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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05062902
• Other study ID #: R44HD107822
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 2024
• Est. completion date: December 2027

Study information

• Verified date: September 2023
• Source: HillMed Inc.
• Contact: Nicholas C Dias, PhD
• Phone: 2816581953
• Email: nickdias[@]hillmedgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The management of pelvic floor overactivity (PFOA) using focal BoNT injection has been gaining clinical interest. Evidence has shown that BoNT injections to the levator ani in patients with CPP generated a greater than 50% improvement in symptoms at least 72% of the time, suggesting a promising efficacy of BoNT therapy. The current clinical standard for BoNT injection employs a fixed injection template or the manual palpation of a contracted muscle, followed by an injection towards the palpating finger. As such, the injection is highly subjective, operator-dependent, variable, and not tailored to individual patients, which may lead to inconsistent outcomes. Trigger point targeted injections have been practiced for many years worldwide, yet a recent randomized controlled trial reported no significant difference in outcome between trigger point targeted BoNT injections versus a saline placebo. Furthermore, it has also been reported that neuromuscular junction (NMJ) and trigger points are distributed in well-defined separate areas with a distance of approximately 10 mm apart. It has also been shown that BoNT injections made 10 mm away from the NMJ can reduce the efficacy of BoNT by 46%. Therefore, injections targeted at the trigger point may, in turn, compromise therapeutic efficacy.

The rationale of this study is that BoNT acts at the NMJ, where the neuromuscular junctions are densely located. By specifying the muscle(s) responsible for the pelvic floor overactivity, and the offending NMJ using high density surface electromyography (HD-sEMG), BoNT can be injected with greater accuracy and objectivity to optimize treatment efficacy. The investigators aim to test the hypothesis that interstitial cystitis patients in the guided injection arm will demonstrate lower hypertonic metrics and improved quality of life. The purpose of this study is to provide preliminary evidence supporting the use of HD-sEMG and NMJ mapping to guide BoNT efficacy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical 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.

Drug:
• Botulinum Neurotoxin
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).

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
HillMed Inc.	Baylor College of Medicine, University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Global response assessment	Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.	1-Month Post Injection
Secondary	Global response assessment	Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.	3-Months Post Injection