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RECRUITING
NCT06796985
PHASE1

Botox for Chronic Pelvic Pain

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-24

Completion Date

2027-03-22

Last Updated

2025-07-29

Healthy Volunteers

No

Interventions

DRUG

Botulinum 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.

DEVICE

High 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.

Locations (1)

University of Miami

Miami, Florida, United States