Portable Biofeedback for Bladder Control Dr. Pramod Reddy

for the treatment of stress and/or urge urinary incontinence when provided in the outpatient setting

Problem Statement Toilet training and achieving bladder control by young children is a globally expected societal & cultural norm. However upto 10% of children entering school still have bladder control issues and upto 1% of 18 yr olds still have bladder control issues. This can also result in infections The lack of bladder control – results in peer-pressure ridicule, parental and child stress and costs associated with medical care and cleansing of the clothes affected by urinary incontinence. The psycho-social stress impact on the child is significant Cost to society and healthcare systems are not insignificant

Urinary Retention: A condition where the bladder overfills without causing the sensation of the need to urinate. Obstructive urinary retention is a condition due to an obstruction of the ureter, which may possibly be caused by kidney stones, fibroid tumors, or bladder neck obstruction from prostate hypertrophy. Non-obstructive urinary retention is caused by a lack of coordination between the bladder and detrusor sphincter mechanisms or a weak or non-existent bladder contraction. Urodynamic Testing: A test or procedure that evaluates the effectiveness of the bladder, sphincters, and/or urethra at storing and releasing urine. Detrusor (bladder wall muscle) over-activity may predict decreased response to biofeedback. Currently, there are no other known clinically or urodynamically important predictors or mediators of biofeedback-assisted pelvic muscle training response.

Problem Statement (2) The issue of an overactive bladder and/or overactive sphincter is found in all age groups and both genders. This device would also help individuals who have developed an overactive bladder to learn how to better control their bladders and sphincter muscle and prevent urinary accidents and infections. The application and audience is huge and the impact is significant – main target population is children and adult women

Job Current practice – is to seek medical care – with multiple trips to the doctors office (cost of care + absences from school for the child and work for the parents + lost time from work is significant) and sometimes the use of medications that have side effects There is cumbersome office based equipment- that allows for biofeedback to allow the child to learn to control the muscles Since most families now have a smart phone – the goal would be to create a system that is a mobile platform/home based that has a muscle electrical activity sensor for bladder and sphincter to allow the child to learn proper control

Need Statement A none invasive, home us, toilet training device providing effective biofeedback for bladder control* and enable to improving urination control by pediatric *Bladder control=provides effective treatment for different lower urinary tract dysfunctions such as urinary incontinence (stress, urge, mixed), fecal incontinence, constipation, urinary retention and voiding dysfunctions

Main requirements The system would use biofeedback device on the child to assess relaxation of the sphincter and also another element to assess urinary flow rate. Any element that comes into contact with the patient must not cause irritation , discomfort or aversion. The device would be developed to let the child know when it is properly relaxing their urethral sphincter. An additional benefit would be if the device could detect bladder volume  The device could alert the child know when they have to go to the bathroom and will ensure that the child is relaxing the appropriate muscles to allow for safe emptying of the bladder. The measurement of the flow rate will allow for the child to see how well they are emptying their bladder – positive feedback This therapy could be taught in the office and then practiced by the child at home

Outcomes Feedback to the user/patient that the bladder needs to be emptied and also how well they are actually emptying Feedback to the user/patient that they are/are not properly relaxing their sphincter muscles and allowing for proper bladder dynamics during emptying of the bladder Providing real-time feedback to the user

Constraints Easy to use and set up Uses the abilities of existing smartphone platforms Paired to consumer technology already available Disposable and non interfering with daily activities. Inconspicuous Varying sizes to enable use by all ages Should be adaptable with all major smartphone operating systems

Summary The availability of a portable platform for bladder and sphincter activity feedback would be a huge benefit for a significant portion of the population that suffers from overactive bladder or the lack of coordination between the bladder and the sphincter muscle. Unlike currently available medications – there are no side effects with biofeedback therapy – that is purpose of the device being proposed Existing feedback equipment is cumbersome, expensive and not readily available and needs supervised care The devise being proposed has the ability to change the management and market for the care of these conditions