Benign Prostatic Hyperplasia
Conditions
Interventions
The Prostatic Artery Embolisation is the interruption of the prostatic blood flow through the microespheres. The method proposed is the superselective technique, with bilateral embolization of the pro
Sponsors
Disciplina de Urologia da Escola Paulista de Medicina da Universidade Federal de São Paulo
Disciplina de Urologia da Escola Paulista de Medicina da Universidade Federal de São Paulo
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Over 40 years Moderate/severe LUTS due to large-volume BPH (>80 mL) IPSS greater than or equal to 8 Quality of life greater than or equal to 3 Urodynamic showing obstruction
Exclusion criteria
Exclusion criteria: Severe atherosclerosis Severe tortuosity in aortic bifurcation Neurogenic dysfunction Urethral stenosis Bladder diverticulum Bladder stone Underactive bladder Creatinine clearance <60ml.min Prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 - Prymary Endpoint The primary endpoint is the evaluation in urodynamics parameters based on maximum flow rate (Qmax) and detrusor pressure on Qmax (PdetQmax) within 12 months. We hope PAE will be a inferior method compared to surgery. The PAE group would reach inferior improvement in Qmax (3-4 ml/sec) compared to the surgery group (> 5 ml/sec). This analysis will be made by a t-test comparing groups in 2 times: pre operative and 6 months post operative. We expect there is statistical difference after treatments in Qmax and PdetQmax comparing groups, with significant "p". The sample calculation was done considering the improvement in Qmax (media and standard deviation of 3 ml.second), accounting 23 patients to each arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 - Secondary Endpoint The secondary endpoint is the evaluation of IPSS and Quality of Life (QoL) questionnaires, comparing groups in 2 times: pre operative and 6 months post operative. We expect no differences in groups when analysed this clinical criteria, with a non significant p (through a t-test). We hope all patients will reach IPSS < 8 (mild symptoms) after treatments. ;3 - Secondary Endpoint In 6 months post operative, the patients in PAE arm will be submitted to a Nuclear Magnetic Resonance. The role of this exam is to measure the prostate shrinkage after embolisation, comparing to pre operative. The analysis will be made through a t-test. | — |
Countries
Brazil
Contacts
Public ContactBruno Lebani
Disciplina de Urologia da Escola Paulista de Medicina da Universidade Federal de São Paulo
Outcome results
None listed