# Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor

> **NIH NIH R44** · ADVANCED TACTILE IMAGING, INC. · 2022 · $839,775

## Abstract

Summary
Pelvic organ prolapse (POP) is a highly prevalent condition affecting 40-50% of women in the US during their
lifetimes. Urinary incontinence (UI) affects up to 48% of women. Both POP and UI are more common in women
than in men, and their prevalence is increased with age. Beyond the physical and the quality of life impacts,
these conditions cause significant morbidity. The true etiology of POP and UI and their variations observed
among individuals is not entirely understood. These disorders are thought to share common pathogeneses,
weakening (elasticity changes) of the connective support tissues and pelvic floor muscle dysfunction. The
lifetime surgery risk for either UI or POP in women is about 20% by the age of 80 years. A POP surgical failure
rate of 61.5% for uterosacral ligament suspension and 70.3% for sacrospinous ligament fixation groups in a
representative study was reported. Substantial improvement is possible if patients with the diseased pelvic
floor conditions undergo imaging and biomechanical diagnostic tests; the results of which could be fed into a
patient-specific optimal treatment. In the Phase I research, a conceptual α-prototype of a vaginal tactile and
ultrasound imaging probe was designed and its imaging performance demonstrated in a pilot study. Tactile
(stress) and ultrasound (anatomy, strain) image fusion furnishes new insights into the female pelvic floor
conditions through biomechanical mapping in multiple tests. In Phase II, we will design and build a pre-
production β-prototype of a Vaginal Tactile Ultrasound Imager (TIUSv), which will incorporate the Phase I
lessons in product development process. We will verify it via bench testing, validate it in a multi-site clinical
study, prepare and submit a 510(k) application to the FDA.

## Key facts

- **NIH application ID:** 10491959
- **Project number:** 5R44HD097805-03
- **Recipient organization:** ADVANCED TACTILE IMAGING, INC.
- **Principal Investigator:** Vladimir Egorov
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $839,775
- **Award type:** 5
- **Project period:** 2019-02-08 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10491959

## Citation

> US National Institutes of Health, RePORTER application 10491959, Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor (5R44HD097805-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10491959. Licensed CC0.

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