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Botox for Chronic Pelvic Pain

RecruitingPhase 1NCT06796985
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
Conditions
  • Pelvic Floor Disorders
Interventions
  • Drug: Botulinum neurotoxin
  • Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
Sponsor
University of Miami
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date
2025-02-24
Primary completion
2027-03-22
Sex
Female
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Females between 18 and 75 years of age 2. Clinical diagnosis of chronic pelvic pain 3. Complaints of 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., 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 pelvic examination 6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment 7. Able to provide informed consent Exclusion Criteria: 1. Males 2. Women \< 18 and \> 76 years of age 3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission 4. Bleeding disorder such as coagulopathy 5. Hypersensitivity to botulinum neurotoxin 6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment 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 last botulinum neurotoxin injection.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06796985