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

Launched by HILLMED INC. · Sep 21, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat chronic pelvic pain, specifically for women who have a condition called interstitial cystitis, which causes pain and discomfort in the bladder and pelvic area. The study aims to see if a special technique called intravaginal high-density surface electromyography can help guide precise injections of botulinum neurotoxin (commonly known as Botox) into the pelvic floor muscles. This treatment hopes to ease muscle overactivity that contributes to chronic pain in this area.

To participate in the trial, women aged 18 to 60 who have been diagnosed with interstitial cystitis and have experienced pelvic pain for at least six months may be eligible. They should also show signs of muscle tightness in the pelvic area. However, women with certain medical histories, such as previous pelvic cancers or neurological disorders, or who are pregnant or breastfeeding, cannot take part in this study. If you join the trial, you can expect to receive the botulinum toxin injection and be monitored afterward to see how well it works for relieving your pain. This trial is not yet recruiting participants, but it represents an exciting step toward personalized pain management for women dealing with chronic pelvic discomfort.

Gender

FEMALE

Eligibility criteria

• 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.