Institutional review board approval was obtained. Children ages 5-17 years old referred
to the pediatric urology clinic at Albany Medical Center Department of Urology for
primary nocturnal enuresis will be screened for enrollment. If a 17 year old turns 18
during study participation, the subject will be consented as an adult using the Informed
Consent Form and parental permission is no longer needed. Behavioral modification
(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 as standard therapy or participation in a research study using a
TENS unit. Patients who have previously tried pharmacologic treatment for nocturnal
enuresis or alternative therapy for urologic disorders within the pasty 30 days, daytime
incontinence symptoms, known "high volume" voiders (determined from history), bedwetting
episodes on the average of less than one time 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), prior use of a TENS
unit or other neuromodulation for bedwetting, and any contraindications to usage of a
TENS unit (other electrical devices such as a pacemaker, pregnancy, bleeding or clotting
disorders, unhealthy tissue, seizure disorders, malignancy, impaired cognition)will be
excluded. Patients who have previously tried the bedwetting alarm will not be excluded
from the study.
The patients will be randomized into two groups of 35 patients each. Group 1 will be the
high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. There is
no sham group in this study as we have previously found posterior tibial TENS to be
effective and lasting, and as such all patients will be "treated" to be best of our
knowing. We will aim to recruit 35 patients per group for a total of 70 patients.
Detailed explanation of the purpose if 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/patients 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 30 minutes for 30 days. TENS units will
be set at a pulse width determined by randomization, frequency of 10Hz, and intensity
determined in the office by the sensitivity threshold of the patient. Voiding diaries
will be kept each night while on TENS therapy. A voiding diary will also be completed 30
days before TENS treatment, patients and families will fill out the Bowel & Bladder
Questionnaire (BBQ), a validated tool for measuring symptoms in children with bladder
dysfunction. Patients will follow up at day 30 and as needed (worsening symptoms, adverse
reactions, concerns, and questions regarding usage of TENS). Patients who record 2 wet
nights per week (a total of 8/30=27% wet nights) will be eligible for the TENS study.
Those who record less than 2 wet nights per week will be ineligible for the TENS study
but will be offered therapy using a bedwetting alarm device or other treatment.