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Behavioural Intervention
TENS for Bedwetting
N/A
Recruiting
Led By Adam Howe, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a TENS unit, a machine that sends electrical signals through the skin, can help children with primary nocturnal enuresis, or bedwetting.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from using the TENS unit may include skin irritation where electrodes are placed and discomfort from the electrical pulses. The intensity will be set to what each child feels sensitive to during office visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of wet nights
Secondary study objectives
Pediatric Incontinence Questionnaire (PIN-Q)
Severity of wet nights
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pulse rate 2Hz (hertz)Experimental Treatment1 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 150HzExperimental Treatment1 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 10HzExperimental Treatment1 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
Find a Location
Who is running the clinical trial?
Albany Medical CollegeLead Sponsor
94 Previous Clinical Trials
12,501 Total Patients Enrolled
Adam Howe, MDPrincipal Investigator - Albany Medical College
Albany Medical Center South Clinical Campus, Albany Medical College
2 Previous Clinical Trials
93 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You wet the bed less than twice a week on average.You have other medical conditions that can cause bedwetting at night, such as bladder inflammation, breathing problems during sleep, or issues with the urinary system.You have had any heart problems in the past.You have used medicine or other treatments for bedwetting or urologic problems in the last 30 days.You have other known bladder or nerve disorders, like overactive bladder or interstitial cystitis.You cannot use a TENS unit if you have a pacemaker or other implanted device, lymphedema, are pregnant, have cancer, bleeding or clotting disorders, unhealthy tissue, seizure disorders, or impaired thinking.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.
Research Study Groups:
This trial has the following groups:- Group 1: Pulse rate 2Hz (hertz)
- Group 2: Pulse rate 150Hz
- Group 3: Pulse rate 10Hz
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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