A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

August 15, 2027

Study Completion Date

December 1, 2027

Conditions
Interstitial CystitisChronic PainPelvic Floor; RelaxationPelvic Floor Disorders
Interventions
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.

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).

Trial Locations (1)

77030

Baylor College of Medicine, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

collaborator

University of Houston

OTHER

lead

HillMed Inc.

INDUSTRY