# Natural Electrospun Scaffolds as an Alternative to Synthetic Mesh for Stress Urinary Incontinence

> **NIH NIH R41** · NOVAGYN LLC · 2024 · $292,752

## Abstract

ABSTRACT
Over 25% of adult women experience pelvic floor disorders including stress urinary incontinence (SUI). Stress
urinary incontinence is characterized by involuntary urination when pressure is exerted on the bladder, such as
coughing, sneezing, laughing, jogging and other forms of physical exercises. Incontinence can have a significant
impact on a woman’s quality of life and while there are non-surgical interventions such as pelvic floor exercises
and pessaries, the failure rate is up to 50%. Many women for which non-surgical interventions have been
inadequate, resort to surgical solutions such as midurethral sling placement. Of the 300,000 patients who receive
midurethral sling surgeries in the US every year, 2-3% experience mesh erosion and up to 20% remain
incontinent which may require revision surgeries where more synthetic mesh is placed, compounding the
problem. The primary objective of this Phase I STTR is to establish feasibility of a natural, coaxial electrospun
scaffold to be used as an alternative to synthetic surgical mesh. Our team is developing a naturally derived
scaffold that will dissolve over time and replace the support of the urethra with healthy formation of scar tissue.
The Phase I project will focus on the fabrication of coaxial scaffolds using silk fibroin and polyhydroxybutyrate
and the attachment and deposition of extracellular matrix (ECM) of fibroblasts to those scaffolds compared to
state-of-the-art polypropylene. The deposition of ECM of fibroblasts onto the scaffold demonstrates feasibility of
the scaffold to promote fibrous growth as the scaffold degrades over time. If our device is successful, we will
decrease the complications and need for revision surgeries for thousands of women undergoing midurethral
sling placements. We hypothesize that a coaxial scaffold with the combination of silk fibroin surrounding a PHB
core will provide increased mechanical properties and cell attachment points. In Specific Aim 1, we will develop
a tunable protocol to fabricate coaxial scaffolds of different weight percentages. In Specific Aim 2, we will validate
that our coaxial scaffolds are mechanically strong enough to support the urethra by comparing to the properties
defined by Lei et al. Finally, in Specific Aim 3, we will compare ECM deposition and proliferation of fibroblasts
on the coaxially spun scaffolds to the synthetic polypropylene mesh. If all criterion are met and feasibility is
developed, our device has the potential to move women’s health to a more biocompatible and effective
alternative for stress urinary incontinence.

## Key facts

- **NIH application ID:** 11007976
- **Project number:** 1R41DK139872-01A1
- **Recipient organization:** NOVAGYN LLC
- **Principal Investigator:** Rebecca Thomson
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $292,752
- **Award type:** 1
- **Project period:** 2024-08-28 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007976

## Citation

> US National Institutes of Health, RePORTER application 11007976, Natural Electrospun Scaffolds as an Alternative to Synthetic Mesh for Stress Urinary Incontinence (1R41DK139872-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11007976. Licensed CC0.

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