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

Enuresis, Nocturnal Clinical Trial

— TENS-Enuresis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413461
• Other study ID #: 19-HPNCL-03
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Fondation Lenval
• Contact: Ronny Bensaid, MD
• Phone: 0492030303
• Email: bensaid.r[@]pediatrie-chulenval-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Other:
• TENS
Transcutaneous Electro Neuro Stimulation
• TENS Sham
placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation

Locations

Country	Name	City	State
France	CH de Cannes	Cannes
France	CH de GRASSE	Grasse
France	CHU de Nice	Nice
France	Hôpitaux Pédiatrique de Nice CHU Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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