Status:
RECRUITING
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
Lead Sponsor:
Albany Medical College
Conditions:
Nocturnal Enuresis
Bedwetting
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief 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 un...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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,
- Medications predisposing to incontinence (eg, Lithium for bipolar disorder)
- Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
- Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease)
- 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)
- Any history of heart disease or complications
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06135311
Start Date
October 24 2023
End Date
December 31 2026
Last Update
October 2 2025
Active Locations (1)
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1
Albany Medical College
Albany, New York, United States, 12208