Efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a study protocol for a multicentre randomised controlled trial.

Introduction: Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6%-27% of women aged 18-50 years worldwide. The aim of this randomised controlled trial (RCT) is to investigate the efficacy and safety of botulinum toxin A (BTA) injection compared with placebo injections in the pelvic floor muscles in women with CPP to improve pain, function and quality of life.

Methods And Analysis: This is a study protocol for a multicentre, double-blinded placebo controlled RCT conducted in five gynaecology departments across the Netherlands.