Urinary Incontinence Clinical Trial
Official title:
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital, Skejby | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
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 all — Click here to view all references
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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