Nocturnal EnuresisNCT06135311
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
A study testing Pulse Width 260us and Pulse Width 50us in people with Nocturnal Enuresis and Bedwetting, run by Albany Medical College at 1 site in United States.
Trial summary
Children referred to pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study.The patients will be randomized… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Nocturnal Enuresis, Bedwetting
- What is being tested?
- Pulse Width 260us and Pulse Width 50us
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 31 Dec 2026
- Phase
- Interventional
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting with nocturnal enuresis (more than 1x a week)
- Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors) during the 30 day period prior to randomization
- Ability to provide informed consent and assent and complete study requirements
Who cannot join
- Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
- Daytime incontinence symptoms
- Known "high volume" voiders (determined from history)
- Bedwetting episodes on the average of less than two times per week,
- Medications predisposing to incontinence (eg, Lithium for bipolar disorder)
- Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
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- Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease)
- Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
- Any history of heart disease or complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208
Laura Davey, CCRC, 518-262-8579, amcurologyresearch@amc.edu
Adam Howe, MD
About this study
Official title: Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
Children referred to pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study.The patients will be randomized into two groups of 35 patients each.Group 1 will be the high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus. The child's TENS unit will be set at a pulse width determined by randomization, frequency of 10Hz, and an intensity to be determined in the office based upon when the child feels sensitive to the TENS unit. The child will be randomized and will place the electrodes along the posterior tibial nerve on the medial ankle each night before bed time for 30 minutes for a total of 30 days. Diaries including nighttime incontinence episodes and a "wet sheet" scale (dry, damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit. Patients will be followed up after one month of TENS with evaluation including the Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with voiding dysfunction [6]; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment. The data will be collected at different time points (baseline and after 1 month of treatment) for each group by itself and the groups compared against each other using statistical analysis.
Read the detailed description
Institutional review board approval was obtained. Children ages 5-17 years old referred to the pediatric urology clinic at Albany Medical Center Department of Urology for primary nocturnal enuresis will be screened for enrollment. If a 17 year old turns 18 during study participation, the subject will be consented as an adult using the Informed Consent Form and parental permission is no longer needed. Behavioral modification (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors) will be utilized first. Patients who fail will next be offered therapy with a bedwetting alarm device as standard therapy or participation in a research study using a TENS unit. Patients who have previously tried pharmacologic treatment for nocturnal enuresis or alternative therapy for urologic disorders within the pasty 30 days, daytime incontinence symptoms, known "high volume" voiders (determined from history), bedwetting episodes on the average of less than one time per week, medications predisposing to incontinence (eg, Lithium for bipolar disorder), other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele), secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae), prior use of a TENS unit or other neuromodulation for bedwetting, and any contraindications to usage of a TENS unit (other electrical devices such as a pacemaker, pregnancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, malignancy, impaired cognition)will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from the study.
The patients will be randomized into two groups of 35 patients each. Group 1 will be the high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. There is no sham group in this study as we have previously found posterior tibial TENS to be effective and lasting, and as such all patients will be "treated" to be best of our knowing. We will aim to recruit 35 patients per group for a total of 70 patients.
Detailed explanation of the purpose if the study, along with the risks and benefits of TENS will be given to the patient and caretakers by a provider prior to obtaining informed consent for enrollment into the study. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus.
Parents/patients of enrolled patients will fill out nightly voiding diaries, recording nighttime incontinence episodes and subjective "wet sheets" scale per night (dry, damp, wet, soaked) for 30 days prior to randomization into the treatment arms. The TENS sessions will be performed nightly at bedtime for 30 minutes for 30 days. TENS units will be set at a pulse width determined by randomization, frequency of 10Hz, and intensity determined in the office by the sensitivity threshold of the patient. Voiding diaries will be kept each night while on TENS therapy. A voiding diary will also be completed 30 days before TENS treatment, patients and families will fill out the Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with bladder dysfunction. Patients will follow up at day 30 and as needed (worsening symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Patients who record 2 wet nights per week (a total of 8/30=27% wet nights) will be eligible for the TENS study. Those who record less than 2 wet nights per week will be ineligible for the TENS study but will be offered therapy using a bedwetting alarm device or other treatment.
- Conditions
- Nocturnal Enuresis, Bedwetting
- Being tested
- Pulse Width 260us, Pulse Width 50us
- Keywords
- Noctural Eneuresis, Bedwetting, TENS
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Width 260usDevice
Also called TENS
electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 260us, intensity setting to patient's tolerance, duration 30 days
Pulse Width 50usDevice
Also called TENS
electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 50us, intensity setting to patient's tolerance, duration 30 days
| Study group | Role | What they receive |
|---|---|---|
| Pulse Width 260us | Experimental | electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 260us, intensity setting to patient's tolerance, duration 30 days Receives: Device: Pulse Width 260us |
| Pulse Width 50us | Experimental | electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 50us, intensity setting to patient's tolerance, duration 30 days Receives: Device: Pulse Width 50us |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of wet nights
Percent of wet nights per month compared in each TENS arm and baseline wet nights
Measured: 30 days
Secondary outcomes (2)
Severity of Wet nights
Mean score (0 dry to 3 soaked) of subjective severity of wetness each night during treatment month compared to baseline month
Measured: 30 days
Bowel and Bladder questionnaire (BBQ)
Score of 0-36 based on subjective voiding and stooling questionnaire (higher scores indicate worse outcomes)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Howe, MD, Albany Medical College
- Investigators
- Adam Howe, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135311
- Sponsor's protocol ID
- 6429
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alcantara AC, Mello MJ, Costa e Silva EJ, Silva BB, Ribeiro Neto JP. Transcutaneous electrical neural stimulation for the treatment of urinary urgency or urge-incontinence in children and adolescents: a Phase II clinica. J Bras Nefrol. 2015 Jul-Sep;37(3):422-6. doi: 10.5935/0101-2800.20150065. English, Portuguese.
PubMed 26398655Barroso U Jr, Lordelo P, Lopes AA, Andrade J, Macedo A Jr, Ortiz V. Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and transcutaneous electrical stimulation: a pilot study. BJU Int. 2006 Jul;98(1):166-71. doi: 10.1111/j.1464-410X.2006.06264.x.
PubMed 16831163Barroso U Jr, Viterbo W, Bittencourt J, Farias T, Lordelo P. Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children. J Urol. 2013 Aug;190(2):673-7. doi: 10.1016/j.juro.2013.02.034. Epub 2013 Feb 16.
PubMed 23422257Bjorkstrom G, Hellstrom AL, Andersson S. Electro-acupuncture in the treatment of children with monosymptomatic nocturnal enuresis. Scand J Urol Nephrol. 2000 Feb;34(1):21-6. doi: 10.1080/003655900750016832.
PubMed 10757265Bouali O, Even L, Mouttalib S, Moscovici J, Galinier P, Game X. [Tibial nerve transcutaneous stimulation for refractory idiopathic overactive bladder in children and adolescents]. Prog Urol. 2015 Sep;25(11):665-72. doi: 10.1016/j.purol.2015.04.005. Epub 2015 May 26. French.
PubMed 26022237Sillen U, Sjostrom S, Doroszkiewicz M, Ekdahl H, Dellenmark-Blom M. Development and Validation of Symptom Score for Total Bladder-Bowel Dysfunction: Subscales for Overactive Bladder and Dysfunctional Voiding. J Urol. 2020 Dec;204(6):1333-1340. doi: 10.1097/JU.0000000000001154. Epub 2020 May 29.
PubMed 32469626Chen ML, Chermansky CJ, Shen B, Roppolo JR, de Groat WC, Tai C. Electrical stimulation of somatic afferent nerves in the foot increases bladder capacity in healthy human subjects. J Urol. 2014 Apr;191(4):1009-13. doi: 10.1016/j.juro.2013.10.024. Epub 2013 Oct 7.
PubMed 24113017Chen YJ, Zhou GY, Jin JH. [Transcutaneous electrical acupoint stimulation combined with auricular acupoint sticking for treatment of primary nocturnal enuresis]. Zhongguo Zhen Jiu. 2010 May;30(5):371-4. Chinese.
PubMed 20518171ELECTROPHYSICAL AGENTS - Contraindications And Precautions: An Evidence-Based Approach To Clinical Decision Making In Physical Therapy. Physiother Can. 2010 Fall;62(5):1-80. doi: 10.3138/ptc.62.5. Epub 2011 Jan 5. No abstract available.
PubMed 21886384Lordelo P, Benevides I, Kerner EG, Teles A, Lordelo M, Barroso U Jr. Treatment of non-monosymptomatic nocturnal enuresis by transcutaneous parasacral electrical nerve stimulation. J Pediatr Urol. 2010 Oct;6(5):486-9. doi: 10.1016/j.jpurol.2009.11.005.
PubMed 20837326Lordelo 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.
PubMed 20561643de Oliveira LF, de Oliveira DM, da Silva de Paula LI, de Figueiredo AA, de Bessa J Jr, de Sa CA, Bastos Netto JM. Transcutaneous parasacral electrical neural stimulation in children with primary monosymptomatic enuresis: a prospective randomized clinical trial. J Urol. 2013 Oct;190(4):1359-63. doi: 10.1016/j.juro.2013.03.108. Epub 2013 Mar 29.
PubMed 23545102Tai C, Shen B, Chen M, Wang J, Liu H, Roppolo JR, de Groat WC. Suppression of bladder overactivity by activation of somatic afferent nerves in the foot. BJU Int. 2011 Jan;107(2):303-9. doi: 10.1111/j.1464-410X.2010.09358.x.
PubMed 20394612Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.
PubMed 22466027Moeller Joensson I, Hagstroem S, Siggaard C, Bower W, Djurhuus JC, Krogh K. Transcutaneous Electrical Nerve Stimulation Increases Rectal Activity in Children. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):80-84. doi: 10.1097/MPG.0000000000000802.
PubMed 25844704