Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study compares safety and efficacy of prostatic artery embolization and pharmacotherapy in the treatment of lower urinary tract symptoms associated wit benign prostatic hyperplasia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dominik Abt

Criteria

Inclusion Criteria:

• men ≥45 years of age

• lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)

• IPSS ≥ 8 points

• QoL ≥ 3 points

• Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml

• informed consent for study participation

Exclusion Criteria:

• renal impairment (GFR < 30ml/min)

• previous prostatic surgery

• 5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry

• history or evidence of prostate cancer

• absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)

• history of neurogenic bladder dysfunction

• not able to complete questionnaires due to cognitive or thought disorders

• language skills insufficient for informed consent and / or completion of questionnaires