Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorAlbany Medical College
About this trial
Children referred to pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. 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.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. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus. The child's TENS unit will be set at a pulse width determined by randomization, frequency of 10Hz, and an intensity to be determined in the office based upon when the child feels sensitive to the TENS unit. The child will be randomized and will place the electrodes along the posterior tibial nerve on the medial ankle each night before bed time for 30 minutes for a total of 30 days. 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 Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with voiding dysfunction \[6\]; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment. The data will be collected at different time points (baseline and after 1 month of treatment) for each group by itself and the groups compared against each other using statistical analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presenting with nocturnal enuresis (more than 1x a week)
Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors) during the 30 day period prior to randomization
Ability to provide informed consent and assent and complete study requirements
Disqualifiers
Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
Daytime incontinence symptoms
Known "high volume" voiders (determined from history)
Bedwetting episodes on the average of less than two times per week,
Trial design
Design model
Parallel
Treatments tested in this trial
Pulse Width 260us
Deviceelectrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 260us, intensity setting to patient's tolerance, duration 30 days
Pulse Width 50us
Deviceelectrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 50us, intensity setting to patient's tolerance, duration 30 days
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Pulse Width 260usExperimental treatment 1 intervention
Group B: Pulse Width 50usExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of wet nights
Percent of wet nights per month compared in each TENS arm and baseline wet nights
Time frame
30 daysSecondary outcomes
1
Severity of Wet nights
Mean score (0 dry to 3 soaked) of subjective severity of wetness each night during treatment month compared to baseline month
Time frame
30 days2
Bowel and Bladder questionnaire (BBQ)
Score of 0-36 based on subjective voiding and stooling questionnaire (higher scores indicate worse outcomes)
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov