What is this study about nocturnal enuresis in children?

This study evaluates two different pulse widths of TENS therapy to treat bedwetting in children aged 5 to 17 who have not improved with behavioral changes. Researchers aim to find how these settings affect nighttime wetting and bladder symptoms. The study is sponsored by Albany Medical College and seeks to improve treatment options for this condition.

Who may be eligible for this nocturnal enuresis clinical trial?

Children aged 5 to 17 with bedwetting more than once a week and who have not responded to behavioral treatments may qualify. The study includes both boys and girls without daytime incontinence or recent medication use for bedwetting. Please review eligibility criteria for more details.

Is there any cost to participate in this nocturnal enuresis clinical trial?

Study-related care, including the TENS device and all trial visits, is provided at no cost. However, personal expenses like travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 5Years - 17Years

All Genders

ID06135311

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

Led by Albany Medical College · Updated on 2025-10-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research investigates the use of Transcutaneous Electrical Nerve Stimulation (TENS) therapy to treat primary nocturnal enuresis (bedwetting) in children aged 5 to 17 years. Children referred to a pediatric urology clinic who have not improved after behavioral modifications will be offered either a bedwetting alarm or TENS therapy. The study aims to compare two different pulse widths of TENS to understand their effects on nighttime wetting episodes and bladder symptoms. Participants will be randomly assigned to one of two groups: one receiving TENS with a high pulse width of 260 microseconds and the other with a low pulse width of 50 microseconds. Each child will use the TENS unit with electrodes placed on the medial ankle along the posterior tibial nerve for 30 minutes at bedtime every night for 30 days. Intensity will be set based on the child's sensitivity, and families will be instructed on device use. There is no placebo group; all participants receive active treatment. During the study, parents and children will keep nightly diaries tracking the frequency and severity of bedwetting using a wet sheet scale. Before and after treatment, they will complete the Bowel & Bladder Questionnaire to assess bladder symptoms. Follow-up visits will occur after one month to evaluate progress and any side effects. The main outcome measured is the percentage of wet nights over 30 days, alongside severity and symptom questionnaire results. Participation includes daily monitoring and a month of treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Presenting with nocturnal enuresis occurring more than once a week
Failed behavioral modification treatment in the 30 days prior to randomization
Ability to provide informed consent and assent and complete study requirements

You will not qualify if you...

Use of pharmacologic treatment or alternative therapy for nocturnal enuresis or urologic disorders within the past 30 days
Presence of daytime urinary incontinence symptoms
Known "high volume" voiders based on history
Bedwetting episodes less than twice per week on average
Taking medications that predispose to incontinence (e.g., Lithium for bipolar disorder)
Other voiding or neurologic disorders such as overactive bladder or myelomeningocele
Secondary causes for nocturnal enuresis like cystitis or obstructive sleep apnea
Contraindications to TENS use including pacemakers, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, or impaired cognition
History of heart disease or related complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 30 days

Participants use a transcutaneous electrical nerve stimulation (TENS) unit nightly at bedtime for 30 minutes, with pulse width set according to their group assignment to treat nocturnal enuresis. They and their caretakers will record nightly voiding diaries during this period.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

Albany Medical College

Albany, New York, United States, 12208

Actively Recruiting

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Research Team

Brenda Romeo, CCRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

Frequently Asked Questions

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Published Research Related To This Trial

Transcutaneous electrical neural stimulation for the treatment of urinary urgency or urge-incontinence in children and adolescents: a Phase II clinica.

Amanda Carolina Almeida de Alcantara, Maria Júlia Gonçalves de Mello, Eduardo Just da Costa e Silva...

https://pubmed.ncbi.nlm.nih.gov/26398655

Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and transcutaneous electrical stimulation: a pilot study.

Ubirajara Barroso, Patrícia Lordêlo, Antônio A Lopes...

https://pubmed.ncbi.nlm.nih.gov/16831163

Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children.

Ubirajara Barroso, Walter Viterbo, Joana Bittencourt...

https://pubmed.ncbi.nlm.nih.gov/23422257

Electro-acupuncture in the treatment of children with monosymptomatic nocturnal enuresis.

G Björkström, A L Hellström, S Andersson

https://pubmed.ncbi.nlm.nih.gov/10757265

[Tibial nerve transcutaneous stimulation for refractory idiopathic overactive bladder in children and adolescents].

O Bouali, L Even, S Mouttalib...

https://pubmed.ncbi.nlm.nih.gov/26022237

Development and Validation of Symptom Score for Total Bladder-Bowel Dysfunction: Subscales for Overactive Bladder and Dysfunctional Voiding.

U Sillén, S Sjöström, M Doroszkiewicz...

https://pubmed.ncbi.nlm.nih.gov/32469626

Electrical stimulation of somatic afferent nerves in the foot increases bladder capacity in healthy human subjects.

Mang L Chen, Christopher J Chermansky, Bing Shen...

https://pubmed.ncbi.nlm.nih.gov/24113017

[Transcutaneous electrical acupoint stimulation combined with auricular acupoint sticking for treatment of primary nocturnal enuresis].

Yong-Jun Chen, Guo-Ying Zhou, Jian-Hong Jin

https://pubmed.ncbi.nlm.nih.gov/20518171

ELECTROPHYSICAL AGENTS - Contraindications And Precautions: An Evidence-Based Approach To Clinical Decision Making In Physical Therapy.

https://pubmed.ncbi.nlm.nih.gov/21886384

Treatment of non-monosymptomatic nocturnal enuresis by transcutaneous parasacral electrical nerve stimulation.

Patrícia Lordêlo, Igor Benevides, Eric Goodwin Kerner...

https://pubmed.ncbi.nlm.nih.gov/20837326