Not Yet RecruitingEarly Phase 1

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

United States46 participantsStarted 2025-09-15

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Woman aged 18 to 60.
✓. Have a clinical diagnosis of IC/BPS.
✓. 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).
✓. Myofascial pain diagnosed with palpable contracted muscle fibers.
✓. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.
✓. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O).
✓. Ability to provide informed consent.

Exclusion criteria

✕. History of pelvic malignancy and sexually transmitted diseases.
✕. Bleeding disorder such as coagulopathy
✕. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.
✕. Pregnancy, breast feeding or desiring for pregnancy in the coming year.
✕. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),
✕

What they're measuring

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

Timeframe: Baseline

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

Timeframe: 1-Month Post Injection

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

Timeframe: 3-Months Post Injection

Trial details

NCT IDNCT05062902

SponsorHillMed Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-15

Contact for this trial

Nicholas C Dias, PhD

2816581953 nickdias@hillmedgroup.com

View on ClinicalTrials.gov More Interstitial Cystitis trials

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Woman aged 18 to 60.
✓. Have a clinical diagnosis of IC/BPS.
✓. 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).
✓. Myofascial pain diagnosed with palpable contracted muscle fibers.
✓. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.
✓. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \> 35 cm∙H2O).
✓. Ability to provide informed consent.

Exclusion criteria

✕. History of pelvic malignancy and sexually transmitted diseases.
✕. Bleeding disorder such as coagulopathy
✕. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.
✕. Pregnancy, breast feeding or desiring for pregnancy in the coming year.
✕. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),
✕

What they're measuring

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

Timeframe: Baseline

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

Timeframe: 1-Month Post Injection

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

Timeframe: 3-Months Post Injection