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

March 26, 2025 updated by: Fondation Lenval

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment
Time Frame: at 2 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
effectiveness of treatment with TENS versus TENS sham procedure at 1 month
Time Frame: at 1 month
measure of number of wet nights per week at the end of treatment
at 1 month
quality of life during treatment
Time Frame: at baseline and at 1 month and at 2 month

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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Lenval

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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