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TENS Treatment for Bedwetting

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ClinicalTrials.gov Identifier: NCT04313192
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Adam Howe, MD, Albany Medical College

Brief 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 into three groups of 20 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.


Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Bed Wetting Device: pulse rate of 2 Hz Device: pulse rate of 10 Hz Device: pulse rate of 150 Hz Not Applicable

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 20 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 20 patients per group for a total of 60 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulse rate 2Hz (hertz)
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
Device: pulse rate of 2 Hz
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
Other Name: TENS

Experimental: Pulse rate 10Hz
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
Device: pulse rate of 10 Hz
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
Other Name: TENS

Experimental: Pulse rate 150Hz
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
Device: pulse rate of 150 Hz
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
Other Name: TENS




Primary Outcome Measures :
  1. Percentage of wet nights [ Time Frame: 30 days ]
    Total number of change in wet nights compared in each TENS arm and baseline wet nights


Secondary Outcome Measures :
  1. 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

  2. Pediatric Incontinence Questionnaire (PIN-Q) [ Time Frame: 30 days ]
    Quality of life questionnaire score after treatment month compared to after baseline month. Scores = mild <20, moderate 21-50, and severe >51



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presenting with nocturnal enuresis (more than 1x a week)
  2. Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
  3. Ability to provide informed consent and assent and complete study requirements

Exclusion Criteria:

  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 (eg, Lithium for bipolar disorder)
  6. Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
  7. Secondary etiologies for nocturnal enuresis (eg, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313192


Contacts
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Contact: Brenda Romeo, CCRC 518-262-8579 amcurologyreseach@amc.edu

Locations
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United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Brenda Romeo, CCRC    518-262-8579    amcurologyresearch@amc.edu   
Principal Investigator: Adam Howe, MD         
Sub-Investigator: Barry Kogan, MD         
Sub-Investigator: Karla Giramonti, FNP         
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Adam Howe, MD Albany Medical College
Publications:
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.
Howe et al. Transcutaneous electric nerve stimulation (TENS) for the treatment of nocturnal enuresis in children. [NOT YET IN PRESS]

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Responsible Party: Adam Howe, MD, Assistant Professor of Surgery, Albany Medical College
ClinicalTrials.gov Identifier: NCT04313192    
Other Study ID Numbers: 5618
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Adam Howe, MD, Albany Medical College:
Nocturnal Enuresis
Bedwetting
TENS
Additional relevant MeSH terms:
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Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations