70 Participants Needed

TENS for Bedwetting

BR
Overseen ByBrenda Romeo, CCRC
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Albany Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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 two groups of 35 patients each.Group 1 will be the high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. 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 pulse width determined by randomization, frequency of 10Hz, 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 30 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 Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with voiding dysfunction \[6\]; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment. 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.

Research Team

AH

Adam Howe, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

This trial is for children who wet the bed more than once a week and haven't improved with behavior changes. They must be able to follow the study's process and have not used drugs or other special treatments for bedwetting in the last month. Kids with daytime accidents, other peeing problems, nerve issues, heart disease, or those who pee a lot aren't eligible.

Inclusion Criteria

You have tried to change your behavior in the last 30 days but it didn't work.
I experience bedwetting more than once a week.
Ability to provide informed consent and assent and complete study requirements

Exclusion Criteria

You have any reasons that make it unsafe for you to use a TENS unit.
People who urinate a lot.
You wet the bed less than twice a week on average.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-randomization

Parents/patients fill out nightly voiding diaries for 30 days prior to randomization

4 weeks

Treatment

Participants receive TENS therapy nightly for 30 minutes over 30 days

4 weeks
1 visit (in-person) at day 30

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation with the Bowel & Bladder Questionnaire

4 weeks
1 visit (in-person) as needed

Treatment Details

Interventions

  • Transcutaneous Electrical Nerve Stimulation
Trial Overview The study tests two settings of TENS units on kids with bedwetting: one uses a high pulse width (260us) and the other a low pulse width (50us). The kids will use these devices at home every night for 30 minutes over a month. Their progress will be tracked using diaries and questionnaires before and after treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Pulse Width 50usExperimental Treatment1 Intervention
electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 50us, intensity setting to patient's tolerance, duration 30 days
Group II: Pulse Width 260usExperimental Treatment1 Intervention
electrodes placed per treatment arm, performed at bedtime, session time 30 min, frequency setting of 10Hz, pulse width setting 260us, intensity setting to patient's tolerance, duration 30 days

Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as TENS for:
  • Pain management
  • Musculoskeletal pain
  • Neck pain
  • Back pain
  • Knee osteoarthritis pain
  • Overactive bladder
  • Urinary retention
  • Temporomandibular joint dysfunction
  • Essential tremor
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as TENS for:
  • Pain management
  • Musculoskeletal pain
  • Neck pain
  • Back pain
  • Knee osteoarthritis pain
  • Overactive bladder
  • Urinary retention
  • Temporomandibular joint dysfunction
  • Essential tremor
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as TENS for:
  • Pain management
  • Musculoskeletal pain
  • Neck pain
  • Back pain
  • Knee osteoarthritis pain
  • Overactive bladder
  • Urinary retention
  • Temporomandibular joint dysfunction
  • Essential tremor

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+
Unbiased ResultsWe believe in providing patients with all the options.
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