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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

December 1, 2025

Conditions
Erectile Dysfunction With Diabetes Mellitus
Interventions
DRUG

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 inhibition of the release of noradrenaline from the adrenergic neurons acting on the cavernosal smooth muscle. Thus, the dominant sympathetic basal tone of the cavernosal smooth muscle is essentially removed, facilitating the occurrence of an erection.

DRUG

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 urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.

Trial Locations (1)

81528

RECRUITING

Aswan University-Faculty of Medicine, Aswān

All Listed Sponsors
collaborator

Aswan University

OTHER

collaborator

Cairo University

OTHER

lead

Aswan University Hospital

OTHER