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Botulinumtoxin type A for treatment of Chronic Pelvic Pain Syndrome (CPPS): a phase 3 randomized, double blind, placebo-controlled, multi-center study
EU CTIS ID: 2023-506372-27-00
What this study is testing
This is a phase 3, randomized, double blind, placebo-controlled, multi-center study aimed to establish the efficacy of botulinumtoxin-A (BoNT/A) injections in pelvic floor muscles in reducing pain in patients with chronic pelvic pain syndrome (CPPS).
- Therapeutic confirmatory (Phase III)
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
- age ≥ 18 years
- Subject able to express consent to participate in the study
- CPPS diagnosis according to the European Association of Urology (EAU) guidelines
- mean of the worst daily pain intensity ≥4 in a PI-NRS for a period of one week within the month preceding V1
- Failure of at least one intervention for chronic pelvic pain (CPP) according to the current best clinical practice
You likely can't join if
- Pregnant or breast-feeding women
- Raised post void residual >150 ml at any time in the 6 months prior to screening
- History of botulinumtoxin injections in the previous 6 months
- Recognized hypersensitivity to botulinumtoxin or to any component of toxin formulation or known botulinumtoxin resistance
- Infection at the proposed injection sites
- Concomitant oral drugs that could interfere with botulinum toxin action, such as aminoglycosides, baclofen or diazepam
See the full eligibility criteria
- age ≥ 18 years
- Subject able to express consent to participate in the study
- CPPS diagnosis according to the European Association of Urology (EAU) guidelines
- mean of the worst daily pain intensity ≥4 in a PI-NRS for a period of one week within the month preceding V1
- Failure of at least one intervention for chronic pelvic pain (CPP) according to the current best clinical practice
- Pregnant or breast-feeding women
- Raised post void residual >150 ml at any time in the 6 months prior to screening
- History of botulinumtoxin injections in the previous 6 months
- Recognized hypersensitivity to botulinumtoxin or to any component of toxin formulation or known botulinumtoxin resistance
- Infection at the proposed injection sites
- Concomitant oral drugs that could interfere with botulinum toxin action, such as aminoglycosides, baclofen or diazepam
- Presence of ongoing pelvic pathology
- Presence of neurological disorders
- Previous or actual major depressive disorder
- Bleeding disorders or current anticoagulant medications
- Previous surgical procedures or trauma on pelvic organs
- Previous or current chemotherapy or radiotherapy on pelvic organs
- Urinary or fecal incontinence within 3 months prior to screening
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 all sexes, 18-64 years, 65+ 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.