Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment

To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885. The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p =0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs. 1.4±2.2; p <0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p =0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p =0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) ( p =0.005 and p =0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs. 1.9±2.0; p =0.011). One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.