The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.

Completed

• Conditions: Urinary Obstruction

• Registration Number: NCT04870749
• Lead Sponsor: Cumhuriyet University

Brief Summary

The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Detailed Description

Aims The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Methods The study included 219 male patients aged 50 and over, who were admitted between March 2020 and August 2020. Patients completed the Visual Prostate Symptom Score (VPSS) along with International Prostate Symptom Score (IPSS). Intravesical prostatic protrusion (IPP), prostate volume, bladder volume, and post voiding residual urine (PVR) were measured by suprapubic ultrasound. Urethral resistance was calculated using the Bladder Outlet Obstruction Number (BOON), and patients over -20 were considered obstructed.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-08-01
• Status Verified: 2021-04
• Study Completion: 2021-04-01
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-30
• Last Update Submitted: 2021-04-30
• Study First Posted: 2021-05-03
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 219

Inclusion Criteria

• Clinical diagnosis of BPH Disease

Exclusion Criteria

• Patients with previous urological surgery
• History of urological malignancy
• Systemic disease (diabetes mellitus, multiple sclerosis, etc.)
• Trauma that may cause LUTS
• Pharmacotherapy for LUTS
• Use diuretic antihypertensive
• PSA > 4 ng/dl
• History of pelvic radiotherapy
• Visual problems that could not complete the VPSS test were not included.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.	During the patient's outpatient clinic examination	In this study, it is aimed to determine the use of VPSS instead of IPSS when needed, the importance of IPP in evaluating LUTS, and the correlation of IPP with VPSS and IPSS, based on BOON in the diagnosis of obstruction.; The data obtained from the study were evaluated with the SPSS 23.0 program. The normality rankings of the data were made by the Shapiro-Wilk test. Since the data are non-parametric, the Spearman correlation test was performed. The Kruskal-Wallis test was performed for calculating the difference of IPSS groups (mild, moderate, severe) according to other parameters. In case of difference, the Mann-Whitney U test was applied to understand which two groups were different. Since the IPP groups (\<5mm, 5-10mm, \>10mm) conformed to the normal distribution, Post-Hoc (Bonferroni) test was used to determine the differences between the 3 groups. The level of error was taken as 0.05.

Trial Locations

Locations (1)

Cumhuriyet Universty; 🇹🇷 Sivas, Turkey