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

NCT04413461 | Completed

• 1 other identifier: 19-HPNCL-03
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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.

Conditions

Enuresis, Nocturnal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effectiveness of treatment with TENS versus TENS sham procedure at 1 month

  at 1 month

• quality of life during treatment

  at baseline and at 1 month and at 2 month

Study Arms (2)

TENS

EXPERIMENTAL

Other: TENS

TENS Sham

PLACEBO COMPARATOR

Other: TENS Sham

Interventions

TENS OTHER

Transcutaneous Electro Neuro Stimulation

TENS

TENS Sham OTHER

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

TENS Sham

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (4)

CH de Cannes

Cannes, France

Location

CH de GRASSE

Grasse, France

Location

CHU de Nice

Nice, France

Location

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, France

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: January 13, 2021
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)