A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
Not yet recruitingEarly phase 1NCT05062902
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
- Conditions
- Interstitial Cystitis
- Chronic Pain
- Pelvic Floor
- Relaxation
- Pelvic Floor Disorders
- Interventions
- Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
- Drug: Botulinum Neurotoxin
- Sponsor
- HillMed Inc.
- Collaborators
- Baylor College of Medicine; University of Houston
- Start date
- 2025-09-15
- Primary completion
- 2027-08-15
- Sex
- Female
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 pelvic examination. 6. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O). 7. Ability to provide informed consent. Exclusion Criteria: * Exclusion criteria consist of the following: 1. History of pelvic malignancy and sexually transmitted diseases. 2. Bleeding disorder such as coagulopathy 3. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis. 4. Pregnancy, breast feeding or desiring for pregnancy in the coming year. 5. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh), 6. Pelvic malignancy (urinary tract, gynecologic, gastrointestinal) 7. Active fistula 8. Radiation cystitis 9. Cyclophosphamide cystitis 10. Pre-existing anorectal disorders 11. Infections near the injection sites 12. History of drug or alcohol abuse 13. Hypersensitivity to BoNT 14. Steroids or hormone usage will be carefully considered by the research team for inclusion. Participants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05062902