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Study of Botulinum Toxin and Saline Solution for Erectile Dysfunction in Patients Unresponsive to Standard Treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a new treatment for erectile dysfunction, a condition where a man has difficulty achieving or maintaining an erection. The study is testing the effectiveness of a medication called Onabotulinumtoxin A, which is a type of botulinum toxin. This medication will be injected directly into the corpora cavernosa, which are the sponge-like regions of the penis that fill with blood to create an erection. The trial aims to see if this treatment can help men who have not responded well to other treatments, such as phosphodiesterase-5 inhibitors, which are commonly used medications for erectile dysfunction.

Participants in the study will receive either the Onabotulinumtoxin A injection or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The main goal of the study is to determine if the injections improve the subjective perception of rigidity, which refers to how firm the erection feels to the participant.

The study will take place over a period of time, with participants required to attend follow-up appointments and undergo certain tests to monitor their progress. The trial is expected to start recruiting participants in 2024 and aims to conclude by 2026. This research could potentially offer a new option for men with erectile dysfunction who have not found success with existing treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have been diagnosed with erectile dysfunction (ED) that does not respond well to standard treatments such as phosphodiesterase-5 inhibitors or certain injections.

    The patient must be over 30 years old and have given consent to participate in the study.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to ensure they can comply with all trial requirements.

    This includes committing to attending follow-up appointments and undergoing necessary tests.

  3. Step 3

    Treatment administration

    The treatment involves the use of Onabotulinumtoxin A, commonly known as botulinum toxin, administered through local injections into the corpora cavernosa.

    The injections are performed using a sodium chloride solution 0.9% as a carrier.

  4. Step 4

    Follow-up appointments

    The patient attends regular follow-up appointments to monitor the effects of the treatment.

    These appointments are crucial for assessing the primary endpoint, which is the subjective perception of rigidity.

  5. Step 5

    Trial completion

    The trial is estimated to conclude by September 2, 2026.

    Throughout the trial, the patient is expected to continue attending all scheduled appointments and comply with the study protocol.

Who can join the trial?

6 criteria

  • The patient must be a man diagnosed with erectile dysfunction (ED), which means having trouble getting or keeping an erection.
  • The patient must have tried treatments like IPDE5 or injections with Caverject or Bimix/Trimix, but they didn't work well enough. This is measured by a score of 12 or less on a specific questionnaire called the IIEF-15.
  • The patient must be over 30 years old.
  • The patient, or someone representing them, must agree to join the study by giving their consent.
  • The patient must be able to follow all the rules and requirements of the clinical trial, according to the person in charge of the study.
  • The patient must agree to attend follow-up appointments and have the necessary tests done.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate.
  • Patients who are under 18 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

Onabotulinumtoxin A is being tested in this clinical trial to see if it can help treat erectile dysfunction. It is injected directly into the corpora cavernosa, which are the two long chambers in the penis that fill with blood to cause an erection. The goal is to see if these injections can improve erectile function in patients who have not had success with other treatments.

What is already known about the treatment

Onabotulinumtoxin A – This medication is administered through injections directly into the corpora cavernosa of the penis. It is currently being studied in clinical trials for its effectiveness in treating erectile dysfunction, particularly in patients who do not respond to standard treatments like phosphodiesterase-5 inhibitors. The main therapeutic indication for Onabotulinumtoxin A in this context is erectile dysfunction. At the molecular level, it works by blocking the release of certain neurotransmitters, which can help relax muscles and improve blood flow. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Erectile Dysfunction – Erectile dysfunction is a condition where a man has difficulty achieving or maintaining an erection sufficient for sexual intercourse. It can result from physical issues such as heart disease, diabetes, or hormonal imbalances, as well as psychological factors like stress or anxiety. The condition may develop gradually, with occasional difficulties becoming more frequent over time. It can affect self-esteem and relationships, leading to emotional distress. The severity of erectile dysfunction can vary, with some men experiencing complete inability to achieve an erection, while others may have inconsistent or brief erections.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514518-10-00Protocol codeBTXDEEstimated enrolment114 patientsSponsorClinica Universidad De Navarra

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