Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.

Introduction: We investigated the value of the transitional zone index (TZI) for predicting treatment response to combination therapy involving α-blockers and 5α-reductase inhibitors for benign prostatic hyperplasia (BPH). Materials and Methods: Symptomatic BPH patients (n = 118) were randomized to receive 0.2 mg tamsulosin alone or with 0.5 mg dutasteride daily for 12 months. The TZI, International Prostate Symptom Scores, maximum urinary flow rates (Q_max), postvoid residual urine volumes, and prostate-specific antigen (PSA) were evaluated at baseline and after 12 months. The groups were subdivided according to a cut-off TZI value of 0.5 to compare treatment-related changes. Results: After 12 months, the combination therapy group had significantly greater decreases in prostate volume (p < 0.001), TZ volume (p < 0.001) and PSA (p < 0.001) than the monotherapy group, regardless of TZI. However, combination therapy resulted in significantly greater Qmax increases (p < 0.001) only in patients with a TZI ≥0.5. Multivariate analysis determined that TZI was the strongest independent predictor of the Qmax increase at 12 months in the combination therapy group (β = 13.7, p < 0.001). Conclusions: Greater Qmax improvement is expected with combination therapy comprising α-blockers and 5α-reductase inhibitors for patients with a TZI ≥0.5. The TZI may be useful for predicting the Qmax response to combination treatment for BPH.

Immunotherapy of bladder cancer is known to have favorable effects, although it is difficult to determine which patients will show a good response because of the different tumor microenvironments (TME). Here, we developed a bladder cancer-on-a-chip (BCOC) to mimic the TME using three-dimensional (3D) bioprinting and microfluidic technology. We fabricated a T24 and a 5637-cell line-based BCOC that also incorporated MRC-5, HUVEC, and THP-1 cells. We evaluated the effects of TME and assessed the immunologic reactions in response to different concentrations of Bacillus Calmette–Guérin (BCG) via live/dead assay and THP-1 monocytic migration, and concentrations of growth factors and cytokines. The results show that cell viability was maintained at 15% filling density in circle-shaped cell constructs at 20 μL/min microfluidic flow rate. A 3D co-culture increased the proliferation of BCOCs. We found that the appropriate time to evaluate the viability of BCOC, concentration of cytokines, and migration of monocytes was 6 h, 24 h, and three days after BGC treatment. Lastly, the immunotherapeutic effects of BCOC increased according to BCG dosage. To predict effects of immunotherapeutic agent in bladder cancer, we constructed a 3D bioprinted BCOC model. The BCOC was validated with BCG, which has been proven to be effective in the immunotherapy of bladder cancer.

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