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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.
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I do not have any known brain or nerve diseases.

TTeNS Trial 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

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

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
541 Previous Clinical Trials
23,907,017 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
~0 spots leftby Jun 2024
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