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Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

ABSTRACT: BACKGROUND:Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective randomized controlled trials comparing PAE with TUR-P are highly warranted. METHODS/DESIGN:This is a single-centre, prospective, randomized, non-inferiority trial comparing treatment effects and adverse events of PAE and TURP in a tertiary referral centre. One hundred patients who are electable for both treatment options are randomized to either PAE or TURP. Changes of the International Prostate Symptom Score (IPSS) after 3 months are defined as primary endpoint. Changes in bladder diaries, laboratory analyses, urodynamic investigations and standardised questionnaires are assessed as secondary outcome measures. In addition contrast-enhanced magnetic resonance imaging of the pelvis before and after the interventions will provide crucial information regarding morphological changes and vascularisation of the prostate. Adverse events will be assessed on every follow-up visit in both treatment arms according to the National Cancer Institute Common Terminology Criteria for Adverse events and the Clavien classification. DISCUSSION:The aim of this study is to assess whether PAE represents a valid treatment alternative to TURP in patients suffering from BPH in terms of efficacy and safety. TRIAL REGISTRATION:ClinicalTrials.gov NCT02054013.

SUBMITTER: Abt D

PROVIDER: S-EPMC4258033 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

Abt Dominik D Mordasini Livio L Hechelhammer Lukas L Kessler Thomas M TM Schmid Hans-Peter HP Engeler Daniel S DS

BMC urology 20141125

<h4>Background</h4>Benign prostatic hyperplasia (BPH) is a prevalent entity in elderly men and transurethral resection of the prostate (TURP) still represents the gold standard of surgical treatment despite its considerable perioperative morbidity. Recently, prostatic artery embolization (PAE) was described as a novel effective and less invasive treatment alternative. Despite promising first results, PAE still has to be considered experimental due to a lack of good quality studies. Prospective r ...[more]

PMID: 25425136

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Project description:ObjectiveTo 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.DesignRandomised, open label, non-inferiority trial.SettingUrology and radiology departments of a Swiss tertiary care centre.Participants103 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.InterventionsPAE performed with 250-400 μm microspheres under local anaesthesia versus monopolar TURP performed under spinal or general anaesthesia.Main outcomes and measuresPrimary 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.ResultsMean 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).ConclusionsThe 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 registrationClinicaltrials.gov NCT02054013.

Dataset Information

Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

Publications

Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial.

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