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

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

Study Overview

• Status: Completed
• Conditions: Urinary Obstruction
• Intervention / Treatment: Diagnostic test: IPP,IPSS,VPSS

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 Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey, 58040
    • Cumhuriyet Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Male patients over 50 years old who applied to Sivas Cumhuriyet University Hospital urology outpatient clinic between March 2020 and August 2020.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lower urinart tract syptoms; Lower urinary tract symptoms (LUTS) are common in older men and one of the main reasons for this is the enlargement in prostate gland volume caused by hormonal changes.	Diagnostic test: IPP,IPSS,VPSS; Prostate volume, IPSS, VPSS and IPP were determined after urological examinations of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.	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.	During the patient's outpatient clinic examination

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: IPSS; IPP; VPSS
• Other Study ID Numbers: CumhuriyetU urology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No