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

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.

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Key information

Conditions

Urinary Obstruction

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cumhuriyet Universty

Sivas, 58040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPP,IPSS,VPSS

Diagnostic Test

Prostate volume, IPSS, VPSS and IPP were determined after urological examinations of the patients.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Diagnostic Role of Visual Prostate Symptom Score and Intravesical Prostatic Protrusion in Male Lower Urinary Tract Symptoms

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: May 3, 2021
Registry last updated: May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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