A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Change in Total International Prostate Symptom Score (IPSS) Following Treatment
研究概览
简要总结
Background Voiding dysfunction in adult women is a clinically significant condition associated with impaired quality of life and limited evidence-based pharmacological treatment options. Selective α1A-adrenergic antagonists such as silodosin may reduce urethral resistance and improve voiding efficiency; however, robust randomized data in women remain limited. This study addresses the need for high-quality evidence in this population.
Objectives To evaluate the efficacy and safety of silodosin compared to placebo in adult women with voiding dysfunction using a randomized cross-over study design.
Methods This is a prospective, multicenter, randomized, placebo-controlled cross-over study conducted at Ministry of Health hospitals in Kuwait. Adult women aged 21 years and older with clinically diagnosed voiding dysfunction will be enrolled. Participants will receive silodosin and placebo in a randomized sequence, separated by a washout period. Each participant will serve as her own control.
Expected Results / Conclusions The study is expected to clarify the role of silodosin in improving voiding symptoms in adult women and to provide safety data to guide future clinical practice.
详细描述
Background:
Female voiding dysfunction and non-neurogenic lower urinary tract symptoms (LUTS) represent a common yet under-recognized clinical problem that significantly impacts quality of life. Symptoms may include hesitancy, straining, weak urinary stream, prolonged voiding time, and a sensation of incomplete bladder emptying. Despite their prevalence, diagnostic pathways and management strategies in women remain heterogeneous and less well standardized compared to male populations. Current international guidance highlights the complexity of female LUTS and emphasizes the need for better characterization and evidence-based treatment strategies, particularly for voiding-predominant symptoms and functional bladder outlet obstruction [1].
The European Association of Urology (EAU) guidelines on female non-neurogenic LUTS underscore that female voiding dysfunction is multifactorial and often underdiagnosed, with limited high-quality evidence guiding pharmacological management [1]. Similarly, contemporary reviews and International Continence Society (ICS) discussions have highlighted substantial gaps in clinical trials addressing female voiding dysfunction, particularly interventional studies evaluating medical therapies targeting urethral and bladder outlet mechanisms [2,3].
Alpha-adrenergic receptors, particularly the α1A subtype, play an important role in urethral smooth muscle tone. Pharmacological blockade of these receptors has a well-established role in male lower urinary tract symptoms. In women, emerging evidence suggests that alpha-blockers may reduce functional urethral resistance and improve voiding efficiency; however, available data remain limited and heterogeneous. A systematic review and meta-analysis evaluating alpha-blocker use in women with LUTS demonstrated potential symptom improvement but emphasized variability in study design, patient selection, and outcome measures, reinforcing the need for well-designed randomized trials [4]. Additional systematic reviews have similarly reported modest benefits of alpha-blockers in selected female populations, while calling for higher-quality evidence to guide routine clinical use [5].
Non-neurogenic female bladder outlet obstruction and voiding dysfunction remain challenging clinical entities, with recent reviews highlighting the lack of standardized therapeutic pathways and the reliance on extrapolated evidence from male studies [6]. These reviews consistently identify selective alpha-blockade as a promising but insufficiently studied therapeutic option, particularly in women without overt anatomical obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must have clinically significant voiding symptoms including one or more of the following:
- •Difficulty initiating voiding
- •Slow urinary stream
- •Intermittent urinary stream
- •Straining to void
- •Sensation of incomplete bladder emptying
- •AND at least one objective parameter suggestive of impaired bladder emptying:
- •Post-void residual urine volume ≥100 mL
- •Maximum urinary flow rate (Qmax) <15 mL/sec with voided volume >150 mL
- •Abnormal pressure-flow findings where available"
排除标准
- •Pregnancy or breastfeeding
- •Active urinary tract infection
- •Neurogenic bladder dysfunction
- •Significant pelvic organ prolapse requiring intervention
- •Previous bladder outlet or urethral surgery
- •Severe renal or hepatic impairment
研究组 & 干预措施
Silodosin → Placebo
Participants will receive silodosin 8 mg orally once daily for 8 weeks, followed by a 2-week washout period, then matching placebo once daily for 8 weeks.
干预措施: Placebo (Drug)
Placebo → Silodosin
Participants will receive matching placebo orally once daily for 8 weeks, followed by a 2-week washout period, then silodosin 8 mg orally once daily for 8 weeks.
干预措施: Placebo (Drug)
Silodosin → Placebo
Participants will receive silodosin 8 mg orally once daily for 8 weeks, followed by a 2-week washout period, then matching placebo once daily for 8 weeks.
干预措施: Silodosin 8 mg (Drug)
Placebo → Silodosin
Participants will receive matching placebo orally once daily for 8 weeks, followed by a 2-week washout period, then silodosin 8 mg orally once daily for 8 weeks.
干预措施: Silodosin 8 mg (Drug)
结局指标
主要结局
Change in Total International Prostate Symptom Score (IPSS) Following Treatment
时间窗: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in total International Prostate Symptom Score (IPSS) from the beginning to the end of each 8-week treatment period. The IPSS consists of 7 symptom questions, each scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The treatment effect of silodosin will be compared with that of placebo within the crossover design.
次要结局
- Change in IPSS Voiding Subscore(Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).)
- Change in Overactive Bladder Symptom Score (OABSS)(Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).)
- Change in Quality-of-Life Score(Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).)
- Change in Post-Void Residual Urine Volume(Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).)
- Change in Maximum Urinary Flow Rate (Qmax)(Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).)
- Adverse Events(Throughout each treatment period and through completion of the 18-week study.)
- Patient Global Impression of Improvement (PGI-I)(End of each 8-week treatment period (Weeks 8 and 18).)
研究者
Said Yaiesh
Specialist Urologist
Jaber Al Ahmad Al Sabah Hospital