Hardness Score (EHS) before and after treatment (Mulhall et al., 2006). * Global assessment questionnaire after treatment (Giuliano et al., 2007).

* All patients will be examined by Duplex Doppler ultrasonography in the basal condition and after the induction of penile erection with the assistance of an intracavernous injection of alprostadil 20 μg/mL. * All patients will receive single dose of ICI of 100u of (BTXA) combined with 5mg oral Tadalafil once daily for 3 months. * The subjects will be re-examined and International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS)and penile color Doppler ultrasound with PGE-1 injection will be done at 6 and 12 weeks from the start of therapy in addition to Global assessment questionnaire will be done at 12 weeks from the start of therapy

\* Procedure * The patients will lied down in supine position. After cleansing the skin with alcohol, intracavernosal injection of single dose 100U (BTX-A) diluted in isotonic saline 2cm proximal to coronal margin at right and left sides will be performed and the injection site will be pressed directly for two minutes. To prevent systemic toxicity, a veno-occlusive ring will be used at the base of the penis at the time of injection and will be kept in place for 15 minutes after injection.

Вмешательства

• Препарат Botulinum toxin A
  Botulinum toxin (BoNT) is One of the most potent toxins known to humans produced by Clostridium botulinum that has been used to treat several striated and smooth muscle disorders. Because the pathophysiology and the reason for patients' lack of response to PDE5I is insufficient smooth muscle relaxation and veno-occlusive disorder (VOD) , BTX-A may prove to be a viable treatment for this patient population due to its availability to facilitate long-acting cavernosal smooth muscle relaxation by in
• Препарат Tadalafil 5mg
  Tadalafil is one of 5-phosphodiesterase inhibitors that used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinat

Первичные конечные точки

• Treatment. [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Secondary adverse events of the drug. [Срок оценки: 3months]

Критерии участия

Критерии включения

• Adult controlled diabetic married men who proved to be vasculogenic ED by Penile Duplex.
• Men who had shown an insufficient response for at least 3 months to the registered PDE5-Is at the highest approved dose, either on-demand or daily, or to PGE1 ICIs.
• Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).

Критерии исключения

• Men who had cardiovascular disease interfering with sexual activity.
• Men with history of an unstable psychiatric conditions
• Presence of penile anatomical abnormalities that would significantly impair erectile function.
• History of spinal or pelvic radical surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Aswan University-Faculty of Medicine — Aswān

Идентификаторы

NCT: NCT06583590 · 943/7/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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