Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

October 24, 2016 updated by: University of Aarhus

Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS, 10 weeks (active) 2 hours a day.
26 children.
Device: Transcutaneous Electric Nerve Stimulation (TENS) - active
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.
Placebo Comparator: TENS, 10 weeks (placebo) 2 hours a day.
26 children.
Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of wet nights
Time Frame: 1 year
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum voided volume though daytime (MVV)
Time Frame: 1 year
1 year
Nighttime urine production (NUP) on wet nights
Time Frame: 1 year
1 year
Percent of wet night where NUP < MVV
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Søren Rittig, DMSc, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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