High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceBotulinum Neurotoxin
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
Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be:
1. Woman aged 18 to 60.
2. Have a clinical diagnosis of IC/BPS.
3. Pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., urinary tract infection).
4. Myofascial pain diagnosed with palpable contracted muscle fibers.
5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.
6. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O).
7. Ability to provide informed consent.
Exclusion Criteria:
* Exclusion criteria consist of the following:
1. History of pelvic malignancy and sexually transmitted diseases.
2. Bleeding disorder such as coagulopathy
3. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.
4. Pregnancy, breast feeding or desiring for pregnancy in the coming year.
5. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),
6. Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)
7. Active fistula
8. Radiation cystitis
9. Cyclophosphamide cystitis
10. Pre-existing anorectal disorders
11. Infections near the injection sites
12. History of drug or alcohol abuse
13. Hypersensitivity to BoNT
14. Steroids or hormone usage will be carefully considered by the research team for inclusion.
Participants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.
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
Official registry record
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.
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