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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01835860
Other study ID # REB-12-81
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 27, 2013
Last updated April 5, 2016
Start date March 2013
Est. completion date December 2015

Study information

Verified date April 2016
Source Regina Qu'Appelle Health Region
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Prostate artery embolization


Locations

Country Name City State
Canada Regina General Hospital Regina Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
Regina Qu'Appelle Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS). 1, 3, 6 and 12 months No
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