A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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).
Study summary
The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).
Eligibility
Primary outcome measure(s)
- Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG — Baseline
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings. - Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG — 1-Month Post Injection
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings. - Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG — 3-Months Post Injection
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Baylor College of Medicine | Houston | Texas |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05062902 on ClinicalTrials.gov ↗ ← All trials in the USA