Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children

Nocturnal Enuresis Clinical Trial

Official title:

Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900495
• Other study ID #: HS16-0389
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria will be offered therapy with a TENS unit. Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000 Analog) and electrode pads and caretakers instructed on how to use the apparatus. The TENS sessions will be performed nightly before bed for 15 minutes. TENS units will be set at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the patient. 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 Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up on these parameters again after another month (one month off of TENS therapy) to assess the durability of treatment effect. The data will be collected at different time points (baseline, 1 month, 2 months) for each group by itself and the groups compared against each other using statistical analysis.

Description:

Institutional review board was obtained. Children ages 5-18 years old referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Behavioral therapy (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 or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study. Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders, 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), secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae), and any contraindications to usage of a TENS unit such as having a pacemaker will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from the study. 128 patients will be chosen for enrollment into the study. The patients will be randomized into four groups of 32 patients each. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed onto the bottom of the feet. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the sham arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. Detailed explanation of the purpose of 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 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 15 minutes for 30 days. TENS units will be set at a frequency of 10 Hz, and intensity determined in the office by the sensitivity threshold of the patient. Voiding diaries will be kept each night while on TENS therapy, additionally recording which TENS setting was used, duration of therapy each night, and any adverse reactions to the TENS unit or increased symptoms (these patients will be terminated from the study and included as a treatment failure). Diaries will then be kept for 30 days after TENS therapy was completed to assess durability of treatment effects. At voiding diary day 30 (before first TENS treatment), day 60 (after completion of TENS therapy), and day 90 (one month off of TENS), patients and families will fill out the Pediatric Urinary Incontinence Questionnaire (PIN-Q), a validated tool for measuring quality of life in children with bladder dysfunction. Patients will follow up at days 0, 30, 60, 90, and as needed (worsening symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Parents will be called on a weekly basis throughout the study to ensure compliance and address any questions or concerns. The results of mean nightly incontinence episodes, mean "wet sheets" scale score (0-3), and PIN-Q will be measured between time points (baseline, 1 month, 2 months for each group by itself and the groups compared against each other using statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• primary nocturnal enuresis
• wet nights occur more than once per week on average
• Failed Behavioral therapy treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
• ability to provide informed consent and complete study requirements

Exclusion Criteria:

• the use of medications for nocturnal enuresis (DDAVP, imipramine, anticholinergics) less than 30 days from time of appointment
• daytime incontinence
• Known "high volume" voiders
• medications predisposing to incontinence (eg, Lithium for bipolar disorder)
• other known voiding or neurologic disorders (eg, overactive bladder, spina bifida, interstitial cystitis)
• secondary etiologies for nocturnal enuresis (cystitis, obstructive sleep apnea, urinary fistula)
• any contraindication to TENS unit usage (pacemaker or other implantable devices, lymphedema, pregnancy, malignancy)
• Any history of heart disease or complications

Related Conditions & MeSH terms

• Bedwetting
• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Device:
• transcutaneous electric nerve stimulation
electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Pediatric Urology Associates	Brooklyn	New York
United States	Cohen Children's Medical Center of NY	New Hyde Park	New York
United States	Pediatric Urology Associates	New Hyde Park	New York
United States	Pediatric Urology Associates	Tarrytown	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	Albany Medical College, Feinstein Institute for Medical Research

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barroso U Jr, Lordêlo P, Lopes AA, Andrade J, Macedo A Jr, Ortiz V. Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and transcutaneous electrical stimulation: a pilot study. BJU Int. 2006 Jul;98(1):166-71. — View Citation

Kajbafzadeh AM, Sharifi-Rad L, Mozafarpour S, Ladi-Seyedian SS. Efficacy of transcutaneous interferential electrical stimulation in treatment of children with primary nocturnal enuresis: a randomized clinical trial. Pediatr Nephrol. 2015 Jul;30(7):1139-45 — View Citation

Lordêlo P, Benevides I, Kerner EG, Teles A, Lordêlo M, Barroso U Jr. Treatment of non-monosymptomatic nocturnal enuresis by transcutaneous parasacral electrical nerve stimulation. J Pediatr Urol. 2010 Oct;6(5):486-9. doi: 10.1016/j.jpurol.2009.11.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wet nights	Total number of change in wet nights compared in each TENS arm to control and baseline wet nights	60 days
Secondary	Severity	compare monthly mean "wet scale" score of each TENS arm to control and baseline score	60 days
Secondary	Patient compliance	assess patient tolerance to TENS therapy and ability to perform TENS therapy at home (correct session time, settings, and consistency of use)	60 days
Secondary	Quality of Life Scores	compare PIN-Q scores at initial visit, after baseline month, after one month of using TENS	60 days
Secondary	Adverse reactions	record any adverse reactions to TENS therapy	60 days
Secondary	Durability	compare patient response, monthly number of wet nights, "wet scale" score (severity), and PIN-Q score (quality of life) of each TENS arm one month after stopping TENS and compare to baseline data and immediately after one month of TENS therapy	90 days

External Links

•   Cohen Children's Medical Center
•   Pediatric Urology Associates, P.C.