Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients
NCT ID: NCT02006303
Last Updated: 2014-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
73 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Green light PVP
The KTP:YAG laser is based on the principle of passing Nd:YAG laser light through a KTP crystal. This halves the wavelength of the emitted laser to 532 nm and doubles its frequency. The emitted light is a visible green light, which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. Prostate tissue is vaporized leaving an appropriate cavity for voiding.
Green light PVP
The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.
Prostatic Artery Embolization
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
Prostatic artery embolization
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
Interventions
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Green light PVP
The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.
Prostatic artery embolization
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates
3. Written informed consent to participate in the study.
4. Ability to comply with the requirements of the study procedures
Exclusion Criteria
2. Presence of bladder stones
3. History of prostate cancer
4. Prostate size \> 150 g
5. History of urethral stenosis or its management
6. Known of suspected neurogenic bladder
7. History of recent hematochezia in the last 3 months
8. Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure
9. Uncorrected coagulopathy
10. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
11. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
12. Subjects who are uncooperative or cannot follow instructions.
13. Mental state that may preclude completion of the study procedure or obtention of informed consent
40 Years
95 Years
MALE
No
Sponsors
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Royal Victoria Hospital, Canada
OTHER
Responsible Party
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Mostafa Elhilali
Professor of Urology
Principal Investigators
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Mostafa Elhilali, MD,PhD,FRCSC
Role: STUDY_CHAIR
Royal Victoria Hospital, Canada
Locations
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Royal Victoria Hospital
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13-100-SDR
Identifier Type: -
Identifier Source: org_study_id
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