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Evaluation of the efficacy of botulinum neurotoxin type A (BoNT-A) in the treatment of erectile dysfunction resistant to phosphodiesterase type 5 inhibitors (PDE5Is)

Evaluation of the efficacy of botulinum neurotoxin type A (BoNT-A) in the treatment of erectile dysfunction resistant to phosphodiesterase type 5 inhibitors (PDE5Is): a randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100817004582N10
Enrollment
40
Registered
2025-10-01
Start date
2025-10-11
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction. Male erectile dysfunction

Interventions

Intervention 1: Intervention group: A tourniquet will be placed at the proximal end of the penis. An injection of 100 units of onabotulinumtoxin A will be performed by diluting 500 units of Mosport in

Sponsors

Urology Research Centre, Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with vasculogenic ED resistant to first-line drug therapy with PDE5Is who do not want second- and third-line treatment.

Exclusion criteria

Exclusion criteria: History of severe cardiovascular disease that interferes with sexual activity History of mental illnesses and disorders The presence of anatomical abnormalities that significantly impair erectile function The presence of hormonal abnormalities that significantly impair erectile function The presence of neurological abnormalities that significantly impair erectile function History of radical pelvic surgery

Design outcomes

Primary

MeasureTime frame
Erectile function. Timepoint: Before intervention, 1, 3 and 6 months after injection. Method of measurement: The International Index of Erectile Dysfunction (IIEF) questionnaire.;Erection quality. Timepoint: Before intervention, 1, 3 and 6 months after injection. Method of measurement: Erectile Hardness Score (EHS) index.

Secondary

MeasureTime frame
Patient satisfaction score of treatment. Timepoint: 1, 3 and 6 months after last injection. Method of measurement: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).;Complications after injection. Timepoint: From the day of injection to 6 months after injection. Method of measurement: Interview and examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaber Khajavi

Urology Research Center, Guilan University of Medical Sciences

drsaberkhajavi@gmail.com+98 13 3352 5259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026