TENS in Nocturnal Enuresis

NCT07594353 | Not Yet Recruiting DMC

• 1 other identifier: TENS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nocturnal Enuresis in Children

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month from the time of the first TENS session

Study Arms (2)

TENS

ACTIVE COMPARATOR

Maintenance home-based parasacral transcutaneous nerve stimulation and continued urotherapy

Device: transcutaneous electrical nerve stimulation

Observational

NO INTERVENTION

Observation alone and continued urotherapy

Interventions

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.

TENS

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Abdelrhman Alshawadfy, Professor

CONTACT

+201091091620; abdelrhmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05