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

NCT ID: NCT04413461

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2024-11-14

Brief Summary

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.

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

Conditions

Enuresis, Nocturnal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

TENS

Group Type: EXPERIMENTAL

TENS

Intervention Type: OTHER

Transcutaneous Electro Neuro Stimulation

TENS Sham

Group Type: PLACEBO_COMPARATOR

TENS Sham

Intervention Type: OTHER

placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation

Interventions

TENS

Transcutaneous Electro Neuro Stimulation

Intervention Type: OTHER

TENS Sham

placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH de Cannes

Cannes, , France

CH de GRASSE

Grasse, , France

CHU de Nice

Nice, , France

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, , France

Countries

France

Other Identifiers

19-HPNCL-03

Identifier Type: -

Identifier Source: org_study_id