Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children
Condition: Nocturnal Enuresis; Bedwetting
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

Summary: 
      Children referred to the pediatric urology clinic for primary nocturnal enuresis will be
      screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria
      will be offered therapy with a TENS unit.

      Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation
      arm with electrodes placed onto the abdomen in the suprapubic region directly over the
      bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior
      tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3
      cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the
      control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per
      group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000
      Analog) and electrode pads and caretakers instructed on how to use the apparatus.

      The TENS sessions will be performed nightly before bed for 15 minutes. TENS units will be set
      at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the
      patient. Diaries including nighttime incontinence episodes and a "wet sheet" scale (dry,
      damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit.
      Patients will be followed up after one month of TENS with evaluation including the Pediatric
      Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in
      children with bladder dysfunction; this questionnaire will be filled out prior to starting
      TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up
      on these parameters again after another month (one month off of TENS therapy) to assess the
      durability of treatment effect. The data will be collected at different time points
      (baseline, 1 month, 2 months) for each group by itself and the groups compared against each
      other using statistical analysis.
    

Detailed description: 
      Institutional review board was obtained. Children ages 5-18 years old referred to the
      pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment.
      Behavioral therapy (limiting evening drinking, double voiding prior to bedtime, bowel habits,
      social anxiety factors) will be utilized first. Patients who fail will next be offered
      therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose
      TENS therapy will be included in the study. Patients who have previously tried pharmacologic
      treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic
      disorders, daytime incontinence symptoms, known "high volume" voiders (determined from
      history), bedwetting episodes on the average of less than two times per week, medications
      predisposing to incontinence (eg, Lithium for bipolar disorder), other known voiding or
      neurologic disorders (eg, overactive bladder, myelomeningocele), secondary etiologies for
      nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae), and any
      contraindications to usage of a TENS unit such as having a pacemaker will be excluded.
      Patients who have previously tried the bedwetting alarm will not be excluded from the study.
      128 patients will be chosen for enrollment into the study.

      The patients will be randomized into four groups of 32 patients each. Group 1 will be the
      direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic
      region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes
      placed onto the bottom of the feet. Group 3 will be the proximal neural loop arm with
      electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of
      S3. Group 4 will be the sham arm with electrodes placed on the scapula. We will aim to
      recruit 32 patients per group for a total of 128 patients. Detailed explanation of the
      purpose of the study, along with the risks and benefits of TENS will be given to the patient
      and caretakers by a provider prior to obtaining informed consent for enrollment into the
      study. The patients will be provided with a TENS unit and electrode pads and caretakers
      instructed on how to use the apparatus.

      Parents of enrolled patients will fill out nightly voiding diaries, recording nighttime
      incontinence episodes and subjective "wet sheets" scale per night (dry, damp, wet, soaked)
      for 30 days prior to randomization into the treatment arms. The TENS sessions will be
      performed nightly at bedtime for 15 minutes for 30 days. TENS units will be set at a
      frequency of 10 Hz, and intensity determined in the office by the sensitivity threshold of
      the patient. Voiding diaries will be kept each night while on TENS therapy, additionally
      recording which TENS setting was used, duration of therapy each night, and any adverse
      reactions to the TENS unit or increased symptoms (these patients will be terminated from the
      study and included as a treatment failure). Diaries will then be kept for 30 days after TENS
      therapy was completed to assess durability of treatment effects. At voiding diary day 30
      (before first TENS treatment), day 60 (after completion of TENS therapy), and day 90 (one
      month off of TENS), patients and families will fill out the Pediatric Urinary Incontinence
      Questionnaire (PIN-Q), a validated tool for measuring quality of life in children with
      bladder dysfunction. Patients will follow up at days 0, 30, 60, 90, and as needed (worsening
      symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Parents will
      be called on a weekly basis throughout the study to ensure compliance and address any
      questions or concerns. The results of mean nightly incontinence episodes, mean "wet sheets"
      scale score (0-3), and PIN-Q will be measured between time points (baseline, 1 month, 2
      months for each group by itself and the groups compared against each other using statistical
      analysis.
    

Intervention name(s): transcutaneous electric nerve stimulation
Intervention type(s): Device
Intervention description(s): electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days
Other intervention name(s): TENS unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nocturnal Enuresis; Bedwetting; TENS