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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
Must not have
Disease affecting lower extremities
Symptomatic urinary tract infection unresolved at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My symptoms have lasted for 3 months or more.
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I do not have any known brain or nerve diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition affects my legs.
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I currently have symptoms of a urinary tract infection.
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I have had 3 or more urinary tract infections in the last year.
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I have problems emptying my bladder completely.
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I have or had bladder cancer.
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I have used treatments like bladder Botox, nerve stimulation for my bladder condition.
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I have advanced pelvic organ prolapse.
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I have a condition where my bladder doesn't empty properly due to a nerve problem.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinary Bladder
Secondary study objectives
Voiding diary
Other study objectives
Incremental cost-effectiveness ratio (ICER)

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

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,731,523 Total Patients Enrolled
American Urogynecologic SocietyOTHER
10 Previous Clinical Trials
591 Total Patients Enrolled
Nemi M Shah, MDPrincipal InvestigatorUniversity of California San Diego/Kaiser Permanente San Diego
~24 spots leftby Nov 2025
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