Artery Embolization vs Operation of Benign Prostate Hyperplasia

NCT04084938 | Recruiting

• 1 other identifier: 2018/1231
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (LUTS), be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.

Conditions

Benign Prostatic Hyperplasia; Post-Op Complication; Embolization Therapeutic; Transurethral Resection of Prostate Syndrome

Keywords

Prostate; Embolization; Complication; Operation; Randomization

Outcome Measures

Primary Outcomes (2)

• Quality of life due to urinary symptoms

  "Quality of life due to urinary symptoms" QoL = or \<3 The scale used: Quality of Life Due to Urinary Symptoms. Scale from 0 to 6, the worse is 6. The patient question: If you were to spend the rest of Your life With Your urinary condition just the way it is now, how would you feel about that?

  3 months

• Number of patients with Prostate Artery Embolization that did not have prostate operation

  The investigators will record the number of patients that did not have prostate surgery after Prostate Artery Embolization. After 3 months the patients will be offered operation when Quality of Life Due to Urinary Symptoms is 4-6 on the scale from 0-6 ie. the patients report unsatisfied (4), unhappy (5) or terrible (6).

  12 months

Secondary Outcomes (3)

• Number of patients with postoperative complications

  3 months

• Hospital stay

  3 months

• Symptoms

  3 months, 1 year, 5 years

Other Outcomes (3)

• Need for catheters

  3 and 12 months

• Erectile function

  3 and 12 months

• Ejaculation

  3 and 12 months

Study Arms (2)

Prostate operation

ACTIVE COMPARATOR

You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.

Procedure: Prostate operation or prostate artery embolization

Prostate artery embolization

ACTIVE COMPARATOR

The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.

Procedure: Prostate operation or prostate artery embolization

Interventions

Prostate operation or prostate artery embolization PROCEDURE

As described above.

Prostate artery embolization; Prostate operation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS \> 8) and QoL = or \>3
• and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment
• or BPH using permanent or intermittent catheterization
• Prostate volume \> 50 ml
• Signed informed consent

You may not qualify if:

• Urological disorders: evidence of clinically significant prostate cancer \[as defined by START criteria\] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer
• Renal insufficiency defined as Glomerular Filtration Rate \< 30 ml/min/1,73m2
• Known severe reactions to iodine-based contrast or gadolinium-based contrast
• Previous prostate operation
• CT examination reveals no access to the prostate arteries.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Aker

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Postoperative Complications

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nils Einar Kløw, MD, PHD

  Department of Radiology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thijs Hagen, MD

CONTACT

+ 47 45002349; thihag@ous-hf.no

Eduard Baco, MD, PHD

CONTACT

+47 95221378; eduaba@online.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized study 1:1

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)