Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
Phase: NA
Conditions: Overactive Bladder, Voiding Disorders, Incontinence, Urinary
Sponsor: University of Utah

 
 
 
 
Project Title 
Feasibility of home parasacral transcutaneous electrical nerve stimulation for voiding dysfunction in the 
pediatric population – a pilot study 
 
NCT ID Number: 117756 
 
Principle Investigators 
Glen Lau, MD, Anthony Schaeffer, MD 
 
Co-Investigators 
DeeAnn Cervantes, NP, AnnMarie Hannon, NP, Heidi White, NP, Neha Malhotra, MD 
 
Document Date 
January 23, 2019 
 
 

 
 
 
Background/Justification 
Overactive bladder (OAB) is the most common voiding dysfunction in children1. While many 
children may outgrow these issues, for some these symptoms persists and can lead to emotional, social, 
behavioral and physical problems.  Multiple treatments exist for OAB but rarely is there guaranteed 
success. Many behavioral and lifestyle treatments involve a significant time investment and office visits 
on the part of the patient and family. Furthermore, medication therapy is often associated with 
bothersome side effects and is discontinued, even despite efficacy2.  As such, treatments with 
potentially less adverse effects, often used in adult urology, are making their way into the pediatric 
urology practice. These include intravesical botulinum toxin injections, sacral nerve stimulation (SNS) 
and percutaneous tibial nerve stimulation (PTNS). 
PTNS, first cleared by the United States Food and Drug Administration (FDA) in 2011 for adult 
use, has evolved into transcutaneous nerve stimulation in the pediatric population; obviating the need 
for needles during treatment. Studies suggest mixed efficacy in electric nerve stimulation for overactive 
bladder in the pediatric population, owing largely to the marked heterogeneity in treatment protocols. 
While some researchers follow the traditional tibial nerve pathway, others take a cue from SNS and 
target the parasacral area, while still others rely on signaling from even further peripheral nerves to 
modulate bladder overactivity 3-5. Perhaps further contributing to the disparate data is the varying 
treatment schedules used. Some centers perform treatments daily, others weekly, others twice or thrice 
a week. Similarly, some physicians recommend twenty-minute treatments, while others thirty or even 
sixty minutes. The majority of studies rely on an office-based treatment model, while a few have 
explored in home treatments3-5. In the United States, there has been no study examining the feasibility 
or efficacy of home parasacral transcutaneous electric nerve stimulation (PTENS) on pediatric voiding 
dysfunction. 
 
Definitions 
Terminology adheres to the standards recommended by the International Children’s Continence Society 
(ICCS) except where specifically noted6. 
Bowel and bladder dysfunction (BBD) concomitant bladder and bowel disturbances – does not explain 
etiology but describes parallel dysfunction 
Lower urinary tract dysfunction a term encompassing many times of urinary dysfunction (see below) in 
children older than 5; excludes bowel dysfunction 
Increased voiding frequency ≥8 voids per day; may be subjectively described as fewer than 8 voids 
Incontinence involuntary leakage of urine; includes continuous and intermittent incontinence – 
continuous incontinence is typically associated with an anatomic abnormality 
 
Daytime incontinence intermittent incontinence that occurs while awake 
 
Enuresis intermittent incontinence that occurs exclusively during sleeping periods; though 
enuresis is sometimes used to refer to daytime incontinence, the ICCS definition specifies nocturnal 
Urgency sudden and unexpected experience of an immediate and compelling need to void 
Overactive bladder condition in which a child experiences urgency symptoms; may or may not be 
associated with incontinence; replaces the term bladder instability7 
Nocturia waking at night specifically to void; distinct from enuresis, in which the child is incontinent 
during sleep 
 
Specific Aims 
Primary Aims 
1. To examine feasibility (adherence) of thrice weekly, thirty minute home treatment sessions 
2. To evaluate recruitment into a randomized trial for pediatric voiding dysfunction 

 
 
3. To refine, if needed, treatment protocol for both study and control groups  
4. To estimate effect size, with point estimates and confidence intervals, of treatment and control 
groups 
Secondary Aims 
1. To confirm safety and identify potential adverse events with use of in-home PTENS 
2. To identify possible barriers to in-home PTENS 
3. To compare the efficacy of in-home, PTENS to traditional behavioral therapy on parameters of 
urinary voiding dysfunction in the pediatric population 
4. To explore efficacy of in-home, PTENS to traditional behavioral therapy on parameters of bowel 
dysfunction in the pediatric population 
 
Recruitment Methods 
 
Participants will be recruited through the Primary Children’s Urology Clinic by nurse 
practitioners. Patients and families of patients with diagnoses of enuresis or daytime incontinence (ICD-
10 R32), bladder instability (ICD-10 N32.89), bladder dysfunction (N31.9), nocturnal enuresis (N39.44), 
nocturnal and diurnal enuresis (ICD-10 N39.498), urinary frequency (ICD-10 R35) and urinary frequency 
(ICD-10 R39.15), who meet inclusion criteria, will be counseled on possible study enrollment by the 
primary treating nurse practitioner. Clinic schedules, with reason for visit, will be queried twice weekly 
by study coordinators (non-clinical personnel) to identify potential subjects based on keywords including 
incontinence, dysuria, urinary tract infection (UTI), enuresis, wetting, urinary retention, incomplete 
emptying, voiding dysfunction and dysfunctional voiding. Providers will be given a list of potential 
subjects.  Subjects will be randomly assigned into either treatment or control by study coordinators 
using an electronic randomization function using Research Electronic Data Capture software (REDCap). 
Patients and families will be asked no more than once to consider participation in the study. A potential 
patient list, screening log and patient numbers will be kept in a secure file on a secure drive on the 
University of Utah servers.   
 
Sample Size 
 
Based on prior work in examining continuous variables for averages and variability during pilot 
studies, the recommended sample size per group is 12 subjects8. To account for attrition, 15 subjects 
will be randomized to each group.  
 
Characteristics of Participants 
 
Inclusion Criteria 
 
 
Toilet trained (>age 6) to age 18 
 
 
Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency 
incontinence, nocturnal enuresis  
 
 
 
 
Exclusion Criteria 
 
 
Known neurologic diagnosis – such as myelomeningocele, caudal regression 
 
 
Known seizure disorder 
 
 
Age < 6 or > 18 
 
 
Lack of follow-up within 6 months of treatment 
 
 
Pacemaker, vagal nerve stimulator, or other implanted electrical device 
 
 
Intolerance of electrical nerve stimulation 
 
 
Pregnancy 
 
 
Implanted metal hardware 
 
 
Open sores or wounds over the sacral area  

 
 
 
 
Currently catheterizing for bladder drainage 
 
 
Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic) 
 
 
Bowel only voiding dysfunction (Constipation ICD-10 K59.00) 
 
 
Non-English speaking families 
 
 
Families with health literacy precluding completion of questionnaires and voiding diaries 
Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic 
treatments 
Untreated urinary tract infection 
 
Summary of Methods 
At the initial visit all subjects will complete a Dysfunctional Voiding Symptom Score (DVSS) and be given 
a packet on controlling overactive bladder and pediatric enuresis (see Appendix 1). All subjects will then 
complete a 48-hour voiding diary, a nighttime wetting log (at home), a urinalysis and culture, a renal and 
bladder ultrasound, a non-invasive uroflowmetry test and they will watch short videos on daytime and 
nighttime wetting as well as constipation in children. (All items at this visit are standard of care) They 
will also complete a medical colon cleanout using polyethylene glycol and senna, as is the current clinic 
standard of care.  
 
In 4-6 weeks, after all testing is completed, all subjects will follow-up for review of these testing results. 
(This follow-up visit is considered standard of care). Patients who had a positive urine culture or other 
abnormalities found on ultrasound or uroflowmetry that suggest an anatomic obstruction will be 
excluded from this research study.  
 
Subjects who are still eligible to participate will then be randomized, at the same office visit, using an 
online randomization tool to either standard behavioral therapy (control) or standard behavioral 
therapy in addition to the PTENS device.  Subjects will then be instructed on standard behavioral 
therapy or standard behavioral therapy in addition to PTENS (see Appendix 2). This randomization is for 
research purposes only.  
 
Subjects will then be contacted weekly by study personnel to assess and document treatment 
adherence as well as identify any potential adverse events. (Research Purposes Only) 
 
 In 6 weeks, subjects will complete (at home) a voiding diary, a wetting log and a DVSS. These will be 
transmitted to the office through secure e-mail and uploaded into the chart. (Research Purposes Only) 
 
In 12 weeks, subjects will follow-up in clinic with repeat voiding diary, wetting log and DVSS for further 
assessment and discussion of treatment adherence, barriers to adherence and adverse events, if any. 
(This visit is standard of care and would occur regardless of the patient participating in the research 
study) 
 
Risks and/or Ethical Issues 
Based on previous data, there is a risk of minor skin irritation or redness at the application site9, and 
families will be informed of this prior to initiation of treatment and be instructed to discontinue 
treatment if this occurs. Previous studies have shown this risk to be <20%9. This can be prevented by 
correct placement and adherence to recommended treatment10. Other foreseeable risks may be pain at 
the site of electrode application. No serious side effects have been reported10. There is a risk of 
psychological stress (some children may experience frustration with the length of the treatment or with 
the process itself) of treatment. This will be monitored throughout the study period.  

 
 
 
There is a risk of loss of confidentiality. Data will be obtained from the medical record and patient 
encounters and be maintained on case report forms that will be stored in a locked office. This data will 
be entered into REDCap. REDCap is a HIPAA-compliant, secure database that restricts access to study 
data based on user roles and permissions. Patient list will be kept in a password-protect file, on a 
password-protected desktop computer, in a locked office. 
 
There is a potential ethical issue of continuing inferior treatment. If interim analysis reveals clear 
superiority of one treatment type or schedule, other study participants will be offered the superior 
treatment option. 
 
Benefits 
Subjects may benefit from this study in improvement in their lower urinary tract symptoms.  
 
Informed Consent Process 
IRB compliant informed consent from parents (or guardians) will be undertaken and documented (See 
Appendix 3). Assent for children will be obtained as age appropriate.  
 
Measures to Protect Privacy and Confidentiality of Participants 
The confidentiality of all patient information will be maintained and all guidelines set forth by HIPAA and 
the IRB will be strictly adhered to. All patient data will be stored on either in a password-protected file, 
on a password-protected desktop computer in a locked office, case report forms in a locked office, or 
electronically in REDCap on a secure server. Any information used in statistical analysis will be de-
identified.  No identification of patients will be made in any presentations or publications related to this 
study 
 
Timetable 
Pilot study and data gathering will be undertaken over the next three months (January 2019 – March 
2019). One month will be given to analyzing the feasibility, designing and randomized trial and 
completing the IRB process. Once pilot study has been completed and analyzed, this data will be used to 
refine and complete a larger scale randomized control trial. Plan will be for study to take place over a 
six-month period, estimated to be Summer through Winter of 2019. 
 
Data Management of Statistical Analysis 
Descriptive statistics of the study population will be completed. Univariate relationships between 
potentially relevant clinical and demographics factors will be determined. 
T-test or Wilcox-Mann-Whitney test and chi-squared test will be used to determine differences and 
relationships between variables. 
Assistance in statistical analysis has been sought from the center for Study Design and Biostatistics. 
 
Cost, Compensation and Participant Reimbursement 
During the initial pilot study, families will not bear the cost of acquiring a TENS unit and a unit will be 
loaned to them after they are randomized.  The unit will be returned at the end of the study.  There will 
be no participant compensation or reimbursement. 
 
Safety and Clinical Monitoring 

 
 
Families will be contact weekly to monitor for any adverse reactions as well as to assess adherence to 
treatment protocol. Contact will consist of a phone call from study personnel. If unable to make contact 
a voicemail with follow-up number will be left. 
 
Provisions for Research Related Injury 
Patients and families will be counseled on known potential adverse reactions (redness and skin 
irritation) and to discontinue use if these should occur. At this time, there are no provisions for research 
related injury. 
 
Future Work 
The goal of this pilot study is to assess recruitment and adherence feasibility as well as understand 
averages and variability in improvement. These data will be used to power and perform a larger, 
randomized control trial to assess efficacy of home-based, PTENS and compare this to traditional 
behavioral therapy. Our goal is not to have the PTENS indication updated to show that it can be used for 
voiding dysfunction 
 
Abbreviations 
BBD Bowel and bladder dysfunction 
ICCS International Children’s Continence Society  
ICD-10 International Statistical Classification of Diseases and Related Health Problems – 10th Revision 
LUTD Lower urinary tract dysfunction 
PTENS Parasacral transcutaneous electrical nerve stimulation 
REDCap Research Electronic Data Capture software 
TENS Transcutaneous electrical nerve stimulation 
UTI Urinary Tract Infection 
 
References 
1. 
Franco I. Overactive bladder in children. Part 1: Pathophysiology. J Urol. 2007;178(3 
Pt 1):761-768; discussion 768. 
2. 
Ramsay S, Bolduc S. Overactive bladder in children. Can Urol Assoc J. 2017;11(1-
2Suppl1):S74-S79. 
3. 
Ferroni MC, Chaudhry R, Shen B, et al. Transcutaneous Electrical Nerve Stimulation 
of the Foot: Results of a Novel At-home, Noninvasive Treatment for Nocturnal 
Enuresis in Children. Urology. 2017;101:80-84. 
4. 
Boudaoud N, Binet A, Line A, et al. Management of refractory overactive bladder in 
children by transcutaneous posterior tibial nerve stimulation: A controlled study. J 
Pediatr Urol. 2015;11(3):138 e131-110. 
5. 
de Paula L, de Oliveira LF, Cruz BP, et al. Parasacral transcutaneous electrical neural 
stimulation (PTENS) once a week for the treatment of overactive bladder in 
children: A randomized controlled trial. J Pediatr Urol. 2017;13(3):263 e261-263 
e266. 
6. 
Austin PF, Bauer SB, Bower W, et al. The standardization of terminology of lower 
urinary tract function in children and adolescents: Update report from the 
standardization committee of the International Children's Continence Society. 
Neurourol Urodyn. 2016;35(4):471-481. 
7. 
Neveus T, von Gontard A, Hoebeke P, et al. The standardization of terminology of 
lower urinary tract function in children and adolescents: report from the 

 
 
Standardisation Committee of the International Children's Continence Society. J 
Urol. 2006;176(1):314-324. 
8. 
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot 
studies in clinical and translational research. Clin Transl Sci. 2011;4(5):332-337. 
9. 
Jorgensen CS, Kamperis K, Borch L, Borg B, Rittig S. Transcutaneous Electrical Nerve 
Stimulation in Children with Monosymptomatic Nocturnal Enuresis: A Randomized, 
Double-Blind, Placebo Controlled Study. J Urol. 2017;198(3):687-693. 
10. 
Bower WF, Yeung CK. A review of non-invasive electro neuromodulation as an 
intervention for non-neurogenic bladder dysfunction in children. Neurourol Urodyn. 
2004;23(1):63-67. 
 
 
 
 
 
 

 
 
Date: 
 
 
48-Hour Weekend Voiding Diary 
Day 1 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
Date: 
 
 
48 Hour Weekend Voiding Diary 
Day 2 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
 
Starting Date: 
 
Nighttime Wetting Log (14 nights) 
 
Night 
Wet (Yes or No) 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Name 
DOB 
MRN 

 
 
 
Date: 
Dysfunctional Voiding Scoring System 
 
Over the last month 
Almost 
never 
Less than 
half the 
time 
About half the 
time 
Almost every 
time 
I have had wet clothes or 
wet underwear during the 
day 
0 
1 
2 
3 
When I wet myself, my 
underwear is soaked 
0 
1 
2 
3 
I miss having a bowel 
movement every day 
0 
1 
2 
3 
I have to push for my bowel 
movements to come out 
0 
1 
2 
3 
I only go to the bathroom 
one or two times each day 
0 
1 
2 
3 
I can hold onto my pee my 
crossing my legs, squatting 
or doing the “pee dance” 
0 
1 
2 
3 
When I have to pee, I 
cannot wait 
0 
1 
2 
3 
I have to push to pee 
0 
1 
2 
3 
When I pee it hurts 
0 
1 
2 
3 
Parents: Has your child 
experience something 
stressful like the example 
below? 
 
No (0) 
 
Yes (3) 
Total 
 
 
Stressors: New baby, new home, new school, school problems, abuse (sexual/physical), home 
problems (divorce/death), special events (birthday), accident/injury, others 
 
 
Name 
DOB 
MRN 

 
 
Bowel and Bladder Retraining and Fitness 
Colon Clean-out 
For all children 
Recommended to be done on a weekend 
 
Senna (Ex-lax®) squares – 1 square for 6-12 year olds; 2 squares for those over 12 
Polyethylene glycol (Miralax®) – 17 grams (one capful) in 8 ounce of water 
Take both senna and polyethylene glycol every 12 hours for four doses.  
(For example, Friday evening, Saturday morning, Saturday evening and Sunday morning) 
 
Stool should be clear/watery at the end of the clean-out. If not, repeat the following weekend. 
 
Bowel Health Maintenance 
For children with bowel dysfunction, such constipation or fecal soiling  
Polyethylene glycol 
Take polyethylene glycol daily – one capful in 8 ounces of water once per day. Adjust dose to 
maintain a soft, semi-formed bowel movement. This may require every other day dosing, half 
capfuls or two capfuls 
 
Toilet sitting 
After each meal and after school for 5-10 minutes sit on a toilet and practice deep breathing 
and pelvic floor relaxation techniques 
 
For all children 
Dietary changes 
Eat plenty of fiber and drink plenty of water (see Guide to Fiber and Fluid below) 
 Age plus five equals the number of grams of dietary fiber a child should eat per day 
Limit dairy to three servings daily – two 8-oz glasses of milk and one cheese/yogurt 
 
Foods and Drinks to Avoid 
Some foods and drinks are known to make you pee more, because they bother your bladder or 
because they have things that make you pee. It doesn’t mean you can’t have them at all, but 
limiting them will help you stay dry 
Spicy foods 
Sugary drinks, including juice 
Caffeine  
 
Fluid Timing 
No fluids within three hours of bedtime 
 
For example, if you go to bed at 9pm you should try not to drink after 6pm 
 
 
This may mean eating dinner earlier! 
 
It is ok to drink a sip of water if you need to take medicine 
 
 

 
 
Exercise 
Exercise, play sports or play outside at least sixty minutes five times per week 
 
Guide to Fiber and Fluid 
High Fiber Foods 
Whole grain bread 
Whole wheat pasta 
Apples, with skin 
Raspberries  
Pears, with skin 
Bran flakes 
Oatmeal 
Black beans 
Green peas 
Artichokes 
 
Drink Plenty of Water 
 
6 years old 
6 cups (48 oz.) 
7 years old 
7 cups (56 oz.) 
≥8 years old 
8 cups  (64 oz.) 
 
Bladder Retraining and Fitness 
Scheduled voiding 
Timed voiding you should pee every two hours while you are awake 
 
You may need to set a watch alarm to help you remember in the beginning 
 
We have a note for school to give to your teacher, if needed 
 
Double voiding after you pee you should wait ten to fifteen minutes and try to pee again 
 
This is especially important at night to keep you dry 
For example, before you get ready for bed you should pee, then after your brush 
your teeth, wash your face, and change your clothes, right before you go to bed, you 
should pee again  
 
You can also do this before long car trips or activities that tend to make you leak 
 
Midnight voiding set an alarm and wake-up once at night to pee 
 
This is for kids who are mostly wet at night 
 
Pelvic floor relaxation 
Be sure to do at least 3-5 relaxation breaths during each void 
Deep breath in and blow out through an open mouth to a count of five 
For younger children, it may help to use bubbles or a pinwheel 
For girls, sit up straight with your feet on the floor (or a stool) and your knees wide apart 
 
It may help to take one foot out of your pants and underwear 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
At 6 weeks 
 
 

 
 
Date: 
 
 
48 Hour Weekend Voiding Diary 
Day 1 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
Date: 
 
 
48 Hour Weekend Voiding Diary 
Day 2 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
 
Starting Date: 
 
Nighttime Wetting Log (Any 7 consecutive nights) 
 
Night 
Wet (Yes or No) 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Name 
DOB 
MRN 
 

 
 
 
Date: 
Dysfunctional Voiding Scoring System 
 
Over the last month 
Almost 
never 
Less than 
half the 
time 
About half the 
time 
Almost every 
time 
I have had wet clothes or 
wet underwear during the 
day 
0 
1 
2 
3 
When I wet myself, my 
underwear is soaked 
0 
1 
2 
3 
I miss having a bowel 
movement every day 
0 
1 
2 
3 
I have to push for my bowel 
movements to come out 
0 
1 
2 
3 
I only go to the bathroom 
one or two times each day 
0 
1 
2 
3 
I can hold onto my pee my 
crossing my legs, squatting 
or doing the “pee dance” 
0 
1 
2 
3 
When I have to pee, I 
cannot wait 
0 
1 
2 
3 
I have to push to pee 
0 
1 
2 
3 
When I pee it hurts 
0 
1 
2 
3 
Parents: Has your child 
experience something 
stressful like the example 
below? 
 
No (0) 
 
Yes (3) 
Total 
 
 
Stressors: New baby, new home, new school, school problems, abuse (sexual/physical), home 
problems (divorce/death), special events (birthday), accident/injury, others 
 
 
 
Name 
DOB 
MRN 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
At 12 weeks 
 
 

 
 
Date: 
 
 
48 Hour Weekend Voiding Diary 
Day 1 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
Date: 
 
 
48 Hour Weekend Voiding Diary 
Day 2 
 
Time 
Fluid 
Intake 
(oz.) 
Voided 
Volume 
(oz.) 
Leaks 
(Y/N)? 
Was leak 
associated 
with 
strong 
desire 
(Y/N)? 
Pad/Pull-
up change 
(Y/N)? 
 
Sensation 
of urgency 
(Y/N)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
DOB 
MRN 

 
 
 
Starting Date: 
 
Nighttime Wetting Log (14 nights) 
 
Night 
Wet (Yes or No) 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Sunday 
 
Monday 
 
Tuesday 
 
Wednesday 
 
Thursday 
 
Friday 
 
Saturday 
 
Name 
DOB 
MRN 

 
 
 
Date: 
Dysfunctional Voiding Scoring System 
 
Over the last month 
Almost 
never 
Less than 
half the 
time 
About half the 
time 
Almost every 
time 
I have had wet clothes or 
wet underwear during the 
day 
0 
1 
2 
3 
When I wet myself, my 
underwear is soaked 
0 
1 
2 
3 
I miss having a bowel 
movement every day 
0 
1 
2 
3 
I have to push for my bowel 
movements to come out 
0 
1 
2 
3 
I only go to the bathroom 
one or two times each day 
0 
1 
2 
3 
I can hold onto my pee my 
crossing my legs, squatting 
or doing the “pee dance” 
0 
1 
2 
3 
When I have to pee, I 
cannot wait 
0 
1 
2 
3 
I have to push to pee 
0 
1 
2 
3 
When I pee it hurts 
0 
1 
2 
3 
Parents: Has your child 
experience something 
stressful like the example 
below? 
 
No (0) 
 
Yes (3) 
Total 
 
 
Stressors: New baby, new home, new school, school problems, abuse (sexual/physical), home 
problems (divorce/death), special events (birthday), accident/injury, others 
 
 
 
Name 
DOB 
MRN 

 
 
Appendix 1 
Controlling Overactive bladder and Pediatric Enuresis (COPE) 
PTENS 
 
What is PTENS? 
 
Parasacral transcutaneous electrical nerve stimulation (PTENS) is electrical current that 
is used to stimulate the nerves near your sacrum. These are the nerves that stimulate your 
bowel and bladder. Transcutaneous electrical nerve stimulation was initially used for muscle 
pain and tension. Nerve stimulation has been shown in adults and children to improve 
symptoms of overactive bladder but traditionally needles are used to transmit electrical 
current. Use of transcutaneous electrodes for nerve stimulation for voiding dysfunction is 
thought to be safe and effective but, at this point, is investigational. It has not been approved 
for use by the Food and Drug Administration. 
 
How do I use PTENS?  
 
PTENS should be used three times per 
week for 30 minutes at a frequency of 10 Hz, 
a pulse width of 200 milliseconds.  Electrode 
pads should be placed on the sacrum, on 
either side of the spine. These will be set by 
your nurse practitioner before you begin use. 
The intensity, or current, should be start at 10 
milliamps and can be slowly increased in 
intensity to a maximum for 40 milliamps. 
These settings are on the dials number 1 – 8 
on the top of your unit. You should NOT 
exceed 4. If there is pain, the settings should 
be turned down by 5 milliamps (half a setting) 
and re-tried until there is no pain. There may 
be a slight sensation. If there is visible muscle 
twitching, the settings should be turned down 
by 5 milliamps and retried until twitching 
stops. Treatments can be done sitting or lying 
down but should be done at a time when the child can be calm or relaxed. Pads should not be 
used if wet. Pads should not touch each other or the spine. A mild amount of redness after use 
is normal, but if there is pain or persistent redness, stop use and call your practitioner. 
 
 
Where can I get a PTENS unit? 
 
You can order a PTENS unit online from 
https://www.lgmedsupply.com/tenslg3000kit.html. They cost $40 - $50 depending on shipping 
and handling. You must bring your unit to your nurse practitioner appointment prior to use. 
You should NOT use the unit without first discussing use with your practitioner. 
 
 

 
 
 
 
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