Prostatic Artery Embolization vs Open Prostatectomy: a comparative study between two different methods for the treatment of Prostate Enlargement.
Not Applicable
- Conditions
- Benign Prostatic HyperplasiaProstatic Adenoma
- Registration Number
- RBR-2h3wqrj
- Lead Sponsor
- Disciplina de Urologia da Escola Paulista de Medicina da Universidade Federal de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Male
- Target Recruitment
- Not specified
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
Severe atherosclerosis
Severe tortuosity in aortic bifurcation
Neurogenic dysfunction
Urethral stenosis
Bladder diverticulum
Bladder stone
Underactive bladder
Creatinine clearance <60ml.min
Prostate cancer
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 - Prymary Endpoint <br>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).<br>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.<br><br>The sample calculation was done considering the improvement in Qmax (media and standard deviation of 3 ml.second), accounting 23 patients to each arm.<br>
- Secondary Outcome Measures
Name Time Method 2 - Secondary Endpoint<br>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<br>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.