EnuresisNCT02600676
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
A study testing Transcutaneous Electric Nerve Stimulation (TENS) - active in people with Enuresis and Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Enuresis, Nocturnal Enuresis, Urinary Incontinence
- What is being tested?
- Transcutaneous Electric Nerve Stimulation (TENS) - active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unremarkable clinical examination
- 3 or more wet nights per week
- No treatment of enuresis 1 week before the treatment starts (for bells two weeks)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Enuresis, Nocturnal Enuresis, Urinary Incontinence
- Being tested
- Transcutaneous Electric Nerve Stimulation (TENS) - active, Transcutaneous Electric Nerve Stimulation (TENS) - placebo
- Medical subject headings
- Enuresis, Nocturnal Enuresis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electric Nerve Stimulation (TENS) - activeDevice
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) - placeboDevice
| Study group | Role | What they receive |
|---|---|---|
| TENS, 10 weeks (active) 2 hours a day. | Active comparator | 26 children. Receives: Device: Transcutaneous Electric Nerve Stimulation (TENS) - active |
| TENS, 10 weeks (placebo) 2 hours a day. | Placebo comparator | 26 children. Receives: Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Maximum voided volume though daytime (MVV)
Measured: 1 year
Nighttime urine production (NUP) on wet nights
Measured: 1 year
Percent of wet night where NUP < MVV
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for EnuresisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Rittig, DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600676
- Sponsor's protocol ID
- 020891
- Status last verified
- Sep 2015
- First submitted
- 3 Nov 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication
Publications
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.
PubMed 18466855Hagglof 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.
PubMed 9599731Kamperis 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.
PubMed 18206924Yeung 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.
PubMed 16643494Rittig 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.
PubMed 17727573Negoro 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.
PubMed 22549838Bower 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.
PubMed 9817339Hasan 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.
PubMed 8618309Appell 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.
PubMed 9495731Hagstroem 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.
PubMed 19695629Hagstroem 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.
PubMed 18609267Bower 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.
PubMed 11696802Hoebeke 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.
PubMed 11696801De 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.
PubMed 15076308Malm-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.
PubMed 17919697
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
- ClinicalTrials.gov ID
- NCT02600676
- Acronym / sponsor ID
- 020891
- Conditions
- Enuresis, Nocturnal Enuresis, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS, 10 weeks (active) 2 hours a day. | Active comparator | Device: Transcutaneous Electric Nerve Stimulation (TENS) - active26 children. |
| TENS, 10 weeks (placebo) 2 hours a day. | Placebo comparator | Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo26 children. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Unremarkable clinical examination
- 3 or more wet nights per week
- No treatment of enuresis 1 week before the treatment starts (for bells two weeks)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electric Nerve Stimulation (TENS) - activeTENS 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. | Device | TENS, 10 weeks (active) 2 hours a day. |
| Transcutaneous Electric Nerve Stimulation (TENS) - placebo | Device | TENS, 10 weeks (placebo) 2 hours a day. |
Primary outcome
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
3 secondary outcomes
Maximum voided volume though daytime (MVV)
Time frame: 1 year
Nighttime urine production (NUP) on wet nights
Time frame: 1 year
Percent of wet night where NUP < MVV
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 18466855Culbert 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.
- Background: PubMed 9599731Hagglof 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.
- Background: PubMed 18206924Kamperis 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.
- Background: PubMed 16643494Yeung 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.
- Background: PubMed 17727573Rittig 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.
- Background: PubMed 22549838Negoro 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.
- Background: PubMed 9817339Bower 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.
- Background: PubMed 8618309Hasan 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.
- Background: PubMed 9495731Appell 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.
- Background: PubMed 19695629Hagstroem 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.
- Background: PubMed 18609267Hagstroem 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.
- Background: PubMed 11696802Bower 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.
- Individual participant dataSharing planned: Yes. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Rittig, DMSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electric Nerve Stimulation (TENS) - active in people with Enuresis and Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of wet nights (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600676, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.