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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 20 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 (bas

Detailed Summary:

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 30 patients per group for a total of
Sponsor: Northwell Health

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Severity [ Time Frame: 60 days ]
    compare monthly mean "wet scale" score of each TENS arm to control and baseline score
  • 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)
  • Quality of Life [ Time Frame: 60 days ]
    compare PIN-Q scores at initial visit, after baseline month, after one month of using TENS
  • Adverse reactions [ Time Frame: 60 days ]
    record any adverse reactions to TENS therapy
  • 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


Original Secondary Outcome: Same as current

Information By: Northwell Health

Dates:
Date Received: August 28, 2016
Date Started: August 2016
Date Completion: March 2020
Last Updated: May 11, 2017
Last Verified: May 2017