Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence (TTeNS)
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About
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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
99 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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