Real World Study in Greek Patients With BPH for Disease Control and QoL Under FDC Treatment With Solifenacin/Tamsulosin.
NCT Number: NCT06528613
Acronym: KALLIRROI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Benign Prostatic Hyperplasia
Sponsor: Elpen Pharmaceutical Co. Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-30

Summary:
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 (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.

Lower urinary tract symptoms (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 lower urinary tract symptoms (LUTS) are a common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the α1-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.

Primary Outcome Measures: The assessment of disease control (BPH) and quality of life of patients., The change in the total score (questions 1-7) and the quality-of-life question score of the International Prostate Symptom Score (IPSS) questionnaire after six months of treatment with a fixed combination of solifenacin/tamsulosin. The total disease control score is calculated by summing the scores of the seven symptom-related questions.

In particular :

Questions 1-6: 6-point response scale from 0 (not at all) to 5 (almost always). Question 7: 6-point response scale from 0 (none) to 5 (5 or more).

This gives an overall score ranging from 0 to 35 where :

0-7: mildly symptomatic, 8-19: moderately symptomatic, 20-35: severely symptomatic. Concerning the quality-of-life question score : 7-point response scale from 0 (no impact on QOL) to 6 (high impact on QOL)., 6 months
Secondary Outcome Measures: The assessment of patients' overall impression of their condition from Benign Prostatic Hyperplasia (BPH)., Assessment from baseline and after six months of solifenacin/tamsulosin fixed-combination treatment of the patient's global impression of change in severity and overall impression of change in condition due to BPH using the PGI- S (Patient Global Impression of Severity) and PGI-C (Patient Global Impression of Change), respectively.

The Patient Global Impression of Change (PGI-C) scale measured patients' ratings of overall change in condition due to BPH compared to study baseline and range from 0 \[very much better\] to 7 \[very much worse\].

The Patient Global Impression of Severity (PGI-S) scale measured patients' ratings of overall severity compared to study baseline and range from none to 7 very severe)., 6 months|Assessment of the safety of the solifenacin/tamsulosin fixed dose combination during the study., The recording of Adverse Events (AE) if they occur during the study. All directly observed adverse events and all adverse events (ΑΕ) spontaneously reported by the patient will be recorded, using accurate and comprehensive medical terminology. The ΑΕ reporting period for this study will begin at the 1st (selection) visit after the patient signs the informed consent form and end at the final follow-up visit. All AEs occurring during the adverse event reporting period must be reported, whether or not the event is considered to be related to the study drug. In all cases, the investigator should indicate whether there is a causal relationship between the reported event and the investigational medicinal product. In addition, any adverse event occurring after the adverse event reporting period that the investigator considers to be possibly related to the study drug should also be reported as an AE., 6 months