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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07623239

Enrollment

2000

Registered

2026-06-03

Start date

2026-06-01

Completion date

2027-09-01

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia)

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

30 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with favorable surgical response at 6 months post-surgery	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.

Contacts

CONTACTYong Wei

drzhuzh@163.com13960985927

Outcome results