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Botox for Chronic Pelvic Pain

RecruitingPhase 1

High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain

Who can join

Ages 18 to 75 · Women

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of Miami · Participants: 30 · Started: Feb 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06796985

Locations in the U.S.

FloridaUniversity of Miami, Miami

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.