Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population
Condition: Overactive Bladder; Voiding Disorders; Incontinence, Urinary
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence; Enuresis
Study type: Interventional

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

Detailed description: 
      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.
    

Intervention name(s): parasacral transcutaneous electrical nerve stimulation (PTENS); Standard Urotherapy
Intervention type(s): Device; Other
Intervention description(s): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.; standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment