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Not yet recruiting NCT07047599

Uroflowmetry and IPSS Factors Influencing Surgical Decision

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Symptom, Benign Prostate Obstruction (BPO), Voiding Dysfunction. Basic parameters: from 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Primary outcome measures

  • Total International Prostate Symptom Score (IPSS) at Baseline [Time frame: Baseline (at the outpatient clinic visit)]
  • Post-Void Residual Urine Volume (PVR) [Time frame: Baseline (at the outpatient clinic visit)]
  • Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry [Time frame: Baseline (at the outpatient clinic visit)]
  • Patient Preference for Surgery Based on a Standardized Question [Time frame: Baseline (at the outpatient clinic visit)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07047599 · MAR.UAD.0025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗