30
Participants
Start Date
February 24, 2025
Primary Completion Date
March 22, 2027
Study Completion Date
March 22, 2027
Botulinum neurotoxin
Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.
High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.
RECRUITING
University of Miami, Miami
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Miami
OTHER