A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorHillMed Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
  • Botulinum Neurotoxin

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

HillMed Inc.

Lead sponsor

Baylor College of Medicine

Collaborator

University of Houston

Collaborator