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Botox for Chronic Pelvic Pain
Sponsor: University of Miami
Summary
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.
Official title: High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-02-24
Completion Date
2027-03-22
Last Updated
2025-07-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
University of Miami
Miami, Florida, United States