- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06135311
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brenda Romeo, CCRC
- Phone Number: 518-262-3349
- Email: romeob@amc.edu
Study Locations
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical College
-
Principal Investigator:
- Adam Howe, MD
-
Sub-Investigator:
- Barry Kogan, MD
-
Sub-Investigator:
- Karla Giramonti, FNP
-
Contact:
- Laura Davey, CCRC
- Phone Number: 518-262-8579
- Email: amcurologyresearch@amc.edu
-
Sub-Investigator:
- Alexandra Rehfuss, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulse Width 260us
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
|
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
Other Names:
|
Experimental: Pulse Width 50us
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of wet nights
Time Frame: 30 days
|
Percent of wet nights per month compared in each TENS arm and baseline wet nights
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Wet nights
Time Frame: 30 days
|
Mean score (0 dry to 3 soaked) of subjective severity of wetness each night during treatment month compared to baseline month
|
30 days
|
Bowel and Bladder questionnaire (BBQ)
Time Frame: 30 days
|
Score of 0-36 based on subjective voiding and stooling questionnaire (higher scores indicate worse outcomes)
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adam Howe, MD, Albany Medical College
Publications and helpful links
General Publications
- ELECTROPHYSICAL 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.
- Lordelo 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.
- 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.
- Barroso 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.
- Barroso 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.
- Bjorkstrom 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.
- Bouali 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.
- Chen 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.
- Chen 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.
- Lordelo 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.
- de 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.
- Tai 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.
- Vance 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.
- Robertson Val, Ward A, Low J, Reed A. Electrotherapy explained: principles and practice (4th edition). Elsevier Ltd (UK), 2006.
- Sharma M, Aggarwal V, Bahadur R, Gupta R. Burns secondary to improper usage of transcutaneous electrical nerve stimulation: a case report. Pb J Ortho. 2011;12(1):72-3.
- Moeller 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.
- Sillen 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. Erratum In: J Urol. 2021 Feb;205(2):638.
- Howe et al. Transcutaneous electric nerve for the treatment of nocturnal enuresis in children. [NOT YET IN PRESS]
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Nocturnal Enuresis
Other Study ID Numbers
- 6429
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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