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

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 common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the a1-blocker/muscarinic receptor antagonist combination in men with moderate to severe storage symptoms, voiding symptoms and PVR \< 150 ml, in order to reduce the risk of acute urinary retention and relieve irritants. (storage) symptoms, leading to an improvement in the patient's quality of life. Given the small abundance of data for patients in Greece with BPH, this study will evaluate the fixed combination of solifenacin/tamsulosin in terms of disease control and improvement of the quality of life of patients with BPH. Before enrolling in the study and before signing the consent form, patients must have already received the drug with solifenacin/tamsulosin and then they are enrolled in the observational study where the physician applies his/her standard clinical practice.

NCT Number	NCT06528613
Lead Sponsor	Elpen Pharmaceutical Co. Inc.
Conditions	Benign Prostatic Hyperplasia
Enrollment	450 participants
Start Date	2024-10-23
Primary Completion	2025-09-30 (estimated)
Study Completion	2025-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-12