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TEST-ON - Does iStim Reduce Urinary Urgency?

NCT04957524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-06

No results posted yet for this 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.

Conditions

Interventions

DEVICE

iStim TENS unit and Transvaginal Probe

iStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe. iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation.

Sponsors & Collaborators

Principal Investigators

  • Anne L Ackerman, MD, PhD · UCLA, Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-05-15
Completion
2025-02-11

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957524 on ClinicalTrials.gov