Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.

Overactive bladder (OAB) is the most common voiding dysfunction in children1. While many children may outgrow these issues, for some these symptoms persists and can lead to emotional, social, behavioral and physical problems. Multiple treatments exist for OAB but rarely is there guaranteed success. Many behavioral and lifestyle treatments involve a significant time investment and office visits on the part of the patient and family. Furthermore, medication therapy is often associated with bothersome side effects and is discontinued, even despite efficacy2. As such, treatments with potentially less adverse effects, often used in adult urology, are making their way into the pediatric urology practice. These include intravesical botulinum toxin injections, sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS).

PTNS, first cleared by the United States Food and Drug Administration (FDA) in 2011 for adult use, has evolved into transcutaneous nerve stimulation in the pediatric population; obviating the need for needles during treatment. Studies suggest mixed efficacy in electric nerve stimulation for overactive bladder in the pediatric population, owing largely to the marked heterogeneity in treatment protocols. While some researchers follow the traditional tibial nerve pathway, others take a cue from SNS and target the parasacral area, while still others rely on signaling from even further peripheral nerves to modulate bladder overactivity 3-5. Perhaps further contributing to the disparate data is the varying treatment schedules used. Some centers perform treatments daily, others weekly, others twice or thrice a week. Similarly, some physicians recommend twenty-minute treatments, while others thirty or even sixty minutes. The majority of studies rely on an office-based treatment model, while a few have explored in home treatments 3-5. In the United States, there has been no study examining the feasibility or efficacy of home parasacral transcutaneous electric nerve stimulation (PTENS) on pediatric voiding dysfunction.

Inclusion Criteria:

• Toilet trained (age 6) to age 17
• Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency incontinence, nocturnal enuresis. (These patients may also have an element of bowel dysfunction; however, we will not include a patient who had ONLY bowel dysfunction and NOT a voiding dysfunction).

Exclusion Criteria:

• Known neurologic diagnosis - such as myelomeningocele, caudal regression
• Known seizure disorder
• Age < 6 or > 17
• Lack of follow-up within 6 months of treatment
• Pacemaker, vagal nerve stimulator, or other implanted electrical device
• Intolerance of electrical nerve stimulation
• Pregnancy
• Implanted metal hardware
• Open sores or wounds over the sacral area
• Currently catheterizing for bladder drainage
• Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic)
• Bowel only voiding dysfunction (Constipation ICD-10 K59.00)
• Non-English speaking families
• Families with health literacy precluding completion of questionnaires and voiding diaries
• Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic treatments
• Untreated urinary tract infection

Individual participant data will be stored on password protected computers in the facility and collected data will be entered in a REDCap database. Individual participant data will not be shared with any individuals other than the study personnel as only these individuals will have access to the data.

patients will be randomized to standard urotherapy or urotherapy + PTENS