High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain

What this Trial Is About

Researchers are evaluating whether precisely targeted injections of botulinum neurotoxin (commonly known as Botox) provide better relief for pelvic floor muscle tightness and pain compared to the standard injection method. This study focuses on women with pelvic floor disorders and aims to understand both the benefits and potential side effects of using targeted Botox injections. It is a Phase 1 randomized clinical trial sponsored by the University of Miami. Participants will be randomly assigned to one of two groups: one group will receive injections using a standard template followed by high-density surface electromyography (HD-sEMG) guided injections, while the other group will receive the HD-sEMG guided injections first followed by the standard template. Each participant will receive approximately 200 units of botulinum neurotoxin injected into the pelvic floor muscles twice during the study. The HD-sEMG device, which helps guide the injections, will be used five times and each use lasts about ten minutes. Participants will remain in the study for up to 15 months. During the study, researchers will assess muscle tightness using HD-sEMG one month after injection and track changes in pelvic pain and symptoms through self-reported questionnaires at baseline and one month post-injection. The primary outcome is the hypertonic index of the pelvic muscles measured by HD-sEMG. Safety and symptom changes will also be monitored. Participants will be closely followed to evaluate effects and any side effects over the course of the trial.

Botox for Chronic Pelvic Pain