Predicting BPH Surgery Outcomes Using a Preoperative Scoring System

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-100
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- 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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: BPH Patients Undergoing Prostate Surgery

Trial outcomes

Primary outcomes

1

Proportion of patients with favorable surgical response at 6 months post-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.

Time frame
6 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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