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

NCT05062902 | Not Yet Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: R44HD107822
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Interstitial Cystitis; Chronic Pain; Pelvic Floor; Relaxation; Pelvic Floor Disorders

Keywords

hypertonicity; chronic pelvic pain; electromyography

Outcome Measures

Primary Outcomes (3)

• Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG

  The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.

  Baseline

• Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG

  The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.

  1-Month Post Injection

• Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG

  The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.

  3-Months Post Injection

Secondary Outcomes (2)

• Global response assessment

  1-Month Post Injection

• Global response assessment

  3-Months Post Injection

Study Arms (2)

Template Injection

ACTIVE COMPARATOR

For the standard template injection, 200 units of BoNT diluted in 6mL of preservative saline will be prepared. 1/4 of the prepared BoNT solution will be administered to each of the pubococcygeus and puborectalis muscle at 5 and 7 o'clock position, respectively. The index finger will be used for palpation as the 20-gauge spinal needle with a trumpet guide (i.e. paracervical block kit) piercing through the vaginal mucosa to the intended muscle groups. The syringe will be withdrawn before each injection to avoid intravascular injection.

Drug: Botulinum Neurotoxin

Guided Injection

EXPERIMENTAL

For the guided injection, pelvic floor injections (total of 4) will be made to the pubococcygeus and puborectalis muscles each, at NMJ locations (1.5 ml per site), at patient-specific locations and depths identified from vaginal HD-sEMG recordings. NMJ mappings will be generated for each participant. The channel locations will provide angle measurements for each NMJ. The device will calculate these parameters based on acquired HD-sEMG. The index finger will be used for palpation and guidance of injection needle through the vaginal mucosa to the defined injection sites. The BoNT dosage with respect to the total 200 units administered to each site will be patient specific, determined as the ratio of the resting average resting root-mean square (RMS) value of a specific region divided by the total average resting RMS.

Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device; Drug: Botulinum Neurotoxin

Interventions

High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device DEVICE

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.

Guided Injection

Botulinum Neurotoxin DRUG

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).

Guided Injection; Template Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.
• Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O).
• Ability to provide informed consent.

You may not qualify if:

• 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.
• Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),
• Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)
• Active fistula
• Radiation cystitis
• Cyclophosphamide cystitis
• Pre-existing anorectal disorders
• Infections near the injection sites
• History of drug or alcohol abuse
• Hypersensitivity to BoNT
• Participants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.

Sponsors & Collaborators

• HillMed Inc.: lead
• Baylor College of Medicine: collaborator
• University of Houston: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Chronic Pain; Pelvic Floor Disorders; Muscle Hypertonia

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Nicholas C Dias, PhD

CONTACT

2816581953; nickdias@hillmedgroup.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 30, 2021
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)