Urge Incontinence, Overactive Bladder
Conditions
Keywords
tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence
Brief summary
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.
Interventions
TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.
The sham intervention is designed to appear almost identical to the TTNS intervention.
Sponsors
American Urogynecologic Society
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Questionnaire (OAB-q) | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voiding diary | 12 weeks | To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incremental cost-effectiveness ratio (ICER) | 12 weeks | 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. |
Countries
United States
Outcome results
None listed