Botulinum Neurotoxin for Chronic Pelvic Pain

This study is looking into a new way to treat chronic pelvic pain (CPP) that comes from overactive pelvic floor muscles. Researchers are testing a special medical device that uses high-density surface electromyography (a way to measure muscle activity) to guide injections of Botulinum Neurotoxin. This toxin helps relax muscles. The goal is to see if guiding the injection precisely can lead to better results compared to standard injection methods. You might be able to join if you are a woman between 18 and 60 years old, have been diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS), and have experienced pelvic pain for at least six months. The study will measure changes in your pelvic muscle activity at one and three months after the injection. The study is currently recruiting 46 participants, but its overall status is unclear.

Study design
This interventional study plans to enroll 46 women. It compares a standard Botulinum Neurotoxin injection to one guided by a new medical device.
What's involved
You would receive an injection of Botulinum Neurotoxin. Your pelvic muscle activity will be measured at the start of the study, and then again one and three months after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your pelvic muscle activity will be measured at one and three months after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05062902

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

Not Yet Recruiting
EARLY_PHASE1Ages 18–60InterventionalTreatment
HillMed Inc.
~46 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceBotulinum Neurotoxin

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
Measured over Baseline
+2 more outcomes measured
Interstitial Cystitis
Chronic Pain
Pelvic Floor; Relaxation
Pelvic Floor Disorders
1 sites across 1 states
Texas1

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  • Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMGBaseline

    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 EMG1-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 EMG3-Months Post Injection

    The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.