Efficacy and Safety of Silodosin for the Treatment of Female LUTS: A 12-Week Prospective, Single-Center Study

IF 1.5 4区 医学 Q3 UROLOGY & NEPHROLOGY LUTS: Lower Urinary Tract Symptoms Pub Date : 2025-01-07 DOI:10.1111/luts.70005
Chung Beum Wee, Tae-Hyoung Kim, Jong Hyun Tae, Se Young Choi
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Abstract

Objectives

This study aimed to evaluate the clinical efficacy and safety of silodosin in female patients with lower urinary tract symptoms (LUTSs), addressing the limited evidence supporting alpha-blocker use in this population.

Methods

A 12-week, single-arm, prospective, open-label study was conducted from May 2021 to January 2023. Female patients aged over 18 with an International Prostate Symptom Score (IPSS) ≥ 8 were enrolled and treated with silodosin (8 mg once daily). Primary endpoints included changes in IPSS from baseline to 12 weeks. Secondary endpoints assessed IPSS quality of life (QOL), Overactive Bladder Symptom Score (OABSS), maximal urinary flow rate (Q max), and residual urine (RU).

Results

Ninety-five patients were enrolled, with 85 included in the analysis. After 12 weeks, the mean total IPSS significantly decreased from 18.65 ± 6.89 at baseline to 12.54 ± 5.28 (p < 0.001). IPSS-QOL improved from 4.14 ± 1.01 to 3.12 ± 0.79 (p < 0.001). OABSS decreased from 6.89 ± 3.41 to 4.28 ± 2.39 (p < 0.001), and RU reduced from 51.39 ± 55.38 to 29.95 ± 29.83 mL (p < 0.001). Q max increased from 13.96 ± 6.74 to 16.48 ± 6.09 mL/s (p < 0.001), while voiding volume increased from 163.02 ± 70.53 to 176.12 ± 47.16 mL (p = 0.026). Silodosin was well tolerated, with no serious adverse events noted.

Conclusions

Silodosin demonstrates efficacy and safety in treating female patients with moderate-to-severe LUTS, suggesting that it can be considered a viable treatment option alongside established therapies. Further studies are warranted to confirm these findings.

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西洛多辛治疗女性LUTS的有效性和安全性:一项为期12周的前瞻性单中心研究
本研究旨在评估西洛多辛在女性下尿路症状(LUTSs)患者中的临床疗效和安全性,解决支持在该人群中使用α -受体阻滞剂的有限证据。方法2021年5月至2023年1月进行了一项为期12周的单臂前瞻性开放标签研究。18岁以上、国际前列腺症状评分(IPSS)≥8分的女性患者入组,接受西洛多辛治疗(8mg,每日1次)。主要终点包括从基线到12周IPSS的变化。次要终点评估IPSS生活质量(QOL)、膀胱过度活动症状评分(OABSS)、最大尿流率(Q max)和残留尿(RU)。结果纳入95例患者,其中85例纳入分析。12周后,平均总IPSS从基线时的18.65±6.89显著下降到12.54±5.28 (p < 0.001)。IPSS-QOL由4.14±1.01改善至3.12±0.79 (p < 0.001)。OABSS由6.89±3.41 mL降至4.28±2.39 mL (p < 0.001), RU由51.39±55.38 mL降至29.95±29.83 mL (p < 0.001)。Q max由13.96±6.74 mL/s增加到16.48±6.09 mL/s (p < 0.001),排尿量由163.02±70.53 mL增加到176.12±47.16 mL (p = 0.026)。西洛多辛耐受性良好,未发现严重不良事件。结论西洛多辛在治疗中重度LUTS女性患者中显示出有效性和安全性,这表明它可以被认为是一种可行的治疗选择。需要进一步的研究来证实这些发现。
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来源期刊
LUTS: Lower Urinary Tract Symptoms
LUTS: Lower Urinary Tract Symptoms UROLOGY & NEPHROLOGY-
CiteScore
3.00
自引率
7.70%
发文量
52
审稿时长
>12 weeks
期刊介绍: LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided. LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.
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