TURP Outcome Prediction Calculator Study (TURP-SCORE)

December 15, 2025 updated by: Adelina Hrkac, General Hospital Sveti Duh

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult male patients with symptomatic benign prostatic hyperplasia undergoing clinically indicated transurethral resection of the prostate (TURP) at a single tertiary urology center.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adelina Hrkac, MD, Klinička bolnica "Sveti Duh", Zavod za urologiju

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 13, 2027

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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