Status:

COMPLETED

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

Lead Sponsor:

Institute for Monitoring of Urogenital Diseases

Conditions:

Inflammation

Lower Urinary Tract Symptoms

Eligibility:

MALE

40+ years

Brief Summary

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...

Detailed Description

Lower Urinary Tract Symptoms (LUTS) are common in men over 45 years of age and have been traditionally attributed to bladder outlet obstruction (BOO) as a result of benign prostatic obstruction (BPO),...

Eligibility Criteria

Inclusion

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Male
  • Age ≥ 40 years
  • Undergo prostatectomy or TRUS-guided biopsy
  • Provide signed Informed Consent

Exclusion

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • treatment with any plant extract or 5a-reductase inhibitors during the last 3 months,
  • history of pelvic radiotherapy,
  • history of prostatectomy or transurethral resection of bladder tumor or previous TRUS-biopsy,
  • presence of an indwelling catheter,
  • prostate cancer found at the biopsy
  • No symptoms (IPSS=0)
  • No specimen is available (ablation/vaporization of the prostate)

Key Trial Info

Start Date :

September 3 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

423 Patients enrolled

Trial Details

Trial ID

NCT04856748

Start Date

September 3 2020

End Date

December 31 2022

Last Update

December 12 2023

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Dept of Urology

Nicosia, Cyprus, 2029

2

Dept of Urology, CHU Mondor

Créteil, France, 94010

3

Dept of Urology, University Hospital of Larissa

Larissa, Greece, 41110

4

Dept of Urology, General Hospital of Larissa

Larissa, Greece, 412221