Uroflowmetry and IPSS Factors Influencing Surgical Decision

NCT07047599 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0025
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Total International Prostate Symptom Score (IPSS) at Baseline

  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)

  Baseline (at the outpatient clinic visit)

• Post-Void Residual Urine Volume (PVR)

  PVR will be assessed using bladder ultrasound following uroflowmetry at the initial visit. Unit of Measure: Milliliters (mL)

  Baseline (at the outpatient clinic visit)

• Maximum Urinary Flow Rate (Qmax) Measured by Uroflowmetry

  Qmax (in mL/sec) will be measured during the initial outpatient visit using non-invasive uroflowmetry. Unit of Measure: Milliliters per second (mL/sec)

  Baseline (at the outpatient clinic visit)

• Patient Preference for Surgery Based on a Standardized Question

  Patients will be asked: "Would you consider surgical treatment if your symptoms remain unchanged in the future?" Response options are Yes/No

  Baseline (at the outpatient clinic visit)

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult male patients aged 40 years and older who present to the urology outpatient clinic with lower urinary tract symptoms (LUTS). All participants will complete the IPSS questionnaire and undergo uroflowmetry testing. Patients will be asked about their willingness to consider surgical treatment if their symptoms persist. No treatment or intervention will be administered as part of the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

günal özgür, Urology Specialist

CONTACT

+905357849485; gunalozgur91@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 2, 2025
• Study Start: September 15, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share