First Non-Invasive Therapy Device for Stress Urinary Incontinence Approved by FDA

DECEMBER 11, 2018
Krista Rossi
FDA, Through noninvasive targeted impulses that are sent to integrate conductive panels to safely and effectively activate the muscles of the pelvic floor via patented technology, the handheld device allows comfortable use in the privacy of a patient’s own home. By attaching to the garment, it is used to enhance coordination and strength of the pelvic floor muscles.

According to previously reported data, after a 12-week treatment period, more than 87% of patients were dry or had mild leakage. In just 4 weeks, 93% of patients experiencing improvement.  

“The burden associated goes far beyond the cost of pads as medical and psychological morbidity in addition to quality of life are profoundly impacted,” Ruth Maher, PT, PhD, DPT, assistant professor of physical therapy at Creighton and director of the Women’s Health Residency Program, said in a recent statement.

“It has a huge impact on the quality of life for women. Women will plan outings around available restrooms, choose not to wear certain clothes for fear of ruining them from leakage and severely curtail their exercise regimens which can have a severe impact on their health across their lifespan. Additionally, this type of incontinence can impede intimacy for up to 65% of women because of leakage during sex.”

As few women often opt to discuss their stress urinary incontinence, intermittent urinary leakage during laughing, coughing, sneezing and exercise become common occurrences. However, the new device may help women take control of the condition rather than simply managing it.

Maher explained that correct use of pelvic floor exercises can be difficult to teach women since the muscles control pressure in the lumbopelvic region and in bowel and bladder regions, rather than a joint. Consequently, clinicians often struggle assessing whether the right muscles are being used by a patient without the aid of a digital pelvic floor exam or some type of imaging.
 
Maher has noted that approximately 40% of women are unable to voluntarily contract their pelvic floor muscles.
 
“The INNOVO therapy shorts facilitate a pelvic floor contraction and reproduce the same contraction consistently,” Maher added. “The benefit of this is 2-fold: the strength and coordination of the pelvic floor improves, but more importantly the device improves the users awareness of their pelvic floor and improves their ability to perform appropriate contractions without the device. In fact, I encourage users to try to contract their pelvic floor muscles while using the shorts.”
 

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