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

Completed · Not applicable

Conditions studied: Nocturnal Enuresis, Bedwetting

In brief

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.

Key facts

Study ID

NCT02900495

Run by

Northwell Health

People needed

147

Starts

2016-08-01

Expected to finish

2020-09-15

Last updated by the study team

2021-02-21

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albany Medical College — Albany, New York, United States
• Pediatric Urology Associates — Brooklyn, New York, United States
• Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
• Pediatric Urology Associates — New Hyde Park, New York, United States
• Pediatric Urology Associates — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.