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

NCT06583590 | Recruiting Phase 2 DMC

• 1 other identifier: 943/7/24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction With Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Treatment.

  The primary outcome is to assess the effect of single intra-cavernosal injection of 100 unit of botulinum-A toxin plus daily intake of 5mg oral tadalafil in 32 adult diabetic patients with erectile dysfunction to detect its effect on on the erectile function status by reporting changes in IIEF and penile doppler parameters.

  3 months

Secondary Outcomes (1)

• Secondary adverse events of the drug.

  3months

Study Arms (1)

Group 1

OTHER

32 patients will be injected single intracavernosal injection of 100 unit of Botulinum toxin A accompained by oral daily tadalafil 5 mg for 3 months.

Drug: Botulinum toxin A; Drug: Tadalafil 5mg

Interventions

Botulinum toxin A DRUG

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.

Also known as: Botox, BTX-A

Group 1

Tadalafil 5mg DRUG

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.

Group 1

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead
• Aswan University: collaborator
• Cairo University: collaborator

Study Sites (1)

Aswan University-Faculty of Medicine

Aswān, Aswan Governorate, 81528, Egypt

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A; Tadalafil

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Hossam-Eldin Hosny Ahmed Awad, Professor

CONTACT

01001666093; sombok@yahoo.com

Moustafa Adam Ali, Professor

CONTACT

01092991101; moustafa.eltaib@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 4, 2024
• Study Start: August 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6-12 months after publication

Locations

EG (1)