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

Launched by ALBANY MEDICAL COLLEGE · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a TENS unit, which is a device that sends electrical pulses to help manage bedwetting (nocturnal enuresis) in children. The trial will include children who wet the bed more than once a week and have not had success with other behavior changes, like limiting drinks before bedtime. Participants will be divided into two groups to test different settings on the TENS unit: one group will use a higher pulse width, and the other will use a lower one. Over the course of 30 days, children will use the device for 30 minutes each night and keep track of their bedwetting episodes.

To be eligible for this trial, children must be between 6 and 12 years old and have experienced bedwetting despite trying other methods. Certain conditions, like daytime incontinence or previous treatments for bedwetting, will exclude them from participation. Throughout the study, families will be guided on how to use the TENS unit, and the children’s progress will be monitored through diaries and questionnaires. After a month, the results will be analyzed to see how effective the different settings are in reducing bedwetting episodes. This trial aims to find the best way to help children overcome this common issue, providing hope for families dealing with bedwetting challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Presenting with nocturnal enuresis (more than 1x a week)
• • 2. 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
• • 3. Ability to provide informed consent and assent and complete study requirements
• Exclusion Criteria:
• • 1. Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
• • 2. Daytime incontinence symptoms
• • 3. Known "high volume" voiders (determined from history)
• • 4. Bedwetting episodes on the average of less than two times per week,
• • 5. Medications predisposing to incontinence (eg, Lithium for bipolar disorder)
• • 6. Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
• • 7. Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease)
• • 8. Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
• • 9. Any history of heart disease or complications