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NCT04957524 · ClinicalTrials.gov registry record · NA

TEST-ON - Does iStim Reduce Urinary Urgency?

A NA study, sponsored by University of California, Los Angeles.

Completed
Registry status
NA
Development phase
24
Enrollment target

NCT04957524: Completed NA study, sponsored by University of California, Los Angeles.

NCT04957524 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04957524, a NA study, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target

Study Summary

Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-home transvaginal electrical stimulation (TES) program works to alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence. This is a cross-over trial. Women \>18 yo presenting with OAB-dry will be randomized to receive one of two TES at home programs for 4 weeks. After completion of the program, the participant's symptoms will be assessed with standardized patient questionnaires. There will then be a 3 week washout period followed by the second at-home TES program. At the completion of the second program, the participant's symptoms will be assessed with the same standardized questionnaires. The participants will be followed for 6 months following the completion of the TES program.

Primary Outcome

The primary outcome is the change in participant's reported urgency as measured by the composite score of the first 8 questions of the OAB-q questionnaire. The questionnaire is out of 8 with higher scores corresponding with more bother from urinary urgency. The primary outcome is the difference between the pre-treament and post-treatment scores. The range is 0 to 48 with a larger difference corresponding to more improvement in patient's urgency over the study period.

Interventions

  • DEVICE iStim TENS unit and Transvaginal Probe

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-12-20
Est. Completion 2025-02-11
Phase NA

What the finished NCT04957524 record still lists

NCT04957524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which iStim TENS unit and Transvaginal Probe is the first listed.

NCT04957524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04957524 about?

NCT04957524 is a clinical study titled "TEST-ON - Does iStim Reduce Urinary Urgency?". Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-...

What is the current status of trial NCT04957524?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2021-12-20. Estimated completion is 2025-02-11.

What interventions are being tested in trial NCT04957524?

The interventions under investigation include: iStim TENS unit and Transvaginal Probe (DEVICE).

Who is sponsoring clinical trial NCT04957524?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04957524's enrollment target sits among peer trials

24 1736th of 2000 higher than 246 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04957524, the US trial registry maintained by the National Library of Medicine. NCT04957524 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.