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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054013
• Other study ID #: CTU 13.030
• Status: Completed
• Phase: N/A
• Start date: February 11, 2014
• Est. completion date: July 16, 2022

Study information

• Verified date: December 2022
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 16, 2022
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Prostatic artery embolization

• monopolar transurethral prostatectomy

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Stephan Engeler

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

Abt D, Müllhaupt G, Hechelhammer L, Markart S, Güsewell 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. — View Citation

Müllhaupt G, Hechelhammer L, Diener PA, Engeler DS, Güsewell 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. — View Citation

Müllhaupt G, Hechelhammer L, Engeler DS, Güsewell 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the International Prostate Symptom Score		Baseline and 12 weeks after intervention
Secondary	Changes of prostate volume using Magnetic Resonance Imaging		Baseline, 12 weeks and 24 months after intervention
Secondary	Changes in bladder diary	Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)	Baseline and at all follow up controls
Secondary	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
Secondary	Changes in urodynamic parameters		Baseline and 12 and 24 months after intervention
Secondary	Duration of hospitalization post procedure		hospital discharge
Secondary	Duration of post procedure catheterization		baseline and post intervention
Secondary	Changes in the CPSI and IIEF		baseline and at all follow-up controls after the intervention
Secondary	Procedure time and radiation parameters		after intervention
Secondary	Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size, measured preoperatively by TRUS and MRI at baseline Comparison of prostate size measured by TRUS and MRI		baseline
Secondary	Percentage of prostate tissue devascularized, based on contrast-enhanced MRI		12 weeks and 24 months after intervention