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Behavioural Intervention

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

Q: How many participants are being enrolled in this investigation?

Affirmative. The records on clinicaltrials.gov demonstrate that participant recruitment for this experiment is still underway, having been initially posted on December 20th 2021 and recently modified on May 16th 2022. 24 volunteers are necessary to join from 1 site involved in the trial.

Q: Does the current protocol of this research trial include individuals aged sixty and above?

This clinical trial not only admits participants aged 18 to 120, but also has separate studies for those under 18 and over 65. Specifically, 7 trials are available for younger patients and 69 more opportunities exist for seniors.

Q: Are there any open slots left in this clinical experiment?

Data hosted on clinicaltrials.gov confirms that this medical experiment, which was initially posted on December 20th 2021, is actively recruiting patients. The trial was most recently updated on May 16th 2022.

N/A

Recruiting

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

TEST-ON Trial Summary

This trial is testing whether an at-home transvaginal electrical stimulation program can alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence.

Eligible Conditions

Overactive Bladder
Nocturia

TEST-ON Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Urinary urgency

Secondary outcome measures

Change in Urinary Urgency Episodes

Change in number of micturitions per 24 hours

Percentage of assigned treatment sessions that were successfully completed

TEST-ON 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,827 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria qualifies an individual for this experiment?

"This medical trial is calling for 24 female participants aged 18 and 120 who present with nocturia alongside certain criteria. These include fluency in English, an urgency response to OAB-q3 greater than 4, more than 8 voids on a bladder diary during wakeful hours, lack of urge incontinence (OAB-q8 < 2 and OAB-q4 <2), and minimal pelvic pain (fGUPI4 < 4)."

Answered by AI

How many participants are being enrolled in this investigation?

"Affirmative. The records on clinicaltrials.gov demonstrate that participant recruitment for this experiment is still underway, having been initially posted on December 20th 2021 and recently modified on May 16th 2022. 24 volunteers are necessary to join from 1 site involved in the trial."

Answered by AI

Does the current protocol of this research trial include individuals aged sixty and above?

"This clinical trial not only admits participants aged 18 to 120, but also has separate studies for those under 18 and over 65. Specifically, 7 trials are available for younger patients and 69 more opportunities exist for seniors."

Answered by AI

Are there any open slots left in this clinical experiment?

"Data hosted on clinicaltrials.gov confirms that this medical experiment, which was initially posted on December 20th 2021, is actively recruiting patients. The trial was most recently updated on May 16th 2022."

Answered by AI

Recent research and studies

BJU InternationalJournal

The Overactive Bladder and the Role of the Pelvic Floor Muscles

Messelink, E.J.. 2002. “The Overactive Bladder and the Role of the Pelvic Floor Muscles”. BJU International. Wiley. doi:10.1046/j.1464-410x.83.s2.7.x.

American Journal of Obstetrics and GynecologyJournal

Transvaginal Electrical Stimulation for Female Urinary Incontinence

Brubaker, Linda, J.Thomas Benson, Alfred Bent, Amanda Clark, and Susan Shott. 1997. “Transvaginal Electrical Stimulation for Female Urinary Incontinence”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(97)70142-x.

Current Pain and Headache ReportsJournal

Understanding Multisymptom Presentations in Chronic Pelvic Pain: The Inter-relationships Between the Viscera and Myofascial Pelvic Floor Dysfunction

Hoffman, Donna. 2011. “Understanding Multisymptom Presentations in Chronic Pelvic Pain: The Inter-relationships Between the Viscera and Myofascial Pelvic Floor Dysfunction”. Current Pain and Headache Reports. Springer Science and Business Media LLC. doi:10.1007/s11916-011-0215-1.

Journal of UrologyJournal