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NCT Number: NCT02054013

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prostatic Artery Embolization

Procedure

monopolar transurethral prostatectomy

Procedure

Primary outcomes

  1. Changes in the International Prostate Symptom Score

    Time frame: Baseline and 12 weeks after intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daniel Stephan Engeler

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2022
First posted
Feb 4, 2014
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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