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TENS in Nocturnal Enuresis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07594353
Enrollment
50
Registered
2026-05-18
Start date
2026-07-01
Completion date
2027-02-28
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Enuresis in Children

Keywords

TENS

Brief summary

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

DEVICEtranscutaneous 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). 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.

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction in wet nights6 month from the time of the first TENS sessionSustained 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.

Contacts

CONTACTAbdelrhman Alshawadfy, Professor
abdelrhmanalshawadfy@gmail.com+201091091620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026