HillMed Inc.
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).
The management of pelvic floor overactivity (PFOA) using focal BoNT injection has been gaining clinical interest. Evidence has shown that BoNT injections to the levator ani in patients with CPP generated a greater than 50% improvement in symptoms at least 72% of the time, suggesting a promising efficacy of BoNT therapy. The current clinical standard for BoNT injection employs a fixed injection template or the manual palpation of a contracted muscle, followed by an injection towards the palpating finger. As such, the injection is highly subjective, operator-dependent, variable, and not tailored…
Inclusion Criteria: * Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be: 1. Woman aged 18 to 60. 2. Have a clinical diagnosis of IC/BPS. 3. 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). 4. Myofascial pain diagnosed with palpable contracted muscle fibers. 5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital…
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.
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).
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