Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis (TENS-Enuresis)

Efficiency of Trans-cutanéous Electrical Nerve Stimulation for Isolated Primary Enuresis : a Randomised Controlled Trial

Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary incontinence during sleep in children aged 5 years and older. It is said to be "primary" if the child has never been clean at night for at least 6 months and "isolated" if there are no other associated urinary symptoms, including daytime symptoms.

It is a common condition with significant repercussions, including disruption of family and social life and a frequent decline in self-esteem. Without treatment, it can persist into adulthood. All these reasons justify taking care of these children.

This is usually based on:

The establishment of hygienic-dietetic rules: Regular urination and before sleeping, limitation of fluid intake in the evening. They are systematically implemented, whatever the subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.

Non-drug treatments: Night-time "pee stop" alarms. They have an efficiency of around 70%. They are little used because they often wake up the whole family and are not reimbursed by social security.

TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic response.

In urology, it is mainly used by stimulating either the sacral region, origin of the vesical innervation, or the tibial nerve. Its main indication is overactive bladder, a source of discomfort and incontinence.

It is used at home, the side effects are exceptional and it does not disturb the activities of the patients.

Few studies have evaluated its effectiveness in isolated primary enuresis.

Study Overview

• Status: Completed
• Conditions: Enuresis, Nocturnal
• Intervention / Treatment: Other: TENS; Other: TENS Sham

Detailed Description

Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary incontinence during sleep in children aged 5 years and older. It is said to be "primary" if the child has never been clean at night for at least 6 months and "isolated" if there are no other associated urinary symptoms, including daytime symptoms.

It is a common condition with significant repercussions, including disruption of family and social life and a frequent decline in self-esteem. Without treatment, it can persist into adulthood.

All these reasons justify taking care of these children.

This is usually based on:

The establishment of hygienic-dietetic rules: Regular urination and before sleeping, limitation of fluid intake in the evening. They are systematically implemented, whatever the subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects.

Non-drug treatments: Night-time "pee stop" alarms. They have an efficiency of around 70%. They are little used because they often wake up the whole family and are not reimbursed by social security.

TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic response.

In urology, it is mainly used by stimulating either the sacral region, origin of the vesical innervation, or the tibial nerve. Its main indication is overactive bladder, a source of discomfort and incontinence.

It is used at home, the side effects are exceptional and it does not disturb the activities of the patients.

Main objective is to compare the effectiveness of treatment with TENS versus TENS sham procedure (placebo) in isolated primary enuresis, one month after the end of treatment in patients from 5 to 17 years old The effectiveness will be evaluated by the evolution of the number of wet nights

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cannes, France
    • CH de Cannes
  • Grasse, France
    • CH de Grasse
  • Nice, France
    • CHU de Nice
  • Nice, France
    • Hôpitaux Pédiatrique de Nice CHU Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Children 5 to 17 years old

• Medium or severe isolated primary enuresis (more than 1 episode per week)
• Never treated or in failure of previous treatment (with treatment discontinuation for at least 1 month)
• Affiliation to a social security scheme
• Good understanding of the protocol
• Signature of informed consent by a parent or the legal representative of parental authority

Exclusion Criteria:

Other pathologies which can influence urination behavior (Daytime urinary disorders)

• Treatment in progress which can modify voiding behavior
• TENS treatment in progress for another pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS	Other: TENS; Transcutaneous Electro Neuro Stimulation
Placebo Comparator: TENS Sham	Other: TENS Sham; placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment	The effectiveness will be evaluated by the evolution of the number of wet nights. Measure of number of wet nights per week at baseline before treatment by TENS and at 1 month after the end of treatment	at 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of treatment with TENS versus TENS sham procedure at 1 month	measure of number of wet nights per week at the end of treatment	at 1 month
quality of life during treatment	measure of quality of life with the Pediatric Quality of Life Inventory (Peds QL) questionnaire. The Pediatric Quality of Life Inventory (PedsQL) is a 23-items generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. For ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). The minimum value is 0 and maximum is 100.	at baseline and at 1 month and at 2 month

Collaborators and Investigators

• Sponsor: Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: 19-HPNCL-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No