Recruiting

Transcutaneous Electrical Nerve Stimulation

Sponsor:

Albany Medical College

Code:

NCT06135311

Conditions

Nocturnal Enuresis

Bedwetting

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Pulse Width 260us

Pulse Width 50us

Study Details

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 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

Nocturnal Enuresis

Bedwetting

Study ID

NCT06135311

Start date

Oct 24, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulse 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

experimental: Pulse 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

Interventions

Pulse 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

Pulse 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

Primary outcome measure

  • Percentage of wet nights [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Brenda Romeo, CCRC

518-262-3349romeob@amc.edu

Locations

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Contacts

Laura Davey, CCRC

518-262-8579amcurologyresearch@amc.edu

Principal Investigator:

Adam Howe, MD

More Information

Sponsor

Albany Medical College

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

  • Noctural Eneuresis
  • Bedwetting
  • TENS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2025-10-02.