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

Urinary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870749
• Other study ID #: CumhuriyetU urology
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Obstruction

Intervention

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

Locations

Country	Name	City	State
Turkey	Cumhuriyet Universty	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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