Phase
Condition
N/ATreatment
Botulinum neurotoxin
High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
Clinical Study ID
Ages 18-60 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females between 18 and 60 years of age
Clinical diagnosis of interstitial cystitis/bladder pain symptoms
Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area forthe past 6 months or more, associated with lower urinary tract symptoms (such asfrequency of urination), in the absence of other explanation of the symptoms (e.g.,UTI) *
Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvicexamination
No botulinum neurotoxin pelvic floor muscle injection treatment within 6 monthsprior to recruitment
Able to provide informed consent
Exclusion
Exclusion Criteria:
Males
Women < 18 and > 60 years of age
History of pelvic malignancy and sexual transmitted diseases that is currently notin remission
Bleeding disorder such as coagulopathy
Hypersensitivity to botulinum neurotoxin
Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior torecruitment
History of neurological disorders, such as spinal cord injury, multiple sclerosis,amyotrophic lateral sclerosis or myasthenia gravis
Pregnancy, breast feeding or planning to get pregnant within one year after the lastbotulinum neurotoxin injection.
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
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