Lower Urinary Tract Symptoms，Prostatic HyperplasiaNCT06448533
The Predictive Value of Prostate Spherical Volume Ratio in Lower Urinary Tract Symptoms and Clinical Progression of Benign Prostatic Hyperplasia:A Single-center Paired Validating Confirmatory Study
An observational study of Lower Urinary Tract Symptoms，Prostatic Hyperplasia, run by Shanghai East Hospital at 1 site in China.
Trial summary
This study was a retrospective cohort study clinical trial designed to assess the predictive ability of the prostate morphometric parameter, Prostate Spherical Volume Ratio, in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia; and to compare the predictive ability of other… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms，Prostatic Hyperplasia
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2022to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male with benign prostatic hyperplasia
Who may be able to join
- All patients had obvious lower urinary tract symptoms such as urinary frequency, increased nocturia, and a feeling of incomplete urination, etc. They all completed prostate MRI, IPSS questionnaire, and uroflowmetry for a clear diagnosis of BPH.
Who cannot join
- 1, previous history of bladder, prostate, urethra surgery; 2, the existence of other diseases that cause urinary dysfunction: such as neurogenic bladder, bladder stones, urethral stenosis, urinary tract infections, acute prostatitis, etc.; 3, the existence of mental, mental disorders, can not be accurately expressed and family members can not help to improve the IPSS scores; 4, to receive prostatic hyperplasia medication, such as: α-blocker therapy, 5α reductase inhibitors, etc. have not been discontinued for 6 months; 5, refused to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
About this study
This study was a retrospective cohort study clinical trial designed to assess the predictive ability of the prostate morphometric parameter, Prostate Spherical Volume Ratio, in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia; and to compare the predictive ability of other anatomical parameters of the prostate (prostatic urethral length, intravesical prostatic protrusion, presumed circle area ratio, and prostate volume) in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia
Read the detailed description
This was a retrospective observational study approved by the Ethics Committee of Shanghai Oriental Hospital. We collected patients with BPH who underwent MRI, urine flow measurement and completed the IPSS questionnaire in our hospital between September 2022 and April 2023, measured each anatomical parameter of the patient's prostate by MRI, analysed the relationship of these prostate parameters with IPSS and urine flow, and conducted a follow-up of the clinical progression of the prostate in these patients to evaluate the predictive efficacy of prostate parameters for LUTS and clinical progression of benign prostatic hyperplasia.
- Being tested
- No intervention
- Keywords
- Lower Urinary Tract Symptoms，prostatic hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical progression of benign prostatic hyperplasia
The primary outcome, described as clinical progression of benign prostatic hyperplasia, was the first occurrence of an increase in the IPSS of at least 4 points, benign prostatic hyperplasia-related prostatic surgery
Measured: 1 year of observation and follow-up after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start10 Sep 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract Symptoms，Prostatic HyperplasiaStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448533
- Sponsor's protocol ID
- 1.0 2022.9.10
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji T, Huang K, He B, Wang H. The predictive value of prostate spherical volume ratio in lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia: a retrospective cohort study. Int Urol Nephrol. 2025 Jul;57(7):2023-2032. doi: 10.1007/s11255-024-04355-4. Epub 2025 Jan 15.
PubMed 39812965
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Prostate Spherical Volume Ratio in Lower Urinary Tract Symptoms and Clinical Progression of Benign Prostatic Hyperplasia:A Single-center Paired Validating Confirmatory Study
- ClinicalTrials.gov ID
- NCT06448533
- Acronym / sponsor ID
- 1.0 2022.9.10
- Keywords
- Lower Urinary Tract Symptoms，prostatic hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 7 Jun 2024 (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 was a retrospective cohort study clinical trial designed to assess the predictive ability of the prostate morphometric parameter, Prostate Spherical Volume Ratio, in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia; and to compare the predictive ability of other anatomical parameters of the prostate (prostatic urethral length, intravesical prostatic protrusion, presumed circle area ratio, and prostate volume) in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia
Detailed description
This was a retrospective observational study approved by the Ethics Committee of Shanghai Oriental Hospital. We collected patients with BPH who underwent MRI, urine flow measurement and completed the IPSS questionnaire in our hospital between September 2022 and April 2023, measured each anatomical parameter of the patient's prostate by MRI, analysed the relationship of these prostate parameters with IPSS and urine flow, and conducted a follow-up of the clinical progression of the prostate in these patients to evaluate the predictive efficacy of prostate parameters for LUTS and clinical progression of benign prostatic hyperplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male with benign prostatic hyperplasia
Key inclusion criteria (1 listed)
- All patients had obvious lower urinary tract symptoms such as urinary frequency, increased nocturia, and a feeling of incomplete urination, etc. They all completed prostate MRI, IPSS questionnaire, and uroflowmetry for a clear diagnosis of BPH.
Key exclusion criteria (1 listed)
- 1, previous history of bladder, prostate, urethra surgery; 2, the existence of other diseases that cause urinary dysfunction: such as neurogenic bladder, bladder stones, urethral stenosis, urinary tract infections, acute prostatitis, etc.; 3, the existence of mental, mental disorders, can not be accurately expressed and family members can not help to improve the IPSS scores; 4, to receive prostatic hyperplasia medication, such as: α-blocker therapy, 5α reductase inhibitors, etc. have not been discontinued for 6 months; 5, refused to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
clinical progression of benign prostatic hyperplasia
Time frame: 1 year of observation and follow-up after enrolment
The primary outcome, described as clinical progression of benign prostatic hyperplasia, was the first occurrence of an increase in the IPSS of at least 4 points, benign prostatic hyperplasia-related prostatic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 39812965Ji T, Huang K, He B, Wang H. The predictive value of prostate spherical volume ratio in lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia: a retrospective cohort study. Int Urol Nephrol. 2025 Jul;57(7):2023-2032. doi: 10.1007/s11255-024-04355-4. Epub 2025 Jan 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms，Prostatic Hyperplasia, run by Shanghai East Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical progression of benign prostatic hyperplasia (time frame: 1 year of observation and follow-up after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448533, which also lists 1 linked publication.
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 7 Jun 2024.