BERKELEY, CA (UroToday.com) - Biofeedback (BF) and electrical stimulation (ES) are used as adjunctive measures to pelvic floor muscle exercises (PFME) for the management of urinary incontinence. The sessions typically require multiple visits to a therapist’s office. InTone™ (InControl Medical LLC, Brookfield, WI) is a class II non-implanted electrical device that utilizes pelvic floor musculature ES and BF to improve urinary continence. The stimulation probe is cylindrical with an ergonomically designed tip which is inserted into the vagina. Electrodes on the dorsal and ventral sides of the device are in direct contact with the vaginal epithelium and stimulate the pelvic floor muscles. An attached control unit provides visual BF as well as verbal cues to the patient. A typical daily Intone session is 12 minutes in duration - 7 minutes of biofeedback-assisted pelvic muscle contractions and 5 minutes of ES.
We conducted a pilot study to assess the efficacy and usability of InTone™ for the treatment of urinary incontinence. Inclusion criteria comprised women with urinary incontinence (stress, urge, mixed), a minimum of one incontinent episode per day documented on bladder diary, and >10g of leakage on 24-hour pad weight testing. All patients completed standardized symptom questionnaires (Urogenital Distress Inventory, UDI6: Incontinence Impact Questionnaire, IIQ7), 48-hour bladder diaries and 24-hour pad weight tests prior to study entry and monthly for 3 months. Objective and subjective improvements were assessed after 12 weeks of device usage. Ease of InTone™ usability was also evaluated with a device usage log and the System Usability Scale (SUS).
Our patient population was predominantly middle-aged with MUI and had previously performed PFME (80%). Eighteen percent of patients had previously undergone suburethral sling.
We noted significant improvements in UDI6, IIQ7, pad weights, pad usage, and daily incontinent episodes for the entire group with 68% of patients achieving a > 50% reduction in daily pad usage and pad weights. Predominantly SUI patients had significant improvements in all measured variables whereas predominantly UUI patients noted reductions in only pad use and incontinent episodes. However, the number of predominantly UUI patients was small and the study was not powered to detect a difference between the two groups. Device usability was good based on SUS score and percent of expected use.
Our results provide preliminary data supporting the use of InTone™ in the conservative management of female urinary incontinence. However, the study is limited by the lack of a control group doing PFME alone. While most of the women in the trial had done or were currently doing PFME, a randomized trial comparing InTone™ to a supervised regimen of PFME alone is needed to determine superiority of InTone™ over PFME alone. Furthermore, we did not use urodynamic testing (UDS) to stratify patients based on the type of incontinence. Pre-treatment urodynamic testing might have provided for a greater degree of insight into the possible differences in outcomes between patients and should be considered for future studies.
- Burke J (2013) SUS: A Retrospective. Journal of Usability Studies 8:29-40
Michael L. Guralnick, MD, FRCSC and R. Corey O’Connor, MD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
Department of Urology, Medical College of Wisconsin, Milwaukee, WI USA