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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
University of Miami
Miami, Florida, United States
RECRUITINGHypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.
Time frame: 1 month post-injection
Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)
Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.
Time frame: Baseline, 1 month post-injection
Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)
Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.
Time frame: Baseline, 1 month post-injection
Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index
Sum score will be collected and scores range from 0-45. Lower score indicates less pain while higher score indicates more pain.
Time frame: Baseline, 1 month post-injection
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