BPH (Benign Prostatic Hyperplasia)NCT07623239
Predicting BPH Surgery Outcomes Using a Preoperative Scoring System
An observational study of BPH (Benign Prostatic Hyperplasia), run by First Affiliated Hospital of Fujian Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 100 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623239
- Sponsor's protocol ID
- 20260301102406738
- Status last verified
- Apr 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to concerns about patient privacy, lack of explicit informed consent for data sharing, and restrictions imposed by local ethics committees and institutional data protection policies. Any request for data sharing would need to be reviewed by the ethics committee of each participating hospital.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07623239
- Acronym / sponsor ID
- 20260301102406738
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- - 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with favorable surgical response at 6 months post-surgery
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to concerns about patient privacy, lack of explicit informed consent for data sharing, and restrictions imposed by local ethics committees and institutional data protection policies. Any request for data sharing would need to be reviewed by the ethics committee of each participating hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH (Benign Prostatic Hyperplasia), run by First Affiliated Hospital of Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Wei (13960985927, drzhuzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with favorable surgical response at 6 months post-surgery (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.