InControl Medical secures FDA clearance for InToneMV

28 May 2014 (Last Updated May 28th, 2014 18:30)

US-based InControl Medical has received clearance from the US Food and Drug Administration (FDA) for InToneMV, which provides non-surgical treatment of male urinary and fecal incontinence.

US-based InControl Medical has received clearance from the US Food and Drug Administration (FDA) for InToneMV, which provides non-surgical treatment of male urinary and fecal incontinence.

InToneMV is a non-invasive treatment option and comprehensive pelvic floor rehabilitation programme for men with bowel and urine leakage.

The device is designed to address the complexities of the pelvic floor, strengthen weakened musculature and improve sphincter closure.

Southern California Center for Sexual Health and Survivorship Medicine executive director Michael Krychman said due to the complex nature of the pelvic floor and bowel leakage, most interventions are invasive and require surgical procedures.

"Strengthening of the pelvic floor muscles will decrease bladder leakage and avoid embarrassment. It also impacts sexual function by increasing desire and performance and restores quality of life."

"Embarrassment and a lack of desirable treatment options can hinder a man's lifestyle by avoiding recreational and social activities and decreasing sexual desire and performance for fear of accidental bowel or urinary leakage," Krychman said.

"Difficulty with bladder control is primarily related to weakness of the pelvic floor muscle and spasms of the bladder muscle, allowing urine loss to occur with increased intra-abdominal pressure (coughing, laughing, sneezing or exercising.)

"Strengthening of the pelvic floor muscles will decrease bladder leakage and avoid embarrassment. It also impacts sexual function by increasing desire and performance and restores quality of life."

The company said that a customisable probe with muscle stimulation effectively strengthens the muscles of the pelvic floor and provides voice-guided volitional exercise and visual biofeedback to reinforce proper completion of exercises.

Data secured from each home-based session is recorded, allowing the health care provider to guide progress during monthly follow up visits.

InControl Medical founder and CEO Herschel Peddicord said the company's original InTone device that was FDA-listed as a Class II medical device for treatment of female urinary incontinence, helped so many, that the company had to design InToneMV, which is a much smaller treatment solution to help both men and women with atrophy.

"It's terribly embarrassing for both men and women to have to live with fecal and urinary incontinence and even worse to have to resort to diapers, pads, meds or a surgical implant. InToneMV works," Peddicord said. "Men no longer need to suffer with fecal or urinary incontinence."

The company is responsible for developing and marketing solutions for women's urinary incontinence including InTone and Apex, and has received ISO 13485 certification from the International Organization for Standardization (ISO) and the CE Mark of the European Commission (EC).