Botulinumtoxin type A for treatment of Chronic Pelvic Pain Syndrome (CPPS): a phase 3 randomized, double blind, placebo-controlled, multi-center study
This research is looking at how effective botulinum toxin (Botox) injections might be in treating ongoing pelvic pain, known as Chronic Pelvic Pain Syndrome (CPPS). Both men and women are taking part. The main goal is to find out if Botox can reduce pain by at least 30% within four weeks compared to a dummy treatment (placebo). Participants will keep a pain diary to track their pain levels daily. Researchers will also check for changes in general health, how much pain medication is needed, and any side effects over several months. This is a crucial step to see if Botox could become a standard treatment for this challenging condition.
At a glance
What is this study about?
This clinical trial is designed to investigate a new way to treat Chronic Pelvic Pain Syndrome (CPPS). This is a condition where people experience ongoing pain in their pelvic area. This pain can last for a long time and affect daily life. The study aims to see if a treatment using botulinum toxin type A, more commonly known as Botox, can help reduce this pain.
Participants in the study, who can be either men or women with CPPS, will receive either the Botox treatment or a 'dummy' treatment called a placebo. A placebo looks exactly like the real treatment but doesn't contain any active medicine. This is a common and important way to fairly test new treatments, as it helps researchers understand if any improvements are truly due to the medicine or other factors. Neither the patient nor their doctor will know whether they are receiving the actual Botox or the placebo, until the study is over.
The main thing researchers want to find out is if Botox can significantly reduce pain. They will be looking for at least a 30% reduction in pain intensity after four weeks of treatment, compared to how much pain a person felt before the study started. Participants will keep a daily diary to record their pain levels. The study will also track other important things like how much pain relief medication people need, their quality of life, and any side effects from the treatment over several months. This comprehensive approach helps ensure a thorough understanding of the treatment's potential impact.
Key takeaways
- This study is testing injecting Botox for ongoing pelvic pain.
- It's for adult men and women with Chronic Pelvic Pain Syndrome (CPPS).
- The main aim is to see if Botox reduces pain by at least 30% in four weeks.
- Half of the participants will receive Botox, and half will get a dummy treatment.
- You'll track your pain in a diary and have regular check-ups for about six months.
Who may be eligible?
This study is looking for adult men and women who are experiencing ongoing pain in their pelvic area, a condition known as Chronic Pelvic Pain Syndrome (CPPS). You need to be at least 18 years old to take part.
The researchers want to include a wide range of adults with this condition, so there isn't an upper age limit mentioned. If you believe your ongoing pelvic pain fits this description, you might be suitable for this trial.
Specific medical details will need to be checked by the study doctors to make sure the trial is safe and appropriate for you.
- Are you 18 years old or older?
- Do you experience ongoing pain in your pelvic area (CPPS)?
- Are you able to attend regular clinic appointments?
- Are you willing to keep a daily pain diary?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given either the active Botox treatment or a matching dummy treatment (placebo) injected into the affected area. Neither you nor your study doctor will know which one you are receiving during the trial.
You'll need to keep a daily diary to record your pain levels for a week before starting treatment, and then regularly throughout the study. You'll also track how much pain medication you use. You can expect to have several visits to the clinic (at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 after treatment) where the study team will check on your pain, general health, and ask you to fill out questionnaires about your symptoms and quality of life. There will also be phone interviews at some points. The total follow-up period will last for about 24 weeks (roughly six months) after your injection.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is Chronic Pelvic Pain Syndrome (CPPS)?
CPPS is when you have ongoing pain in your lower tummy and pelvic area that lasts for a long time, often more than six months.
What is Botox, and why is it being used for pain?
Botox (botulinum toxin) is a medicine that can relax muscles. It's being tested here to see if it can help relieve pelvic pain, possibly by calming overactive muscles or nerves in the pelvic area.
Will I know if I'm getting the real treatment or the dummy treatment?
No, during the study, neither you nor your doctor will know if you're receiving the Botox or the inactive dummy treatment (placebo). This helps make the study results fair.
How will my pain be measured?
You'll keep a daily diary where you rate your pain on a simple numbered scale. Researchers will look for a decent improvement, like your pain being reduced by 30% or more.
How long will I be involved in the study?
If you join, your participation will involve regular check-ups and pain tracking for approximately 24 weeks, or about six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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