RecruitingNot ApplicableNCT06135311

Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children

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


Sponsor

Albany Medical College

Enrollment

70 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Pulse Width 260us and a medical device called Pulse Width 50us for people with bedwetting and nocturnal enuresis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 5 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulse Width 260us

electrodes 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

DEVICEPulse Width 50us

electrodes 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


Locations(1)

Albany Medical College

Albany, New York, United States

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NCT06135311


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