Benign Prostatic Hyperplasia (BPH)TURP-SCORENCT07277556
TURP Outcome Prediction Calculator Study
An observational study of Benign Prostatic Hyperplasia (BPH), run by General Hospital Sveti Duh.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 13 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- BPH, LUTS, TURP, Uroflowmetry, IPSS, Outcome Prediction
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month, 3 Months
Change in Qmax After TURP
Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP
Measured: 1 Month, 3 Months
Change in Post-Void Residual Urine (PVR)
Reduction in ultrasound-measured residual urine after voiding following TURP
Measured: 1 Month, 3 Months
Change in Voided Volume on Uroflowmetry
Improvement in total voided volume after TURP
Measured: 1 Month, 3 Months
Secondary outcomes (2)
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
Measured: 1 Month, 3 Months
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)
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start2 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion13 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelina Hrkac, General Hospital Sveti Duh
- Investigators
- Adelina Hrkac, MD, Principal investigator, Klinička bolnica "Sveti Duh", Zavod za urologiju
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277556
- Sponsor's protocol ID
- KBSD-2025-03-3557
- Other IDs
- KBSD-URO--2025
- Acronym
- TURP-SCORE
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Parameters for Developing a TURP Outcome Calculator for Preoperative Patient Assessment
- ClinicalTrials.gov ID
- NCT07277556
- Acronym / sponsor ID
- TURP-SCORE / KBSD-2025-03-3557
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- BPH, LUTS, TURP, Uroflowmetry, IPSS, Outcome Prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 13 Dec 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Change in Qmax After TURP
Time frame: 1 Month, 3 Months
Improvement in maximum urinary flow rate (Qmax) measured by uroflowmetry after TURP
Change in Post-Void Residual Urine (PVR)
Time frame: 1 Month, 3 Months
Reduction in ultrasound-measured residual urine after voiding following TURP
Change in Voided Volume on Uroflowmetry
Time frame: 1 Month, 3 Months
Improvement in total voided volume after TURP
2 secondary outcomes
Composite Surgical Success Rate
Time frame: 1 Month, 3 Months
Complication Rate Following TURP
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adelina Hrkac, MD principal investigator
Klinička bolnica "Sveti Duh", Zavod za urologiju
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by General Hospital Sveti Duh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelina Hrkac, MD (00385958146992, adelina.surjan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IPSS Score After TURP (time frame: 1 Month, 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.