To evaluate the efficacy and safety of vibegron add-on therapy for persistent overactive bladder (OAB) symptoms after α1-blocker monotherapy for benign prostatic hyperplasia (BPH).
Eligible patients were aged ≥ 50 years and diagnosed with BPH. All patients had received an α1-blocker for ≥ 8 weeks, yet had persistent OAB symptoms. Patients were randomized 1:1 to receive add-on vibegron (50 mg) or to continue α1-blocker monotherapy. The primary efficacy endpoint was the between-group difference from baseline (week 0) to week 12 in total overactive bladder symptom score (OABSS). Secondary endpoints included bladder diary parameters, OABSS subscores; International Prostate Symptom Score total, storage/voiding, quality-of-life score; and patient satisfaction assessed by the Patient Global Impression. Safety was assessed by recording treatment-emergent adverse events.
Overall, 158 patients were randomized into two groups (n = 79 each). The least-squares mean change in the primary endpoint (OABSS total score) was -1.9 (95% confidence interval [CI]: -2.4 to -1.5) with α1-blocker monotherapy and -3.3 (95% CI: -3.8 to -2.9) with vibegron add-on therapy; the between-group difference was -1.4 (95% CI: -2.0 to -0.8; p < 0.001), indicating a significant improvement with add-on therapy. Across the secondary endpoints, favorable outcomes were observed. Higher satisfaction was reported in the vibegron add-on therapy group than in the α1-blocker monotherapy group. Vibegron was well tolerated, and no serious drug-related treatment-emergent adverse events were observed.
Vibegron add-on therapy to an α1-blocker may be effective and safe for treating BPH with persistent OAB symptoms.
Lower urinary tract symptoms. 2026 Mar [Epub]
Masaki Yoshida, Yoshinori Nishino, Hiroshi Nagae, Shinobu Kato, Sadaaki Sakamoto, Morifumi Hojo, Toshihide Miyauchi, Shinji Kageyama, Shinichi Takahashi, Hideya Kuroda, Naoki Mori, Yasuhiro Kasagi, Koichi Masunaga, Yoshiyuki Nabeshima, Masanori Nomiya, Koichi Iwashita, Koichi Miyamae, Masayuki Otani, Kazuya Kawahara, Makoto Ikeda, Shinichi Kubono, Nobuhiro Haga
Department of Urology, Sakurajyuji Hospital, Kumamoto, Japan., Nishino Clinic, Gifu, Japan., Nagae Prostate Care Clinic, Shizuoka, Japan., Kato Urological Clinic, Kanagawa, Japan., Department of Urology, Nakamura Hospital, Oita, Japan., Department of Urology, Koga Hospital 21, Fukuoka, Japan., Department of Urology, Oita Urology Hospital, Oita, Japan., Kageyama Clinic, Shizuoka, Japan., Takahashi Urological Clinic, Oita, Japan., KURODA UROLOGY CLINIC, Osaka, Japan., Department of Urology, Tagawa Municipal Hospital, Fukuoka, Japan., Kasagi Urology Clinic, Oita, Japan., Itabashi Tokumaru Clinic, Tokyo, Japan., Department of Urology, Fukuoka Tokushukai Hospital, Fukuoka, Japan., Department of Urology, National Center for Geriatrics and Gerontology, Aichi, Japan., Shiizako Urological Clinic, Oita, Japan., Maehara Urology Clinic, Kumamoto, Japan., Otani Clinic, Oita, Japan., KAWAHARA Nephro-Urology Clinic, Kagoshima, Japan., Medical Affairs, Kyorin Pharmaceutical Co. Ltd., Tokyo, Japan., Medical Department, Kissei Pharmaceutical Co. Ltd., Tokyo, Japan., Department of Urology, Fukuoka University, Faculty of Medicine, Fukuoka, Japan.