Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02006303
Status:
UNKNOWN
Last Update Posted:
2014-11-04
First Post:
2013-11-28
Brief Title:
Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients
Sponsor:
Royal Victoria Hospital Canada
Organization:
Royal Victoria Hospital Canada
Study Overview
Official Title:
Prostatic Artery Embolization Versus 532 nm Green Light Laser Photoselective Vaporization of the Prostate for Treating Catheter-Dependent Patients With Benign Prostatic Hyperplasia A Randomized Controlled Clinical Study
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile as GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia BPH Subjects who consent will be randomized to either the Prostate embolization PAE arm or to the GreenLight PVP arm
The primary endpoint of efficacy of the procedure is measured by the ability of the patient to void The secondary endpoints recorded will include patients satisfaction measured by International Prostate Symptom Score IPSS peak flow rate Qmax and post-void residual urine volume PVR and prostate specific antigen PSA will be measured at 3 6 and 12 months post treatment Also reduction in prostate volume is considered by MRI preoperatively 3 months and 12 months
The primary endpoint of efficacy of the procedure is measured by the ability of the patient to void The secondary endpoints recorded will include patients satisfaction measured by International Prostate Symptom Score IPSS peak flow rate Qmax and post-void residual urine volume PVR and prostate specific antigen PSA will be measured at 3 6 and 12 months post treatment Also reduction in prostate volume is considered by MRI preoperatively 3 months and 12 months
Detailed Description:
The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile compared to GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia BPH that have failed medical management
The target population is composed of subjects referred to the urology department for treatment of BPH who have failed medical treatment who present with permanent bladder catheterization and who meet the eligibility criteria
Subjects who consent will be randomized to either the Prostate embolization PAE arm or to the GreenLight PVP arm
The primary endpoint of efficacy of the procedure is measured by the successful removal of bladder catheter and ability of the patient to void As well the secondary endpoints recorded will be International Prostate Symptom Score IPSS peak flow rate Qmax and post-void residual urine volume PVP and prostate specific antigen PSA will be measured at 3 6 and 12 months post treatment Trans-rectal ultrasound TRUS will be performed for measurement of prostate volume for the stratified randomization process All adverse events will be captured and analyzed MRI will be performed preoperatively 3 months and 12 months Hospital stays after the procedures will not be considered serious adverse events unless a hospital admission occurs because of a complication of the treatment performed
The target population is composed of subjects referred to the urology department for treatment of BPH who have failed medical treatment who present with permanent bladder catheterization and who meet the eligibility criteria
Subjects who consent will be randomized to either the Prostate embolization PAE arm or to the GreenLight PVP arm
The primary endpoint of efficacy of the procedure is measured by the successful removal of bladder catheter and ability of the patient to void As well the secondary endpoints recorded will be International Prostate Symptom Score IPSS peak flow rate Qmax and post-void residual urine volume PVP and prostate specific antigen PSA will be measured at 3 6 and 12 months post treatment Trans-rectal ultrasound TRUS will be performed for measurement of prostate volume for the stratified randomization process All adverse events will be captured and analyzed MRI will be performed preoperatively 3 months and 12 months Hospital stays after the procedures will not be considered serious adverse events unless a hospital admission occurs because of a complication of the treatment performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None