Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Phase 2

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Procedure: Prostate artery embolization

• Registration Number: NCT01835860
• Lead Sponsor: Saskatchewan Health Authority - Regina Area

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization	Prostate artery embolization	Prostate artery embolization

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Regina General Hospital; 🇨🇦 Regina, Saskatchewan, Canada