TURP Outcome Prediction Calculator Study

NCT07277556 | Not Yet Recruiting

• 2 other identifiers: KBSD-2025-03-3557KBSD-URO--2025
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

BPH; LUTS; TURP; Uroflowmetry; IPSS; Outcome Prediction

Outcome Measures

Primary Outcomes (4)

• 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.

  1 Month, 3 Months

• Change in Qmax After TURP

  Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP

  1 Month, 3 Months

• Change in Post-Void Residual Urine (PVR)

  Reduction in ultrasound-measured residual urine after voiding following TURP

  1 Month, 3 Months

• Change in Voided Volume on Uroflowmetry

  Improvement in total voided volume after TURP

  1 Month, 3 Months

Secondary Outcomes (2)

• Composite Surgical Success Rate

  1 Month, 3 Months

• Complication Rate Following TURP

  30 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Sveti Duh: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Adelina Hrkac, MD

  Klinička bolnica "Sveti Duh", Zavod za urologiju

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelina Hrkac, MD

CONTACT

00385958146992; adelina.surjan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FEBU, Principal Investigator

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 13, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share