Botulinum Neurotoxin Injections for Chronic Pelvic Pain

Overseen By Nicholas C Dias, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: HillMed Inc.

Must not be taking: Steroids, Hormones

Disqualifiers: Pelvic malignancy, Neurological disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that ongoing Botulinum neurotoxin therapies require a complete washout period (time without taking the medication) before participation.

What data supports the effectiveness of the drug Botulinum Neurotoxin for treating chronic pelvic pain?

Research shows that Botulinum Neurotoxin injections can significantly reduce pain and improve quality of life for women with chronic pelvic pain, especially when other treatments have failed. Studies indicate that it may help with conditions like dyspareunia (painful intercourse) and myofascial pelvic pain, although more high-quality research is needed to confirm these findings. ^{1 2 3 4 5}

How does the drug Botulinum Neurotoxin differ from other treatments for chronic pelvic pain?

Botulinum Neurotoxin is unique because it works by blocking nerve signals to muscles, causing temporary muscle relaxation, which can relieve pain from muscle spasms. This is different from other treatments that may focus on reducing inflammation or pain through medication or physical therapy. It is particularly useful for patients whose pain is due to muscle hyperactivity and who have not found relief with other treatments. ^{3 4 6 7 8}

What is the purpose of this trial?

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).

Eligibility Criteria

Women aged 18-60 with chronic pelvic pain due to overactive pelvic floor muscles, diagnosed with interstitial cystitis or myofascial pain. They must have had symptoms like bladder discomfort and frequent urination for at least 6 months without other causes. Participants should not be pregnant, breastfeeding, planning pregnancy soon, have a history of certain diseases (like neurological disorders), previous pelvic surgeries, or substance abuse.

Inclusion Criteria

Ability to provide informed consent

I have had bladder or pelvic pain and frequent urination for over 6 months without any other known cause.

I have been diagnosed with muscle pain due to tight muscle fibers.

Exclusion Criteria

I have a bleeding disorder.

Pregnancy, breast feeding or desiring for pregnancy in the coming year

I have a history of neurological disorders like MS or ALS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botulinum neurotoxin injections guided by high-density surface electromyography for pelvic floor muscle overactivity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Periodic assessments

Treatment Details

Interventions

• Botulinum Neurotoxin
• High Density Surface Electromyographic, Precision Botulinum Neurotoxin Injection Guidance Medical Device

Trial Overview The trial is testing if using high-density surface electromyography inside the vagina can help guide injections of Botulinum neurotoxin to treat overactivity in the pelvic floor muscles that contribute to chronic pelvic pain.

Participant Groups

Group I: Guided Injection Experimental Treatment 2 Interventions

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.

Group II: Template Injection Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

HillMed Inc.

Lead Sponsor

Trials

1

Recruited

50+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Dyspareunia with Botulinum Neurotoxin Type A: Clinical Improvement and Influence of Patients' Characteristics. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Applications of botulinum toxin to the female pelvic floor: Botulinum toxin for genito-pelvic pain penetration disorder and chronic pelvic pain in women. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin injection for chronic pelvic pain: A systematic review. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The use of botulinum toxin in the pelvic floor for women with chronic pelvic pain-a new answer to old problems? [2010]

5. England pubmed.ncbi.nlm.nih.gov

Botulinum injections for myofascial pelvic pain. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum toxin for the treatment of genital pain syndromes. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin for pelvic pain in women. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Methodological approaches to botulinum toxin for the treatment of chronic pelvic pain, vaginismus, and vulvar pain disorders. [2020]