TENS in Nocturnal Enuresis

May 22, 2026 updated by: Abdelrhman Alshawadfy, Suez Canal University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS
Maintenance home-based parasacral transcutaneous nerve stimulation and continued urotherapy
Device: transcutaneous 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.
No Intervention: Observational
Observation alone and continued urotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month from the time of the first TENS session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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