Botox for Chronic Pelvic Pain

Last updated: March 6, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Botulinum neurotoxin

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

Clinical Study ID

NCT06796985
20240022
7R01DK133800-03
  • Ages 18-60
  • Female

Study Summary

The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Females between 18 and 60 years of age

  2. Clinical diagnosis of interstitial cystitis/bladder pain symptoms

  3. Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area forthe past 6 months or more, associated with lower urinary tract symptoms (such asfrequency of urination), in the absence of other explanation of the symptoms (e.g.,UTI) *

  4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers

  5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvicexamination

  6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 monthsprior to recruitment

  7. Able to provide informed consent

Exclusion

Exclusion Criteria:

  1. Males

  2. Women < 18 and > 60 years of age

  3. History of pelvic malignancy and sexual transmitted diseases that is currently notin remission

  4. Bleeding disorder such as coagulopathy

  5. Hypersensitivity to botulinum neurotoxin

  6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior torecruitment

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

  8. Pregnancy, breast feeding or planning to get pregnant within one year after the lastbotulinum neurotoxin injection.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Botulinum neurotoxin
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
March 22, 2027

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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