TENS for Bedwetting

Overseen By Brenda Romeo, CCRC

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Albany Medical College

Must not be taking: Lithium

Disqualifiers: Daytime incontinence, Neurologic disorders, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

60 Participants Needed

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 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.

Research Team

Adam Howe, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

This trial is for children with primary nocturnal enuresis (bedwetting) more than once a week, who haven't improved with behavior changes. They must be able to follow the study plan and have not used drugs or other therapies for bedwetting in the last month. Kids with daytime wetting, less frequent bedwetting, secondary causes of bedwetting, heart disease, or conditions that make TENS use unsafe can't join.

Inclusion Criteria

Ability to provide informed consent and assent and complete study requirements

You wet the bed at night more than once a week.

You have tried changing your behavior to reduce nighttime drinking, using the bathroom before bed, managing bowel habits, and dealing with social anxiety, but it didn't work.

Exclusion Criteria

You have problems with bladder control during the day.

You are taking medications that can make you more likely to have trouble controlling your bladder.

You often have to pee a lot.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive TENS therapy nightly for 15 minutes over 30 days, with frequency settings based on randomization

4 weeks

1 visit (in-person) for initial setup, daily home sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation with the Pediatric Urinary Incontinence Questionnaire

4 weeks

1 visit (in-person) at day 30, additional visits as needed

Treatment Details

Interventions

• TENS Treatment

Trial Overview The study tests if TENS units at different pulse rates (2 Hz, 10 Hz, 150 Hz) help reduce bedwetting in kids. Participants are randomly assigned to one of three groups and use the TENS unit nightly for a month. Their progress is tracked through diaries and quality-of-life questionnaires before and after treatment.

Participant Groups

Group I: Pulse rate 2Hz (hertz) Experimental Treatment 1 Intervention

electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days

Group II: Pulse rate 150Hz Experimental Treatment 1 Intervention

electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days

Group III: Pulse rate 10Hz Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+