RecruitingPhase 1NCT06796985

Botox for Chronic Pelvic Pain

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

Sponsor

University of Miami

Enrollment

30 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Pelvic Floor Disorders

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Females between 18 and 75 years of age
Clinical diagnosis of chronic pelvic pain
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) \*
Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
Able to provide informed consent

Exclusion Criteria8

Males
Women \< 18 and \> 76 years of age
History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
Bleeding disorder such as coagulopathy
Hypersensitivity to botulinum neurotoxin
Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.

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Interventions

DRUGBotulinum neurotoxin

Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.

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

A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.