Does Anejaculation Reflect Better Clinical Outcomes in BPO Patients Receiving Silodosin?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
This observational study aims to evaluate the relationship between silodosin-induced anejaculation and clinical outcomes in male patients with benign prostatic obstruction (BPO). Silodosin is a commonly used alpha-blocker for lower urinary tract symptoms (LUTS). However, it may cause ejaculatory dysfunction, particularly anejaculation. In this study, patients receiving silodosin for the first time will be grouped based on whether they experience anejaculation or not. Treatment response will be assessed using urinary flow rate, post-void residual urine, and International Prostate Symptom Score (IPSS). Sexual function will be evaluated using the International Index of Erectile Function-5 (IIEF-5) before and after treatment. The study aims to explore whether the presence of anejaculation is associated with improved symptom relief or differences in sexual health.
详细描述
This is a observational study designed to investigate the association between silodosin-induced anejaculation and clinical outcomes in patients diagnosed with benign prostatic obstruction (BPO). Silodosin is an alpha-1A adrenergic receptor antagonist frequently used in the treatment of lower urinary tract symptoms (LUTS) secondary to BPO. One of the common adverse effects of silodosin is ejaculatory dysfunction, particularly anejaculation or retrograde ejaculation.
In this study, male patients over 40 years of age who are newly prescribed silodosin (8 mg/day) for LUTS will be enrolled. Baseline assessments will include serum PSA levels, prostate volume measurement via ultrasonography, uroflowmetry, post-void residual (PVR) urine volume, the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function-5 (IIEF-5). These assessments will be repeated at the first routine follow-up visit, approximately one month after treatment initiation.
Patients will be divided into two groups based on the presence or absence of anejaculation. The primary objective is to compare changes in LUTS-related parameters (IPSS, uroflowmetry, PVR) and erectile function (IIEF-5 scores) between the two groups. This study will help determine whether anejaculation, a common side effect of silodosin, correlates with improved therapeutic response or changes in sexual health outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40 years or older
- •Diagnosed with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO)
- •Initiating silodosin 8 mg/day therapy for the first time
- •Able to complete IPSS and IIEF-5 questionnaires
- •Willing and able to provide written informed consent
排除标准
- •History of prior treatment with silodosin or other α-blockers in the last 3 months
- •Known neurogenic bladder or history of neurological disease affecting voiding
- •History of prostate surgery or pelvic radiation
- •Diagnosed prostate or bladder malignancy
- •Use of medications affecting sexual function (e.g., PDE5 inhibitors) within the last month
- •Severe cardiovascular, hepatic, or renal comorbidities
- •Cognitive impairment preventing informed consent or questionnaire completion
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: Baseline and 1 Month
IPSS will be measured at baseline and after 1 month of silodosin therapy. The change in score will be compared between patients who develop anejaculation and those who do not.
Change in Maximum Urinary Flow Rate (Qmax)
时间窗: Baseline and 1 Month
Qmax will be measured via uroflowmetry at baseline and 1 month. Changes will be compared between the two groups.
次要结局
- Change in Erectile Function (IIEF-5 Score)(Baseline and 1 Month)
- Change in Post-Void Residual Urine Volume (PVR)(Baseline and 1 Month)
研究者
Tarik Emre Sener
Assoc. Prof.
Marmara University