CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
pulse rate of 2 Hz +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04313192
NCT04313192N/ACompleted

Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children

Albany Medical College·interventional·Posted Mar 18, 2020·Updated Apr 15, 2026

In Brief

A clinical study evaluating pulse rate of 2 Hz, pulse rate of 10 Hz, and 1 other intervention for Nocturnal Enuresis and Bed Wetting. Completed, enrolled 125 participants across 1 site.

Detailed Summary

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 three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz (hertz). Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. 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 frequency determined by randomization, pulse width of 260 seconds, 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 15 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 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 18, 2020
Enrollment StartJan 20, 2020
Primary CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 6.3 years ago

Interventions

pulse rate of 2 Hzdevice

electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days

pulse rate of 10 Hzdevice

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

pulse rate of 150 Hzdevice

electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days