Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacin/tamsulosin

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
Second Department of Urology, Sismanoglio Hospital, Athens, Greece.
NOT_YET_RECRUITING
Athens
Department of Urology, Venizelio General Ηospital
RECRUITING
Heraklion
Department of Urology, General Hospital of Messinia
RECRUITING
Kalamata
Department of Urology, General Hospital of Larissa
RECRUITING
Larissa
Department of Urology, University Hospital of Rion
RECRUITING
Pátrai
First Department of Urology, School of Medicine, Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Contact Information
Primary
Polyanthi Papanastasiou
p.papanastasiou@elpen.gr
+302111865777
Backup
Alexandros Ginis
aginis@elpen.gr
+302111865734
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 450
Sponsors
Leads: Elpen Pharmaceutical Co. Inc.

This content was sourced from clinicaltrials.gov