Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
Phase: NA
Conditions: Nocturnal Enuresis, Bed Wetting
Sponsor: Albany Medical College

NCT04313192 
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Optimal frequency used in transcutaneous electrical nerve 
stimulation (TENS) for treating nocturnal enuresis in children 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR: 
 
 
Adam Howe, MD 
Department of Surgery, Division of Urology 
 
 
 
Albany Medical College, MC108 
 
 
 
47 New Scotland Ave 
 
 
 
Albany, NY  12208 
 
 
 
518-262-8579 
 
 
 
 
Sub-Investigators: 
 
 
Barry Kogan, MD 
 
Karla Giramonti, FNP 
 
Brenda Romeo, CCRC 
 
Laura Davey, CCRC 
 
 
 
Jordan Gitlin, MD 
 
Northwell Health Center 
 
Ronnie Fine, MD 
 
Lane Palmer, MD 
 
Jessica Sultan, PA 
 
Jovita Kwan, NP 
 
 
 
 

 
 
 
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A. STUDY BACKGROUND AND PURPOSE 
Nocturnal enuresis is a common pediatric problem of both urologic and neurologic/behavioral 
etiology.  It can result in a great deal of patient and caretaker embarrassment and frustration with 
psychiatric consequences.  While some patients respond to conventional therapy aimed at behavioral 
practices, many fails and need additional measures.  The bedwetting alarm is usually next in line; 
however, many patients do not wear the device properly; “heavy sleepers” will usually not form the 
cognitive connections when the alarm sounds, and caretakers will not respond properly in awaking the 
patient during the alarm.  After this comes pharmacologic therapy, which comes with its own set of 
medical side-effects and costs to the patient.   
 
 
Neuromodulation has been shown to control various voiding disorders in both adults and children, 
along with experimentation with TENS units in controlling symptoms.  TENS units placed in various 
locations stimulating a neurologic loop have been shown to control urinary symptoms in children with 
promising results [1,2,5,7,10,11,12].  TENS units have been shown to be safe with rare side effects and 
have the potential to be used in the convenience of a patient's home instead of undergoing surgery or 
multiple clinic sessions like other forms of neuromodulation.   
 
Previous studies have shown evidence for neurologic manipulation in treating nocturnal enuresis 
[4,8,10].  If our study shows TENS units are an effective therapeutic option in decreasing nocturnal 
episodes, this form of management could be offered to the patient with the benefits of convenience of 
usage and avoidance of additional medications, thus enhancing the patient's and caretaker's quality of 
life that comes with the improvement of symptoms.  Our recent findings have shown that when 
combined with proper behavioral voiding techniques, nightly posterior tibial nerve TENS for one 
month showed promising results in decreased enuresis and patient quality of life with lasting durability 
[18].  In that study, we used a pulse rate of 10 Hz during treatment, however this was chosen based on 
this frequency being used in prior studies.  This study will identify the most efficacious pulse rate used 
when placing the TENS unit on the ankle to obtain the best results, which has yet to be determined.  
These findings will in turn lead to proper patient development, physical, mental, and overall health.    
      
The goal of this study is to determine which pulse rate is the most effective to use in posterior tibial 
transcutaneous electric nerve stimulation for treating nocturnal enuresis in children.   
 
 
Specific Aim:  To determine if a short, moderate, or long pulse rate used in posterior tibial TENS 
(Groups 1-3) is optimal in improving nocturnal enuresis (decreased nocturnal episodes and increased 
patient/caretaker satisfaction). 
 
 
Hypothesis:  A moderate frequency used in TENS will show the most improvement in 
nocturnal enuresis compared to short and long frequencies.  
 
B. STUDY DESIGN 
Children ages 5-18 years old referred to the pediatric urology clinic at Albany Medical Center Division 
of Urology and Northwell Heath Division of pediatric urology for primary nocturnal enuresis will be 
screened for enrollment. Information shared between these two institutions will be de-identified (i.e., 
age, gender, and randomization number will be shared, but name, date of birth, and medical record 

 
 
 
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number will not be shared).  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 (e.g., 
Lithium for bipolar disorder), other known voiding or neurologic disorders (e.g., overactive bladder, 
myelomeningocele), secondary etiologies for nocturnal enuresis (e.g., 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 we have previously found posterior 
tibial TENS to be effective and lasting, and as such all patients will be treated.  We will aim to recruit 
30 patients per group for a total of 90 patients.  
 
Study Procedures 
The first visit (Day 0) will take place in the clinic during the patient’s routine visit. A detailed 
explanation of the purpose of the study, along with the risks and benefits of TENS will be given to the 
patient and parents by a provider prior to obtaining informed consent for enrollment into the study. 
After informed consent and assent, if applicable, has been obtained, parents or the patient will fill out 
the Pediatric Urinary Incontinence Questionnaire (PIN-Q), a validated tool for measuring quality of 
life in children with bladder dysfunction [6]. The patients and parents will be taught behavioral 
modification and the 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.   
 
After the 30 days the patient will again be seen in the clinic for the randomization visit (Day 30). The 
PIN-Q will be completed, and the voiding diary collected.  The diary will be reviewed for nocturnal 
enuresis episodes and the patient will be randomized into the study if they have at least 2 nocturnal 
enuresis episodes per week. If the patient does not qualify, they will be offered therapy with a 
bedwetting alarm device or other treatment. 
 
The parent will receive the TENS unit and electrode pads for their child.  The patients/parents will be 
instructed on how to use the device including positioning of electrodes, as well as given written 
instructions. The TENS unit settings will be pre-determined at the clinic and measures will be taken to 
ensure that the settings cannot be altered at home. 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. 
 
 
 

 
 
 
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Group 1 he/she will be in the short frequency group.  This means that the TENS therapy will use a 
pulse rate of 2 Hz.   
 
Group 2, he/she will be in the moderate frequency group.  This means that the TENS therapy will use 
a pulse rate of 10 Hz.  
 
Group 3, he/she will be in the long frequency group.  This means that the TENS therapy will use a 
pulse rate of 150 Hz.  
 
Parents/patient will be given a voiding diary again for the month that they are using the TENS unit 
before bedtime.  In this diary, the number of incontinent episodes, the severity of wetness each night, 
and the duration of TENS therapy, and adverse reactions to the TENS unit will need to be recorded. 
 
 
 
 
At the end of the 30-day treatment period the visit will be done in the office (Day 60).  
The TENS unit and the treatment voiding diary will be returned, and the PIN-Q will be completed.  
The parents/child will also be asked the question “Would you use TENS therapy again for your 
[child's] bedwetting problem?”  Any persistent issues will be addressed during the final visit as well.  
 
C. SUBJECT POPULATION (WHO, WHAT, WHERE) 
Inclusion criteria for cases:  
1. Age 5-18 years of age seen at Albany Medical Center Division of Urology 
2. Presenting with nocturnal enuresis (more than 1x a week) 
3. Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to 
bedtime, bowel habits, social anxiety factors) 
4. Ability to provide informed consent and assent and complete study requirements 
 
Exclusion criteria for cases:  
1. Patients who have previously tried pharmacologic treatment for nocturnal enuresis, 
neuromodulation or other alternative therapy for urologic disorders within the past 30 days 
2. Daytime incontinence symptoms  
3. Known “high volume” voiders (determined from history)  
4. Bedwetting episodes on the average of less than two times per week, 
5. Medications predisposing to incontinence (e.g., Lithium for bipolar disorder) 
6. Other known voiding or neurologic disorders (e.g., overactive bladder, myelomeningocele, 
interstitial cystitis, etc.) 
7. Secondary etiologies for nocturnal enuresis (e.g., cystitis, obstructive sleep apnea, urinary 
fistulae, heart disease) 
8. 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)  
9. Any history of heart disease or complications 
 
 

 
 
 
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D. DATA ANALYSIS 
The data collection list is attached to the protocol. The data will be collected on a deidentified excel 
spreadsheet by patient study number and the deidentified data will be entered into the database.   
The source documents and informed consents will be kept in the Urology Research Office. 
The objective of this study is to evaluate which pulse rate is the most efficacious in transcutaneous 
electric nerve stimulation (TENS) as a therapeutic option for nocturnal enuresis in children. The 
proposed study will be a randomized clinical trial. There will be three treatment arms:  
 1. Group1:TENS pulse rate is set to 2 Hz 
 2. Group2:TENS pulse rate is set to 10 Hz 
 3. Group3:TENS pulse rate is set to 150 Hz  
The study will be conducted for a total of 2 months (60 days), with two 30-day phases:  
1. Baseline Measurement of“ wet nights”(without treatment)for30days[Month1]  
2. Active TENS treatment for 30 days [Month 2]  
The Pediatric Incontinence Quality of Life Measure questionnaire (PinQ) is completed at the end of the 
baseline month. 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. 
RANDOMIZATION  
Subjects will be randomly assigned with equal probability to either one of the three study groups. 
Randomization will be done by the statisticians at AMC to provide randomization. Allocation-
concealment will be achieved by using sealed envelopes opened only after subjects are enrolled.   
Rrecord keeping will be from daily patient diaries before and during TENS treatment.  The number of 
wet beds per month, the compliance rate (used TENS or not), the wetness scale (0 to 3), whether there 
was wetness during the day, whether there was a bowel movement, the PinQ scores before and at the 
completion of treatment, and any patient comments are recorded. Patient demographic will include 
age, gender, and pertinent urological history, if any.     
BLINDING  
There will be no blinding. Both study participants/caretakers and physicians will have knowledge of 
the treatment assignments.  
INTENTION-TO-TREAT  
All subjects will be analyzed according to the intention-to-treat [ITT] principle. A patient will be 
considered evaluable and will be included in the intention-to-treat analysis if the patient has 
documented at least 12 sessions of their designated TENS treatment (about 3 times a week of TENS 
therapy. Analyses that take into account the actual treatment received (e.g. non-compliance, etc.) will 
be carried out as a secondary analysis (per protocol [PP] analysis).  
Primary Statistical Objective:  
The primary objective of the study is to compare the three TENS treatment groups after one month of 
treatment, with respect to:  

 
 
 
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The reduction in the number of “wet nights” from baseline to after one month of therapy  
The proportion of responders after one month of therapy  
The change in PinQ scores from baseline to one month of therapy.  
Secondary Statistical Objectives:  
Secondary objectives include: comparison of the three treatment groups with respect to the number of 
“wet nights” and PinQ scores, separately, over time (by weekly diary entries)). Analysis will be carried 
out to determine if there are time dependent  changes in the number of “wet nights” or in PinQ scores  
across the three TENS treatment groups. The number of “wet nights” according to severity will be 
examined as well. This will generate information on whether tolerance or sensitization occurs with this 
treatment.    
Pairwise comparisons of TENS groups will also be carried out to compare each arm with one another 
using Tukey’s multiple comparison tests.  
Outcome Variables and Schedule of Assessments:  
The primary outcome variable of interest is patient’s percentage change in “wet nights” from before to 
during TENS.   Also evaluated will be the response to treatment at the end of the 30-day TENS therapy 
period. A patient is said to have a (favorable) response to the treatment if he/she has a decrease of at 
least 50% in the number of “wet nights” in a month from baseline to after one month of TENS therapy.  
Demographics and patient characteristics will be collected at baseline (age, gender, medical history). 
The following outcomes will be measured at baseline and at  1 month (at the end of the 30-day TENS 
therapy):  
 Number of “wetnights”  
 Severity of enuresis (dry, damp, wet, soaked)  
 PinQ scores  
Statistical Methods  
For the primary objectives:  
 Analysis of variance with a fixed effect of treatment with Tukey’s multiple comparison test will 
be used to test for differences in the reduction in wet nights among the three treatment arms.  
Reduction will be parameterized as a relative change from baseline to one month. PinQ 
response before and after treatment will be compared among the three groups using repeated 
measures ANOVA with Tukey’s multiple comparison tests.    
 The Chi-square test or Fisher’s exact test, as appropriate, will be used to compare the rates of 
response between the three treatment arms at the end of the 30-day treatment period.  
For the secondary objectives, a repeated measures analysis of variance  will be used to analyze  the 
outcomes of interest on a week to week basis (number of “wet nights”). A treatment-by-time 
interaction will be examined to determine if the patterns of change in “wet nights” or PinQ scores over 
time differ across groups. Adjusted pairwise comparisons (Tukey or Bonferroni method) will be used 
to compare treatment groups to one another.  

 
 
 
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Data transformations may be applied, if necessary, in order to meet the required standard model 
assumptions.  
 
Sample Size Considerations  
We propose to recruit 30 patients to be randomly assigned to each of the three groups for a total of 90. 
Allowing for 20% dropout rate (due to non-compliance, insufficient number of treatment sessions, lost 
to follow-up or protocol violation, etc.), we expect 24 patients per group with complete evaluable data.  
The primary outcome variable will be percentage change in the number of wet nights relative to 
baseline.  The study will have 81% power to detect differences in the change in percentage of wet 
nights among the three groups of 30% or more. This calculation also assumes that the normal month to 
month variation is percentage of wet nights is 30% and an alpha of 0.05.       
Based on investigator expertise and some published studies, we assume that the proportions of 
responders based on our criteria of a “favorable response” for each of the three TENS groups will be 
70% for moderate frequency (Group 2), 60% for short frequency (Group 1), and 40% for long 
frequency (Group 3).  
The estimated 60% response rate for the sacral region stimulation was based on studies by Lordêlo1 et. 
al. (2010) and Oliveira2, et. al. (2013). Our previous findings showed placing the TENS unit on the 
foot was superior to the sacral region with frequencies set to 10 Hz, which is our moderate frequency 
in this study.   We also believe that the response will be better with a lowfrequency compared to a high 
frequency.  
Conduct of the study 
The principal investigator, Dr. Adam Howe, is responsible for overall oversight of the data, monitoring 
the data, assuring protocol compliance, and conducting the safety reviews. Our prior study showed all 
patients enrolled in the study had no safety concerns. Dr. Howe will also be responsible for compiling 
the data sheets, day to day oversight of research and ensuring the integrity and privacy of the data. 
During the review process the principal investigator, along with the other investigators, will evaluate 
whether the study should continue unchanged, require modification/amendment, or close to enrollment 
after 30 patients have been enrolled (half-way point of the study). The principal investigators or the 
Institutional Review Board (IRB) have the authority to stop or suspend the study or require 
modifications. 
Any worsening symptoms or adverse reactions will be reported to the examiners, by way of voiding 
diaries, phone calls from parents, monthly clinic visits, or reported by parents aside from these 
instances.  For patients with any severe or persistently worsening symptoms or adverse reactions, 
TENS therapy will be immediately discontinued, they will be removed from the study and considered 
treatment failures and receive medical treatment as necessary.  Skin irritation is the most common 
adverse reaction to TENS units; however, this is mostly associated with allergy to the self-adhesive 
electrodes [9].  While pain may be a complication with TENS, studies have shown TENS is actually 
beneficial in treatment of pain over different areas of the body [14].  
Patients with contraindications to TENS (eg, other electrical devices, pregnancy, bleeding or clotting 
disorders, unhealthy tissue, seizure disorders, malignancy, impaired cognition) will be excluded from 
the study.  Patients will be taught safe practice with the use of a TENS unit, such as performing a 
sensory discrimination test in the office, checking and cleaning skin before starting a TENS session, 
monitoring skin for signs of irritation, changing adhesive on electrode pads after each use, securing 

 
 
 
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electrodes with even pressure distribution and full contact, and watching for signs of TENS unit 
malfunction requiring maintenance [9].   
 
Patients and parents will be instructed to adjust the intensity to the level they can tolerate, so if the 
TENS intensity is too high then the patients will not be able to tolerate. Pain is the main issue with 
increased intensity (when it is not used to actually treat pain), therefore intensity will be minimized as 
per protocol to prevent this (“to the patient’s tolerance”).  Increased intensity would be assumed to lead 
to skin break down, however, reports of this are exceedingly rare (15).  Patient education will be 
crucial here.   
While reports of dermatitis have been reported in the literature, in most of these cases the dermatitis is 
caused by an allergy to the adhesive on the TENS electrode pads and not the actual electrical 
stimulation.  Skin irritation can occur, but this is mostly seen in cases where TENS therapy has been 
used for multiple hours in a row.  There has been only one case report in the literature (and not even 
searchable in Pubmed) of an actual burn from a TENS unit (16).  In contrast, TENS therapy is actually 
used for pain relief on burn patients.   Therefore, the risk of being burned from TENS therapy is 
extraordinarily low.   
The effects of prolonged TENS usage have been studied in the literature before. Joennsson et al 
showed TENS therapy, with setting the same as in our proposal, for a mean duration of 566 minutes 
(range from 362-770 minutes) did not lead to any adverse reactions in 20 children with overactive 
bladder (17). 
E. RISKS 
The risks are minor and unanticipated. If there are any irritation to the TENS unit, the patient will be 
taken off of the study.  
 
Adverse reactions to the TENS units:  The parents and patient will be closely monitored and 
encouraged to call during the treatment period with any questions, concerns, or if the child is not 
experiencing any adverse reactions to TENS therapy.  Risks can include pain, skin irritation, 
dermatitis, or burns. The most common reaction to the TENS unit is skin irritation related to an allergy 
to the self-adhesive electrodes.   
 
Safe use of TENS units:  The parents and patient will be educated to safely use the TENS unit, 
including monitoring for signs of irritation, changing adhesive on the electrode pads after each use and 
securing the electrodes appropriately and alternating the side of each electrode in terms of laterality 
(for example, place the electrode pads on the right foot on one day, then on the left foot on the next 
day, etc.). Failure to adhere to safety guidelines could result in an adverse reaction to TENS therapy 
and dismissal from the study.  
 
 Malfunction of the TENS units:  The parents will be taught how to monitor the TENS unit they are 
given for signs of malfunction that will require immediate maintenance. 
 
F. BENEFITS 
Patients enrolled into this study will have failed first-line conventional behavioral modification.  The 
patients may or may not have previously tried the bedwetting alarm device and failed.  They would be 

 
 
 
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offered TENS therapy and thus enrollment into the study as an alternative to pharmacologic therapy 
for nocturnal enuresis (ie, desmopressin, imipramine, anticholinergics) after proper counseling of the 
risks and benefits by the provider and signing an informed consent.  TENS units have been shown to 
be safe with very rare side effects reported in studies.  Patients experiencing side effects or adverse 
reactions to TENS will terminate treatment and receive prompt medical attention.  Follow up after 
treatment will determine if continuation of TENS therapy should resume as to avoid unnecessary 
treatment delay with other modalities.   
 
G. CONFIDENTIALITY 
All data will be kept in an excel database file on the secure AMC network with access restricted to the 
study personnel which is HIPPAA compliant to protect the confidentiality of patients. Consents will be 
taken in private locations to ensure privacy is not invaded. Data will be stored until at least 3 years 
after IRB closure or after Publication whichever is longer. 
H. OPTIONS 
Rather than participate in this study the subject can opt for standard assessment and care. 
 
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19.  Howe et al. Transcutaneous electric nerve stimulation (TENS) for the treatment of nocturnal 
enuresis in children. [NOT YET IN PRESS]