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

Enuresis, Nocturnal Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT04413461
• Study type: Interventional
• Source: Fondation Lenval
• Contact: Ronny Bensaid, MD
• Phone: 0492030303
• Email: bensaid.r@pediatrie-chulenval-nice.fr
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Completion date: May 2025