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 range

18 Years – 60 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 60 Years

Sex

FEMALE

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.

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria