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

ABSTRACT:

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. A total of 94 women over 16 years, with at least 6 months of CPP without anatomical cause and pelvic floor hypertonicity refractory to first-line pelvic floor physical therapy will be included. Participants will be randomised equal

SUBMITTER: Spruijt M 

PROVIDER: S-EPMC10335469 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature