Overactive Bladder Clinical Trial
— TTeNSOfficial title:
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
Verified date | October 2023 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 6 episodes urgency incontinence on 3-day voiding diary - Duration of symptoms = 3 months - Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks - No known neurologic disease - Ability to complete home sessions and clinic follow up - Ability to complete voiding diaries - Internet access and proficiency - English or Spanish-speaking Exclusion Criteria: - Pregnant - Known or suspected urinary retention - Symptomatic urinary tract infection unresolved at the time of randomization - Recurrent urinary tract infection (= 3/12 months) - Bladder pain syndrome - Known or suspected advanced (stage III or IV) pelvic organ prolapse - Neurogenic bladder - Current or prior bladder malignancy - Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation - Pacemaker or other implantable device - Disease affecting lower extremities - Bilateral metallic lower limb implant - Incarceration |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | American Urogynecologic Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incremental cost-effectiveness ratio (ICER) | To describe the cost effectiveness of a 12-week course of home-based TTNS therapy using an ICER calculated from the sum of direct medical and indirect non-medical costs relative to health-related quality of life, as measured by the European Quality of Life-5 Dimensions index. | 12 weeks | |
Primary | Overactive Bladder Questionnaire (OAB-q) | To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group. | 12 weeks | |
Secondary | Voiding diary | To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group. | 12 weeks |
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