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RECRUITING
NCT06583590
PHASE2/PHASE3

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

Sponsor: Aswan University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

MALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-08-01

Completion Date

2025-12-01

Last Updated

2024-12-03

Healthy Volunteers

No

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.

Locations (1)

Aswan University-Faculty of Medicine

Aswān, Aswan Governorate, Egypt