Efficiency of Trans-cutanéous Electrical Nerve Stimulation for Isolated Primary Enuresis : a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enuresis, Nocturnal
- Sponsor
- Fondation Lenval
- Enrollment
- 54
- Locations
- 4
- Primary Endpoint
- effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
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
Outcomes
Primary Outcomes
effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment
Time Frame: at 2 months
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
Secondary Outcomes
- 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)