← Back to all trials
Not Yet Recruiting
NCT07623239
Predicting BPH Surgery Outcomes Using a Preoperative Scoring System
Conditions: BPH (Benign Prostatic Hyperplasia)
Sex: Male
Ages: 30 Years – 100 Years
Healthy volunteers: No
Enrollment: 2000
Sponsor: First Affiliated Hospital of Fujian Medical University
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07623239). StuddyBuddy aggregates publicly available trial information.
