Predicting BPH Surgery Outcomes Using a Preoperative Scoring System

NCT07623239 | Not Yet Recruiting

• 1 other identifier: 20260301102406738
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Outcome Measures

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.

  6 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yong Wei

CONTACT

13960985927; drzhuzh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-04