Clinical Trials Update
Female Urinary Incontinence
InTone: A Revolutionary Device for Home Pelvic Floor Electrical Stimulation and Biofeedback for Urinary Incontinence
The purpose of this study is to assess whether or not InTone improves urinary incontinence in women. Other objectives are to determine improvement in pelvic floor muscle strength (as measured by InTone device), to determine any improvement in sexual function based on a sexual function questionnaire, and to determine usability and tolerability of the InTone device. A somewhat similar device has been studied by others and found to offer benefit in women with stress urinary incontinence or mixed urinary incontinence. However, in that study, the device was used to provide biofeedback or electrical stimulation, combined with pelvic floor muscle training, but not all three therapies together. In the study being conducted at Froedtert & The Medical College of Wisconsin, InTone is used to provide biofeedback and electrical stimulation with pelvic floor muscle exercises in patients with stress, urge or mixed urinary incontinence.
A new device for the conservative management of urinary incontinence has been developed that combines pelvic floor muscle training, biofeedback and electrical stimulation. InTone is a nonimplanted cylindrical device that is inserted into the vagina. Its diameter is adjustable to the size of the vaginal opening. It uses surface electrodes to provide pelvic floor muscle electrical stimulation, as well as sensors that detect pelvic floor muscle contraction force, and provides visual biofeedback to the patient regarding pelvic muscle contraction/relaxation. It also provides verbal cues to the patient regarding the timing of each pelvic muscle contraction, thereby taking patients through a full pelvic floor muscle training session. It is able to record and store data regarding usage and strength parameters, providing a mechanism to track progress. The trial will enroll 30 to 50 women. All participants will receive an InTone device, which they may keep after participation in the study is completed.
This study is sponsored by InControl Medical.