Transcutaneous Electrical Nerve Stimulator (TENS) for Overactive Bladder

N/A

Waitlist Available

Led By Rajeev Chaudhry, MD

Research Sponsored by Rajeev Chaudhry

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation of the nerves in the foot can help improve overactive bladder conditions in children.

Eligible Conditions

Overactive Bladder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with decreased urinary frequency

Secondary study objectives

Number of participants with improved over active bladder symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Electrical stimulationExperimental Treatment1 Intervention

Transcutaneous Electrical Nerve Stimulator (TENS) will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects. Subjects will be required to keep a daily voiding diary for one week before treatment to establish a control, during the treatment week and for one week after treatment. Subjects will also be asked to complete a validated questionnaire prior to treatment, during treatment week and one week after treatment. The primary outcomes of this study are improvement in objective measures of frequency as indicated by voiding diary and subjective symptom improvement based on questionnaire comparison.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Nerve Stimulator (TENS)

2011

Completed Phase 1

~20

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