TENS for Bedwetting

Overseen By Brenda Romeo, CCRC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Albany Medical College

Must not be taking: Lithium

Disqualifiers: Daytime incontinence, Heart disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a TENS unit, which uses mild electrical pulses, can assist children with nocturnal enuresis who haven't succeeded with behavior changes like limiting drinks before bed. The trial will compare two different TENS unit settings to determine which is more effective. Children who wet the bed more than once a week and have not succeeded with behavior changes are suitable candidates for this trial. Participants will use the TENS device for 30 minutes each night for a month, with progress tracked through diaries and questionnaires. As an unphased trial, this study provides a unique opportunity to explore a new approach to managing nocturnal enuresis.

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 Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe for children. In studies on its use for bedwetting, TENS has been applied without major safety issues. Most children experience only slight discomfort, with mild skin irritation at the electrode sites being the most common side effect.

Current research does not report any serious side effects from TENS. However, monitoring for any discomfort during use is important, as reactions can vary among children. Overall, TENS is considered a safe, non-invasive, and drug-free method to help manage bedwetting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcutaneous Electrical Nerve Stimulation (TENS) for bedwetting because it offers a non-invasive, drug-free alternative to current options like desmopressin or enuresis alarms. Unlike these standard treatments, TENS uses electrical pulses to stimulate nerves, which may enhance bladder control by affecting nerve pathways. The therapy's customization, with settings like pulse widths of 50us and 260us, tailors the treatment to each patient's comfort and tolerance, potentially improving compliance and outcomes for children who struggle with bedwetting.

What evidence suggests that TENS is effective for bedwetting?

Research has shown that transcutaneous electrical nerve stimulation (TENS) might help reduce bedwetting in children. One study found that applying TENS to a nerve in the leg improved the frequency and severity of bedwetting during and after treatment. Another study reported that TENS reduced the number of wet days each week and daily accidents. However, a review of several studies did not find clear evidence that TENS is superior to other treatments for bedwetting. While results are mixed, some evidence suggests that TENS might help manage bedwetting by reducing its frequency and severity. This trial will compare two different pulse width settings of TENS, 50us and 260us, to evaluate their effectiveness in reducing bedwetting. ^{1 2 3 5 6}

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pulse Width 50us Experimental Treatment 1 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 260us Experimental Treatment 1 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:

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

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

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

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02900495

Transcutaneous Electric Nerve Stimulation (TENS) for the ... The results of mean nightly incontinence episodes, mean "wet sheets" scale score (0-3), and PIN-Q will be measured between time points (baseline, 1 month, 2 ...

2. 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.

3. 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.

4. 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.

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. aetna.com aetna.com/cpb/medical/data/400_499/0431.html

Enuresis - Medical Clinical Policy Bulletins Primary nocturnal enuresis (NE) refers to involuntary loss of urine during sleep in patients who have never achieved a sustained period of dryness.