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Study identifier: NCT06528613 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin.

Condition: Benign Prostatic Hyperplasia  ·  Sponsor: Elpen Pharmaceutical Co. Inc.

PhaseN/A
Planned participants450
Who can joinMale, 18 Years to 100 Years
Healthy volunteersNo

About this study

Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size. Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". However, the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination. BPH can only be defined histologically (increase in the number of epithelial cells and stromal cells), but in clinical practice it is characterized by lower urinary tract symptoms \[LUTS\]. The disease leads to increased pressure in the urethra, causing resistance to urine flow, known as Bladder Outlet Obstruction (BOO). This resistance can also lead to changes in bladder function caused by the obstruction, such as overactivity of the bladder detrusor muscle or, conversely, reduced detrusor contractility. BOO can present as LUTS, infections or retention, as well as other conditions. LUTS can be divided into storage (irritant), obstructive (urinary) and post-urinary symptoms and appear frequently causing intense discomfort, reducing the quality of life. LUTS are traditionally associated with bladder outlet resistance (BOO), most commonly when histologic BPH progresses through benign prostatic enlargement (BPE) to benign prostatic obstruction (BPO).The European Urological Association (EAU) reports that LUTS are a comm…

This description comes directly from the study's public registry record.

Talk to the study team

Polyanthi Papanastasiou  ·  +302111865777  ·  p.papanastasiou@elpen.gr

Alexandros Ginis  ·  +302111865734  ·  aginis@elpen.gr

Always discuss trial participation with your own doctor first.

Locations (6)

Second Department of Urology, Sismanoglio Hospital, Athens, Greece.Athens, Greece, GreeceNot Yet Recruiting
Department of Urology, Venizelio General ΗospitalHeraklion, Greece, GreeceRecruiting
Department of Urology, General Hospital of MessiniaKalamata, Greece, GreeceRecruiting
Department of Urology, General Hospital of LarissaLarissa, Greece, GreeceRecruiting
Department of Urology, University Hospital of RionPátrai, Greece, GreeceRecruiting
First Department of Urology, School of Medicine, Aristotle University of ThessalonikiThessaloniki, Greece, GreeceRecruiting

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Source record: clinicaltrials.gov/study/NCT06528613