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Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

Primary Purpose

Enuresis, Nocturnal Enuresis, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcutaneous Electric Nerve Stimulation (TENS) - active
Transcutaneous Electric Nerve Stimulation (TENS) - placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enuresis

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unremarkable clinical examination
  • 3 or more wet nights per week
  • No treatment of enuresis 1 week before the treatment starts (for bells two weeks)

Exclusion Criteria:

  • Nighttime urine production on wet nights > 130 % of "maximum voided volume" (MVV) for age
  • Ongoing constipation and/or faecal incontinence that are not successfully treated
  • Daytime incontinence
  • Prior or ongoing treatment with TENS
  • Current or previous clinical history, clinical or laboratory findings or daily treatment with drugs that can be related to diseases or conditions that are expected to change the parameters investigated, especially diseases of the kidney and urinary tract or endocrine disorder
  • Neurological and/or significant anatomical abnormalities of the urinary tract
  • Previous operation in the urinary tract
  • Recurrent urinary tract infections
  • Incomplete bladder emptying (assessed with ultrasound) which means post micturition urine volume in the bladder > 20 ml or > 10 % of the total urine production

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TENS, 10 weeks (active) 2 hours a day.

TENS, 10 weeks (placebo) 2 hours a day.

Arm Description

26 children.

26 children.

Outcomes

Primary Outcome Measures

Frequency of wet nights
Non-response is a reduction in wet nights < 50%, partial response a reduction of 50-89%, response a reduction of 90-99% and full response a reduction of 100% or less than one wet night in a month

Secondary Outcome Measures

Maximum voided volume though daytime (MVV)
Nighttime urine production (NUP) on wet nights
Percent of wet night where NUP < MVV

Full Information

First Posted
November 3, 2015
Last Updated
October 24, 2016
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02600676
Brief Title
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
Official Title
Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double blind, placebo controlled study of the effect of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic nocturnal enuresis (MNE).
Detailed Description
Objectives: Nighttime urinary incontinence (enuresis) is seen by 5-10% of children from six to fifteen years. Enuresis is a socially and psychologically stressful condition that can lead to bullying and low self esteem. Today the condition is treated with desmopressin or bells, that awake children at nighttime urination. One third of children suffering from enuresis are refractory to first line of treatment. Transcutaneous Electric Nerve Stimulation (TENS) has been documented efficacious on symptoms in children with daytime incontinence. Little is known regarding the effect of TENS on monosymptomatic nocturnal enuresis (MNE). The aim of our study is to investigate the effect of TENS on children diagnosed with MNE. Methods: This is a randomized, double blind, placebo controlled study of the effect of TENS in fifty-two children with MNE. The study period is from September 2015 to September 2016. The children recruited will receive TENS one hour during daytime and one hour during sleep for a total treatment period of ten weeks. The surface electrodes will be placed on the skin over s2-s3. TENS is safe and not associated with adverse effects. Expected results: The investigators hypothesize a reduction in number of wet nights in the enuretic children receiving active TENS. If TENS proves effective in children with enuresis it will be implemented as part of enuresis treatment in the clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis, Nocturnal Enuresis, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS, 10 weeks (active) 2 hours a day.
Arm Type
Active Comparator
Arm Description
26 children.
Arm Title
TENS, 10 weeks (placebo) 2 hours a day.
Arm Type
Placebo Comparator
Arm Description
26 children.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electric Nerve Stimulation (TENS) - active
Intervention Description
TENS is a non-invasive method using surface electrodes. Except a few cases with local skin irritation in the area where the electrodes are applied, there is no evidence of side effects of TENS treatment.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electric Nerve Stimulation (TENS) - placebo
Primary Outcome Measure Information:
Title
Frequency of wet nights
Description
Non-response is a reduction in wet nights < 50%, partial response a reduction of 50-89%, response a reduction of 90-99% and full response a reduction of 100% or less than one wet night in a month
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Maximum voided volume though daytime (MVV)
Time Frame
1 year
Title
Nighttime urine production (NUP) on wet nights
Time Frame
1 year
Title
Percent of wet night where NUP < MVV
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unremarkable clinical examination 3 or more wet nights per week No treatment of enuresis 1 week before the treatment starts (for bells two weeks) Exclusion Criteria: Nighttime urine production on wet nights > 130 % of "maximum voided volume" (MVV) for age Ongoing constipation and/or faecal incontinence that are not successfully treated Daytime incontinence Prior or ongoing treatment with TENS Current or previous clinical history, clinical or laboratory findings or daily treatment with drugs that can be related to diseases or conditions that are expected to change the parameters investigated, especially diseases of the kidney and urinary tract or endocrine disorder Neurological and/or significant anatomical abnormalities of the urinary tract Previous operation in the urinary tract Recurrent urinary tract infections Incomplete bladder emptying (assessed with ultrasound) which means post micturition urine volume in the bladder > 20 ml or > 10 % of the total urine production
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Rittig, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication
Citations:
PubMed Identifier
18466855
Citation
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18206924
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PubMed Identifier
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Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

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