Quantitative Comparison of Results Obtained by Self-administered IPSS, Sanitary Staff-supervised IPSS and Directed Medical History and Its Correlation With Clinical Parameters in the Assessment of Lower Urinary Tract Symptoms in Males
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlation between different clinical severity scores in LUTS
研究概览
简要总结
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.
详细描述
The IPSS is a validated questionnaire (also in spanish language) widely used to evaluate lower urinary tract symptoms (LUTS) in males. It contains 7 multiple-choice questions related to urinary symptoms with a Likert response scale and 1 question assessing quality of life. This test has been approved for self-administration and its purpose is quantifying and monitoring symptoms severity.
The aim of this study is to compare the scores achieved in a self-administered IPSS questionnaire with those obtained when the questionnaire is answered with the help and supervision of a sanitary staff. These results will also be contrasted with the scores retrieved in a standard directed medical interview and correlated with objective functional parameters of lower urinary tract symptoms.
A descriptive prospective study will be carried out analysing lower urinary tract symptoms from patients over 50 years old.
All patients will be provided with a IPSS to be fulfilled at home and after a short period of time without any change in his LUTS treatment, the patient will repeat the questionnaire in the hospital under the supervision of a sanitary staff.
A standard structured medical interview focusing in LUTS will be performed to every patient. In order to compare the results achieved with both IPSS with those obtained during the interview a Likert score was assigned to each question.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •males older than 50 years, with LUTS
排除标准
- •Urinary tract infection
- •Bladder tumor o lithiasis
- •changes in LUTS treatment during the analysis period (pharmacological or surgical)
- •urethral manipulation during the analysis period (catheterization or cystoscopy)
结局指标
主要结局
correlation between different clinical severity scores in LUTS
时间窗: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.
correlation between the scores obtained with an self-administered IPSS, a sanitary staff-supervised IPSS and a standard medical interview focused on LUTS based on a Likert severity scale 0-4 (5 levels of severity)
次要结局
- correlation between clinical severity scores and objective severity symptoms(data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.)
研究者
EDUARDO VICENTE PALACIO
Senior and Consultor Staff in the Department of Urology
Corporacion Parc Tauli