Uroflowmetry and IPSS Factors Influencing Surgical Decision

Marmara University

Status: Not yet enrolling

Conditions: Lower Urinary Tract Symptom; Benign Prostate Obstruction (BPO); Voiding Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT07047599

MAR.UAD.0025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Surgery-Willing Group

Description:

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

Description:

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.