Actively Recruiting
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
Led by Albany Medical College · Updated on 2025-10-02
70
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 17 years old
- Experiencing bedwetting more than once a week
- Have not improved after at least 30 days of behavioral modification treatments
- Able to provide informed consent and complete study activities
You will not qualify if you...
- Used medications or other treatments for bedwetting or urinary issues within the past 30 days
- Having daytime incontinence symptoms
- Known to have high urine volume voiding
- Bedwetting occurs less than twice a week on average
- Taking medications that cause incontinence (e.g., Lithium)
- Diagnosed with other voiding or neurological disorders (e.g., overactive bladder, myelomeningocele, interstitial cystitis)
- Bedwetting caused by other medical conditions (e.g., cystitis, sleep apnea, urinary fistulae, heart disease)
- Contraindications to TENS use (e.g., pacemaker, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
- History of heart disease or related complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
Research Team
B
Brenda Romeo, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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