Assessment of Clinical and Uroflowmetry Parameters as Predictors of Surgical Preference in Male Patients With Lower Urinary Tract Symptoms: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry
研究概览
简要总结
This study aims to identify which symptoms or test findings lead men with lower urinary tract symptoms (LUTS) to consider surgical treatment. Male patients who visit the outpatient clinic for LUTS will be asked whether they would consider surgery in the future if their symptoms persist. Along with this, symptom severity scores (IPSS), quality of life scores, and uroflowmetry measurements such as maximum flow rate (Qmax) and post-void residual volume (PVR) will be collected. The goal is to determine which factors are most strongly associated with a desire for surgery. This is an observational, non-interventional study.
详细描述
This prospective observational study is designed to evaluate which clinical and uroflowmetry parameters are associated with a desire for surgical treatment in male patients presenting with lower urinary tract symptoms (LUTS). Participants will complete the International Prostate Symptom Score (IPSS) questionnaire, including the quality of life (QoL) item, and undergo uroflowmetry testing. Parameters such as maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), and IPSS subdomain scores (e.g., weak stream, nocturia, urgency) will be analyzed. Patients will also be asked a standardized question regarding their surgical preference if their symptoms remain unchanged.
The primary aim is to determine which symptoms or objective findings (e.g., specific IPSS items, reduced Qmax) are most predictive of a preference for surgical intervention. The study will help guide clinical decision-making by identifying symptom patterns or test results that are more likely to prompt patients to consider surgery. No therapeutic intervention will be performed as part of this study.
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 and older
- •Presenting with lower urinary tract symptoms (LUTS)
- •Able to complete the IPSS questionnaire
- •Undergoing uroflowmetry as part of routine evaluation
- •Able and willing to provide informed consent
排除标准
- •History of urological surgery (e.g., TURP, HoLEP, radical prostatectomy)
- •Presence of known prostate or bladder cancer
- •Active urinary tract infection at the time of evaluation
- •Neurological conditions affecting voiding (e.g., Parkinson's disease, spinal cord injury)
- •Inability to perform uroflowmetry or incomplete IPSS data
结局指标
主要结局
Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry
时间窗: Baseline (at the outpatient clinic visit)
Qmax (in mL/sec) will be measured during the initial outpatient visit using non-invasive uroflowmetry. Unit of Measure: Milliliters per second (mL/sec)
Total International Prostate Symptom Score (IPSS) at Baseline
时间窗: Baseline (at the outpatient clinic visit)
Total IPSS score will be recorded for each participant at the time of initial outpatient clinic evaluation to assess symptom severity. Unit of Measure: Points (0 to 35)
Post-Void Residual Urine Volume (PVR)
时间窗: Baseline (at the outpatient clinic visit)
PVR will be assessed using bladder ultrasound following uroflowmetry at the initial visit. Unit of Measure: Milliliters (mL)
Patient Preference for Surgery Based on a Standardized Question
时间窗: Baseline (at the outpatient clinic visit)
Patients will be asked: "Would you consider surgical treatment if your symptoms remain unchanged in the future?" Response options are Yes/No
次要结局
未报告次要终点
研究者
Tarik Emre Sener
Assoc. Prof.
Marmara University