TENS in Nocturnal Enuresis

ConditionNocturnal Enuresis in Children

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age5-16

SponsorSuez Canal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

transcutaneous electrical nerve stimulation
Device
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). Intensity/Amplitude: Adjusted to the maximum tolerance of the child without causing pain, or just below the motor threshold (avoiding leg muscle contractions). Session 15-60 minutes}\\) (20 minutes is common in clinical settings). Frequency of Treatment: 2-3 times per week. Total Duration: Usually a total of 30-40 sessions over 6 months.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: TENSActive comparator 1 intervention

Group B: ObservationalNo intervention 0 interventions

Trial outcomes

Primary outcomes

Reduction in wet nights

Sustained treatment response at 6 months, defined as maintenance of at least a 50% reduction in the number of wet nights from pre-treatment baseline, without the need for additional active treatment, based on a 14-night enuresis diary.

Time frame

6 month from the time of the first TENS session

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

Source ClinicalTrials.gov

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