- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277556
TURP Outcome Prediction Calculator Study (TURP-SCORE)
Identification of Predictive Parameters for Developing a TURP Outcome Calculator for Preoperative Patient Assessment
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.
Study Overview
Status
Conditions
Detailed Description
Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to lower urinary tract symptoms (LUTS), subvesical obstruction, and related complications such as urinary retention, bladder stones, recurrent infections, and renal impairment. Transurethral resection of the prostate (TURP) remains the standard surgical treatment for symptomatic benign prostatic obstruction (BPO). However, a subset of patients, particularly those with an underlying hypocontractile detrusor, may not benefit from TURP and continue to experience significant voiding dysfunction after surgery. Since formal urodynamic pressure-flow studies are invasive, time-consuming, and resource-intensive, there is clinical value in identifying non-invasive predictors of surgical success.
This prospective observational study will evaluate preoperative clinical, ultrasound, and uroflowmetry parameters associated with successful postoperative outcomes after TURP. Adult male patients with symptomatic BPH and an indication for TURP will undergo standardized assessment including medical history, IPSS questionnaire, digital rectal examination, serum PSA, ultrasound-determined prostate volume and post-void residual urine, and uroflowmetry parameters such as Qmax and voided volume. Comorbidities relevant to bladder function, including diabetes mellitus and neurological conditions, will be recorded. TURP will be performed according to standard clinical practice, and resected tissue will undergo routine histopathological evaluation.
Postoperative follow-up will include IPSS reassessment, uroflowmetry, and ultrasound measurement of residual urine at one month and during subsequent routine evaluations. Surgical outcomes will be categorized as successful or unsuccessful based on subjective symptom improvement and objective urinary flow parameters. Using the collected data, the study will identify which preoperative variables correlate with favorable postoperative outcomes. These parameters will subsequently be used to inform the development of a predictive TURP outcome calculator.
The anticipated value of this study is to support individualized clinical decision-making in patients with BPH, particularly those in whom the distinction between obstruction and impaired detrusor contractility is unclear. By identifying patients who are less likely to benefit from TURP based on non-invasive parameters, the resulting calculator may help reduce unnecessary procedures, avoid postoperative morbidity, and potentially limit the need for invasive urodynamic testing.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Adelina Hrkac, MD
- Phone Number: 00385958146992
- Email: adelina.surjan@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
- Able to provide informed consent
Exclusion Criteria:
- Suspected or confirmed prostate cancer
- No clinical evidence of BPH
- Prior urodynamic diagnosis of underactive/neurogenic bladder
- Prior prostate surgery
- Inability to participate in follow-up
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Qmax After TURP
Time Frame: 1 Month, 3 Months
|
Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP
|
1 Month, 3 Months
|
|
Change in Post-Void Residual Urine (PVR)
Time Frame: 1 Month, 3 Months
|
Reduction in ultrasound-measured residual urine after voiding following TURP
|
1 Month, 3 Months
|
|
Change in Voided Volume on Uroflowmetry
Time Frame: 1 Month, 3 Months
|
Improvement in total voided volume after TURP
|
1 Month, 3 Months
|
|
Change in IPSS Score After TURP
Time Frame: 1 Month, 3 Months
|
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.
|
1 Month, 3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Surgical Success Rate
Time Frame: 1 Month, 3 Months
|
Proportion of patients achieving predefined surgical success, based on combined improvements in IPSS, Qmax, voided volume, and post-void residual urine
|
1 Month, 3 Months
|
|
Complication Rate Following TURP
Time Frame: 30 Days
|
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)
|
30 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adelina Hrkac, MD, Klinička bolnica "Sveti Duh", Zavod za urologiju
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBSD-2025-03-3557
- KBSD-URO--2025 (Registry Identifier: KB Sveti Duh Urology Institutional Research Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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