Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis (TENS-Enuresis)
Primary Purpose
Enuresis, Nocturnal
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TENS
TENS Sham
Sponsored by
About this trial
This is an interventional other trial for Enuresis, Nocturnal
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
Sites / Locations
- CH de Cannes
- CH de GRASSE
- CHU de Nice
- Hôpitaux Pédiatrique de Nice CHU LenvalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TENS
TENS Sham
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04413461
Brief Title
Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis
Acronym
TENS-Enuresis
Official Title
Efficiency of Trans-cutanéous Electrical Nerve Stimulation for Isolated Primary Enuresis : A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis, Nocturnal
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Experimental
Arm Title
TENS Sham
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
Transcutaneous Electro Neuro Stimulation
Intervention Type
Other
Intervention Name(s)
TENS Sham
Intervention Description
placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation
Primary Outcome Measure Information:
Title
effectiveness of treatment with Transcutaneous Electro Neuro Stimulation (TENS) versus TENS sham procedure at 1 month post treatment
Description
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
Secondary Outcome Measure Information:
Title
effectiveness of treatment with TENS versus TENS sham procedure at 1 month
Description
measure of number of wet nights per week at the end of treatment
Time Frame
at 1 month
Title
quality of life during treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronny Bensaid, MD
Phone
0492030303
Email
bensaid.r@pediatrie-chulenval-nice.fr
Facility Information:
Facility Name
CH de Cannes
City
Cannes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel MARTINEZ OZENDA
Facility Name
CH de GRASSE
City
Grasse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel NGUYEN, MD
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille FAUDEUX
Facility Name
Hôpitaux Pédiatrique de Nice CHU Lenval
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronny Bensaid, MD
Phone
0492030303
Email
bensaid.r@pediatrie-chulenval-nice.fr
First Name & Middle Initial & Last Name & Degree
Dominique Donzeau
Email
donzeau.d@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Ronny Bensaid, MD
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis
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