A Urine-Based Biomarker for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

A Retrospective Multi-Center Study

Weining Liang; Zhigang Wu; Guowei Zhang; Weikang Chen; Xiangnong Hu; Jianjun Yang; Jie Meng; Yan Zeng; Hongjun Li; Xuejun Shang

Disclosures

Transl Androl Urol. 2020;9(5):2218-2226. 

In This Article

Methods

Subjects

From Sep 2015 to May 2018, 372 patients (age ranging from 20 to 61 years old, male) were recruited and diagnosed as having CP/CPPS at the Jinling Hospital Affiliated to the Nanjing University School of Medicine, the Nanjing University of Chinese Medicine Affiliated Integrated Traditional and Western Medicine, Jinan Military General Hospital. Of the 372 patients, 225 underwent an NIH-CPSI questionnaire survey.[21] For inclusion into this study, CP/CPPS patients must meet the following criteria: males with CP/CPPS history and clinical symptoms, including urinary frequency, urgency, and retention, the inflammatory reaction, or reflective (perineal pain, abdominal bulge, and discomfort). A portion of patients presented with premature ejaculation or other symptoms includes infertility. Upon rectal exam, CP/CPPS patients confirmed changes of EPS found over the average person, including WBC and lecithin corpuscle (phosphatidylcholine) in secretion. Also, routine urinary tests or culture showed no significant anomaly of acute inflammatory cell types or other urinary tract infections. An NIH-CPSI questionnaire survey was used to report pain, symptoms of abdominal discomfort, finding urination symptoms, and quality of life to give rise to a total score.

The Institutional Research Ethics Committee approved all research analysis. The written informed consent was retrieved from all individuals, and case-report-forms (CRF) were administered during outpatient visits to collect the information of age, routine urinary test, EPS and NIH-CPSI, etc. All procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013).

Sample Collection

Midsegment urine samples were attained in the morning and were at once frozen. They were stored at −20 °C until ready for use. Subjects were excluded when there were incomplete clinical data, inadequate quantities of urine samples, or grossly bloody and thick urine, or with alcohol consumption.

PSEP Assay

The double-blinded PSEP-ELISA assay was performed as described according to the manufacturer's instruction [Onco Biomedical Technology (Suzhou) CO., Ltd].[20] Void human urine samples were added to the 96-well microplate trays and incubated at 37 °C for one hour. After antibody incubation, the reaction was visualized by the addition of chromogenic tetramethylbenzidine (TMB). The resulting color development shows the amount of PSEP in urine samples. The absorbance of the samples was read at 450 nm/630 nm.

Statistical Analysis

The statistical analysis was performed blindly. For the cross-sectional study analysis, a database collected all information from each patient, including age, routine urinary test, EPS, including WBC, and lecithin corpuscle in secretion and NIH-CPSI. WBC and lecithin corpuscle stratified data in secretion and NIH-CPSI, respectively, according to different classification methods. The mean of PSEP concentration and detection rate of PSEP are calculated, respectively. Contingency tables and Spearman's correlation coefficient were used to test for independence between PSEP positive/negative status and concentration with Chi-square test statistics by SAS9.4 (The SAS software was developed by The State University of North Carolina, the USA in 1966) for each factor including WBC and lecithin corpuscle and NIHCPSI. Data were stratified by counting methods to minimize potential confounding factors when testing for association between PSEP and CP/CPPS status. The differences were significant when P<0.05. We conduct power analyses for the assessment of our sample size by G power software.

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