# A device to treat high-tone pelvic floor dysfunction in women

> **NIH NIH R43** · BOLD TYPE LLC · 2023 · $384,959

## Abstract

Abstract
Bold Type is developing the “SmartWand”, an interactive, connected pelvic floor system (device and
mobile app) to guide patients through pelvic floor physical therapy (PT) in the privacy of their home. PT
is a highly effective and first-line treatment for high tone pelvic floor dysfunction (HTPFD), a major contributor to
chronic pelvic pain (CPP), affecting up to 15% of women in the United States. Despite proven effectiveness, only
20% of women complete the PT treatment course, which includes a home exercise component with an external
and internal exercise regimen. Women report limitations in continuing PT as time, cost, access to therapy, the
lack of direct feedback from the home program and the inability to measure progress at home.
Bold Type’s team has decades of product development experience with medical devices, quality, and regulatory
affairs. We have developed proprietary hardware and software development kits that allow us to design and
implement medical devices efficiently by leveraging reusable subsystems that are designed and documented to
comply with FDA regulations. To meet the critical need for accessible and improved PT, we hypothesize that:
(1) an ergonomic wand design will improve usability, (2) an innovative system for performing PT can be
developed that provides guidance and biofeedback to physical therapists and patients; and (3) patients will be
able to effectively perform PT using the guidance and biofeedback provided by the platform.
We propose the following Specific Aims for this project: 1) Finalize the wand design from three preliminary
design prototypes using human factors validation testing. A formative usability evaluation of three preliminary
wand prototypes will be conducted in 15 mechanical wand experienced HTPFD patients to identify preferred
design features. We will use simulated-use testing under the supervision of a pelvic floor physical therapist and
systematically collect data from test participants using the unpowered device prototype; 2) Develop a wireless,
handheld “SmartWand” and mobile app that (1) records pressure and location (depth and orientation) in the
female pelvis in relation to the pelvic floor muscles, (2) provides the user audio and visual feedback on wand
pressure, position, and orientation, and (3) transfers data to a database for storage and analysis; and 3) Validate
the system developed in Specific Aim 2 on a group of 10 healthy women and 10 women with HTPFD. Women
>18 years will be recruited by Grace Physical Therapy and therapists assigned to perform pressure pain
thresholds and instruct on wand use. The success metric for Aim 3 is that with guidance from the app, the
participants will be able to perform wand exercises with minimal variance as compared to measurements made
by the PT (within 15% of applied pressure, 5 degrees of angle/orientation and within 8 mm of insertion depth).

## Key facts

- **NIH application ID:** 10697072
- **Project number:** 1R43HD112277-01
- **Recipient organization:** BOLD TYPE LLC
- **Principal Investigator:** Jose Luis Bohorquez
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $384,959
- **Award type:** 1
- **Project period:** 2023-06-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10697072

## Citation

> US National Institutes of Health, RePORTER application 10697072, A device to treat high-tone pelvic floor dysfunction in women (1R43HD112277-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10697072. Licensed CC0.

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