Nocturnal EnuresisNCT04313192
TENS Treatment for Bedwetting
A study testing pulse rate of 2 Hz, pulse rate of 10 Hz and pulse rate of 150 Hz in people with Nocturnal Enuresis and Bed Wetting, 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 18 years
- Conditions the study is for
- Nocturnal Enuresis, Bed Wetting
- What is being tested?
- pulse rate of 2 Hz, pulse rate of 10 Hz and pulse rate of 150 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
- 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)
Show all 9Show fewer
- 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.
About this study
Official title: Optimal Frequency 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 three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz (hertz). Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. 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 frequency determined by randomization, pulse width of 260 seconds, 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 15 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 Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment on QOL. 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 5-18 years old referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. 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 or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study. Patients who have previously tried pharmacologic treatment for nocturnal enuresis or 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 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 such as having a pacemaker will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from the study.
The patients will be randomized into three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz. Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. There is no sham group in this study as the investigator has previously found posterior tibial TENS to be effective and lasting, and as such all patients will be treated. The investigator will aim to recruit 30 patients per group for a total of 90 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 15 minutes for 30 days. TENS units will be set at a 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 Pediatric Urinary Incontinence Questionnaire (PIN-Q), a validated tool for measuring quality of life 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, Bed Wetting
- Being tested
- pulse rate of 2 Hz, pulse rate of 10 Hz, pulse rate of 150 Hz
- Keywords
- Nocturnal Enuresis, 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 rate of 2 HzDevice
Also called TENS
electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days
pulse rate of 10 HzDevice
Also called TENS
electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days
pulse rate of 150 HzDevice
Also called TENS
electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days
| Study group | Role | What they receive |
|---|---|---|
| Pulse rate 2Hz (hertz) | Experimental | electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days Receives: Device: pulse rate of 2 Hz |
| Pulse rate 10Hz | Experimental | electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days Receives: Device: pulse rate of 10 Hz |
| Pulse rate 150Hz | Experimental | electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days Receives: Device: pulse rate of 150 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wet Nights
%change in wet nights 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
Pediatric Incontinence Questionnaire (PIN-Q)
Scores on a scale. Quality of life questionnaire score after treatment month compared to after baseline month. Score ranges from 0-80. Lower scores are better and higher scores are worse. Scores = mild <20, moderate 21-50, and severe >51.
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 Mar 2020
- Study start20 Jan 2020
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 125 participants (actual)
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
- NCT04313192
- Sponsor's protocol ID
- 5618
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2020
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 26022237Bower WF, Wong EMC, Yeung CK. Development of a validated quality of life tool specific to children with bladder dysfunction. Neurourol Urodyn. 2006;25(3):221-227. doi: 10.1002/nau.20171.
PubMed 16496391Chen 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 20518171Lordelo 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 22466027ELECTROPHYSICAL 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 21886384Robertson Val, Ward A, Low J, Reed A. Electrotherapy explained: principles and practice (4th edition). Elsevier Ltd (UK), 2006.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT04313192
- Acronym / sponsor ID
- 5618
- Conditions
- Nocturnal Enuresis, Bed Wetting
- Keywords
- Nocturnal Enuresis, Bedwetting, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz (hertz). Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. 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 frequency determined by randomization, pulse width of 260 seconds, 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 15 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 Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment on QOL. 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.
Detailed description
Institutional review board approval was obtained. Children ages 5-18 years old referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. 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 or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study. Patients who have previously tried pharmacologic treatment for nocturnal enuresis or 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 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 such as having a pacemaker will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from the study.
The patients will be randomized into three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz. Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. There is no sham group in this study as the investigator has previously found posterior tibial TENS to be effective and lasting, and as such all patients will be treated. The investigator will aim to recruit 30 patients per group for a total of 90 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 15 minutes for 30 days. TENS units will be set at a 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 Pediatric Urinary Incontinence Questionnaire (PIN-Q), a validated tool for measuring quality of life 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulse rate 2Hz (hertz) | Experimental | Device: pulse rate of 2 Hzelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days |
| Pulse rate 10Hz | Experimental | Device: pulse rate of 10 Hzelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days |
| Pulse rate 150Hz | Experimental | Device: pulse rate of 150 Hzelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
- Ability to provide informed consent and assent and complete study requirements
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| pulse rate of 2 HzAlso: TENSelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days | Device | Pulse rate 2Hz (hertz) |
| pulse rate of 10 HzAlso: TENSelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days | Device | Pulse rate 10Hz |
| pulse rate of 150 HzAlso: TENSelectrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days | Device | Pulse rate 150Hz |
Primary outcome
Percentage of Wet Nights
Time frame: 30 days
%change in wet nights compared in each TENS arm and baseline wet nights
2 secondary outcomes
Severity of Wet Nights
Time frame: 30 days
Pediatric Incontinence Questionnaire (PIN-Q)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26398655Alcantara 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.
- Background: PubMed 16831163Barroso 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.
- Background: PubMed 23422257Barroso 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.
- Background: PubMed 10757265Bjorkstrom 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.
- Background: PubMed 26022237Bouali 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.
- Background: PubMed 16496391Bower WF, Wong EMC, Yeung CK. Development of a validated quality of life tool specific to children with bladder dysfunction. Neurourol Urodyn. 2006;25(3):221-227. doi: 10.1002/nau.20171.
- Background: PubMed 24113017Chen 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.
- Background: PubMed 20518171Chen 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.
- Background: PubMed 20837326Lordelo 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.
- Background: PubMed 20561643Lordelo 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.
- Background: PubMed 23545102de 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.
- Background: PubMed 20394612Tai 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.
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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.
Adam Howe, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulse rate of 2 Hz, pulse rate of 10 Hz and pulse rate of 150 Hz in people with Nocturnal Enuresis and Bed Wetting, run by Albany Medical College at 1 site in United States.
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 15 Apr 2026. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Wet Nights (time frame: 30 days). 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 NCT04313192, which also lists 18 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 15 Apr 2026.