Transcutaneous tibial nerve stimulation combined mirabegron therapy significantly improves benign prostatic hyperplasia and overactive bladder: a prospective randomized controlled trial.

To evaluate the efficacy and safety of combining transcutaneous tibial nerve stimulation (TTNS) with mirabegron for treating benign prostatic hyperplasia (BPH) and overactive bladder (OAB) in male patients. A total of 62 participants were prospectively randomized into two cohorts: the control group to receive oral mirabegron (50 mg daily), while the combination group to receive combined TTNS and mirabegron. The primary outcomes were changes in voiding frequency and urgency severity, assessed using a 3-day voiding diary. Secondary outcomes included the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), Health-Related Quality of Life (HRQoL) score, symptom severity, and urodynamic parameters at weeks 6 and 12. Of the 62 participants, 30 received TTNS along with mirabegron, and 32 received mirabegron alone. At both timepoints, the combination group demonstrated significantly greater reductions in lower urinary tract symptoms (LUTS), including urgency, increased urinary frequency, and incontinence episodes, than the control group (P < 0.05). Furthermore, the combination group exhibited significantly higher OAB-q HRQoL scores and lower IPSS, OAB-q symptom bother, and Overactive Bladder Symptom Score (OABSS) values (all P < 0.05). No substantial differences were observed in drug-related adverse events or urodynamic parameters between groups (P > 0.05). Combined TTNS and mirabegron therapy significantly improved BPH and OAB symptoms and enhanced quality of life, without increasing adverse effects compared to mirabegron monotherapy.