Randomized Trial of Percutaneous Versus Transcutaneous Tibial Nerve Stimulation in The Treatment of Refractory Overactive Bladder: Results From The TRANSPER Trial

ABSTRACT Background Overactive bladder (OAB) affects ~21% of the Spanish population. In patients, refractory to pharmacological therapy, tibial nerve stimulation—percutaneous (PTNS) or transcutaneous (TTNS)—is an established treatment option. As maintenance therapy is often required, home‐based TTNS could reduce the healthcare burden. We compared the clinical efficacy of TTNS and PTNS in refractory OAB. Methods We conducted a prospective, randomized, double‐blind, single‐center, parallel‐arm clinical trial (IRB 2022‐598‐1). Adults with pharmacologically refractory OAB were randomized to PTNS or TTNS using sealed envelopes; patients and evaluators were blinded to allocation. Stimulation was delivered at 200 μs pulse duration and 20 Hz frequency, with adjustable amplitude (0–10 mA). Treatment consisted of twelve weekly 30 min sessions. Primary outcomes were changes in OABq‐SF symptom severity and quality‐of‐life (QoL) scores from baseline to 1 week after treatment, and Treatment Benefit Scale (TBS) responses. Secondary outcomes included bladder diary parameters. Statistical analyses included the chi‐square, Wilcoxon, and Mann‐Whitney U tests. Results Fifty patients were enrolled (TTNS, n = 23; PTNS, n = 27). Mean age was 56 years (SD 15.4), and 78% were women. Baseline characteristics were comparable. Both groups showed significant improvements in OABq‐SF symptom (TTNS − 10.7, p = 0.001; PTNS − 11.7, p = 0.001) and QoL scores (TTNS + 11.5, p = 0.011; PTNS + 11.8, p = 0.003), with no significant between‐group differences. Treatment satisfaction was similar (TTNS 69.6% vs. PTNS 63%). Bladder diary parameters improved in both groups. The main limitation was the modest sample size. Conclusions TTNS was non‐inferior to PTNS for the primary outcomes in patients with refractory OAB. TTNS may be a feasible home‐based alternative, potentially reducing outpatient resource utilization. This clinical trial is registered in ClinicalTrial.gov , NCT ID not yet assigned.