Uroflowmetry and IPSS Factors Influencing Surgical Decision

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.

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Key information

Conditions

Lower Urinary Tract Symptom Benign Prostate Obstruction (BPO) Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations Voiding Dysfunction

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

günal özgür, Urology Specialist

CONTACT

[email protected]

+905357849485

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Assessment of Clinical and Uroflowmetry Parameters as Predictors of Surgical Preference in Male Patients With Lower Urinary Tract Symptoms: A Prospective Observational Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 2, 2025
Registry last updated: Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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