Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

NCT02600676 | Completed DMC

• 1 other identifier: 020891
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Enuresis; Nocturnal Enuresis; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Maximum voided volume though daytime (MVV)

  1 year

• Nighttime urine production (NUP) on wet nights

  1 year

• Percent of wet night where NUP < MVV

  1 year

Study Arms (2)

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

ACTIVE COMPARATOR

26 children.

Device: Transcutaneous Electric Nerve Stimulation (TENS) - active

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

PLACEBO COMPARATOR

26 children.

Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo

Interventions

Transcutaneous Electric Nerve Stimulation (TENS) - active DEVICE

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.

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

Transcutaneous Electric Nerve Stimulation (TENS) - placebo DEVICE

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

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (21)

• 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.

  PMID: 18466855 BACKGROUND

• 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.

  PMID: 9599731 BACKGROUND

• 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.

  PMID: 18206924 BACKGROUND

• 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.

  PMID: 16643494 BACKGROUND

• 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.

  PMID: 17727573 BACKGROUND

• 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.

  PMID: 22549838 BACKGROUND

• 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.

  PMID: 9817339 BACKGROUND

• 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.

  PMID: 8618309 BACKGROUND

• 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.

  PMID: 9495731 BACKGROUND

• 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.

  PMID: 19695629 BACKGROUND

• 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.

  PMID: 18609267 BACKGROUND

• 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.

  PMID: 11696802 BACKGROUND

• 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.

  PMID: 11696801 BACKGROUND

• 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.

  PMID: 15076308 BACKGROUND

• 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.

  PMID: 17919697 BACKGROUND

• 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.

  PMID: 20561643 BACKGROUND

• 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.

  PMID: 19846164 BACKGROUND

• 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.

  PMID: 3057221 BACKGROUND

• 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.

  PMID: 7966678 BACKGROUND

• 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.

  PMID: 14694460 BACKGROUND

• 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.

  PMID: 16753432 BACKGROUND

MeSH Terms

Conditions

Enuresis; Nocturnal Enuresis; Urinary Incontinence

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Søren Rittig, DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)