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OpenTrials
Completed

NCT Number: NCT01835860

Prostatic Artery Embolization for Benign Prostatic Hyperplasia

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).

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Key information

Conditions

Benign Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate artery embolization

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Saskatchewan Health Authority - Regina Area

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2013
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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