Combining Botulinum Toxin A and Tadalafil for Diabetic Men with Erectile Dysfunction
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.
This study is testing if combining a muscle relaxant with a common erectile dysfunction pill can help diabetic men who haven't found relief with regular treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | Aswan University Hospital Academic / other |
| Locations | 1 site (Aswān, Aswan Governorate) |
| Trial ID | NCT06583590 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of combining Botulinum toxin A with oral Tadalafil in diabetic men suffering from erectile dysfunction that has not responded to standard treatments. A total of 32 male patients will be recruited from outpatient clinics at Cairo and Aswan Universities. Participants will undergo a series of assessments, including clinical examinations and questionnaires, before and after receiving the treatment over a three-month period. The study aims to determine the durability of the treatment's effects through various evaluation methods.
Who should consider this trial
Good fit: Ideal candidates are adult married men with controlled diabetes and severe erectile dysfunction unresponsive to approved pharmacological treatments.
Not a fit: Patients with cardiovascular diseases, unstable psychiatric conditions, or anatomical abnormalities affecting erectile function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for diabetic men with erectile dysfunction who do not respond to existing therapies.
How similar studies have performed: While the combination of these treatments is innovative, similar approaches have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Aswān, Aswan Governorate
- Aswan University-Faculty of Medicine — Aswān, Aswan Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Hossam-Eldin Hosny Ahmed Awad, Professor
- Email: sombok@yahoo.com
- Phone: 01001666093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.