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

> **NIH NIH R44** · HILLMED INC · 2021 · $251,964

## Abstract

Abstract
Chronic pelvic pain (CPP) negatively impacts the social and sexual quality of life in up to 20% of women in the
US. Interstitial cystitis/ bladder pain syndrome (IC/BPS), which affects 6.5% of women in the US, is one of the
most debilitating CPP conditions. Pelvic floor overactivity (PFOA) is prevalent among patients with CPP and
presents in up to 85% of women with IC/BPS. Conservative treatment strategies employ physical therapy
interventions that include manual soft tissue mobilization, dilation, and muscle retraining. When conservative
therapies fail, injection therapies may be indicated. Specifically, botulinum neurotoxin (BoNT, or
onabotulinumtoxinA) has received growing interest in managing PFOA. BoNT blocks acetylcholine release,
thereby inhibiting neuromuscular transmission at the neuromuscular junction (NMJ). By inhibiting neuromuscular
transmission in spastic muscles, transient muscle relaxation commences, and pain is relieved. Despite its
potency and safety, BoNT can cause dose-dependent adverse effects and is expensive. Studies have shown
that increasing the injection distance by 1 cm away from the NMJs reduces the efficacy of BoNT by 46%. An
NMJ-targeted precision BoNT injection technique will retain therapeutic effects, reduce adverse effects and cost.
Unfortunately, an NMJ-targeted precision BoNT injection technique is not yet available. To address this gap in
CPP management, we have 1) successfully developed a novel vaginal high-density surface electromyography
(HD-sEMG) technique to reliably and quantitatively assess PFOA and accurately map the NMJ distributions of
overactive pelvic floor muscles (PFMs), and 2) successfully demonstrated a significant improvement (66%) in
BoNT injection treatment outcomes with vs. without HD-sEMG guidance. Inspired by the promising research
results, the HillMed and the University of Houston PIs co-invented a novel technique for personalized BoNT
injections, guided using vaginal HD-sEMG, for managing CPP and PFOA.
This FastTrack SBIR project aims to develop a commercializable, personalized, precision BoNT injection medical
device, i.e., the PelviMap, utilizing a vaginal HD-sEMG technology, to optimize the treatment outcomes in CPP
management. In Phase I, we will develop the vaginal HD-sEMG probe to further improve its diagnostic
performance, and develop PFOA severity assessment and NMJ mapping algorithms into a clinician-friendly
automated software package, which will be fully integrated into the proposed PelviMap system. In Phase II, we
will assess the efficacy of the developed personalized, precision BoNT injection medical device (PelviMap) in a
clinical trial study with 46 women with IC/BPS, and 15 healthy controls in collaboration with Baylor College of
Medicine. The deliverable of this proposal is to, for the first time, develop a marketed NMJ-targeted precision
BoNT injection system to optimize the BoNT treatment efficiency in CPP management. Successful
commercialization can help up ...

## Key facts

- **NIH application ID:** 10386341
- **Project number:** 1R44HD107822-01
- **Recipient organization:** HILLMED INC
- **Principal Investigator:** Nicholas Dias
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $251,964
- **Award type:** 1
- **Project period:** 2021-09-23 → 2024-08-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10386341

## Citation

> US National Institutes of Health, RePORTER application 10386341, An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management (1R44HD107822-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10386341. Licensed CC0.

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