Women's Incontinence and Sexual Health Program
Trial Studies Female Incontinence Device
Froedtert & The Medical College of Wisconsin have begun a clinical study of InTone, a new medical device that treats female urinary incontinence. The 12-week study will evaluate the effectiveness of InTone in women with stress incontinence, urge incontinence, or mixed (stress AND urge) incontinence.
Stress incontinence is unwanted bladder leakage that can occur after coughing, sneezing, laughing, or exercise. Urge incontinence is a strong, sudden need to urinate due to bladder spasms.
More information on InTone can be found at www.incontrolmedical.com
To enroll in the clinical trial with Froedtert & The Medical College of Wisconsin, please call (414) 805-0805 and select option 6.
Women who qualify for the study will receive an InTone device and instructions on how to properly use it at home. Study subjects will be evaluated at intervals during the 12-week study period for progress, physical changes and safety factors. Subjects will complete incontinence questionnaires at regular intervals and complete a “bladder diary.”
InTone is an inserted device that combines muscle stimulation, exercises and guided biofeedback to strengthen the muscles in the pelvic floor. Each daily session takes about 10 minutes and is done in the privacy of the patient’s own home. Data from each session is recorded, and after two weeks, the physician analyzes the recorded data and adjusts InTone based on the patient’s progress. At-home treatment sessions continue, with additional checkups to evaluate progress. It is anticipated that patients will experience progress in a few weeks, and may experience effective relief in about 90 days.
According to Michael Guralnick, MD, Medical College of Wisconsin urologist and principal investigator for the study, data from daily InTone sessions will be collected and analyzed by the study investigators. “This is just as a physician who prescribes InTone would do,” Dr. Guralnick said. “In an efficacy study, we aim to determine whether the treatment delivers its intended result – and to what degree it does so. In other words, does it effectively treat urinary incontinence.” Secondarily, the study will measure improvement in pelvic floor muscle tone, improvement in sexual function based on a questionnaire, and finally, the usability and tolerability of the InTone device.
“We want women to know that ‘leaking’ isn’t normal, it could get worse, and it can be effectively treated,” said Herschel “Buzz” Peddicord, president and CEO of InControl Medical, LLC, and inventor of InTone. “We encourage women to talk to their doctors about it – and we encourage doctors to ask their patient.”
In pre-market testing, 85 percent of test subjects who used InTone reported that their incontinence symptoms disappeared. “Obviously we are excited about that,” Peddicord said. “We believe InTone can be the new standard of care for the treatment of female urinary incontinence, or unwanted bladder leakage.”
InTone is now available by prescription to patients in the United States. It was developed by InControl Medical, LLC; based in Brookfield, Wis. InControl Medical, LLC provides specialty medical products for women’s health, and InTone is sourced and manufactured entirely in the United States.
Last Review Date: Feb. 7, 2013