Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia
|Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Benign Genital Diseases, Male Lower Urinary Tract Symptoms Prostatic Diseases||Procedure: Prostatic Arterial Embolization Procedure: Sham procedure|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Randomized, Evaluator-blind, Controlled Trial to Evaluate the Efficacy and Safety of Prostatic Arterial Embolization Versus a Sham Procedure for Benign Prostatic Hyperplasia With Severe LUTS Not Adequately Controlled With Alpha-blockers|
- Change from baseline in the International Prostate Symptom Score [ Time Frame: 6 months ]
- Disease specific quality of life question of the International Prostate Symptom Score [ Time Frame: 6 months ]
- Change from baseline in the Benign Prostatic Hyperplasia Impact Index (BPH-II) [ Time Frame: 6 months ]
- Change from baseline in the International Index of Erectile Function (IIEF) [ Time Frame: 6 months ]
- Change from baseline in the peak urinary flow rate (Qmax) [ Time Frame: 6 months ]
- Change from baseline in the post-void residual volume [ Time Frame: 6 months ]
- Change from baseline in prostate volume [ Time Frame: 6 months ]
- Change from baseline in the Prostate Specific Antigen (PSA) [ Time Frame: 6 months ]
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Prostatic Arterial Embolization
Selective catheterization of the prostatic arteries followed by slow injection of Bead Block 300-500 or PVA 100+200 micra particles under fluoroscopic control.
Procedure: Prostatic Arterial Embolization
The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is "near stasis" in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way.
Sham Comparator: Sham procedure
Selective catheterization of the prostatic arteries followed by removal of the catheter with no particles injected.
Procedure: Sham procedure
The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.
This is a randomized, parallel-group, evaluator-blind, superiority, controlled clinical trial of PAE versus a sham procedure in patients with BPH with severe LUTS not adequately controlled by medical therapy with alpha-blockers.
This study has a screening visit at day -14, a baseline visit at day -2, a randomization and intervention visit at day 0, follow up visits at months 1, 3 and 6.
Patients initially randomized to the sham procedure and who completed the 6 month follow-up period will be offered the possibility of performing PAE at no cost. All patients will be invited to participate in a 6 months post-trial extension study.
Patients over 45 years-old with a diagnosis of BPH associated with severe LUTS defined by an IPSS>=20 after a minimum of 6 months treatment with alpha-blockers and with a prostate volume ≥ 40 mL will start a two weeks screening period. Eligible patients will be started either tamsulosin 0.4 mg q.d., alfuzosin 10 mg q.d. or silodosin 8 mg q.d., which will be maintained throughout the study period, and have the intervention scheduled for the following 2 days (study day 0), when they will be randomized to PAE or to a sham procedure if the procedure is technically feasible
Those patients in whom angiography has shown that PAE is technically feasible will be randomized to one of the study arms on a 1:1 ratio. Patients in both groups will be submitted to exactly the same procedure, except that patients randomized to the control group will not be injected with polyvinyl alcohol particles. Patients will be discharged as soon as their clinical condition is stabilized
Patients will be assessed at 1, 3 and 6 months with IPSS, QoL, IIEF, BPH-II and will perform prostatic ultrasonography, uroflowmetry and PSA at month 1 and 6. At 1 month a pelvic NMR will be performed to evaluate prostate volume and the degree of ischemia.
Patients completing the 6 month follow-up period will be invited to enter a 6 months extension study. In this extension study, patients will be evaluated at month 12 for all efficacy variables. Patients initially randomized to the sham procedure who wanted to perform PAE after the conclusion of the trial will be evaluated only at months 1, 3 and 6 after PAE.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02074644
|Contact: João M Pisco, M.D., Ph.D||+(351)firstname.lastname@example.org|
|Hospital de Saint Louis||Recruiting|
|Lisboa, Portugal, 1200-249 Lisboa|
|Contact: João M Pisco, M.D., Ph.D. +(351)968069178|
|Principal Investigator: João M Pisco, M.D., Ph.D.|
|Study Director:||João M Pisco, M.D,. Ph.D.||Hospital de Saint Louis|