The efficacy and safety of additional administration of
propiverine were prospectively studied for
naftopidil-resistant
nocturia in patients with
benign prostatic hypertrophy (BPH). Patients of 50 years and over with BPH who experienced
nocturia twice a night or more and an overall International Prostate Symptom Score (IPSS) of 8 or more were first administered
naftopidil (50 or 75 mg/day) for 4 weeks. Thirty subjects who did not show improvement in
nocturia and requested further treatment were enrolled in the present study.
Propiverine was then administered concomitantly 10 mg/day for 8 weeks. Significant improvement was observed with additional
propiverine in the frequency of
nocturia on voiding diary, total IPSS, voiding symptom, storage symptom and nocturnal voiding scores. No significant change was observed in the peak urinary flow rate (Qmax), mean urinary flow rate (Qave), voided urine volume, or residual urine volume. Adverse events were
dysuria (2 cases), increased residual urine (6 cases), weak urine flow (1 case), thirsty (2 cases), angular
cheilitis (1 case). Administration of
propiverine was suspended in 7 subjects, 1 following
dysuria and 6 following increased residual urine volume. The
suspension of
propiverine following increased residual urine volume was significantly more prevalent in subjects with pretreatment Qmax values of less than 10 ml/second or in subjects whose
prostate specific antigen (PSA) levels were 2 ng/ml or more. In conclusion, the results indicate that additional administration of
propiverine may be useful for the patients with BPH who have
naftopidil-resistant
nocturia. However, caution must be exercised regarding Qmax and PSA levels.