Uroflowmetry and IPSS Factors Influencing Surgical Decision
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Surgery-Willing Group
Group B: Non-Surgery-Willing Group
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline (at the outpatient clinic visit)2
Post-Void Residual Urine Volume (PVR)
PVR will be assessed using bladder ultrasound following uroflowmetry at the initial visit. Unit of Measure: Milliliters (mL)
Time frame
Baseline (at the outpatient clinic visit)3
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)
Time frame
Baseline (at the outpatient clinic visit)4
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
Time frame
Baseline (at the outpatient clinic visit)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: