Precision Guided Botulinum Neurotoxin Botox Injections to Treat Chronic Pelvic Floor Pain in Women Phase 1 Randomized Study Using High-Density Surface EMG for Injection Guidance

What this Trial Is About

Researchers are evaluating whether targeted injections of botulinum neurotoxin Botox guided by high-density surface electromyography HD-sEMG provide better relief from pelvic floor muscle tightness and pain compared to the standard injection method. The study focuses on women with chronic pelvic floor disorders and aims to better understand the effects of these precision injections on pain and muscle function. Participants will receive botulinum neurotoxin injections twice during the study, with each injection delivering approximately 200 units into the pelvic floor muscles. Two groups receive treatments in different sequences one group gets the standard injection followed by HD-sEMG guided injection, and the other group receives HD-sEMG guided injection first followed by the standard method. Additionally, the HD-sEMG device will be used five times during the study to guide injections and optimize outcomes. Participants will be monitored for up to 15 months, with assessments including measurements of pelvic muscle tightness using HD-sEMG one month after injections. Self-reported pelvic pain and symptoms will be evaluated at baseline and one month post-injection using standardized questionnaires. Safety and treatment effects will be closely observed throughout the study period to better understand the impact of these injection methods on chronic pelvic pain.

Botox for Chronic Pelvic Pain