Interstitial CystitisEarly Phase 1NCT05062902
A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
A Early Phase 1 study testing High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device and Botulinum Neurotoxin in people with Interstitial Cystitis and Chronic Pain, run by HillMed Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Interstitial Cystitis, Chronic Pain, Pelvic Floor; Relaxation
- What is being tested?
- High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device and Botulinum Neurotoxin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be:
- 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.
Who cannot join
- 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),
- Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)
Show all 15Show fewer
- Active fistula
- Radiation cystitis
- Cyclophosphamide cystitis
- Pre-existing anorectal disorders
- Infections near the injection sites
- History of drug or alcohol abuse
- Hypersensitivity to BoNT
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor College of Medicine
Houston, Texas, 77030
Christopher P Smith, MD, MBA, MSS, 713-798-4001, cps@bcm.edu
About this study
Official title: An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
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).
Read the detailed description
The management of pelvic floor overactivity (PFOA) using focal BoNT injection has been gaining clinical interest. Evidence has shown that BoNT injections to the levator ani in patients with CPP generated a greater than 50% improvement in symptoms at least 72% of the time, suggesting a promising efficacy of BoNT therapy. The current clinical standard for BoNT injection employs a fixed injection template or the manual palpation of a contracted muscle, followed by an injection towards the palpating finger. As such, the injection is highly subjective, operator-dependent, variable, and not tailored to individual patients, which may lead to inconsistent outcomes. Trigger point targeted injections have been practiced for many years worldwide, yet a recent randomized controlled trial reported no significant difference in outcome between trigger point targeted BoNT injections versus a saline placebo. Furthermore, it has also been reported that neuromuscular junction (NMJ) and trigger points are distributed in well-defined separate areas with a distance of approximately 10 mm apart. It has also been shown that BoNT injections made 10 mm away from the NMJ can reduce the efficacy of BoNT by 46%. Therefore, injections targeted at the trigger point may, in turn, compromise therapeutic efficacy.
The rationale of this study is that BoNT acts at the NMJ, where the neuromuscular junctions are densely located. By specifying the muscle(s) responsible for the pelvic floor overactivity, and the offending NMJ using high density surface electromyography (HD-sEMG), BoNT can be injected with greater accuracy and objectivity to optimize treatment efficacy. The investigators aim to test the hypothesis that interstitial cystitis patients in the guided injection arm will demonstrate lower hypertonic metrics and improved quality of life. The purpose of this study is to provide preliminary evidence supporting the use of HD-sEMG and NMJ mapping to guide BoNT efficacy.
- Being tested
- High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device, Botulinum Neurotoxin
- Keywords
- hypertonicity, chronic pelvic pain, electromyography
- Medical subject headings
- Cystitis, Interstitial, Chronic Pain, Pelvic Floor Disorders, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceDevice
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 NeurotoxinDrug
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 group | Role | What they receive |
|---|---|---|
| Template Injection | Active comparator | For the standard template injection, 200 units of BoNT diluted in 6mL of preservative saline will be prepared. 1/4 of the prepared BoNT solution will be administered to each of the pubococcygeus and puborectalis muscle at 5 and 7 o'clock position, respectively. The index finger will be used for palpation as the 20-gauge spinal needle with a trumpet guide (i.e. paracervical block kit) piercing through the vaginal mucosa to the intended muscle groups. The syringe will be withdrawn before each injection to avoid intravascular injection. Receives: Drug: Botulinum Neurotoxin |
| Guided Injection | Experimental | For the guided injection, pelvic floor injections (total of 4) will be made to the pubococcygeus and puborectalis muscles each, at NMJ locations (1.5 ml per site), at patient-specific locations and depths identified from vaginal HD-sEMG recordings. NMJ mappings will be generated for each participant. The channel locations will provide angle measurements for each NMJ. The device will calculate these parameters based on acquired HD-sEMG. The index finger will be used for palpation and guidance of injection needle through the vaginal mucosa to the defined injection sites. The BoNT dosage with respect to the total 200 units administered to each site will be patient specific, determined as the ratio of the resting average resting root-mean square (RMS) value of a specific region divided by the total average resting RMS. Receives: Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device; Drug: Botulinum Neurotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Measured: Baseline
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Measured: 1-Month Post Injection
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
Measured: 3-Months Post Injection
Secondary outcomes (2)
Global response assessment
Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.
Measured: 1-Month Post Injection
Global response assessment
Compared to prior to the treatment, is the patient very much better, much better, a little better, no change, a little worse, much worse, or very much worse.
Measured: 3-Months Post Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start15 Sep 2025 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HillMed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine, University of Houston
- Responsible party
- Principal investigator, Nicholas Dias, HillMed Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062902
- Sponsor's protocol ID
- R44HD107822
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2021
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
- ClinicalTrials.gov ID
- NCT05062902
- Acronym / sponsor ID
- R44HD107822
- Keywords
- hypertonicity, chronic pelvic pain, electromyography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- HillMed Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine, University of Houston
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The management of pelvic floor overactivity (PFOA) using focal BoNT injection has been gaining clinical interest. Evidence has shown that BoNT injections to the levator ani in patients with CPP generated a greater than 50% improvement in symptoms at least 72% of the time, suggesting a promising efficacy of BoNT therapy. The current clinical standard for BoNT injection employs a fixed injection template or the manual palpation of a contracted muscle, followed by an injection towards the palpating finger. As such, the injection is highly subjective, operator-dependent, variable, and not tailored to individual patients, which may lead to inconsistent outcomes. Trigger point targeted injections have been practiced for many years worldwide, yet a recent randomized controlled trial reported no significant difference in outcome between trigger point targeted BoNT injections versus a saline placebo. Furthermore, it has also been reported that neuromuscular junction (NMJ) and trigger points are distributed in well-defined separate areas with a distance of approximately 10 mm apart. It has also been shown that BoNT injections made 10 mm away from the NMJ can reduce the efficacy of BoNT by 46%. Therefore, injections targeted at the trigger point may, in turn, compromise therapeutic efficacy.
The rationale of this study is that BoNT acts at the NMJ, where the neuromuscular junctions are densely located. By specifying the muscle(s) responsible for the pelvic floor overactivity, and the offending NMJ using high density surface electromyography (HD-sEMG), BoNT can be injected with greater accuracy and objectivity to optimize treatment efficacy. The investigators aim to test the hypothesis that interstitial cystitis patients in the guided injection arm will demonstrate lower hypertonic metrics and improved quality of life. The purpose of this study is to provide preliminary evidence supporting the use of HD-sEMG and NMJ mapping to guide BoNT efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Template Injection | Active comparator | Drug: Botulinum NeurotoxinFor the standard template injection, 200 units of BoNT diluted in 6mL of preservative saline will be prepared. 1/4 of the prepared BoNT solution will be administered to each of the pubococcygeus and puborectalis muscle at 5 and 7 o'clock position, respectively. The index finger will be used for palpation as the 20-gauge spinal needle with a trumpet guide (i.e. paracervical block kit) piercing through the vaginal mucosa to the intended muscle groups. The syringe will be withdrawn before each injection to avoid intravascular injection. |
| Guided Injection | Experimental | Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device, Drug: Botulinum NeurotoxinFor the guided injection, pelvic floor injections (total of 4) will be made to the pubococcygeus and puborectalis muscles each, at NMJ locations (1.5 ml per site), at patient-specific locations and depths identified from vaginal HD-sEMG recordings. NMJ mappings will be generated for each participant. The channel locations will provide angle measurements for each NMJ. The device will calculate these parameters based on acquired HD-sEMG. The index finger will be used for palpation and guidance of injection needle through the vaginal mucosa to the defined injection sites. The BoNT dosage with respect to the total 200 units administered to each site will be patient specific, determined as the ratio of the resting average resting root-mean square (RMS) value of a specific region divided by the total average resting RMS. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be:
Key exclusion criteria (15 listed)
- Participants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical deviceA 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. | Device | Guided Injection |
| Botulinum NeurotoxinBotulinum 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). | Drug | Guided Injection, Template Injection |
Primary outcome
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
Time frame: 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
Time frame: 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
Time frame: 3-Months Post Injection
The pelvic floor hypertonicity will be assessed by evaluating the amplitudes of intra-vaginal high-density surface electromyography recordings.
2 secondary outcomes
Global response assessment
Time frame: 1-Month Post Injection
Global response assessment
Time frame: 3-Months Post Injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device and Botulinum Neurotoxin in people with Interstitial Cystitis and Chronic Pain, run by HillMed Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas C Dias, PhD (2816581953, nickdias@hillmedgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.