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
About this trial
This is an interventional treatment trial for Enuresis
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
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
NCT ID
NCT02600676
First Posted
November 3, 2015
Last Updated
October 24, 2016
Sponsor
University of Aarhus
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
Culbert TP, Banez GA. Wetting the bed: integrative approaches to nocturnal enuresis. Explore (NY). 2008 May-Jun;4(3):215-20. doi: 10.1016/j.explore.2008.02.014. No abstract available.
Results Reference
background
PubMed Identifier
9599731
Citation
Hagglof B, Andren O, Bergstrom E, Marklund L, Wendelius M. Self-esteem in children with nocturnal enuresis and urinary incontinence: improvement of self-esteem after treatment. Eur Urol. 1998;33 Suppl 3:16-9. doi: 10.1159/000052236.
Results Reference
background
PubMed Identifier
18206924
Citation
Kamperis K, Hagstroem S, Rittig S, Djurhuus JC. Combination of the enuresis alarm and desmopressin: second line treatment for nocturnal enuresis. J Urol. 2008 Mar;179(3):1128-31. doi: 10.1016/j.juro.2007.10.088. Epub 2008 Jan 18.
Results Reference
background
PubMed Identifier
16643494
Citation
Yeung CK, Sreedhar B, Sihoe JD, Sit FK, Lau J. Differences in characteristics of nocturnal enuresis between children and adolescents: a critical appraisal from a large epidemiological study. BJU Int. 2006 May;97(5):1069-73. doi: 10.1111/j.1464-410X.2006.06074.x.
Results Reference
background
PubMed Identifier
17727573
Citation
Rittig S, Frokiaer J. Basis and therapeutical rationale of the urinary concentrating mechanism. Int J Clin Pract Suppl. 2007 Sep;(155):2-7. doi: 10.1111/j.1742-1241.2007.01461.x.
Results Reference
background
PubMed Identifier
22549838
Citation
Negoro H, Kanematsu A, Doi M, Suadicani SO, Matsuo M, Imamura M, Okinami T, Nishikawa N, Oura T, Matsui S, Seo K, Tainaka M, Urabe S, Kiyokage E, Todo T, Okamura H, Tabata Y, Ogawa O. Involvement of urinary bladder Connexin43 and the circadian clock in coordination of diurnal micturition rhythm. Nat Commun. 2012 May 1;3:809. doi: 10.1038/ncomms1812.
Results Reference
background
PubMed Identifier
9817339
Citation
Bower WF, Moore KH, Adams RD, Shepherd R. A urodynamic study of surface neuromodulation versus sham in detrusor instability and sensory urgency. J Urol. 1998 Dec;160(6 Pt 1):2133-6. doi: 10.1097/00005392-199812010-00049.
Results Reference
background
PubMed Identifier
8618309
Citation
Hasan ST, Robson WA, Pridie AK, Neal DE. Transcutaneous electrical nerve stimulation and temporary S3 neuromodulation in idiopathic detrusor instability. J Urol. 1996 Jun;155(6):2005-11.
Results Reference
background
PubMed Identifier
9495731
Citation
Appell RA. Electrical stimulation for the treatment of urinary incontinence. Urology. 1998 Feb;51(2A Suppl):24-6. doi: 10.1016/s0090-4295(98)90004-8.
Results Reference
background
PubMed Identifier
19695629
Citation
Hagstroem S, Mahler B, Madsen B, Djurhuus JC, Rittig S. Transcutaneous electrical nerve stimulation for refractory daytime urinary urge incontinence. J Urol. 2009 Oct;182(4 Suppl):2072-8. doi: 10.1016/j.juro.2009.05.101. Epub 2009 Aug 20.
Results Reference
background
PubMed Identifier
18609267
Citation
Hagstroem S, Rittig N, Kamperis K, Mikkelsen MM, Rittig S, Djurhuus JC. Treatment outcome of day-time urinary incontinence in children. Scand J Urol Nephrol. 2008;42(6):528-33. doi: 10.1080/00365590802098367.
Results Reference
background
PubMed Identifier
11696802
Citation
Bower WF, Moore KH, Adams RD. A pilot study of the home application of transcutaneous neuromodulation in children with urgency or urge incontinence. J Urol. 2001 Dec;166(6):2420-2.
Results Reference
background
PubMed Identifier
11696801
Citation
Hoebeke P, Van Laecke E, Everaert K, Renson C, De Paepe H, Raes A, Vande Walle J. Transcutaneous neuromodulation for the urge syndrome in children: a pilot study. J Urol. 2001 Dec;166(6):2416-9.
Results Reference
background
PubMed Identifier
15076308
Citation
De Gennaro M, Capitanucci ML, Mastracci P, Silveri M, Gatti C, Mosiello G. Percutaneous tibial nerve neuromodulation is well tolerated in children and effective for treating refractory vesical dysfunction. J Urol. 2004 May;171(5):1911-3. doi: 10.1097/01.ju.0000119961.58222.86.
Results Reference
background
PubMed Identifier
17919697
Citation
Malm-Buatsi E, Nepple KG, Boyt MA, Austin JC, Cooper CS. Efficacy of transcutaneous electrical nerve stimulation in children with overactive bladder refractory to pharmacotherapy. Urology. 2007 Nov;70(5):980-3. doi: 10.1016/j.urology.2007.06.1109. Epub 2007 Oct 24.
Results Reference
background
PubMed Identifier
20561643
Citation
Lordelo P, Teles A, Veiga ML, Correia LC, Barroso U Jr. Transcutaneous electrical nerve stimulation in children with overactive bladder: a randomized clinical trial. J Urol. 2010 Aug;184(2):683-9. doi: 10.1016/j.juro.2010.03.053. Epub 2010 Jun 18.
Results Reference
background
PubMed Identifier
19846164
Citation
Lordelo P, Soares PV, Maciel I, Macedo A Jr, Barroso U Jr. Prospective study of transcutaneous parasacral electrical stimulation for overactive bladder in children: long-term results. J Urol. 2009 Dec;182(6):2900-4. doi: 10.1016/j.juro.2009.08.058. Epub 2009 Oct 28.
Results Reference
background
PubMed Identifier
3057221
Citation
Tanagho EA, Schmidt RA. Electrical stimulation in the clinical management of the neurogenic bladder. J Urol. 1988 Dec;140(6):1331-9. doi: 10.1016/s0022-5347(17)42038-6. No abstract available.
Results Reference
background
PubMed Identifier
7966678
Citation
Elabbady AA, Hassouna MM, Elhilali MM. Neural stimulation for chronic voiding dysfunctions. J Urol. 1994 Dec;152(6 Pt 1):2076-80. doi: 10.1016/s0022-5347(17)32312-1.
Results Reference
background
PubMed Identifier
14694460
Citation
Bower WF, Yeung CK. A review of non-invasive electro neuromodulation as an intervention for non-neurogenic bladder dysfunction in children. Neurourol Urodyn. 2004;23(1):63-7. doi: 10.1002/nau.10171.
Results Reference
background
PubMed Identifier
16753432
Citation
Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.
Results Reference
background
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Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
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