A Prospective, Multicenter, Open-Label Study of Dose Escalation Therapy in Male Patients With Nocturia Refractory to 0.2-mg Tamsulosin Monotherapy

Abstract

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.

Safety and efficacy of tamsulosin 0.4 mg as an initial dose in 1,219 Korean patients with moderate to severe lower urinary tract symptoms: data from a phase IV study

“…Our results are in accordance with those that treatment with 0.4 mg of tamsulosin in patients with nocturia not responding to 0.2 mg reduced nocturia from 2.71 to 1.98 per night. 10 It has been reported that alpha adrenergic blockers ameliorate the function of bladder storage by increasing bladder blood flow and/or inhibiting urethral afferent activity. 18 , 19 Therefore, it could be reasonably speculated that tamsulosin 0.4 mg increased nocturnal bladder capacity and sequentially reduced nocturia.…”

“… 8 Recent studies have reported that increasing the dose of tamsulosin to 0.4 mg is effective and safe in Asian men with LUTS who do not respond to an initial dose of 0.2 mg tamsulosin. 9 , 10 , 11 , 12 However, it is still unclear whether tamsulosin 0.4 mg as the initial dose is effective and safe in Asian men with LUTS. To the best of our knowledge, only one randomized clinical, double-blind, phase 3 trial has been reported thus far.…”

Development of a voiding diary using urination recognition technology in mobile environment

“…The voiding diary is a useful method to show the patient’s real-life voiding habits and patterns. Therefore, in many lower urinary tract diseases such as overactive bladder and benign prostate hyperplasia, voiding diary is included in the research method as an essential evaluation ( Choi et al, 2018 ; Chuang et al, 2018 ; Hsiao et al, 2019 ; Lee et al, 2018 ; Yu et al, 2019 ).…”