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

NCT04870749 | Completed

• 1 other identifier: CumhuriyetU urology
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Obstruction

Keywords

IPP; IPSS; VPSS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

IPP,IPSS,VPSS DIAGNOSTIC_TEST

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

lower urinart tract syptoms

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of BPH Disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Cumhuriyet Universty

Sivas, 58040, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Urology

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: March 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: April 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)