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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04870749
Enrollment
219
Registered
2021-05-03
Start date
2020-03-01
Completion date
2021-04-01
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Obstruction

Keywords

IPP, IPSS, VPSS

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.

Interventions

DIAGNOSTIC_TESTIPP,IPSS,VPSS

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

Sponsors

Cumhuriyet University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.During the patient's outpatient clinic examinationIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026