Development and Internal Validation of a Clinical Nomogram to Diagnose Prostatic Inflammation in Men With Lower Urinary Tract Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 423
- 试验地点
- 7
- 主要终点
- Nomogram for the prediction of prostatic inflammation in patients with LUTS
研究概览
简要总结
Rationale: Histological inflammation of the prostate is a common finding in the results of the histopathological examinations after a prostate biopsy or a transurethral or open prostatectomy.
Several studies have investigated the role of prostatic inflammation in the development of prostatic enlargement and pathogenesis of Lower Urinary Tract Symptoms (LUTS). Therefore, prostatic inflammation could be a potential treatment target for men with LUTS.
Objective: The aim of the study is the development and the validation of a nomogram based on clinical parameters that could predict the presence of prostatic inflammation.
Study design: Non-interventional, multicentric, cross-sectional, observational prospective study.
Study population: Men, age ≥ 40 yrs, with LUTS who will undergo any prostatic surgery for BPH (Open, laparoscopic, robotic, transurethral resection/enucleation, laser prostatectomy) or TRUS-biopsy according to the standard clinical practice of the participating urologists
Intervention: All included males receive standard care for their symptoms according to the physician's practice. For this study, baseline demographic and clinical characteristics of the patients are recorded and correlated with the histological outcome.
Main study parameters/endpoints: Development and validation of the Prostatic Inflammation Nomogram
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional treatment or intervention related to the study is required.
Therefore no negative outcomes are expected as the standard treatment is unchanged. There is no additional burden for the patients.
详细描述
Lower Urinary Tract Symptoms (LUTS) are common in men over 45 years of age and have been traditionally attributed to bladder outlet obstruction (BOO) as a result of benign prostatic obstruction (BPO), which is often associated with benign prostatic enlargement (BPE) resulting from the histologic condition of benign prostatic hyperplasia (BPH).
Additionally, more recent research focuses on the role of prostatic inflammation in the development of prostatic enlargement and consequently the severity of LUTS and the natural history of these symptoms. Several models and hypotheses have been suggested for the pathogenesis of this condition. Also, the relationship of the inflammation pattern with the progression of BPH is currently investigated through the molecular and metabolic pathways, which can be responsible for this connection.
For this reason, the present study aims to develop a nomogram based on clinical parameters that will diagnose the presence of prostatic inflammation. Should the nomogram prove valid (that is: it can make reliable estimations of prostatic inflammation presence in men with LUTS), it will allow physicians to use patient characteristics to identify patients with increased risk of prostatic inflammation in order to optimise medical strategies for the management of LUTS
The study has the following objectives:
Primary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Age ≥ 40 years
- •Undergo prostatectomy or TRUS-guided biopsy
- •Provide signed Informed Consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •treatment with any plant extract or 5a-reductase inhibitors during the last 3 months,
- •history of pelvic radiotherapy,
- •history of prostatectomy or transurethral resection of bladder tumor or previous TRUS-biopsy,
- •presence of an indwelling catheter,
- •prostate cancer found at the biopsy
- •No symptoms (IPSS=0)
- •No specimen is available (ablation/vaporization of the prostate)
结局指标
主要结局
Nomogram for the prediction of prostatic inflammation in patients with LUTS
时间窗: Immediately after the biopsy/surgery
The predictive nomogram will estimate the personalised risk of the presence of prostatic inflammation in patients with LUTS
次要结局
- Validation of the Nomogram(Three months after the inclusion of the last patient)
研究者
Stavros Gravas
Professor of Urology
Institute for Monitoring of Urogenital Diseases