An interventional study of TENS and TENS Sham in Enuresis, Nocturnal, sponsored by Fondation Lenval. Completed at 4 sites in France. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Fondation Lenval · Not applicable, Interventional, and Other
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.
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
845 studies on the registry are indexed under Enuresis; 81 are open to participants now.
This study's enrollment of 54 is below the median of 64 across 654 interventional studies indexed under Enuresis.
Browse Enuresis studies →Fondation Lenval is the lead sponsor of 60 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children 5 to 17 years old
Exclusion Criteria:
Other pathologies which can influence urination behavior (Daytime urinary disorders)
Other: TENS
Other: TENS Sham
Transcutaneous Electro Neuro Stimulation
placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation
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
Time frame: at 2 months
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
Time frame: at 1 month
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.
Time frame: at baseline and at 1 month and at 2 month
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Fondation Lenval