Lower Urinary Tract SymptomNCT07047599
Uroflowmetry and IPSS Factors Influencing Surgical Decision
An observational study of Lower Urinary Tract Symptom and Benign Prostate Obstruction (BPO), run by Marmara University.
Trial summary
This study aims to identify which symptoms or test findings lead men with lower urinary tract symptoms (LUTS) to consider surgical treatment. Male patients who visit the outpatient clinic for LUTS will be asked whether they would consider surgery in the future if their symptoms persist. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptom, Benign Prostate Obstruction (BPO), Voiding Dysfunction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult male patients aged 40 years and older who present to the urology outpatient clinic with lower urinary tract symptoms (LUTS). All participants will complete the IPSS questionnaire and undergo uroflowmetry testing. Patients will be asked about their willingness to consider surgical treatment if their symptoms persist. No treatment or intervention will be administered as part of the study.
Who may be able to join
- Male patients aged 40 years and older
- Presenting with lower urinary tract symptoms (LUTS)
- Able to complete the IPSS questionnaire
- Undergoing uroflowmetry as part of routine evaluation
- Able and willing to provide informed consent
Who cannot join
- History of urological surgery (e.g., TURP, HoLEP, radical prostatectomy)
- Presence of known prostate or bladder cancer
- Active urinary tract infection at the time of evaluation
- Neurological conditions affecting voiding (e.g., Parkinson's disease, spinal cord injury)
- Inability to perform uroflowmetry or incomplete IPSS data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Clinical and Uroflowmetry Parameters as Predictors of Surgical Preference in Male Patients With Lower Urinary Tract Symptoms: A Prospective Observational Study
This study aims to identify which symptoms or test findings lead men with lower urinary tract symptoms (LUTS) to consider surgical treatment. Male patients who visit the outpatient clinic for LUTS will be asked whether they would consider surgery in the future if their symptoms persist. Along with this, symptom severity scores (IPSS), quality of life scores, and uroflowmetry measurements such as maximum flow rate (Qmax) and post-void residual volume (PVR) will be collected. The goal is to determine which factors are most strongly associated with a desire for surgery. This is an observational, non-interventional study.
Read the detailed description
This prospective observational study is designed to evaluate which clinical and uroflowmetry parameters are associated with a desire for surgical treatment in male patients presenting with lower urinary tract symptoms (LUTS). Participants will complete the International Prostate Symptom Score (IPSS) questionnaire, including the quality of life (QoL) item, and undergo uroflowmetry testing. Parameters such as maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), and IPSS subdomain scores (e.g., weak stream, nocturia, urgency) will be analyzed. Patients will also be asked a standardized question regarding their surgical preference if their symptoms remain unchanged.
The primary aim is to determine which symptoms or objective findings (e.g., specific IPSS items, reduced Qmax) are most predictive of a preference for surgical intervention. The study will help guide clinical decision-making by identifying symptom patterns or test results that are more likely to prompt patients to consider surgery. No therapeutic intervention will be performed as part of this study.
- Keywords
- Lower Urinary Tract Symptoms, Benign Prostate Obstruction (BPO), Voiding Dysfunction, IPSS, Urolfowmetry
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery-Willing Group | This group includes male patients with lower urinary tract symptoms (LUTS) who indicate that they would prefer or consider surgical treatment if their symptoms remain unchanged. Participants in this group will complete the IPSS questionnaire, undergo uroflowmetry testing, and provide clinical and demographic data. No therapeutic intervention will be administered during the study. | |
| Non-Surgery-Willing Group | This group includes male patients with lower urinary tract symptoms (LUTS) who indicate that they do not prefer surgical treatment and would rather be followed conservatively, even if their symptoms persist. These participants will also complete the IPSS questionnaire, undergo uroflowmetry testing, and provide relevant clinical and demographic information. No therapeutic intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total International Prostate Symptom Score (IPSS) at Baseline
Total IPSS score will be recorded for each participant at the time of initial outpatient clinic evaluation to assess symptom severity.
Unit of Measure: Points (0 to 35)
Measured: Baseline (at the outpatient clinic visit)
Post-Void Residual Urine Volume (PVR)
PVR will be assessed using bladder ultrasound following uroflowmetry at the initial visit.
Unit of Measure: Milliliters (mL)
Measured: Baseline (at the outpatient clinic visit)
Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry
Qmax (in mL/sec) will be measured during the initial outpatient visit using non-invasive uroflowmetry.
Unit of Measure: Milliliters per second (mL/sec)
Measured: Baseline (at the outpatient clinic visit)
Patient Preference for Surgery Based on a Standardized Question
Patients will be asked: "Would you consider surgical treatment if your symptoms remain unchanged in the future?" Response options are Yes/No
Measured: Baseline (at the outpatient clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047599
- Sponsor's protocol ID
- MAR.UAD.0025
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to publicly share individual participant data (IPD). However, de-identified data may be shared upon reasonable scientific request for academic or research purposes. Such requests will be evaluated on a case-by-case basis and may require institutional ethics approval and a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical and Uroflowmetry Parameters as Predictors of Surgical Preference in Male Patients With Lower Urinary Tract Symptoms: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07047599
- Acronym / sponsor ID
- MAR.UAD.0025
- Keywords
- Lower Urinary Tract Symptoms, Benign Prostate Obstruction (BPO), Voiding Dysfunction, IPSS, Urolfowmetry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
This study aims to identify which symptoms or test findings lead men with lower urinary tract symptoms (LUTS) to consider surgical treatment. Male patients who visit the outpatient clinic for LUTS will be asked whether they would consider surgery in the future if their symptoms persist. Along with this, symptom severity scores (IPSS), quality of life scores, and uroflowmetry measurements such as maximum flow rate (Qmax) and post-void residual volume (PVR) will be collected. The goal is to determine which factors are most strongly associated with a desire for surgery. This is an observational, non-interventional study.
Detailed description
This prospective observational study is designed to evaluate which clinical and uroflowmetry parameters are associated with a desire for surgical treatment in male patients presenting with lower urinary tract symptoms (LUTS). Participants will complete the International Prostate Symptom Score (IPSS) questionnaire, including the quality of life (QoL) item, and undergo uroflowmetry testing. Parameters such as maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), and IPSS subdomain scores (e.g., weak stream, nocturia, urgency) will be analyzed. Patients will also be asked a standardized question regarding their surgical preference if their symptoms remain unchanged.
The primary aim is to determine which symptoms or objective findings (e.g., specific IPSS items, reduced Qmax) are most predictive of a preference for surgical intervention. The study will help guide clinical decision-making by identifying symptom patterns or test results that are more likely to prompt patients to consider surgery. No therapeutic intervention will be performed as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery-Willing Group | – | –This group includes male patients with lower urinary tract symptoms (LUTS) who indicate that they would prefer or consider surgical treatment if their symptoms remain unchanged. Participants in this group will complete the IPSS questionnaire, undergo uroflowmetry testing, and provide clinical and demographic data. No therapeutic intervention will be administered during the study. |
| Non-Surgery-Willing Group | – | –This group includes male patients with lower urinary tract symptoms (LUTS) who indicate that they do not prefer surgical treatment and would rather be followed conservatively, even if their symptoms persist. These participants will also complete the IPSS questionnaire, undergo uroflowmetry testing, and provide relevant clinical and demographic information. No therapeutic intervention will be performed. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult male patients aged 40 years and older who present to the urology outpatient clinic with lower urinary tract symptoms (LUTS). All participants will complete the IPSS questionnaire and undergo uroflowmetry testing. Patients will be asked about their willingness to consider surgical treatment if their symptoms persist. No treatment or intervention will be administered as part of the study.
Key inclusion criteria (5 listed)
- Male patients aged 40 years and older
- Presenting with lower urinary tract symptoms (LUTS)
- Able to complete the IPSS questionnaire
- Undergoing uroflowmetry as part of routine evaluation
- Able and willing to provide informed consent
Key exclusion criteria (5 listed)
- History of urological surgery (e.g., TURP, HoLEP, radical prostatectomy)
- Presence of known prostate or bladder cancer
- Active urinary tract infection at the time of evaluation
- Neurological conditions affecting voiding (e.g., Parkinson's disease, spinal cord injury)
- Inability to perform uroflowmetry or incomplete IPSS data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total International Prostate Symptom Score (IPSS) at Baseline
Time frame: Baseline (at the outpatient clinic visit)
Total IPSS score will be recorded for each participant at the time of initial outpatient clinic evaluation to assess symptom severity. Unit of Measure: Points (0 to 35)
Post-Void Residual Urine Volume (PVR)
Time frame: Baseline (at the outpatient clinic visit)
PVR will be assessed using bladder ultrasound following uroflowmetry at the initial visit. Unit of Measure: Milliliters (mL)
Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry
Time frame: Baseline (at the outpatient clinic visit)
Qmax (in mL/sec) will be measured during the initial outpatient visit using non-invasive uroflowmetry. Unit of Measure: Milliliters per second (mL/sec)
Patient Preference for Surgery Based on a Standardized Question
Time frame: Baseline (at the outpatient clinic visit)
Patients will be asked: "Would you consider surgical treatment if your symptoms remain unchanged in the future?" Response options are Yes/No
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No. This study does not plan to publicly share individual participant data (IPD). However, de-identified data may be shared upon reasonable scientific request for academic or research purposes. Such requests will be evaluated on a case-by-case basis and may require institutional ethics approval and a data use agreement.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptom and Benign Prostate Obstruction (BPO), run by Marmara University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact günal özgür, Urology Specialist (+905357849485, gunalozgur91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total International Prostate Symptom Score (IPSS) at Baseline (time frame: Baseline (at the outpatient clinic visit)). The study lists 4 primary outcomes in all. 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 5 Sep 2025.