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

NCT02900495 | Completed DMC

• 1 other identifier: HS16-0389
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 5

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.

Conditions

Nocturnal Enuresis; Bedwetting

Keywords

Nocturnal Enuresis; Bedwetting; TENS

Outcome Measures

Primary Outcomes (1)

• Change in Wet nights

  Total number of change in wet nights compared in each TENS arm to control and baseline wet nights

  60 days

Secondary Outcomes (5)

• Severity

  60 days

• Patient compliance

  60 days

• Quality of Life Scores

  60 days

• Adverse reactions

  60 days

• Durability

  90 days

Study Arms (4)

Suprapubic TENS

EXPERIMENTAL

electrodes, 'transcutaneous electric nerve stimulation' placed onto the lower abdomen in the suprapubic region directly over the bladder

Device: transcutaneous electric nerve stimulation

Posterior Tibial TENS

EXPERIMENTAL

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

Parasacral TENS

EXPERIMENTAL

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

Shoulder TENS

PLACEBO COMPARATOR

electrodes, 'transcutaneous electric nerve stimulation' placed over the scapula on the shoulder/back

Device: transcutaneous electric nerve stimulation

Interventions

transcutaneous electric nerve stimulation DEVICE

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

Also known as: TENS unit

Parasacral TENS; Posterior Tibial TENS; Shoulder TENS; Suprapubic TENS

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Northwell Health: lead
• Feinstein Institute for Medical Research: collaborator
• Albany Medical College: collaborator

Study Sites (5)

Albany Medical College

Albany, New York, 12208, United States

Location

Pediatric Urology Associates

Brooklyn, New York, 11220, United States

Location

Cohen Children's Medical Center of NY

New Hyde Park, New York, 11040, United States

Location

Pediatric Urology Associates

New Hyde Park, New York, 11042, United States

Location

Pediatric Urology Associates

Tarrytown, New York, 10591, United States

Location

Related Publications (3)

• Kajbafzadeh AM, Sharifi-Rad L, Mozafarpour S, Ladi-Seyedian SS. Efficacy of transcutaneous interferential electrical stimulation in treatment of children with primary nocturnal enuresis: a randomized clinical trial. Pediatr Nephrol. 2015 Jul;30(7):1139-45. doi: 10.1007/s00467-014-3039-5. Epub 2015 Jan 25.

  PMID: 25618771 RESULT

• 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.

  PMID: 20837326 RESULT

• 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.

  PMID: 16831163 RESULT

Related Links

• Pediatric Urology Associates, P.C.

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Lane S Palmer, MD

  Cohen Children's Medical Center of NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: September 14, 2016
• Study Start: August 1, 2016
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)