Predicting BPH Surgery Outcomes Using a Preoperative Scoring System

Development and Clinical Application Value of a Predictive Scoring System for Postoperative Outcomes Following Transurethral Resection of the Prostate Based on Preoperative Multidimensional Objective Indicators

This study aims to develop and validate a preoperative predictive scoring system for surgical outcomes in patients with benign prostatic hyperplasia (BPH) undergoing prostate surgery (including but not limited to transurethral resection of the prostate, laser enucleation, photoselective vaporization, or robot-assisted simple prostatectomy).

It is a multicenter retrospective study involving patients from four hospitals in China. Preoperative multidimensional objective indicators, including clinical data, prostate MRI parameters, and urodynamic measurements, will be collected. The primary outcome is a favorable surgical response defined by a postoperative-to-preoperative International Prostate Symptom Score (IPSS) ratio ≤ 0.5 at 6 months after surgery.

Multivariable logistic regression, restricted cubic splines, and bootstrap internal validation will be used to construct and evaluate the scoring system. The goal is to provide an objective, individualized tool for optimizing surgical decision-making in BPH patients.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

2000

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

No

Sampling Method

Non-Probability Sample

Study Population

This study population consists of adult male patients diagnosed with benign prostatic hyperplasia (BPH) who underwent prostate surgery (including transurethral resection of the prostate, laser enucleation, photoselective vaporization, or robot-assisted simple prostatectomy) between January 1, 2020 and August 30, 2025. Participants were recruited from four hospitals in China: The First Affiliated Hospital of Fujian Medical University, Fujian Medical University Union Hospital, Fuzhou Hospital of Traditional Chinese Medicine, and The First People's Hospital of Yunnan Province. All patients are of Chinese ethnicity and were selected based on the eligibility criteria described above. No specific community-based recruitment or sampling methods were applied; all consecutive eligible patients during the study period were included.

Description

Inclusion Criteria:

  • - Postoperative pathological diagnosis of benign prostatic hyperplasia (BPH)
  • Completion of pelvic or prostate magnetic resonance imaging (MRI) plain scan within 1 month before surgery
  • Completion of urodynamic study within 1 month before surgery
  • Completion of International Prostate Symptom Score (IPSS) both before and after surgery
  • Complete and retrievable clinical and pathological data
  • Generally good condition without infection, autoimmune disease, hematologic disease, or other malignancies
  • Complete follow-up data with follow-up duration of at least 6 months after surgery

Exclusion Criteria:

  • - Concomitant prostate cancer or other malignancies
  • Prior prostate surgery or pelvic radiotherapy
  • Severe cardiac, pulmonary, hepatic, or renal insufficiency precluding tolerance of surgery
  • Intraoperative or postoperative severe complications affecting efficacy assessment
  • Follow-up duration less than 6 months or missing key data
  • Poor patient compliance precluding completion of necessary assessments and follow-up
  • Incomplete clinical, imaging, urodynamic, or pathological data, or loss to 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

Cohorts and Interventions

Group / Cohort
BPH Patients Undergoing Prostate Surgery
Patients with BPH who underwent prostate surgery (various techniques including TURP, laser enucleation, PVP, or RASP) between Jan 2020 and Aug 2025 across four centers. Preoperative MRI and urodynamic data collected. Primary outcome: IPSS ratio ≤0.5 at 6 months post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with favorable surgical response at 6 months post-surgery
Time Frame: 6 months after surgery
Favorable surgical response is defined as a ratio of postoperative International Prostate Symptom Score (IPSS) to preoperative IPSS ≤ 0.5 at 6 months after surgery. IPSS assesses lower urinary tract symptoms, with scores ranging from 0 to 35 (higher scores indicating more severe symptoms). A ratio ≤ 0.5 represents at least 50% improvement from baseline.
6 months after surgery

Collaborators and Investigators

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

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)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD may not be shared due to concerns about patient privacy, lack of explicit informed consent for data sharing, and restrictions imposed by local ethics committees and institutional data protection policies. Any request for data sharing would need to be reviewed by the ethics committee of each participating hospital.

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.

Clinical Trials on BPH (Benign Prostatic Hyperplasia)

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