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A prospective, multicenter, open-label study of dose escalation therapy in male patients with nocturia refractory to 0.2-mg tamsulosin monotherapy

  • Ho Song Yu,
  • Jeong Woo Lee,
  • Jihyeong Yu,
  • Min Chul Cho,
  • Sung Yong Cho

Publication: Int Neurourol J , December 2019

Purpose
To investigate the efficacy and safety of 0.4 mg of tamsulosin in patients with nocturia not responding to 0.2 mg.

Methods
Patients with intractable nocturia after treatment with 0.2 mg of tamsulosin for>1 month were included in a multicenter, prospective, observational, single-arm study. Patients were prescribed 0.4 mg of tamsulosin and followed up for 2 months to assess nocturnal voiding and nocturia-related bother. Changes in the mean number of nocturnal voids, the proportion of 50% responders, 3-day frequency-volume chart parameters, and questionnaire scores were assessed.

Results
Sixty-two patients were prescribed 0.2 mg of tamsulosin, of whom 56 were prescribed 0.4 mg of tamsulosin. Ten patients dropped out. A single case of orthostatic hypotension was reported. The mean age was 68 years. After 1 and 2 months of taking 0.4 mg of tamsulosin, 23.9% and 22.7% of patients demonstrated a>50% reduction of nocturia, and 16.1% and 19.4% of patients rated the treatment as “very effective,” respectively. Dose escalation to 0.4 mg of tamsulosin, compared to 0.2 mg, did not show an additional effect on reducing nocturnal urine volume. Multivariate logistic regression analysis showed that lower serum sodium levels (odds ratio [OR], 0.41, P=0.037) and the presence of urge incontinence (OR, 7.08, P=0.036) were predictors of a significant improvement of nocturia in response to 0.4 mg of tamsulosin.

Conclusions
Dose escalation may yield a significant improvement of nocturia in>20% of patients, and may be especially helpful in patients with lower sodium levels and urge incontinence.

Commented by Prof. Van Kerrebroeck

To investigate the efficacy and safety of 0.4 mg of tamsulosin in patients with nocturia not responding to 0.2 mg.

In this study patients with non-resolved nocturia after treatment with 0.2 mg of tamsulosin were included in a multicenter, prospective, observational, single-arm study in which they were prescribed 0.4 mg of tamsulosin and followed up for 2 months to assess nocturnal voiding and nocturia-related bother. Changes in the mean number of nocturnal voids, the proportion of 50% responders, 3-day frequency-volume chart parameters, and questionnaire scores were assessed. In total 56 patients (mean age 68 years) were included but 10 dropped out. After 1 and 2 months of taking 0.4 mg of tamsulosin, 23.9% and 22.7% of patients demonstrated a >50% reduction of nocturia, and 16.1% and 19.4% of patients rated the treatment as “very effective,” respectively. Multivariate logistic regression analysis showed that lower serum sodium levels and the presence of urgency incontinence were predictors of a significant improvement of nocturia in response to 0.4 mg of tamsulosin. The authors conclude that dose escalation may yield a significant improvement of nocturia in >20% of patients, and may be especially helpful in patients with lower sodium levels and urgency incontinence.