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Uroflowmetry and IPSS Factors Influencing Surgical Decision

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07047599
Enrollment
100
Registered
2025-07-02
Start date
2025-09-15
Completion date
2026-06-01
Last updated
2025-09-05

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

Conditions

Benign Prostate Obstruction (BPO), Lower Urinary Tract Symptom, Voiding Dysfunction

Keywords

Lower Urinary Tract Symptoms, Benign Prostate Obstruction (BPO), Voiding Dysfunction, IPSS, Urolfowmetry

Brief 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. 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.

Interventions

None listed

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Total International Prostate Symptom Score (IPSS) at BaselineBaseline (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)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 UroflowmetryBaseline (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 QuestionBaseline (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

Contacts

Primary Contactgünal özgür, Urology Specialist
gunalozgur91@hotmail.com+905357849485

Outcome results

None listed

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