Urinary ObstructionNCT04870749
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.
An observational study of Urinary Obstruction, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Urinary Obstruction
- What is being tested?
- IPP,IPSS,VPSS
- How many people
- 219 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Apr 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients over 50 years old who applied to Sivas Cumhuriyet University Hospital urology outpatient clinic between March 2020 and August 2020.
Who may be able to join
- Clinical diagnosis of BPH Disease
Who cannot join
- 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
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- PSA > 4 ng/dl
- History of pelvic radiotherapy
- Visual problems that could not complete the VPSS test were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Obstruction
- Being tested
- IPP,IPSS,VPSS
- Keywords
- IPP, IPSS, VPSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPP,IPSS,VPSSDiagnostic test
Prostate volume, IPSS, VPSS and IPP were determined after urological examinations of the patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: IPP,IPSS,VPSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the patient's outpatient clinic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Mar 2020
- Primary completion1 Aug 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Saygin, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870749
- Sponsor's protocol ID
- CumhuriyetU urology
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Visual Prostate Symptom Score and Intravesical Prostatic Protrusion in Male Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT04870749
- Acronym / sponsor ID
- CumhuriyetU urology
- Conditions
- Urinary Obstruction
- Keywords
- IPP, IPSS, VPSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lower urinart tract syptoms | – | Diagnostic Test: IPP,IPSS,VPSSLower 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients over 50 years old who applied to Sivas Cumhuriyet University Hospital urology outpatient clinic between March 2020 and August 2020.
Key inclusion criteria (1 listed)
- Clinical diagnosis of BPH Disease
Key exclusion criteria (9 listed)
- Patients with previous urological surgery
- History of urological malignancy
- Systemic disease (diabetes mellitus, multiple sclerosis, etc.)
- Trauma that may cause LUTS
- Pharmacotherapy for LUTS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPP,IPSS,VPSSProstate volume, IPSS, VPSS and IPP were determined after urological examinations of the patients. | Diagnostic test | lower urinart tract syptoms |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Obstruction, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms. (time frame: During the patient's outpatient clinic examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.