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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different frequencies of TENS therapy (a type of nerve stimulation) can help children who frequently wet the bed at night. Researchers will divide participants into three groups to test low, medium, and high-frequency settings of the TENS device. Children who have not succeeded with behavioral changes, such as limiting drinks before bedtime, and experience bedwetting more than once a week might be suitable candidates. The goal is to determine if TENS therapy can reduce nighttime accidents and improve quality of life. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could lead to new treatment options for bedwetting.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that cause incontinence, like Lithium for bipolar disorder.

What prior data suggests that this TENS device is safe for children with bedwetting?

Research has shown that TENS (Transcutaneous Electrical Nerve Stimulation) can safely help with bedwetting. Studies have found that using TENS on the back of the leg is easy to do at home and is usually well-tolerated.

Previous research linked TENS to fewer wet nights and daytime accidents, indicating it can help manage these symptoms. Importantly, these studies reported very few side effects, making TENS a promising treatment for children.

Different settings for TENS, such as 2 Hz, 10 Hz, and 150 Hz, have similar safety data, with no major safety concerns reported. Overall, TENS appears to be a safe and gentle option for children dealing with bedwetting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for bedwetting involve medications like desmopressin or behavioral therapies. But this trial is exploring something quite different: Transcutaneous Electrical Nerve Stimulation (TENS). Researchers are excited because TENS offers a non-invasive approach, using electrodes placed on the skin to send small electrical pulses. These pulses, varying between 2Hz, 10Hz, and 150Hz, might help train the nerves involved in bladder control, potentially reducing bedwetting episodes without medication. This could be a game-changer for those who prefer a drug-free option or for whom other treatments haven't been effective.

What evidence suggests that TENS treatment is effective for bedwetting?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce bedwetting in children. One study found that applying TENS to a nerve in the leg improved the frequency and severity of bedwetting. Another study discovered that TENS decreased nighttime accidents in children with an overactive bladder, a condition linked to bedwetting. This trial will test different pulse rates of TENS treatment—2Hz, 10Hz, and 150Hz—to evaluate their effectiveness. However, some research suggests that TENS might not always be more effective than no treatment. Overall, TENS is considered a promising option for managing bedwetting, but results can vary. ^{1 2 3 6 7}

Who Is on the Research Team?

Adam Howe, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S277297372200995X

Transcutaneous electrical nerve stimulation for at-home ... Posterior tibial TENS showed greatest and continued improvements in frequency and severity of enuresis both during and after TENS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02900495

Transcutaneous Electric Nerve Stimulation (TENS) for the ... Efficacy of transcutaneous interferential electrical stimulation in treatment of children with primary nocturnal enuresis: a randomized clinical trial.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36069167/

A systematic review and meta-analysis of randomized ... Our results suggest that PTENS has no clear benefit in the management of children with NE compared to controls.

4. jpurol.com jpurol.com/article/S1477-5131(24)00361-9/pdf

Immediate and continued results of parasacral ... The use of parasacral TENS in children with OAB is effective and results in a significant reduction in daytime incontinence, nocturnal enuresis ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04313192

NCT04313192 | TENS Treatment for Bedwetting Patients will be followed up after one month of TENS with evaluation including the Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7136445/

Role of Transcutaneous Electrical Nerve Stimulation in ... Our analysis found that TENS resulted in a greater decrease of wet days/wk, daily voiding frequency, daily incontinence episodes, and daily number of voids.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11729710/

Physiotherapy intervention on monosymptomatic nocturnal ... Transcutaneous Electrical Nerve Stimulation (TENS) was evaluated in three studies (Study 5, 7 and 8). It was observed significant positive results in ...