Clinical Trial Data
Flourish conducted a clinical trial where women experiencing stress urinary incontinence used Flourish daily for 30 days (half were post-menopausal). The frequency of incontinence episodes using Flourish was compared to a 7-day baseline period.
Results
Immediate
Results were immediate and maintained.
Confident
90% said concern about possibly wetting themselves was absent or minimal when using Flourish.
In control
90% said their level of satisfaction with their control of urinary incontinence was good or very good when using Flourish.
Positive experience
95% said their overall experience with Flourish was good or very good.
"I’m a very active mom, with two very active girls. One of our favorite activities is jumping on the trampoline, but lately I’ve felt like an ‘old mom’ watching from the sidelines, so I wouldn’t pee my pants. Using Flourish let me participate once again with my girls."
"I was squatting in my garden and had a sneezing attack. NO LEAK!! YAY!!"
Findings
Efficacy
We consider clinically meaningful results to be a 70% reduction in incontinence episodes. Results surpassed that baseline, with an 81.6% reduction in the number of incontinence episodes that women experienced. In addition, almost half the women in the study exceeded a 90% reduction.
Comfort and ease of placement
The first day of use, 90% of users reported placement as easy or very easy. At the end of the 30-day period, 95% reported it was easy or vary easy. In addition, 80% said that overall comfort was good or very good on the first day; and 85% said it was good or very good at the end of 30 days.
Satisfaction
Prior to using Flourish, 70% of women rated satisfaction with their control of urinary incontinence as poor or very poor; 30% rated control as moderate. After 30 days using Flourish, 90% rated control as good or very good; 10% rated it as moderate. Before using the Flourish device, 80% said the impact of incontinence on their life was moderate or severe – and 75% said the impact was none or minimal after 30 days.
Safety
Flourish had no impact on the ability to empty the bladder when intentionally voiding. There were no changes in gynecologic exams before and after using Flourish, and few reports of vaginal or vulvar complaints attributable to the use of the device. There were no occurrences that required treatment or discontinuation of the device. One subject chose to discontinue due to discomfort.
Next Steps
The combination of efficacy, comfort, ease of use and avoidance of surgery make Flourish a highly desirable management option across the entire spectrum of SUI severity.
We are actively seeking funding and investors to help bring this investigational device to market. Ready to learn more? Contact us at corporate@flourish-medical.com.
