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

NCT06135311 | Recruiting FDA Device

• 1 other identifier: 6429
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Noctural Eneuresis; Bedwetting; TENS

Outcome Measures

Primary Outcomes (1)

• Percentage of wet nights

  Percent of wet nights per month compared in each TENS arm and baseline wet nights

  30 days

Secondary Outcomes (2)

• Severity of Wet nights

  30 days

• Bowel and Bladder questionnaire (BBQ)

  30 days

Study Arms (2)

Pulse Width 260us

EXPERIMENTAL

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

Pulse Width 50us

EXPERIMENTAL

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

Interventions

Pulse Width 260us DEVICE

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

Also known as: TENS

Pulse Width 260us

Pulse Width 50us DEVICE

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

Also known as: TENS

Pulse Width 50us

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

Related Publications (18)

• Alcantara AC, Mello MJ, Costa e Silva EJ, Silva BB, Ribeiro Neto JP. Transcutaneous electrical neural stimulation for the treatment of urinary urgency or urge-incontinence in children and adolescents: a Phase II clinica. J Bras Nefrol. 2015 Jul-Sep;37(3):422-6. doi: 10.5935/0101-2800.20150065. English, Portuguese.

  PMID: 26398655 BACKGROUND

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  PMID: 16831163 BACKGROUND

• Barroso U Jr, Viterbo W, Bittencourt J, Farias T, Lordelo P. Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children. J Urol. 2013 Aug;190(2):673-7. doi: 10.1016/j.juro.2013.02.034. Epub 2013 Feb 16.

  PMID: 23422257 BACKGROUND

• Bjorkstrom G, Hellstrom AL, Andersson S. Electro-acupuncture in the treatment of children with monosymptomatic nocturnal enuresis. Scand J Urol Nephrol. 2000 Feb;34(1):21-6. doi: 10.1080/003655900750016832.

  PMID: 10757265 BACKGROUND

• Bouali O, Even L, Mouttalib S, Moscovici J, Galinier P, Game X. [Tibial nerve transcutaneous stimulation for refractory idiopathic overactive bladder in children and adolescents]. Prog Urol. 2015 Sep;25(11):665-72. doi: 10.1016/j.purol.2015.04.005. Epub 2015 May 26. French.

  PMID: 26022237 BACKGROUND

• Sillen U, Sjostrom S, Doroszkiewicz M, Ekdahl H, Dellenmark-Blom M. Development and Validation of Symptom Score for Total Bladder-Bowel Dysfunction: Subscales for Overactive Bladder and Dysfunctional Voiding. J Urol. 2020 Dec;204(6):1333-1340. doi: 10.1097/JU.0000000000001154. Epub 2020 May 29.

  PMID: 32469626 BACKGROUND

• Chen ML, Chermansky CJ, Shen B, Roppolo JR, de Groat WC, Tai C. Electrical stimulation of somatic afferent nerves in the foot increases bladder capacity in healthy human subjects. J Urol. 2014 Apr;191(4):1009-13. doi: 10.1016/j.juro.2013.10.024. Epub 2013 Oct 7.

  PMID: 24113017 BACKGROUND

• Chen YJ, Zhou GY, Jin JH. [Transcutaneous electrical acupoint stimulation combined with auricular acupoint sticking for treatment of primary nocturnal enuresis]. Zhongguo Zhen Jiu. 2010 May;30(5):371-4. Chinese.

  PMID: 20518171 BACKGROUND

• ELECTROPHYSICAL AGENTS - Contraindications And Precautions: An Evidence-Based Approach To Clinical Decision Making In Physical Therapy. Physiother Can. 2010 Fall;62(5):1-80. doi: 10.3138/ptc.62.5. Epub 2011 Jan 5. No abstract available.

  PMID: 21886384 BACKGROUND

• Lordelo P, Benevides I, Kerner EG, Teles A, Lordelo 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.

  PMID: 20837326 BACKGROUND

• Lordelo P, Teles A, Veiga ML, Correia LC, Barroso U Jr. Transcutaneous electrical nerve stimulation in children with overactive bladder: a randomized clinical trial. J Urol. 2010 Aug;184(2):683-9. doi: 10.1016/j.juro.2010.03.053. Epub 2010 Jun 18.

  PMID: 20561643 BACKGROUND

• de Oliveira LF, de Oliveira DM, da Silva de Paula LI, de Figueiredo AA, de Bessa J Jr, de Sa CA, Bastos Netto JM. Transcutaneous parasacral electrical neural stimulation in children with primary monosymptomatic enuresis: a prospective randomized clinical trial. J Urol. 2013 Oct;190(4):1359-63. doi: 10.1016/j.juro.2013.03.108. Epub 2013 Mar 29.

  PMID: 23545102 BACKGROUND

• Tai C, Shen B, Chen M, Wang J, Liu H, Roppolo JR, de Groat WC. Suppression of bladder overactivity by activation of somatic afferent nerves in the foot. BJU Int. 2011 Jan;107(2):303-9. doi: 10.1111/j.1464-410X.2010.09358.x.

  PMID: 20394612 BACKGROUND

• Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.

  PMID: 22466027 BACKGROUND

• Moeller Joensson I, Hagstroem S, Siggaard C, Bower W, Djurhuus JC, Krogh K. Transcutaneous Electrical Nerve Stimulation Increases Rectal Activity in Children. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):80-84. doi: 10.1097/MPG.0000000000000802.

  PMID: 25844704 BACKGROUND

• Robertson Val, Ward A, Low J, Reed A. Electrotherapy explained: principles and practice (4th edition). Elsevier Ltd (UK), 2006.

  BACKGROUND

• Sharma M, Aggarwal V, Bahadur R, Gupta R. Burns secondary to improper usage of transcutaneous electrical nerve stimulation: a case report. Pb J Ortho. 2011;12(1):72-3.

  BACKGROUND

• Howe et al. Transcutaneous electric nerve for the treatment of nocturnal enuresis in children. [NOT YET IN PRESS]

  BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Adam Howe, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Romeo, CCRC

CONTACT

518-262-3349; romeob@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)