Observational study on BPH treatment in Greek men
Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacin/tamsulosin
This study is trying to see if a combination of two medications can help Greek men with moderate to severe BPH symptoms feel better when other treatments haven't worked well enough.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Elpen Pharmaceutical Co. Inc. Industry-sponsored |
| Locations | 6 sites (Athens, Greece and 5 other locations) |
| Trial ID | NCT06528613 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Greek male patients suffering from benign prostatic hyperplasia (BPH) who have moderate to severe symptoms and are not adequately responding to monotherapy. The study aims to assess disease control and quality of life under fixed-dose combination treatment with Solifenacin and Tamsulosin. It will involve multiple urology departments across Greece, collecting data on patient experiences and outcomes related to their BPH treatment. The study will help to better understand the effectiveness of this combination therapy in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are adult males with moderate to severe BPH symptoms who are currently on monotherapy but not achieving satisfactory results.
Not a fit: Patients with mild symptoms of BPH or those who are not currently receiving treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for BPH, enhancing patient quality of life.
How similar studies have performed: While there have been studies on BPH treatments, this specific combination therapy in a real-world observational setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Athens, Greece and 5 other locations
- Second Department of Urology, Sismanoglio Hospital, Athens, Greece. — Athens, Greece, Greece (Not_yet_recruiting)
- Department of Urology, Venizelio General Ηospital — Heraklion, Greece, Greece (Recruiting)
- Department of Urology, General Hospital of Messinia — Kalamata, Greece, Greece (Recruiting)
- Department of Urology, General Hospital of Larissa — Larissa, Greece, Greece (Recruiting)
- Department of Urology, University Hospital of Rion — Pátrai, Greece, Greece (Recruiting)
- First Department of Urology, School of Medicine, Aristotle University of Thessaloniki — Thessaloniki, Greece, Greece (Recruiting)
Study contacts
- Study coordinator: Polyanthi Papanastasiou
- Email: p.papanastasiou@elpen.gr
- Phone: +302111865777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.