PAE vs TURP for Lower Urinary Tract Symptoms

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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 [1]


BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.

Clinical Question

In men with moderate-severe BPH/LUTS is Prostatic Artery Embolisation (PAE) non-inferior to Transurethral Resection of the Prostate (TURP) in improving IPSS at 12 weeks post-op?

Bottom Line

PAE is not ready for prime-time yet.

Major Points

Lower urinary tract symptoms (LUTS) caused by benign prostatic hypertrophy (BPH) is a common condition in men, particularly as they age. For approximately nine decades, TURP has been the main treatment for this condition, though adverse events are common after the procedure. A plethora of alternatives have been investigated. This paper describes a head to head comparison of PAE and TURP for treatment of LUTS, but does not demonstrate non-inferiority of PAE. Both treatments had a similar positive effect of IPSS scores, but TURP provided better improvement of QMax and PVR. TURP appears to have a higher rate of adverse events.


Guidelines

Guidelines offer slightly conflicting advice in regards to the adoption of PAE for treatment of LUTS. Canadian guidelines recommend that PAE is not offered due to inferiority to TURP. American guidelines (AUA) do not recommend PAE outside a clinical trials setting. European guidelines (EAU) recommend offering PAE to men with moderate to severe LUTS who do not want invasive surgery and are willing to accept a risk of inferior outcomes compared with TURP.


Design

  • single centre, Randomised, open label, non-inferiority trial
  • N=103
    • PAE (n=51)
    • TURP (n=52)
  • Setting: Single centre in Switzerland (St Gallan Cantonal Hospital)
  • Enrollment: 11 February 2014 and 24 May 2017
  • Mean follow-up: 12 weeks
  • Analysis: Per protocol
  • Primary outcome:Change in baseline IPSS at 12 weeks

Population

Inclusion Criteria

  • Men >40yrs
  • TURP indicated
  • Refractory to medical treatment or unwilling to undergo/continue medical treatment
  • Prostate size 25-80ml, as measured by transabdominal US
  • IPSS≥8, with an IPSS related QoL of ≥3
  • Maximum urinary flow rate of <12mL/s or urinary retention


Exclusion Criteria

  • Severe atherosclerosis, aneurysmal changes or severe torturosity in aortic bifurcation or internal iliac arteries
  • Acontractile detrusor
  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Bladder diverticulum
  • Bladder stone
  • Allergy to IV contrast
  • Contraindication for MRI
  • Pre-interventionally proven prostate Ca
  • eGFR<60mL/min


Baseline Characteristics

Characteristics were well matched between the two treatment groups and no significant differences were observed. Details below are for the PAE group:

  • Mean age: 65.7 years
  • Mean BMI: 26.5
  • Mean Charlson comorbidity index: 3.6
  • IPSS: 19.38
  • Prostate volume on MRI: 52.8mL

Interventions

1:1 randomisation between PAE and TURP.

Prostate artery embolisation

  • Performed by a single, experienced interventional radiologist
  • Cone beam CT used to identify prostatic arteries and prevent off-target embolisation
  • Embolisation performed according to established techniques, bilaterally if possible
  • Successful if absence of normal prostatic blush and complete stasis of flow on CT angiography post-embolisation

TURP

  • Performed under spinal/GA by multiple Urologists
  • Used 24Fr resectoscope with a cutting power of 180 W and coagulation of 60W, standard tungsten wire loop and electrolyte free mannitol-sorbitol solution

All patients received perioperative Abx prophylaxis, an anti-inflammatory and PPI. Prostatic drug treatments were discontinued on the day of TURP and 2wks after PAE.


Outcomes

Primary Outcomes

Change in IPSS from baseline to 12 weeks post-op. Study designed to assess for non-inferiority of PAE when compared to TURP.

  • Non-inferiority defined as a mean difference in IPSS between groups of less than 3.
    • Derived from previous studies with a SD of expected change in IPSS of 4.6. This then determined their power calculation requiring only 38 patients per group and therefore aiming for 100 patients.
  • IPSS is a self administered score of LUTS scored 0-35
    • 7 or less: mild symptoms
    • 8-19: moderate symptoms
    • 20 or more: severe symptoms
  • Mean change in IPSS from baseline to 12/52:
    • PAE: - 9.23 vs TURP: -10.77
    • Difference of 1.54 favouring TURP (p=0.31, 95% confidence interval of -1.45 to 4.52)
    • Non-inferiority of PAE (difference between means <3 points) 95% CI -1.45 to 4.52, p=0.17 - large variation between individual outcomes
    • When adjusted for covariance: mean difference between treatments of 2.87 in favour of TURP - 95% CI 0.53 to 5.21, p=0.46 for non-inferiority


Secondary Outcomes

Comparisons are PAE vs TURP

Free uroflowmetry (max flow)
5.19ml/s vs 15.34 ml/s (difference 10.15 95%CI -14.67- -5.63, p<0.001)
Post void residuals (U/S)
-86.36ml vs -199.98ml (difference 113.62, CI 39.25 to 187.98, p=0.003)


Quality of life related to LUTS
-2.33 vs TURP -2.69 (difference 0.35, CI -0.30 to 1.00, p=0.15)
Questionnaire chronic prostatitis symptoms index (CPSI)
-7.83 vs -7.16 (difference 0.67 in favour of PAE, CI -3.65 to -2.32, p=0.53)
International index of erectile dysfunction short form
-0.98 vs -1.84 (difference 0.87 in favour of PAE, CI -1.89 to 3.63, p=0.53)
Haemoglobin
-4.3 vs TURP -13.8, p=0.001
PSA (Initial increase post PAE, which reduced by 12 weeks)
-2.00 vs -3.11, difference 1.11, CI -0.89 to 3.10, p=0.07
Increase in voided volume
28.7 vs TURP 18.9 (difference 9.8 in favour of PAE, CI -38.94 to 58.54, p=0.69)
Reduction in daytime frequency
0.75 vs 0.89 (difference of 0.14 in favour of TURP, CI-1.08 to 1.37, p=0.81)
Decrease in nocturia
0.35 vs 0.21 (difference of 0.14 in favour of TURP, CI -0.83 to 0.55, p=0.68)
Prostate volume reduction (MRI)
-12.17ml vs -30.27ml (18.11, CI 10.11 to 26.10, p=<0.001)
Pressure flow studies (International Continence Society standards) - percentage of reduction of detrusor pressure at QMax, signifying reduction in obstruction
56% vs 93% p=0.003

Subgroup Analysis

No subgroup analyses to report.

Adverse Events

  • Assessment of adverse events (modified Clavien system)
    • PAE n=35, TURP n=70, p=0.003
    • Risk of one adverse event: PAE 62.5%, TURP 70.6%, RR after PAE 0.89, CI 0.67 to 0.75, p=0.52
    • Risk of two or more adverse events: PAE 16.7%, TURP 45.1%, RR 0.37, CI 0.18 to 0.75, p=0.005
    • Similar distribution of severity between groups p=0.44
  • Post op pain
    • PAE 56.3%, TURP 31.9%, RR 1.76, CI 1/08 to 2.87, p=0.03
    • Maximum pain score higher in PAE: PAE 4.0, TURP 3.1, difference 0.9, CI 0.76 to 2.42, p=0.28
    • Severe pain reported; PAE n=9, TURP n=2, RR 4.41, CI 1.00-19.33, p=0.06


Criticisms

  • The study appears to be under-powered which meant that the primary study question could not be answered with clarity.
  • The study was based in a single centre and a multi-centre approach may provide additional information about PAE efficacy, which requires expert skill to administer.
  • While the 12 week follow up period was adequate for the primary outcome, additional data regarding long term efficacy would be useful


Funding

  • The trial was supported by a grant from the research committee of St Gallen Cantonal Hospital


Further Reading


  • In 2019 a systematic review and meta-analysis examined multiple studies of PAE for LUTS [2]
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