NCT06528613 Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin.
| NCT ID | NCT06528613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elpen Pharmaceutical Co. Inc. |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2024-10-23 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \[LUTS\]. 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.
Eligibility Criteria
Inclusion Criteria: * Male adult patient with moderate to severe symptoms of BPH receiving monotherapy and not responding adequately. * Male adult patient with BPH who has fully understood the study procedures and signed an informed consent form. Exclusion Criteria: \-
Contact & Investigator
Alexandros Ginis
STUDY DIRECTOR
Elpen Pharmaceutical Co. Inc.
Frequently Asked Questions
Who can join the NCT06528613 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06528613 currently recruiting?
Yes, NCT06528613 is actively recruiting participants. Contact the research team at p.papanastasiou@elpen.gr for enrollment information.
Where is the NCT06528613 trial being conducted?
This trial is being conducted at Athens, Greece, Heraklion, Greece, Kalamata, Greece, Larissa, Greece and 2 additional locations.
Who is sponsoring the NCT06528613 clinical trial?
NCT06528613 is sponsored by Elpen Pharmaceutical Co. Inc.. The principal investigator is Alexandros Ginis at Elpen Pharmaceutical Co. Inc.. The trial plans to enroll 450 participants.