Botox for Chronic Pelvic Pain
ConditionPelvic Floor Disorders
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
Females between 18 and 75 years of age
Clinical diagnosis of chronic pelvic pain
Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency 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
Disqualifiers
Males
Women < 18 and > 76 years of age
History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
Bleeding disorder such as coagulopathy
Trial design
Treatments tested in this trial
- Botulinum neurotoxin
- High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Miami
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov