TENS in Nocturnal Enuresis

N/ANot Yet RecruitingNCT07594353

Suez Canal University50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Nocturnal Enuresis in Children

Interventions

transcutaneous electrical nerve stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

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

Central Contacts

Abdelrhman Alshawadfy, Professor

CONTACT

+201091091620 abdelrhmanalshawadfy@gmail.com

Data from ClinicalTrials.gov

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