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Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children

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ClinicalTrials.gov Identifier: NCT02900495
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Feinstein Institute for Medical Research
Albany Medical College
Information provided by (Responsible Party):
Adam S Howe, Albany Medical College

Brief Summary:

Children referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria will be offered therapy with a TENS unit.

Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000 Analog) and electrode pads and caretakers instructed on how to use the apparatus.

The TENS sessions will be performed nightly before bed for 15 minutes. TENS units will be set at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the patient. 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. . They will then follow up on these parameters again after another month (one month off of TENS therapy) to assess the durability of treatment effect. The data will be collected at different time points (baseline, 1 month, 2 months) for each group by itself and the groups compared against each other using statistical analysis.


Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Bedwetting Device: transcutaneous electric nerve stimulation Not Applicable

Detailed Description:

Institutional review board was obtained. Children ages 5-18 years old referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Behavioral therapy (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, neuromodulation or other alternative therapy for urologic disorders, 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), secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae), 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. 128 patients will be chosen for enrollment into the study.

The patients will be randomized into four groups of 32 patients each. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed onto the bottom of the feet. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the sham arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. Detailed explanation of the purpose of 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 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 10 Hz, and intensity determined in the office by the sensitivity threshold of the patient. Voiding diaries will be kept each night while on TENS therapy, additionally recording which TENS setting was used, duration of therapy each night, and any adverse reactions to the TENS unit or increased symptoms (these patients will be terminated from the study and included as a treatment failure). Diaries will then be kept for 30 days after TENS therapy was completed to assess durability of treatment effects. At voiding diary day 30 (before first TENS treatment), day 60 (after completion of TENS therapy), and day 90 (one month off of TENS), 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 days 0, 30, 60, 90, and as needed (worsening symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Parents will be called on a weekly basis throughout the study to ensure compliance and address any questions or concerns. The results of mean nightly incontinence episodes, mean "wet sheets" scale score (0-3), and PIN-Q will be measured between time points (baseline, 1 month, 2 months for each group by itself and the groups compared against each other using statistical analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Suprapubic TENS
electrodes, 'transcutaneous electric nerve stimulation' placed onto the lower abdomen in the suprapubic region directly over the bladder
Device: transcutaneous electric nerve stimulation
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 unit

Experimental: Posterior Tibial TENS
electrodes, 'transcutaneous electric nerve stimulation' placed over the posterior tibial nerve behind the medial malleolus of the ankle and another electrode on the bottom of the foot
Device: transcutaneous electric nerve stimulation
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 unit

Experimental: Parasacral TENS
electrodes, 'transcutaneous electric nerve stimulation' placed over the S3 foramen on the sacrum on each side of the midline in the lower back/upper buttocks
Device: transcutaneous electric nerve stimulation
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 unit

Placebo Comparator: Shoulder TENS
electrodes, 'transcutaneous electric nerve stimulation' placed over the scapula on the shoulder/back
Device: transcutaneous electric nerve stimulation
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 unit




Primary Outcome Measures :
  1. Change in Wet nights [ Time Frame: 60 days ]
    Total number of change in wet nights compared in each TENS arm to control and baseline wet nights


Secondary Outcome Measures :
  1. Severity [ Time Frame: 60 days ]
    compare monthly mean "wet scale" score of each TENS arm to control and baseline score

  2. Patient compliance [ Time Frame: 60 days ]
    assess patient tolerance to TENS therapy and ability to perform TENS therapy at home (correct session time, settings, and consistency of use)

  3. Quality of Life [ Time Frame: 60 days ]
    compare PIN-Q scores at initial visit, after baseline month, after one month of using TENS

  4. Adverse reactions [ Time Frame: 60 days ]
    record any adverse reactions to TENS therapy

  5. Durability [ Time Frame: 90 days ]
    compare patient response, monthly number of wet nights, "wet scale" score (severity), and PIN-Q score (quality of life) of each TENS arm one month after stopping TENS and compare to baseline data and immediately after one month of TENS therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary nocturnal enuresis
  • wet nights occur more than once per week on average
  • Failed Behavioral therapy treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
  • ability to provide informed consent and complete study requirements

Exclusion Criteria:

  • the use of medications for nocturnal enuresis (DDAVP, imipramine, anticholinergics) less than 30 days from time of appointment
  • daytime incontinence
  • Known "high volume" voiders
  • medications predisposing to incontinence (eg, Lithium for bipolar disorder)
  • other known voiding or neurologic disorders (eg, overactive bladder, spina bifida, interstitial cystitis)
  • secondary etiologies for nocturnal enuresis (cystitis, obstructive sleep apnea, urinary fistula)
  • any contraindication to TENS unit usage (pacemaker or other implantable devices, lymphedema, pregnancy, malignancy)
  • 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): NCT02900495


Contacts
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Contact: Lane S Palmer, MD 516-466-6953 ext 2 lpalmer@northwell.edu
Contact: Adam S Howe, MD 518-435-5163 ahowe@northwell.edu

Locations
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United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Brenda A Romeo, CCRC    518-262-8579    amcurologyresearch@amc.edu   
Contact: Adam Howe, MD    518-262-8579    howea@amc.edu   
Principal Investigator: Adam Howe, MD         
Sub-Investigator: Karla Giramonti, FNP         
Pediatric Urology Associates Completed
Brooklyn, New York, United States, 11220
Cohen Children's Medical Center of NY Completed
New Hyde Park, New York, United States, 11040
Pediatric Urology Associates Completed
New Hyde Park, New York, United States, 11042
Pediatric Urology Associates Completed
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Northwell Health
Feinstein Institute for Medical Research
Albany Medical College
Investigators
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Principal Investigator: Lane S Palmer, MD Cohen Children's Medical Center of NY

Additional Information:
Publications of Results:
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Responsible Party: Adam S Howe, Assistant Professor of Surgery, Albany Medical College
ClinicalTrials.gov Identifier: NCT02900495     History of Changes
Other Study ID Numbers: HS16-0389
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share this information
Keywords provided by Adam S Howe, 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
Signs and Symptoms