COMPLETED

TENS Treatment for Bedwetting

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 30 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.

Official Title

Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children

Quick Facts

Study Start:2020-01-20
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04313192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Presenting with nocturnal enuresis (more than 1x a week)
  2. 2. Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
  3. 3. Ability to provide informed consent and assent and complete study requirements
  1. 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. 2. Daytime incontinence symptoms
  3. 3. Known "high volume" voiders (determined from history)
  4. 4. Bedwetting episodes on the average of less than two times per week,
  5. 5. Medications predisposing to incontinence (eg, Lithium for bipolar disorder)
  6. 6. Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
  7. 7. Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease)
  8. 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. 9. Any history of heart disease or complications

Contacts and Locations

Principal Investigator

Adam Howe, MD
PRINCIPAL_INVESTIGATOR
Albany Medical College

Study Locations (Sites)

Albany Medical College
Albany, New York, 12208
United States

Collaborators and Investigators

Sponsor: Albany Medical College

  • Adam Howe, MD, PRINCIPAL_INVESTIGATOR, Albany Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-20
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2020-01-20
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • Nocturnal Enuresis
  • Bedwetting
  • TENS

Additional Relevant MeSH Terms

  • Nocturnal Enuresis
  • Bed Wetting