Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

NCT02054013 | Completed

• 1 other identifier: CTU 13.030
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity. The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Changes in the International Prostate Symptom Score

  Baseline and 12 weeks after intervention

Secondary Outcomes (10)

• Changes of prostate volume using Magnetic Resonance Imaging

  Baseline, 12 weeks and 24 months after intervention

• Changes in bladder diary

  Baseline and at all follow up controls

• Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10

  Baseline and 1 day, 2 days, 1 and 6 weeks post intervention

• Changes in urodynamic parameters

  Baseline and 12 and 24 months after intervention

• Duration of hospitalization post procedure

  hospital discharge

Study Arms (2)

Prostatic artery embolization

EXPERIMENTAL

Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity

Procedure: Prostatic artery embolization

Conventional monopolar transurethral prostatectomy

OTHER

Standard treatment

Procedure: monopolar transurethral prostatectomy

Interventions

Prostatic artery embolization PROCEDURE

Prostatic artery embolization

monopolar transurethral prostatectomy PROCEDURE

Conventional monopolar transurethral prostatectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men older than 40
• Patient must be a candidate for TURP
• Refractory to medical therapy or patient is not willing to consider (further) medical treatment
• Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound
• IPSS ≥8
• QoL ≥3
• Qmax\<12 and/or urinary retention
• Written informed consent

You may not qualify if:

• Mild symptoms (IPSS \<8)
• Severe atherosclerosis
• Severe tortuosity in the aortic bifurcation or internal iliac arteries
• Acontractile detrusor
• Neurogenic lower urinary tract dysfunction
• Urethral stenosis
• Bladder diverticulum
• Bladder stone with surgical indication
• Allergy to intravenous contrast media
• Contraindication for MRI imaging
• Preinterventionally proven adenocarcinoma of the prostate
• Renal failure (GFR\<60ml/min)

Sponsors & Collaborators

• Daniel Stephan Engeler: lead

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (6)

• Abt D, Mordasini L, Hechelhammer L, Kessler TM, Schmid HP, Engeler DS. Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial. BMC Urol. 2014 Nov 25;14:94. doi: 10.1186/1471-2490-14-94.

  PMID: 25425136 BACKGROUND

• Abt D, Hechelhammer L, Mullhaupt G, Markart S, Gusewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.

  PMID: 29921613 BACKGROUND

• Mullhaupt G, Hechelhammer L, Diener PA, Engeler DS, Gusewell S, Schmid HP, Mordasini L, Abt D. Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials. World J Urol. 2020 Oct;38(10):2595-2599. doi: 10.1007/s00345-019-03036-7. Epub 2019 Dec 7.

  PMID: 31813028 BACKGROUND

• Mullhaupt G, Hechelhammer L, Engeler DS, Gusewell S, Betschart P, Zumstein V, Kessler TM, Schmid HP, Mordasini L, Abt D. In-hospital cost analysis of prostatic artery embolization compared with transurethral resection of the prostate: post hoc analysis of a randomized controlled trial. BJU Int. 2019 Jun;123(6):1055-1060. doi: 10.1111/bju.14660. Epub 2019 Jan 28.

  PMID: 30578705 BACKGROUND

• Abt D, Mullhaupt G, Hechelhammer L, Markart S, Gusewell S, Schmid HP, Mordasini L, Engeler DS. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single-centre Trial. Eur Urol. 2021 Jul;80(1):34-42. doi: 10.1016/j.eururo.2021.02.008. Epub 2021 Feb 19.

  PMID: 33612376 BACKGROUND

• Mullhaupt G, Hechelhammer L, Graf N, Mordasini L, Schmid HP, Engeler DS, Abt D. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Obstruction: 5-year Outcomes of a Randomised, Open-label, Noninferiority Trial. Eur Urol Focus. 2024 Sep;10(5):788-795. doi: 10.1016/j.euf.2024.03.001. Epub 2024 Mar 25.

  PMID: 38531756 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Daniel Engeler, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: February 11, 2014
• Primary Completion: September 19, 2017
• Study Completion: July 16, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CH (1)