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Novel treatment with botulinum toxin for erectile dysfunction unresponsive to conventional treatment
EU CTIS ID: 2024-514518-10-00
What this study is testing
To test the therapeutic efficacy of intracavernous injections (ICI) of Onabotulinumtoxin A (BoNT-A) in the treatment of erectile dysfunction (ED)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with ED with insufficient response to IPDE5 or intracavernous injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤ 12).
- The patient is over 30 years old
- The patient, or his or her representative, has given consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- Patient must commit to attending follow-up appointments and undergoing the appropriate tests.
You likely can't join if
- Patients who do not accept informed consent
- Patients who do not accept or cannot commit to attending the follow-up sessions.
- Patients under 30 years of age.
- Known hypersensitivity to BoNT-A
- Serious infections or diseases or hepatic, renal or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria.
- Patients with robotic radical prostatectomy less than 6 months ago
See the full eligibility criteria
- Patients diagnosed with ED with insufficient response to IPDE5 or intracavernous injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤ 12).
- The patient is over 30 years old
- The patient, or his or her representative, has given consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- Patient must commit to attending follow-up appointments and undergoing the appropriate tests.
- Patients who do not accept informed consent
- Patients who do not accept or cannot commit to attending the follow-up sessions.
- Patients under 30 years of age.
- Known hypersensitivity to BoNT-A
- Serious infections or diseases or hepatic, renal or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria.
- Patients with robotic radical prostatectomy less than 6 months ago
- Patients with a history of known neurogenic damage
- Patients with a history of radiotherapy treatment
- Patients with known psychiatric disorder
- Patients with anatomical abnormalities in the penis.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.