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Behavioural Intervention

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

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 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

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.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,264,090 Total Patients Enrolled
Anne L Ackerman, MD, PhDPrincipal InvestigatorUCLA, Department of Urology

Media Library

iStim TENS unit and Transvaginal Probe (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04957524 — N/A
Overactive Bladder Research Study Groups: Customizable Amplitude, Set Amplitude
Overactive Bladder Clinical Trial 2023: iStim TENS unit and Transvaginal Probe Highlights & Side Effects. Trial Name: NCT04957524 — N/A
iStim TENS unit and Transvaginal Probe (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04957524 — N/A
~7 spots leftby Sep 2025
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