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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using Botulinum Neurotoxin (BoNT) injections to treat Chronic Pelvic Pain (CPP). Researchers aim to determine if a special device can better target overactive pelvic floor muscles during injections. Participants are divided into two groups: one receives standard injections, while the other receives injections guided by a high-density surface electromyographic, precision Botulinum Neurotoxin injection guidance medical device. Women who have experienced bladder or pelvic pain for at least six months, along with frequent urination, and have been diagnosed with interstitial cystitis/bladder pain syndrome may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking medical advancements.

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 prior data suggests that this device is safe for guiding Botulinum Neurotoxin injections?

Research has shown that botulinum toxin (BoNT) injections are generally safe for treating chronic pelvic pain. Studies have found these injections to be effective and usually well-tolerated by patients with similar conditions. For example, in other studies on chronic pelvic pain, BoNT injections reduced symptoms without causing major side effects.

Although researchers are still testing this treatment for chronic pelvic pain, BoNT has been widely studied for other conditions, indicating a certain level of safety. However, individual experiences may vary. It's important to consult a healthcare provider about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chronic pelvic pain because they offer a more tailored approach than traditional methods like pain medications, physical therapy, or surgery. The Botulinum Neurotoxin injections being studied have two distinctive methods: Template Injection and Guided Injection. The Template Injection delivers the neurotoxin to standard muscle sites, whereas the Guided Injection uses high-definition surface electromyography (HD-sEMG) to map and target specific neuromuscular junctions for each patient. This personalized targeting could enhance effectiveness by ensuring the neurotoxin reaches the most relevant areas for pain relief, potentially leading to more significant symptom improvement compared to the more general approaches used today.

What evidence suggests that Botulinum Neurotoxin injections guided by high-density surface electromyography could be effective for Chronic Pelvic Pain?

Research has shown that botulinum neurotoxin (BoNT) can help reduce chronic pelvic pain. Studies have found that many women experienced at least a 33% decrease in pain after receiving these injections. In this trial, participants will receive either a standard template injection or a guided injection using high-density surface electromyography (HD-sEMG) to map muscle activity. The guided injection aims to increase precision and possibly enhance effectiveness. These findings suggest that BoNT injections, particularly when precisely guided, might offer relief for those with chronic pelvic pain. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8780260/

Botulinum Toxin-A Injection in Chronic Pelvic Pain Syndrome ... We showed an improvement in pain perception in all cohorts that underwent treatment in the overall population and in specific disease ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17991

The Efficacy of Botulinum Toxin A Injection in Pelvic Floor ... Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0041010125001102

Chronic pelvic pain and botulinum toxin There have been numerous uncontrolled studies of botulinum toxin for chronic pelvic pain in women showing benefit, however, the few randomized controlled ...

4. fertstert.org fertstert.org/article/S0015-0282(21)00747-0/fulltext

RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF ... This study supports that BoNt can be used safely and effectively to treat chronic pelvic pain on women with a history of endometriosis and ongoing spasm in the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06796985

Study Details | NCT06796985 | Botox for Chronic Pelvic Pain The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders. Official ...

6. link.springer.com link.springer.com/article/10.1007/s00192-025-06346-0

The Significance of Type A Botulinum Toxin Ten-Point ... This study aims to evaluate the efficacy, safety, and socioeconomic impact of botulinum toxin type A trigger point injection therapy and ...