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

NCT ID: NCT05062902
Registry status: Not yet recruiting
Study type: Interventional
Phase: Early Phase 1
Sponsor: HillMed Inc.
Conditions: Chronic Pain, Interstitial Cystitis, Pelvic Floor Disorders, Pelvic Floor; Relaxation

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

Enrollment: 46 participants (Estimated).

What is being studied

Intervention: Amino Acids, Peptides, and Proteins
Intervention: Bacterial Proteins
Intervention: Bacterial Toxins
Intervention: Biological Factors
Drug: Botulinum Neurotoxin
Intervention: Botulinum Toxins
Intervention: Endopeptidases
Intervention: Enzymes
Intervention: Enzymes and Coenzymes
Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
Intervention: Hydrolases
Intervention: Metalloendopeptidases
Intervention: Metalloproteases
Intervention: Peptide Hydrolases
Intervention: Proteins
Intervention: Toxins, Biological

Who may be eligible

Ages: 18 Years to 60 Years
Sex: Female
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

Texas, United States: 1

Sample of listed locations

Baylor College of Medicine — Houston, Texas, 77030, United States — Site recruitment status not specified in the registry data

Study details

Start date: September 15, 2025
Primary completion date: August 15, 2027
Completion date: December 1, 2027
First posted: September 30, 2021
Collaborators: Baylor College of Medicine, University of Houston

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05062902
Registry last updated: August 19, 2025
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT05062902 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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