Recruiting

Prostatic Artery Embolization vs. Green Light PVP

Sponsor:

Royal Victoria Hospital, Canada

Code:

NCT02006303

Conditions

Benign Prostate Hyperplasia

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Green light PVP

Prostatic artery embolization

Study Details

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.

Conditions

Benign Prostate Hyperplasia

Urinary Retention

Study ID

NCT02006303

Start date

Dec, 2013

Status verified date

Nov, 2014

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male subjects, over 50 years of age at the time of enrollment.
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:

1. Previous surgical treatment for BPH
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

Study Design

Enrollment

73 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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

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.

Primary outcome measure

  • Ability of the patient to void after removal of the urethral catheter [ Time Frame: At 24-hours for PVP green light laser and 1-3 weeks for embolization ]

Central Contacts and Locations

Central contacts

Mostafa Elhilali, MD,PhD,FRCSC

1- 514- 843-1516mostafa.elhilali@muhc.mcgill.ca

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Mostafa Elhilali, MD,PhD,FRCSC

1- 514- 843-1516mostafa.elhilali@muhc.mcgill.ca

Mohamed Elkoushy, MD. MSc, PhD

1-514- 318- 6777melkoushy@yahoo.com

Principal Investigator:

Mostafa Elhilali, MD,PhD,FRCSC

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Carlos Torres, MD,FRCPC

1-514- 934-1934x44454citorresp@yahoo.com

Louis-Martin Boucher, MD, PhD

1- 514- 934-8003lmboucher@yahoo.com

Principal Investigator:

Carlos Torres, MD,FRCPC

More Information

Sponsor

Royal Victoria Hospital, Canada

Last update posted

Nov 4, 2014

Last verified

Nov, 2014

Keywords

  • Benign Prostate Hyperplasia
  • Green light
  • Photoselective vaporization of the prostate
  • Prostatic artery embolization
  • Outcome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Royal Victoria Hospital, Canada on 2014-11-04.