Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial.

Importance: Overactive bladder is a distressing syndrome that significantly affects quality of life. Transcutaneous tibial nerve stimulation (TTNS) has been proposed as a home-based, patient-centered therapy that could improve access to treatment for this condition.

Objective: We aimed to determine the efficacy of 12 weeks of TTNS versus sham therapy in reducing symptomatic bother in ambulatory women with urgency urinary incontinence.

Study design: This was a double-masked, sham-controlled randomized trial. The primary outcome was the change in Overactive Bladder Questionnaire scores. Secondary outcomes included those with 50% or greater reduction in urgency incontinence episodes on 3-day voiding diaries and Patient Global Impression of Improvement.

Results: One hundred women were randomized (65 intervention, 35 sham) and included in analysis. Both groups experienced clinically meaningful improvement in Overactive Bladder Questionnaire scores postintervention from baseline, which was not significant between groups (symptom severity: intervention -19.5 ± 20.2 vs sham -19.4 ± 20.4, P = 1.0; health-related quality of life -16.6 ± 18.5 vs -13.8 ± 16.8, P = 0.5). In the TTNS group, 58.8% of women achieved 50% or greater reduction in urgency incontinence episodes versus 41.7% of women in the sham group (P = 0.2), and 25% versus 18% were "much" or "very much improved" (P = 0.2). A sensitivity analysis confirmed these findings.

Conclusions: Clinically meaningful reductions in overactive bladder symptoms were observed in both TTNS and sham therapy without significant differences between groups; however, a trend toward greater reduction in incontinence episodes and overall impression of improvement was noted in the active treatment. The therapeutic benefit from regularly connecting with a clinician should be considered when developing new therapies.