Predicting BPH Surgery Outcomes Using a Preoperative Scoring System (NCT07623239) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predicting BPH Surgery Outcomes Using a Preoperative Scoring System
2,000 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
30 Years – 100 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with favorable surgical response at 6 months post-surgery
Timeframe: 6 months after surgery
Trial details
NCT IDNCT07623239
SponsorFirst Affiliated Hospital of Fujian Medical University