The Effects of Chlormadinone Acetate on Lower Urinary Tract Symptoms and Erectile Functions of Patients with Benign Prostatic Hyperplasia: A Prospective Multicenter Clinical Study
Purpose. To evaluate the effects of chlormadinone acetate (CMA), progesterone-derived antiandrogen, on lower urinary tract symptoms (LUTS) and erectile functions of benign prostatic hyperplasia (BPH). Methods. A multicenter, single-cohort prospective study was conducted. A total of 114 patients received CMA for 16 weeks. The endpoints were changes in International Prostate Symptom Scores (IPSS), IPSS-QOL, International Index of Erectile Function-5, prostate volume, and residual urine volume. Results. Significant improvements were observed in IPSS from week 8 to week 48 (32 weeks after treatment). IPSS-QOL improvements were also significant from week 8 to week 48. increased to a maximum at Week 16 and remained elevated throughout the study. Moreover, a decrease of 25% in prostate volume was observed at Week 16. IPSS, QOL, and Qmax changes during the study were not different between the previously treated and untreated patients. IPSS storage subscore changes differed between the age groups. Few severe adverse reactions were observed, except for erectile dysfunction. Conclusions. CMA rapidly and significantly reduced prostate volume and improved voiding and storage symptoms and QOL. Our results suggest that CMA is safe and beneficial, especially for elderly patients with LUTS associated with BPH. 1. Introduction Cases of glandular hyperplasia and those of mixture type with stromal hyperplasia constitute approximately 90% of benign prostatic hyperplasia (BPH) cases; therefore, antiandrogens are very likely effective in most patients with BPH reducing prostate volume, relieving mechanical obstructions at the prostatic urethra, and improving urinary flow. Meanwhile, 5-alpha reductase inhibitors (5-ARIs), which inhibit the conversion of testosterone to dihydrotestosterone, have been approved for treating BPH. Because adverse effects on sexual function are less frequently encountered with 5-ARI treatment than with antiandrogen treatment, the 2012 Guidelines of the European Association of Urology recommend 5-ARIs, including dutasteride, as a first-line treatment for BPH in patients with large prostate volumes of 40？mL or more. Conversely, for patients with small prostate volumes of less than 40？mL, anticholinergic treatment with an α1-blocker is first recommended [1]. The Medical Therapy of Prostatic Symptoms (MTOPS) study also concluded that patients with baseline prostate volumes of 31？mL or more showed a high rate of clinical progression of BPH such as exacerbation of lower urinary tract symptoms (LUTS), urinary retention, or requiring surgical treatments
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