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Electrical Stimulation

TTNS for Overactive Bladder (TTeNS Trial)

N/A

Waitlist Available

Led By Nemi M Shah, MD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

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

Must have

Duration of symptoms ≥ 3 months

No known neurologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

TTeNS Trial Summary

This trial is comparing two treatments for people with OAB - one treatment (TTNS) and a sham (fake) treatment. The goal is to see if TTNS is more effective than the sham treatment, as measured by change in OAB-q scores.

Who is the study for?

This trial is for adults with urgency urinary incontinence who've had symptoms for at least 3 months and have internet access. They must not be on certain bladder medications, pregnant, or have conditions like neurogenic bladder, severe pelvic organ prolapse, recurrent UTIs, or lower limb metal implants.Check my eligibility

What is being tested?

The study tests transcutaneous tibial nerve stimulation (TTNS) against a sham intervention to see which is better at improving overactive bladder symptoms. Participants will do the treatments at home and report changes in their condition using online tools.See study design

What are the potential side effects?

Potential side effects of TTNS may include mild pain or skin irritation where the device attaches to the leg. Since it's non-invasive and uses low electrical currents, serious side effects are unlikely.

TTeNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My symptoms have lasted for 3 months or more.

Select...

I do not have any known brain or nerve diseases.

TTeNS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 Bladder

Secondary outcome measures

Voiding diary

Other outcome measures

Incremental cost-effectiveness ratio (ICER)

TTeNS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

30-minute treatments, twice weekly x12 weeks

Group II: Sham GroupPlacebo Group1 Intervention

30-minute treatments, twice weekly x12 weeks

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,113,729 Total Patients Enrolled

American Urogynecologic SocietyOTHER

10 Previous Clinical Trials

623 Total Patients Enrolled

Nemi M Shah, MDPrincipal InvestigatorUniversity of California San Diego/Kaiser Permanente San Diego

Frequently Asked Questions

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

Are there any available opportunities for participants in this clinical investigation?

"According to clinicaltrials.gov, this particular trial is not actively enrolling patients at the moment; however, it was first posted on September 20th 2021 and last updated December 15th 2021. Fortunately, there are 200 alternative studies that participants can join in the interim."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

2021. "Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936464.

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