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

NCT ID: NCT06448533

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-10

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Urinary Tract Symptoms,Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39812965 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1.0 2022.9.10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.