TURP Outcome Prediction Calculator Study
ConditionBenign Prostatic Hyperplasia (BPH)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorGeneral Hospital Sveti Duh
About this trial
The goal of this observational study is to identify which preoperative clinical, ultrasound, and uroflowmetry parameters can help predict the success of transurethral resection of the prostate (TURP) in adult male patients with symptomatic benign prostatic hyperplasia (BPH). The main questions it aims to answer are:
Which preoperative parameters (IPSS, prostate volume, post-void residual urine, Qmax, comorbidities) are associated with successful postoperative outcomes?
Can these parameters be used to develop a non-invasive calculator to estimate the likelihood of TURP success?
Participants will undergo routine clinical evaluation that is part of standard care, including:
* completion of the IPSS questionnaire * digital rectal examination * ultrasound measurement of prostate volume and residual urine * uroflowmetry (Qmax and voided volume) * standard laboratory testing Eligible participants will then undergo TURP as clinically indicated and return for postoperative assessments of symptom improvement and urinary flow parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 18 years or older
Clinical diagnosis of benign prostatic hyperplasia (BPH)
Indication for TURP based on symptoms or complications
Completed preoperative evaluation (IPSS, ultrasound, PSA, uroflowmetry)
Disqualifiers
Suspected or confirmed prostate cancer
No clinical evidence of BPH
Prior urodynamic diagnosis of underactive/neurogenic bladder
Prior prostate surgery
Trial population
Adult male patients with symptomatic benign prostatic hyperplasia undergoing clinically indicated transurethral resection of the prostate (TURP) at a single tertiary urology center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in IPSS Score After TURP
Improvement in lower urinary tract symptoms measured by the International Prostate Symptom Score (IPSS - validated questionnaire ranging from 0 to 35 points, where higher scores indicate more severe symptoms) one month after TURP compared to baseline.
Time frame
1 Month, 3 Months2
Change in Qmax After TURP
Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP
Time frame
1 Month, 3 Months3
Change in Post-Void Residual Urine (PVR)
Reduction in ultrasound-measured residual urine after voiding following TURP
Time frame
1 Month, 3 Months4
Change in Voided Volume on Uroflowmetry
Improvement in total voided volume after TURP
Time frame
1 Month, 3 MonthsSecondary outcomes
1
Composite Surgical Success Rate
Proportion of patients achieving predefined surgical success, based on combined improvements in IPSS, Qmax, voided volume, and post-void residual urine
Time frame
1 Month, 3 Months2
Complication Rate Following TURP
Frequency of postoperative complications categorized using Clavien-Dindo classification of surgical complications ranging from Grade 1 to Grade V (Grade 1 representing minor deviations from the normal postoperative course and Grade V representing patient death)
Time frame
30 DaysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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