NCT06796985

Botox for Chronic Pelvic Pain

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Floor Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-24
• Primary completion: 2027-03-22
• Completion: 2027-03-22
• First posted: 2025-01-28
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study