An Early Phase 1 interventional study of High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device and Botulinum Neurotoxin in Interstitial Cystitis, Chronic Pain and Pelvic Floor; Relaxation, sponsored by HillMed Inc.. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by HillMed Inc. · Early Phase 1, Interventional, and Treatment
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).
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 46 is close to the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →This is the only study on the registry with HillMed Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for interstitial cystitis/bladder pain syndrome (IC/BPS) patients will be:
Exclusion Criteria:
Exclusion criteria consist of the following:
Participants with on-going BoNT therapies will not be screened until the complete drug is confirmed.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Botulinum Neurotoxin
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.
Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device · Drug: Botulinum Neurotoxin
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 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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-Months 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.
Time frame: 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.
Time frame: 3-Months Post Injection
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Aug 2027, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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