Testing a new silicone device for treating urinary incontinence in women
Phase IIB Clinical and Nonclinical Testing of Soft Spring Continence Pessary for Women, in Support of FDA 510(k) Clearance Requirements
['FUNDING_SBIR_2'] · LIV LABS INC. · NIH-10761149
This study is testing a new, comfortable silicone device that women with stress urinary incontinence can use themselves to help manage their condition better than current options.
Quick facts
| Phase | ['FUNDING_SBIR_2'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | LIV LABS INC. (nih funded) |
| Locations | 1 site (Chicago, UNITED STATES) |
| Trial ID | NIH-10761149 on ClinicalTrials.gov |
What this research studies
This research focuses on a novel, reusable silicone pessary designed for women suffering from stress urinary incontinence (SUI). The device is self-administered and aims to provide a patient-controlled treatment option that is more comfortable and effective than existing disposable pessaries. It is designed to gently compress the urethra without causing discomfort, making it suitable for women with vaginal atrophy. The study includes a pivotal clinical trial to evaluate the efficacy and safety of this device across multiple sites.
Who could benefit from this research
Good fit: Ideal candidates for this research are women over the age of 25 who experience stress urinary incontinence.
Not a fit: Patients who do not have stress urinary incontinence or those who are not suitable for vaginal devices may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could provide a more effective and comfortable treatment option for millions of women suffering from urinary incontinence.
How similar studies have performed: Previous studies have shown promising results with similar patient-controlled devices, indicating potential for success in this novel approach.
Where this research is happening
Chicago, UNITED STATES
- LIV LABS INC. — Chicago, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: ROBERTS, MELODY ANN — LIV LABS INC.
- Study coordinator: ROBERTS, MELODY ANN
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.