Efficacy and safety of pelvic floor magnetic stimulation combined with mirabegron in men with benign prostatic hyperplasia and overactive bladder in a prospective randomized controlled trial.

Abstract

Objective: This study aimed to evaluate the therapeutic efficacy and safety profile of pelvic floor magnetic stimulation (PFMS) in combination with mirabegron in male patients diagnosed with benign prostatic hyperplasia (BPH) and overactive bladder (OAB).

Patients and methods: Eighty-six patients were prospectively randomized into two cohorts. The control group received oral mirabegron (50 mg daily), whereas the experimental group underwent combined PFMS and mirabegron therapy. Primary endpoints included variations in urinary frequency and urgency intensity, measured through a 3-day voiding diary. Secondary endpoints included changes in the International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQol) index, and symptom burden, assessed at weeks 6 and 12.

Results: Among the participants, 42 received the combination therapy and 44 received mirabegron monotherapy. At both time points, the combination group demonstrated significantly reduced lower urinary tract symptoms (LUTS) - including urgency, frequency, and incontinence - relative to the monotherapy group (P < 0.05). Moreover, OAB-q HRQol scores were consistently higher in the combination group (P < 0.05). Significant improvements were also observed in the IPSS, OAB-q symptom bother index, and Overactive Bladder Symptom Score (OABSS) within the combination cohort (P < 0.05). The incidence of drug-associated adverse events did not differ significantly between groups (P > 0.05).

Conclusion: PFMS combined with mirabegron markedly alleviated BPH and OAB symptoms and improved patient-reported quality of life, without increasing the risk of adverse events compared to mirabegron monotherapy.