iStim TENS unit and Transvaginal Probe for Overactive Bladder (TEST-ON Trial)

N/A

Waitlist Available

Led By Anne L Ackerman, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be the difference in score from the date of enrollment to the end of both treatment arms. this will range from 11 weeks to 20 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if an at-home electrical stimulation device can help women with overactive bladder who haven't responded to other treatments. The device sends gentle electrical pulses to the pelvic area to strengthen muscles and reduce symptoms. Women will use the device for a few weeks, take a break, and then try a second program, with their symptoms monitored throughout.

Eligible Conditions

Overactive Bladder
Nocturia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be the difference in score from the date of enrollment to the end of both treatment arms. this will range from 11 weeks to 20 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be the difference in score from the date of enrollment to the end of both treatment arms. this will range from 11 weeks to 20 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be the difference in score from the date of enrollment to the end of both treatment arms. this will range from 11 weeks to 20 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

Urinary urgency

Secondary study objectives

Change in Urinary Urgency Episodes

Change in number of micturitions per 24 hours

Percentage of assigned treatment sessions that were successfully completed

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

Active Control

Group I: Customizable AmplitudeExperimental Treatment1 Intervention

In this arm, the participant will set the frequency to 12 Hz and pulse duration to 1 millisecond. The participant will be instructed to increase the amplitude gradually and set it at the maximal tolerable amplitude. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day.

Group II: Set AmplitudeActive Control1 Intervention

This arm is to test a specific amplitude. Participants will be instructed to set the amplitude to 20 mA, frequency to 20 Hz, and pulse duration to 5 mS. The parameters will stay the same for the entire session. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day.

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