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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT02054013
First received: January 31, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Benign Prostatic Hyperplasia
Procedure: Prostatic artery embolization
Procedure: monopolar transurethral prostatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Changes in the International Prostate Symptom Score [ Time Frame: Baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of prostate volume using Magnetic Resonance Imaging [ Time Frame: Baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
  • Changes in bladder diary [ Time Frame: Baseline and 12 weeks after intervention ] [ Designated as safety issue: No ]
    Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)

  • Pre- and postoperative changes in C-reactive Protein, feline serum amyloid A, Interleukin-6 and Interleukin-10 [ Time Frame: Baseline and 1 day, 6 and 12 weeks post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostatic artery embolization
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
Standard treatment
Procedure: monopolar transurethral prostatectomy

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054013

Contacts
Contact: Daniel Engeler, MD daniel.engeler@kssg.ch

Locations
Switzerland
Cantonal Hospital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Engeler, MD       daniel.engeler@kssg.ch   
Principal Investigator: Daniel Engeler, MD         
Sub-Investigator: Livio Mordasini, MD         
Sub-Investigator: Dominik Abt, MD         
Sub-Investigator: Lukas Hechelhammer, MD         
Sub-Investigator: Hans-Peter Schmid, MD         
Sponsors and Collaborators
Daniel Stephan Engeler
Investigators
Principal Investigator: Daniel Engeler, MD Cantonal Hospital St Gallen
  More Information

No publications provided

Responsible Party: Daniel Stephan Engeler, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02054013     History of Changes
Other Study ID Numbers: CTU 13.030
Study First Received: January 31, 2014
Last Updated: February 5, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 18, 2014