NCT02822924

Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH.

Detailed description

Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common condition among elderly men with a prevalence increasing with age. When sufficiently large, the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent urination, increased risk of urinary tract infections and urinary retention. While medication is often prescribed as the first treatment option, it often does not adequately restore normal urine flow. Many patients being treated with medication may not achieve sustained improvement in symptoms, or they may stop taking the medication because of side effects, therefore other forms of treatments may be necessary. Although surgery with transurethral resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an endoscope is inserted through the penis, and removal of the prostate piece by piece. While considered a safe technique with a mortality rate below 0.25%, it is not without adverse events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of cases. Others include infection and urethral stricture. Therefore TURP is only recommended for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE) is a potentially promising, minimally invasive alternative procedure for BPH. Results from early studies showed that PAE might be a safe and effective treatment for BPH.

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Prostate artery embolization (PAE)	Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.

Timeline

• Start date: 2013-10-07
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2016-07-06
• Last updated: 2022-10-21

Locations

1 site across 1 country: Hong Kong