Actively Recruiting

Phase Not Applicable
MALE
ID04084938

Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia

Led by Oslo University Hospital · Updated on 2023-12-27

140

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating prostate artery embolization (PAE) compared to the established surgical treatment for men with lower urinary tract symptoms (LUTS) caused by an enlarged benign prostate. The study aims to assess patient acceptance, morbidity, complications, and functional outcomes, as well as length of hospital stay, costs, and recovery time. Both treatments are being studied to help select the best option for patients. A total of 140 men will be randomly assigned to one of the two treatments. Before treatment, patients undergo computed tomography angiography to determine eligibility based on their pelvic arteries, and magnetic resonance imaging to rule out prostate cancer. PAE involves placing a catheter in an artery in the groin under local anesthesia to inject small particles into the prostate arteries. Surgery is performed under general anesthesia either through the penis catheter for small prostates or through a lower abdomen incision for larger prostates. All patients stay in the urology unit after treatment. Follow-up visits occur at 3 months, 1 year, and 5 years to record acute and long-term complications. Participants will have clinical visits to assess urinary symptoms and quality of life using questionnaires, and urodynamic examinations measure functional outcomes. Researchers will also track hospital stay length, costs, and recovery time. The main outcomes include quality of life related to urinary symptoms at 3 months and the number of patients who avoid surgery after PAE at 12 months. This study helps provide important information for international guidelines and treatment decisions for benign prostatic hyperplasia.

CONDITIONS

Brief Title

Artery Embolization vs Operation of Benign Prostate Hyperplasia

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men with moderate to severe lower urinary tract symptoms from benign prostate hyperplasia (IPSS score > 8) and quality of life score of 3 or higher
  • Symptoms refractory to medical treatment for at least 6 months or patient unwilling to accept medical treatment
  • Use of permanent or intermittent catheterization for BPH
  • Prostate volume larger than 50 ml
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Evidence of clinically significant prostate cancer on prostate biopsy
  • Prostatitis or neurogenic bladder conditions such as detrusor-sphincter dyssynergia
  • Urethral strictures, bladder neck contracture, bladder stones, or bladder cancer
  • Renal insufficiency with Glomerular Filtration Rate less than 30 ml/min/1.73m2
  • Known severe reactions to iodine-based or gadolinium-based contrast agents
  • Previous prostate operation
  • CT exam showing no access to the prostate arteries

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for computed tomography angiography and magnetic resonance imaging

Treatment

Duration - Hospital stay plus recovery time as determined by treating physicians

Participants undergo either prostate artery embolization or prostate surgery to treat lower urinary tract symptoms due to benign prostate hyperplasia.

1 procedure in radiology or operating room followed by hospital stay in the urology unit

Follow-up

Duration - Up to 5 years

Participants have clinical visits to assess quality of life, symptoms, and complications after treatment.

Clinical visits at 3 months, 1 year, and 5 years post-treatment

Trial Site Locations

Total: 1 location

1

Oslo University Hospital, Aker

Oslo, Norway

Actively Recruiting

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Research Team

T

Thijs Hagen, MD

E

Eduard Baco, MD, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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