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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02054013
Recruitment Status : Active, not recruiting
First Posted : February 4, 2014
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: Prostatic artery embolization Procedure: monopolar transurethral prostatectomy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : February 11, 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Changes in the International Prostate Symptom Score [ Time Frame: Baseline and 12 weeks after intervention ]

Secondary Outcome Measures :
  1. Changes of prostate volume using Magnetic Resonance Imaging [ Time Frame: Baseline, 12 weeks and 24 months after intervention ]
  2. Changes in bladder diary [ Time Frame: Baseline and at all follow up controls ]
    Changes in bladder diary (difference of voids during daytime and night-time, difference voided volume, difference liquid intake, difference incontinence episodes)

  3. Pre- and postoperative changes in C-reactive Protein, Prostate-specific antigen (PSA), serum amyloid A, Interleukin-6 and Interleukin-10 [ Time Frame: Baseline and 1 day, 2 days, 1 and 6 weeks post intervention ]
  4. Changes in urodynamic parameters [ Time Frame: Baseline and 12 and 24 months after intervention ]
  5. Duration of hospitalization post procedure [ Time Frame: hospital discharge ]
  6. Duration of post procedure catheterization [ Time Frame: baseline and post intervention ]
  7. Changes in the CPSI and IIEF [ Time Frame: baseline and at all follow-up controls after the intervention ]
  8. Procedure time and radiation parameters [ Time Frame: after intervention ]
  9. 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 [ Time Frame: baseline ]
  10. Percentage of prostate tissue devascularized, based on contrast-enhanced MRI [ Time Frame: 12 weeks and 24 months after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054013


Locations
Switzerland
Cantonal Hospital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Daniel Stephan Engeler
Investigators
Principal Investigator: Daniel Engeler, MD Cantonal Hospital St Gallen
More Information

Publications:
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
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

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