Benign Prostatic Hyperplasia Clinical Trial
Official title:
A Randomised Clinical Trial to Compare Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate Compared Versus the Transurethral Resection of the Prostate to Treat the Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.
Verified date | May 2018 |
Source | Fundacion Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Status | Completed |
Enrollment | 81 |
Est. completion date | May 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms - Refractory to medical treatment for at least 6 months - Qmax (maximum urinary flow) less than 10 mL/second Exclusion Criteria: - Patients not candidates for transurethral resection of the prostate (TURP) - Advanced atherosclerosis and tortuosity of the iliac arteries - No visualization of the prostatic artery CT angiography study - Urethral stenosis, detrusor failure or neurogenic bladder - Glomerular filtration < 30 mL/min - Presence of malignant tumor - History of allergy to iodinated contrast - Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarre |
Lead Sponsor | Collaborator |
---|---|
Fundacion Miguel Servet |
Spain,
Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12. — View Citation
DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol. 2000 Jun;11(6):767-70. — View Citation
Mauro MA. Can hyperplastic prostate follow uterine fibroids and be managed with transcatheter arterial embolization? Radiology. 2008 Mar;246(3):657-8. doi: 10.1148/radiol.2463071721. — View Citation
Pisco J, Campos Pinheiro L, Bilhim T, Duarte M, Rio Tinto H, Fernandes L, Vaz Santos V, Oliveira AG. Prostatic arterial embolization for benign prostatic hyperplasia: short- and intermediate-term results. Radiology. 2013 Feb;266(2):668-77. doi: 10.1148/radiol.12111601. Epub 2012 Nov 30. Erratum in: Radiology. 2013 Sep;268(3):929. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum urinary flow (Qmax) | Maximum urinary flow (Qmax) measured prior intervention and one year later | 12 months | |
Secondary | International Prostate Symptom Score (IPSS) measured before and after the intervention | 12 months | ||
Secondary | Reduction in prostate volume | 12 months | ||
Secondary | Sexual function | Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention. | 12 months |
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 |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
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 |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
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 | |
Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
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 |