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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; 361 doi: https://doi.org/10.1136/bmj.k2338 (Published 19 June 2018) Cite this as: BMJ 2018;361:k2338 Visual abstract, showing the study population, design and primary outcomes.

Linked editorial

Prostate artery embolisation for benign prostatic hyperplasia

Linked opinion

Prostatic artery embolisation: time to improve collaboration

  1. Dominik Abt, consultant urologist1,
  2. Lukas Hechelhammer, section chief of interventional radiology2,
  3. Gautier Müllhaupt, consultant urologist1,
  4. Stefan Markart, radiologist2,
  5. Sabine Güsewell, biostatistician3,
  6. Thomas M Kessler, head4,
  7. Hans-Peter Schmid, department chief1,
  8. Daniel S Engeler, associate professor of urology1,
  9. Livio Mordasini, consultant urologist1
  1. 1Department of Urology, St Gallen Cantonal Hospital, 9007 St Gallen, Switzerland
  2. 2Department of Radiology and Nuclear Medicine, St Gallen Cantonal Hospital, St Gallen, Switzerland
  3. 3Clinical Trials Unit, St Gallen Cantonal Hospital, St Gallen, Switzerland
  4. 4Neuro-Urology, Spinal Cord Injury Center and Research, University of Zürich, Balgrist University Hospital, Zürich, Switzerland
  1. Correspondence to: D Abt dominik.abt{at}kssg.ch (or @AbtDominik on Twitter)
  • Accepted 6 May 2018

Abstract

Objective To compare prostatic artery embolisation (PAE) with transurethral resection of the prostate (TURP) in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in terms of patient reported and functional outcomes.

Design Randomised, open label, non-inferiority trial.

Setting Urology and radiology departments of a Swiss tertiary care centre.

Participants 103 patients aged ≥40 years with refractory lower urinary tract symptoms secondary to benign prostatic hyperplasia were randomised between 11 February 2014 and 24 May 2017; 48 and 51 patients reached the primary endpoint 12 weeks after PAE and TURP, respectively.

Interventions PAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia.

Main outcomes and measures Primary outcome was change in international prostate symptoms score (IPSS) from baseline to 12 weeks after surgery; a difference of less than 3 points between treatments was defined as non-inferiority for PAE and tested with a one sided t test. Secondary outcomes included further questionnaires, functional measures, magnetic resonance imaging findings, and adverse events; changes from baseline to 12 weeks were compared between treatments with two sided tests for superiority.

Results Mean reduction in IPSS from baseline to 12 weeks was −9.23 points after PAE and −10.77 points after TURP. Although the difference was less than 3 points (1.54 points in favour of TURP (95% confidence interval −1.45 to 4.52)), non-inferiority of PAE could not be shown (P=0.17). None of the patient reported secondary outcomes differed significantly between treatments when tested for superiority; IPSS also did not differ significantly (P=0.31). At 12 weeks, PAE was less effective than TURP regarding changes in maximum rate of urinary flow (5.19 v 15.34 mL/s; difference 10.15 (95% confidence interval −14.67 to −5.63); P<0.001), postvoid residual urine (−86.36 v −199.98 mL; 113.62 (39.25 to 187.98); P=0.003), prostate volume (−12.17 v −30.27 mL; 18.11 (10.11 to 26.10); P<0.001), and desobstructive effectiveness according to pressure flow studies (56% v 93% shift towards less obstructive category; P=0.003). Fewer adverse events occurred after PAE than after TURP (36 v 70 events; P=0.003).

Conclusions The improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia seen 12 weeks after PAE is close to that after TURP. PAE is associated with fewer complications than TURP but has disadvantages regarding functional outcomes, which should be considered when selecting patients. Further comparative study findings, including longer follow-up, should be evaluated before PAE can be considered as a routine treatment.

Trial registration Clinicaltrials.gov NCT02054013.

Footnotes

  • Contributors: DA and LH did the literature search, designed the study, collected the data, interpreted the data, and wrote the report. DA is guarantor. GM collected the data, interpreted the data, and wrote the report. SM collected the data, and interpreted the data. SG did the statistical analysis, interpreted the data, and wrote the report. TMK, H-PS, and DSE designed the study, collected the data, interpreted the data, and wrote the report. LM did the literature search, designed the study, collected the data, interpreted the data, and wrote the report. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: The trial was supported by a grant from the research committee of St Gallen Cantonal Hospital (14/08). The funder had no role in the conduct or analysis of the trial.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from St Gallen Cantonal Hospital for the submitted work; no financial relationship with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: The study was approved by the local ethics committee (EKSG14/004), and all participants gave written informed consent before taking part in the study.

  • Data sharing: Participants gave consent for anonymised data sharing. Requests for an anonymised, full dataset of physician level data and statistical code will be considered if the proposed use aligns with public good purposes, does not conflict with other requests, does not conflict with the planned use by the trial steering committee, contingent on approval from the local ethics committee (EKOS). Requests can be addressed to the corresponding author.

  • The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

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