Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Saskatchewan Health Authority

Status and phase: Completed; Phase 3; Phase 2

Conditions: Benign Prostate Hyperplasia

Treatments: Procedure: Prostate artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01835860

REB-12-81

Details and patient eligibility

About

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).

Enrollment: 13 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Embolization

Other group

Description:

Prostate artery embolization

Treatment:

Procedure: Prostate artery embolization