Lower Urinary Tract Symptoms (LUTS)UROFLOW-IPSSNCT07016776
Uroflowmetry Curve Types and IPSS in Men With LUTS
An observational study of Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH), run by Tarik Emre Sener.
Trial summary
This prospective observational study aims to evaluate the relationship between different uroflowmetry curve types and International Prostate Symptom Score (IPSS) domains in men presenting with lower urinary tract symptoms (LUTS). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH), Voiding Dysfunction
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 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: Male outpatients aged 40 years and older with LUTS who presented to the urology department of a tertiary academic center.
Who may be able to join
- Male patients aged 40 years or older
- Presenting with lower urinary tract symptoms (LUTS)
- Able to complete the IPSS questionnaire
- Underwent uroflowmetry and serum creatinine testing
Who cannot join
- History of prior prostate surgery
- Active urinary tract infection
- Known diagnosis of neurogenic bladder
- Current use of indwelling urinary catheter
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: Evaluation of the Association Between Uroflowmetry Curve Patterns and IPSS Domains in Men With Lower Urinary Tract Symptoms
This prospective observational study aims to evaluate the relationship between different uroflowmetry curve types and International Prostate Symptom Score (IPSS) domains in men presenting with lower urinary tract symptoms (LUTS). Participants will undergo routine clinical evaluations including uroflowmetry, laboratory assessments, and completion of the IPSS questionnaire.
Each participant will be classified into one of five predefined uroflowmetry curve types (normal/bell-shaped, plateau, staccato, intermittent, or tower-like). The IPSS will be analyzed both as a total score and as two subdomains: storage and voiding symptoms. Additional data such as age, comorbidities, medication use, prostate volume, eGFR, and QoL score will also be recorded to assess potential correlations and predictive factors for symptom severity.
The goal of this study is to better understand how objective urodynamic findings correlate with patient-reported symptoms and to inform clinical decision-making in men with LUTS.
Read the detailed description
This is a single-center, prospective, cross-sectional observational study conducted at Marmara University, Faculty of Medicine, Department of Urology. The study includes male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS) who are capable of completing the International Prostate Symptom Score (IPSS) questionnaire and undergoing uroflowmetry.
The primary objective is to evaluate the association between uroflowmetry curve types and IPSS scores, particularly focusing on the IPSS storage domain (questions 2, 4, 7), voiding domain (questions 1, 3, 5, 6), and the total score. Patients will be classified according to five uroflowmetry curve patterns: 1) normal (bell-shaped), 2) plateau, 3) staccato, 4) interrupted/intermittent, and 5) tower-like.
Demographic and clinical data will be collected including age, height, weight, smoking status, comorbidities (HTN, DM, CHF/CAD), history of urinary tract infections or retention, medication use (alpha-blockers, 5-ARI, anticholinergics), and medication adherence. Objective parameters such as prostate volume, PSA, serum creatinine, and estimated glomerular filtration rate (eGFR) will also be recorded.
The study will explore statistical associations between uroflowmetry curve types and symptom severity across the IPSS domains. The goal is to identify specific curve types that may correlate with increased symptom burden and/or predict surgical preference. Data analysis will include descriptive statistics, correlation analysis, and regression modeling as appropriate.
This study does not involve any experimental intervention and poses minimal risk to participants. All procedures and assessments are part of routine clinical practice. Ethical approval has been obtained, and informed consent will be acquired from all participants.
- Conditions
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH), Voiding Dysfunction
- Keywords
- International Prostate Symptom Score (IPSS), Uroflowmetry, Flow curve pattern, Male urinary symptoms, Prospective observational study
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
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 |
|---|---|---|
| Men with LUTS (Lower Urinary Tract Symptoms) | Male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS), evaluated using the International Prostate Symptom Score (IPSS), uroflowmetry, and standard clinical parameters. All participants will be classified based on their uroflowmetry curve type and IPSS subdomain scores (storage and voiding symptoms). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between uroflowmetry curve type and total IPSS score
Assessment of the relationship between different uroflowmetry curve patterns (normal, plateau, staccato, intermittent, tower) and total International Prostate Symptom Score (IPSS) in men with LUTS.
Measured: At baseline (single time point)
Secondary outcomes (2)
Association between uroflowmetry curve type and IPSS storage symptom sub-score
Evaluation of the correlation between flow curve pattern and IPSS storage domain (questions 2, 4, and 7).
Measured: At baseline
Association between uroflowmetry curve type and IPSS voiding symptom sub-score
Evaluation of the correlation between flow curve pattern and IPSS voiding domain (questions 1, 3, 5, and 6).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract Symptoms (LUTS)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarik Emre Sener
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016776
- Sponsor's protocol ID
- MAR.UAD.0022
- Acronym
- UROFLOW-IPSS
- Status last verified
- Aug 2025
- First submitted
- 30 May 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to the lack of a formal data sharing platform. However, de-identified data may be provided upon reasonable request by qualified researchers, in line with ethical approval and institutional policies.
Publications
Tarcan, T., et al. (2024). "ICS educational module: The practice of uroflowmetry in adults." Continence 9: 101065
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Uroflowmetry Curve Patterns and IPSS Domains in Men With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT07016776
- Acronym / sponsor ID
- UROFLOW-IPSS / MAR.UAD.0022
- Conditions
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH), Voiding Dysfunction
- Keywords
- International Prostate Symptom Score (IPSS), Uroflowmetry, Flow curve pattern, Male urinary symptoms, Prospective observational study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tarik Emre SenerUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 12 Jun 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 prospective observational study aims to evaluate the relationship between different uroflowmetry curve types and International Prostate Symptom Score (IPSS) domains in men presenting with lower urinary tract symptoms (LUTS). Participants will undergo routine clinical evaluations including uroflowmetry, laboratory assessments, and completion of the IPSS questionnaire.
Each participant will be classified into one of five predefined uroflowmetry curve types (normal/bell-shaped, plateau, staccato, intermittent, or tower-like). The IPSS will be analyzed both as a total score and as two subdomains: storage and voiding symptoms. Additional data such as age, comorbidities, medication use, prostate volume, eGFR, and QoL score will also be recorded to assess potential correlations and predictive factors for symptom severity.
The goal of this study is to better understand how objective urodynamic findings correlate with patient-reported symptoms and to inform clinical decision-making in men with LUTS.
Detailed description
This is a single-center, prospective, cross-sectional observational study conducted at Marmara University, Faculty of Medicine, Department of Urology. The study includes male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS) who are capable of completing the International Prostate Symptom Score (IPSS) questionnaire and undergoing uroflowmetry.
The primary objective is to evaluate the association between uroflowmetry curve types and IPSS scores, particularly focusing on the IPSS storage domain (questions 2, 4, 7), voiding domain (questions 1, 3, 5, 6), and the total score. Patients will be classified according to five uroflowmetry curve patterns: 1) normal (bell-shaped), 2) plateau, 3) staccato, 4) interrupted/intermittent, and 5) tower-like.
Demographic and clinical data will be collected including age, height, weight, smoking status, comorbidities (HTN, DM, CHF/CAD), history of urinary tract infections or retention, medication use (alpha-blockers, 5-ARI, anticholinergics), and medication adherence. Objective parameters such as prostate volume, PSA, serum creatinine, and estimated glomerular filtration rate (eGFR) will also be recorded.
The study will explore statistical associations between uroflowmetry curve types and symptom severity across the IPSS domains. The goal is to identify specific curve types that may correlate with increased symptom burden and/or predict surgical preference. Data analysis will include descriptive statistics, correlation analysis, and regression modeling as appropriate.
This study does not involve any experimental intervention and poses minimal risk to participants. All procedures and assessments are part of routine clinical practice. Ethical approval has been obtained, and informed consent will be acquired from all participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with LUTS (Lower Urinary Tract Symptoms) | – | –Male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS), evaluated using the International Prostate Symptom Score (IPSS), uroflowmetry, and standard clinical parameters. All participants will be classified based on their uroflowmetry curve type and IPSS subdomain scores (storage and voiding symptoms). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male outpatients aged 40 years and older with LUTS who presented to the urology department of a tertiary academic center.
Key inclusion criteria (4 listed)
- Male patients aged 40 years or older
- Presenting with lower urinary tract symptoms (LUTS)
- Able to complete the IPSS questionnaire
- Underwent uroflowmetry and serum creatinine testing
Key exclusion criteria (4 listed)
- History of prior prostate surgery
- Active urinary tract infection
- Known diagnosis of neurogenic bladder
- Current use of indwelling urinary catheter
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
Association between uroflowmetry curve type and total IPSS score
Time frame: At baseline (single time point)
Assessment of the relationship between different uroflowmetry curve patterns (normal, plateau, staccato, intermittent, tower) and total International Prostate Symptom Score (IPSS) in men with LUTS.
2 secondary outcomes
Association between uroflowmetry curve type and IPSS storage symptom sub-score
Time frame: At baseline
Association between uroflowmetry curve type and IPSS voiding symptom sub-score
Time frame: At baseline
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 3 Sep 2025.
- Results publicationTarcan, T., et al. (2024). "ICS educational module: The practice of uroflowmetry in adults." Continence 9: 101065
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to the lack of a formal data sharing platform. However, de-identified data may be provided upon reasonable request by qualified researchers, in line with ethical approval and institutional policies.
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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 Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH), run by Tarik Emre Sener.
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 4 inclusion and 4 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 3 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 Gunal Ozgur MD, FEBU, 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?
Association between uroflowmetry curve type and total IPSS score (time frame: At baseline (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016776, which also lists 1 linked publication.
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 Sep 2025.