Uroflowmetry and IPSS Factors Influencing Surgical Decision

NCT ID: NCT07047599

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-06-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery-Willing Group

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.

No interventions assigned to this group

Non-Surgery-Willing Group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Tarik Emre Sener

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

günal özgür, Urology Specialist

Role: CONTACT

gunalozgur91@hotmail.com

+905357849485

Other Identifiers

MAR.UAD.0025

Identifier Type: -

Identifier Source: org_study_id