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Botulinum Toxin

Botulinum Neurotoxin Injections for Chronic Pelvic Pain

Phase < 1

Waitlist Available

Research Sponsored by HillMed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Bleeding disorder such as coagulopathy

History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-months post injection

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using electromyography to guide botulinum toxin injection can help treat pelvic floor muscle overactivity that causes chronic pelvic pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include localized pain where the injection was given, muscle weakness around the treated area, allergic reactions to Botulinum neurotoxin, and less commonly systemic effects such as general muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am a woman aged between 18 and 60.

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I have been diagnosed with interstitial cystitis/bladder pain syndrome.

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I have been diagnosed with pelvic muscle tenderness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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

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I have a history of anorectal problems.

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I have an active fistula.

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I have bladder inflammation due to radiation.

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I have bladder inflammation from Cyclophosphamide.

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I have infections near where injections are given.

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I have had cancer in my pelvic area or sexually transmitted diseases.

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I have had surgery in my pelvic area.

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I have cancer in my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months post injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-months post injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Global response assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Guided InjectionExperimental Treatment2 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 InjectionActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum Neurotoxin

2020

Completed Phase 1

~50

0 / 15Eligibility criteria met