Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Benign Prostate Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835860
• Other study ID #: REB-12-81
• 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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

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