# Regenerative therapy for stress urinary incontinence and pelvic floor disorder

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $575,362

## Abstract

PROJECT SUMMARY/ABSTRACT:
Stress urinary incontinence (SUI) and pelvic floor disorder (PFD) are major problems affecting millions of women
worldwide. Non-surgical therapies are mostly ineffective and not durable. The most effective are mesh surgeries
for SUI and pelvic organ prolapse (POP). However, many women suffered major complications after surgery
resulting in the ban of all mesh use for POP in the USA (FDA Apr 16, 2019). We began research in regenerative
therapy for SUI in 2002. Our long-term goal is to better understand the pathophysiology and develop a minimally
invasive and highly effective regenerative therapy for women with SUI and PFD.
In current project, we proposed to activate striated muscle satellite cells in situ with a novel mechanical stimulus
we recently developed, Microenergy acoustic pulses (MAP), as a regenerative therapy for SUI and PFD. In
severe cases, we propose a combination of myostatin inhibition by clustered regularly interspaced short
palindromic repeats interference (CRISPRi) and MAP to achieve better results. Our main hypothesis is that
dysfunction of tissue resident progenitor cells is the major contributor to SUI and PFD and myostatin inhibition
followed by MAP will provide the best strategy for maximal recovery of urethra and pelvic floor structure and
function.
The ability to activate and differentiate tissue resident stem/progenitor cells would be a powerful curative
approach for many human diseases, and this ability is the basis of the innovations we are developing for focally
enhancing muscle regeneration to treat SUI and PFD. These objectives lead us to propose 1). to elucidate and
compare the pathophysiology of reversible and irreversible stress urinary incontinence and pelvic floor disorders
in vaginal birth injury-induced rat models; 2). to compare the molecular mechanisms of myostatin inhibition and
microenergy acoustic pulses on the regeneration of striated muscle satellite cells from reversible and irreversible
models of SUI and PFD; 3). to compare the therapeutic and preventive effects of myostatin inhibition and
microenergy acoustic pulse therapy in the irreversible rat model of stress urinary incontinence and pelvic floor
disorder. Successful completion of the project will form the scientific basis for designing better prevention and
treatment for millions of women suffering from SUI and PFD.

## Key facts

- **NIH application ID:** 10107825
- **Project number:** 5R01DK124609-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** TOM F LUE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $575,362
- **Award type:** 5
- **Project period:** 2020-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10107825

## Citation

> US National Institutes of Health, RePORTER application 10107825, Regenerative therapy for stress urinary incontinence and pelvic floor disorder (5R01DK124609-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10107825. Licensed CC0.

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