The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).
Woman aged 18 to 60.
Have a clinical diagnosis of IC/BPS.
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., urinary tract infection).
Myofascial pain diagnosed with palpable contracted muscle fibers.
History of pelvic malignancy and sexually transmitted diseases.
Bleeding disorder such as coagulopathy
History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.
Pregnancy, breast feeding or desiring for pregnancy in the coming year.
Crossover
High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
DeviceA 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.
Botulinum Neurotoxin
DrugBotulinum 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).
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Global response assessment
Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.
Global response assessment
Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.
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