InControl Medical wins FDA nod for OTC incontinence device

InControl Medical (Brookfield, Wisc.) has received FDA clearance for its Attain over-the-counter, non-implantable muscle stimulator for urinary and bowel incontinence.

The Attain system is designed for at-home use to treat women who are suffering with stress, urge, mixed urinary incontinence and bowel incontinence.

“It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too,” Dr. Lauren Streicher, medical director of the Northwestern Medicine Center for Sexual Health and Menopause and clinical professor of obstetrics and gynecology at Northwestern University, said in a press release. “All kidding aside, many of my patients who suffer with urinary incontinence can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence.”

Attain offers a guided exercise program to help solve incontinence. The muscle stimulation occurs at alternating specific frequencies to increase pelvic floor muscle strength and calm the detrusor muscle. The stimulation provides a full, deep muscle contraction, providing neuromuscular re-training.

“Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers.”

The device features a lighted biofeedback graph and visual cues to help guide a user through timed, volitional contractions along with a relation phase. It also offers a customizable probe that inflates to be a unique fit to give stimulation in full contact with vaginal or rectal walls, ensuring deep muscle contraction. The probe also offers active resistance for a full muscle contraction to reposition musculature in a resting position between contractions, according to the company.

“Our medical devices are highly successful in treating stress, urge and mixed urinary incontinence in women,” Herschel Peddicord, founder of InControl Medical, said. “Now after clinical testing, this new revolutionary device is cleared to treat bowel leakage as well. Our goal is to eliminate incontinence as a life factor for many women as possible.”