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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of wet nights

Secondary outcome measures

Bowel and Bladder questionnaire (BBQ)

Severity of Wet nights

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor

91 Previous Clinical Trials

11,427 Total Patients Enrolled

Adam Howe, MDPrincipal InvestigatorAlbany Medical College

2 Previous Clinical Trials

83 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the particiants involved in this trial?

"That is correct. Per the clinicaltrials.gov listing, this medical trial opened for recruitment on October 24th 2023 and was amended most recently on November 16th 2023. The study requires a total of 70 participants across 1 site to commence operations."

Answered by AI

Are adults aged 50 and above eligible to enrol in this clinical trial?

"The age requirements for participation in this clinical trial are 5 years old up to 17 years of age."

Answered by AI

Is recruitment of participants ongoing for this clinical trial?

"The clinical trial in question is still looking for participants, based on the information readily available at clinicaltrials.gov. This medical study was first posted on October 24th 2023 and has been amended as recently as November 16th 2023."

Answered by AI

Do I meet the criteria to become a participant in this experiment?

"To become part of this trial, a potential participant must suffer from enuresis and be between 5 and 17 years old. Approximately 70 people will be accepted into the study."

Answered by AI

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