TENS in Nocturnal Enuresis

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.

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Key information

Conditions

Nocturnal Enuresis in Children

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Reduction in wet nights

Time frame: 6 month from the time of the first TENS session

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrhman Alshawadfy, Professor

CONTACT

[email protected]

+201091091620 ext. 002

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 18, 2026
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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