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

Sponsor

Albany Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135311

Collaborator

(none)

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Enuresis Bedwetting	Device: Pulse Width 260us Device: Pulse Width 50us	N/A

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 will be screened for enrollment. If a 17 year old turns 18 during study participation, the subject will be consented as an adult using the Informed Consent Form and parental permission is no longer needed. Behavioral modification (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors) will be utilized first. Patients who fail will next be offered therapy with a bedwetting alarm device as standard therapy or participation in a research study using a TENS unit. Patients who have previously tried pharmacologic treatment for nocturnal enuresis or alternative therapy for urologic disorders within the pasty 30 days, daytime incontinence symptoms, known "high volume" voiders (determined from history), bedwetting episodes on the average of less than one time per week, medications predisposing to incontinence (eg, Lithium for bipolar disorder), other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele), secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae), prior use of a TENS unit or other neuromodulation for bedwetting, and any contraindications to usage of a TENS unit (other electrical devices such as a pacemaker, pregnancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, malignancy, impaired cognition)will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from 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. There is no sham group in this study as we have previously found posterior tibial TENS to be effective and lasting, and as such all patients will be "treated" to be best of our knowing. We will aim to recruit 35 patients per group for a total of 70 patients.

Detailed explanation of the purpose if the study, along with the risks and benefits of TENS will be given to the patient and caretakers by a provider prior to obtaining informed consent for enrollment into the study. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus.

Parents/patients of enrolled patients will fill out nightly voiding diaries, recording nighttime incontinence episodes and subjective "wet sheets" scale per night (dry, damp, wet, soaked) for 30 days prior to randomization into the treatment arms. The TENS sessions will be performed nightly at bedtime for 30 minutes for 30 days. TENS units will be set at a pulse width determined by randomization, frequency of 10Hz, and intensity determined in the office by the sensitivity threshold of the patient. Voiding diaries will be kept each night while on TENS therapy. A voiding diary will also be completed 30 days before TENS treatment, patients and families will fill out the Bowel & Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with bladder dysfunction. Patients will follow up at day 30 and as needed (worsening symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Patients who record 2 wet nights per week (a total of 8/30=27% wet nights) will be eligible for the TENS study. Those who record less than 2 wet nights per week will be ineligible for the TENS study but will be offered therapy using a bedwetting alarm device or other treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 24, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Device: 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 Other Names: TENS
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	Device: 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 Other Names: TENS

Arm

Intervention/Treatment

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

Device: 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

Other Names:

TENS

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

Device: 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

Other Names:

TENS

Outcome Measures

Primary Outcome Measures

Percentage of wet nights [30 days]
Percent of wet nights per month compared in each TENS arm and baseline wet nights

Secondary Outcome Measures

Severity of Wet nights [30 days]
Mean score (0 dry to 3 soaked) of subjective severity of wetness each night during treatment month compared to baseline month
Bowel and Bladder questionnaire (BBQ) [30 days]
Score of 0-36 based on subjective voiding and stooling questionnaire (higher scores indicate worse outcomes)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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