← Back to Search

Procedure

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

Presenting with nocturnal enuresis (more than 1x a week)

Be younger than 18 years old

Must not have

Medications predisposing to incontinence

Daytime incontinence symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a TENS unit on children with enuresis (bedwetting). Two groups of 35 patients will use the unit for 30 minutes each night for 30 days, with one group using a high pulse width and the other using a low pulse width. Results will be measured using diaries & a questionnaire.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from using the TENS unit might include discomfort where the electrodes are placed or skin irritation. Since it's non-invasive, serious side effects are unlikely but any adverse reactions will be recorded in diaries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience bedwetting more than once a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication that could cause incontinence.

Select...

I experience daytime incontinence.

Select...

I have a bladder or nerve disorder.

Select...

I have a history of heart disease or complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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

Bowel and Bladder questionnaire (BBQ)

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

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

0 / 5Eligibility criteria met