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Study on Botulinum Toxin Type A for Adults with Chronic Pelvic Pain Syndrome (CPPS)

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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 the effects of Chronic Pelvic Pain Syndrome (CPPS), a condition that causes persistent pain in the pelvic region. The study will explore the use of Botulinum Toxin Type A, commonly known as Botox, as a treatment option. Botox is a protein that, when injected, can help relax muscles and reduce pain. The trial will compare the effects of Botox injections to a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to determine if Botox injections in the pelvic floor muscles can effectively reduce pain in patients with CPPS. Participants in the study will receive either Botox or a placebo through an injection into the muscles. The study will last for several months, with regular check-ins to monitor the participants' pain levels and any changes in their condition. The main goal is to see if there is a significant reduction in pain for those receiving Botox compared to those receiving the placebo.

Throughout the study, participants will be asked to keep a diary of their pain levels and any medications they take for relief. The study will also track any side effects or changes in symptoms, such as urinary or bowel issues. By the end of the study, researchers hope to gather enough information to understand the potential benefits of using Botox for managing CPPS and improving the quality of life for those affected by this condition.

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

    Initial visit and assessment

    Upon joining the study, you will attend an initial visit where your eligibility will be confirmed. This includes verifying your age, ability to consent, and diagnosis of chronic pelvic pain syndrome (CPPS).

    You will be asked to rate your pain intensity using a scale called the Pain Intensity Numeric Rating Scale (PI-NRS) over a period of one week. This will help establish a baseline for your pain levels.

  2. Step 2

    Randomization and treatment

    You will be randomly assigned to receive either the active treatment, botulinum toxin type A, or a placebo. This is done to ensure the study is fair and unbiased.

    The treatment involves an intramuscular injection into the pelvic floor muscles. The exact dosage and frequency will be determined by the study protocol.

  3. Step 3

    Follow-up visits and assessments

    You will attend follow-up visits at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24. During these visits, your response to the treatment will be assessed.

    At each visit, you will complete questionnaires to evaluate changes in pain, use of rescue medication, and any side effects. These include the DN4 questionnaire and the Pelvic Floor Muscles Hyperalgesia (PFMH) score.

  4. Step 4

    Evaluation of treatment response

    The primary goal is to determine if there is a significant reduction in your pain intensity by at least 30% at week 4 compared to the baseline.

    Secondary assessments will include changes in other health scores and the incidence of any adverse events, such as changes in urinary or bowel function.

  5. Step 5

    Completion of the study

    At the end of the study period, your overall response to the treatment will be evaluated. This includes reviewing all collected data and determining the effectiveness of the treatment.

    You will have a final visit to discuss your experience and any remaining questions or concerns you may have.

Who can join the trial?

5 criteria

  • Must be an adult aged 18 years or older.
  • Must be able to give consent to participate in the study. This means you understand the study and agree to take part.
  • Must have a diagnosis of chronic pelvic pain syndrome (CPPS) according to the guidelines from the European Association of Urology.
  • Must have experienced a mean of the worst daily pain intensity of 4 or higher on a pain scale from 0 to 10, for at least one week in the month before the first visit.
  • Must have tried at least one treatment for chronic pelvic pain that did not work, according to the best current medical practices.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means you must be 18 years or older.
  • Patients who do not have chronic pelvic pain syndrome (CPPS) cannot participate. CPPS is a condition that causes pain in the lower part of the belly.
  • Patients who are part of a vulnerable population cannot participate. This usually includes groups like children, pregnant women, or people who cannot make decisions for themselves.
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Investigated drugs

Botulinumtoxin type A is a medication used in this clinical trial to help reduce pain in patients with Chronic Pelvic Pain Syndrome (CPPS). It is commonly known for its ability to relax muscles. In this study, the medication is injected into the pelvic floor muscles. The goal is to see if these injections can help decrease the pain that patients with CPPS experience. By relaxing the muscles in the pelvic area, it is hoped that the tension and discomfort associated with CPPS will be reduced, leading to an improvement in the patient's quality of life.

What is already known about the treatment

Botulinumtoxin type A – This medication is administered through injections directly into the pelvic floor muscles. It is currently being studied in a phase 3 clinical trial to determine its effectiveness in treating chronic pelvic pain syndrome (CPPS) in adults. The main therapeutic use of Botulinumtoxin type A in this context is to reduce pain associated with CPPS. At the molecular level, it works by blocking the release of certain chemicals in the nerves that signal muscles to contract, leading to muscle relaxation and pain relief. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Chronic Pelvic Pain Syndrome – Chronic Pelvic Pain Syndrome (CPPS) is a condition characterized by persistent pain in the pelvic region, lasting for at least six months. The pain can be constant or intermittent and may vary in intensity. It often affects the lower abdomen, pelvis, or perineum and can be associated with urinary symptoms, sexual dysfunction, and emotional distress. The exact cause of CPPS is not well understood, but it is believed to involve a combination of factors, including inflammation, nerve damage, and muscle tension. The condition can affect both men and women, although the symptoms may differ slightly between genders. Over time, CPPS can significantly impact the quality of life, leading to challenges in daily activities and emotional well-being.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506372-27-00Protocol codeCPPSEstimated enrolment110 patientsSponsorOspedale San Raffaele S.r.l.

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