NCT04856748: PIN

Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms

Completed Last updated 12 December 2023

What this trial tests

trial in Inflammation in 423 participants. Completed in 31 December 2022.

Timeline

3 September 2020

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	Institute for Monitoring of Urogenital Diseases
Status	Completed
Study type	OBSERVATIONAL
Enrollment	423
Start date	3 September 2020
Primary completion	30 September 2022
Estimated completion	31 December 2022
Sites	7 locations across France, Italy, Greece, Cyprus, Portugal, Spain

Conditions studied

• Inflammation — all drugs for Inflammation →
• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →

Sponsor

Institute for Monitoring of Urogenital Diseases

Who can join

40 and older, male only, with Inflammation or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Histological inflammation of the prostate is a common finding in the results of the histopathological examinations after a prostate biopsy or a transurethral or open prostatectomy.

Several studies have investigated the role of prostatic inflammation in the development of prostatic enlargement and pathogenesis of Lower Urinary Tract Symptoms (LUTS). Therefore, prostatic inflammation could be a potential treatment target for men with LUTS.

Objective: The aim of the study is the development and the validation of a nomogram based on clinical parameters that could predict the presence of prostatic inflammation.

Study design: Non-interventional, multicentric, cross-sectional, observational prospective study.

Study population: Men, age ≥ 40 yrs, with LUTS who will undergo any prostatic surgery for BPH (Open, laparoscopic, robotic, transurethral resection/enucleation, laser prostatectomy) or TRUS-biopsy according to the standard clinical practice of the participating urologists

Intervention: All included males receive standard care for their symptoms according to the physician's practice. For this study, baseline demographic and clinical characteristics of the patients are recorded and correlated with the histological outcome.

Main study parameters/endpoints: Development and validation of the Prostatic Inflammation Nomogram

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional treatment or intervention related to the study is required.

Therefore no negative outcomes are expected as the standard treatment is unchanged. There is no additional burden for the patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and validation of a clinical nomogram to predict prostatic inflammation in men with lower urinary tract symptoms.
   Gravas S, De Nunzio C, Campos Pinheiro L, Ponce de León J, et al · · 2025 · cited 8× · PMID 38971935 · DOI 10.1038/s41391-024-00857-5