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

F

Fondation Lenval

Status

Completed

Conditions

Enuresis, Nocturnal

Treatments

Other: TENS Sham
Other: TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT04413461
19-HPNCL-03

Details and patient eligibility

About

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.

Full 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

Enrollment

54 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups, including a placebo group

TENS
Experimental group
Treatment:
Other: TENS
TENS Sham
Placebo Comparator group
Treatment:
Other: TENS Sham

Trial contacts and locations

4

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Central trial contact

Ronny Bensaid, MD

Data sourced from clinicaltrials.gov

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