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Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostate Hyperplasia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Prostate artery embolization
Sponsored by
Saskatchewan Health Authority - Regina Area
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring BPH

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)
  2. Urinary retention (related to BPH) leading to catheterization.
  3. Refractory to medical treatment or patient is not willing to consider medical treatment
  4. Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.

Exclusion Criteria:

  1. Mild symptoms (IPSS <8)
  2. Moderate to severe lower urinary tract symptoms (i.e. IPSS>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).
  3. Suspected malignancy.
  4. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
  5. Advanced atherosclerosis and unsuitable vascular access.
  6. Allergy to intravenous contra

Sites / Locations

  • Regina General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Embolization

Arm Description

Prostate artery embolization

Outcomes

Primary Outcome Measures

Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).

Secondary Outcome Measures

Full Information

First Posted
March 27, 2013
Last Updated
April 5, 2016
Sponsor
Saskatchewan Health Authority - Regina Area
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1. Study Identification

Unique Protocol Identification Number
NCT01835860
Brief Title
Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saskatchewan Health Authority - Regina Area

4. Oversight

5. Study Description

Brief Summary
To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
BPH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embolization
Arm Type
Other
Arm Description
Prostate artery embolization
Intervention Type
Procedure
Intervention Name(s)
Prostate artery embolization
Primary Outcome Measure Information:
Title
Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).
Time Frame
1, 3, 6 and 12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living) Urinary retention (related to BPH) leading to catheterization. Refractory to medical treatment or patient is not willing to consider medical treatment Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery. Exclusion Criteria: Mild symptoms (IPSS <8) Moderate to severe lower urinary tract symptoms (i.e. IPSS>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living). Suspected malignancy. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency. Advanced atherosclerosis and unsuitable vascular access. Allergy to intravenous contra
Facility Information:
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada

12. IPD Sharing Statement

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Prostatic Artery Embolization for Benign Prostatic Hyperplasia

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