Benign Prostatic Hyperplasia Clinical Trial
Official title:
Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.
The objective of the study is to confirm in a larger and less selected population ("real
life conditions") the positive risk-benefit balance observed with silodosin in double-blind,
randomised clinical trials.
The following aspects will be evaluated:
- the effects on lower urinary tract symptoms (LUTS), by means of the International
Prostate Symptoms Score (IPSS) questionnaire
- the effect on the most frequent and bothersome symptoms, by means of International
Continence Society (ICS)-male questionnaire
- the effects on Quality of Life (QoL) due to urinary symptoms
- the safety profile
- the adherence to therapy
- the patient satisfaction with treatment The effectiveness and safety of the drug will
be investigated also in different subgroups of subjects according to age, severity of
the disease, concomitant disease and medications.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
| Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
| Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
| Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
| Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
| Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
| Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
| Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
| Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
| Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
| Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
| Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
| Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
| Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
| Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
| Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
| Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
| Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
| Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
| Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |