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Not yet recruiting NCT07594353

TENS in Nocturnal Enuresis

No phase Interventional Nocturnal Enuresis in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous electrical nerve stimulation.
Who it may be relevant to
Registry conditions: Nocturnal Enuresis in Children. Basic parameters: 5 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Maintenance Parasacral Electrical Nerve Stimulation Versus Observation After Initial Response in Children With Primary Nocturnal Enuresis: A Randomized Controlled Trial

Overview

Paracascral transcutaneous electrical nerve stimulation (PTENS) is a credible therapeutic option for nocturnal enuresis. The investigators shall investigate whether maintenance PTENS after initial response improves durability of remission compared with observation alone.

Interventions

  • Device transcutaneous electrical nerve stimulation
    Parasacral transcutaneous electrical nerve stimulation (parasacral TENS or PTENS) is a non-invasive, neuromodulation intervention used for pediatric overactive bladder (OAB) and neurogenic bladder dysfunction, with emerging evidence for treating nocturnal enuresis. Target Area: Posteriorly on the skin at the sacral nerve outflow level (S2-S3), approximately one fingerbreadth away from the midline. Frequency: 10-20 Hz. Pulse Width: 200--700 mus (commonly used to activate sensory nerves). Intensi

Primary outcome measures

  • Reduction in wet nights [Time frame: 6 month from the time of the first TENS session]

Eligibility criteria

Inclusion criteria

  • Diagnosis of primary monosymptomatic nocturnal enuresis (PMNE) based on International Children's Continence Society (ICCS) criteria.
  • Persistent symptoms after at least 8 weeks of standardized urotherapy, including counseling on timed voiding, evening fluid management, and bowel optimization.
  • Baseline severity of ≥3 wet nights per week on a 14-night diary.
  • Ability of the child and caregiver to complete diaries and comply with home treatment and follow-up.

Exclusion criteria

  • Non-monosymptomatic enuresis, daytime urgency, daytime incontinence, dysfunctional voiding, or significant post-void residual.
  • Neurogenic bladder, spinal dysraphism, cerebral palsy, epilepsy uncontrolled on treatment, or other neurologic diseases affecting lower urinary tract function.
  • Congenital or acquired urinary tract abnormalities.
  • Active urinary tract infection.
  • Untreated or refractory constipation at enrollment.
  • Implanted electrical devices, significant dermatologic lesions at electrode sites, or other contraindications to electrical stimulation.
  • Cognitive, behavioral, or social circumstances preventing adherence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07594353 · TENS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗