Botox for Chronic Pelvic Pain

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 24, 2025

Primary Completion Date

March 22, 2027

Study Completion Date

March 22, 2027

Conditions
Pelvic Floor Disorders
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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Miami

OTHER