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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02600676
Other study ID # 020891
Secondary ID
Status Completed
Phase N/A
First received November 3, 2015
Last updated October 24, 2016
Start date September 2015
Est. completion date August 2016

Study information

Verified date September 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 14 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
Transcutaneous Electric Nerve Stimulation (TENS) - placebo


Locations

Country Name City State
Denmark Aarhus University Hospital, Skejby Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (21)

Appell RA. Electrical stimulation for the treatment of urinary incontinence. Urology. 1998 Feb;51(2A Suppl):24-6. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Elabbady AA, Hassouna MM, Elhilali MM. Neural stimulation for chronic voiding dysfunctions. J Urol. 1994 Dec;152(6 Pt 1):2076-80. — View Citation

Hägglöf B, Andrén O, Bergström 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Lordêlo 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. — View Citation

Lordêlo 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. — View 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. Epub 2007 Oct 24. — View 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. — View Citation

Nevéus T, von Gontard A, Hoebeke P, Hjälmås K, Bauer S, Bower W, Jørgensen 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. — View Citation

Rittig S, Frøkiaer J. Basis and therapeutical rationale of the urinary concentrating mechanism. Int J Clin Pract Suppl. 2007 Sep;(155):2-7. Review. — View Citation

Tanagho EA, Schmidt RA. Electrical stimulation in the clinical management of the neurogenic bladder. J Urol. 1988 Dec;140(6):1331-9. Review. — View 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. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year No
Secondary Maximum voided volume though daytime (MVV) 1 year No
Secondary Nighttime urine production (NUP) on wet nights 1 year No
Secondary Percent of wet night where NUP < MVV 1 year No
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