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




Prostatic artery embolization versus conventional TUR-P in the treatment of benign prostatic hyperplasia: protocol for a prospective randomized non-inferiority trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Urology

, 14:94

First Online: 25 November 2014Received: 22 October 2014Accepted: 13 November 2014

Abstract

BackgroundBenign 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-designThis 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.

DiscussionThe 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 registrationClinicalTrials.gov NCT02054013.

KeywordsProstate Benign prostatic hyperplasia Transurethral resection of the prostate Embolization Prostatic artery embolization Comparative clinical trial AbbreviationsBPHBenign prostate hyperplasia

CIConfidence interval

GCPGood clinical practice

IIEFInternational index of erectile function

IPSSInternational prostate symptom score

MRIMagnetic resonance imaging

NIH-CPSINational institute of health – chronic prostatitis symptoms score

PAEProstatic artery embolization

PIPrinciple investigator

PSAProstate specific antigen

TURPTransurethral resection of the prostate

TRUSTransrectal ultrasound.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2490-14-94 contains supplementary material, which is available to authorized users.

Dominik Abt, Livio Mordasini contributed equally to this work.

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Autor: Dominik Abt - Livio Mordasini - Lukas Hechelhammer - Thomas M Kessler - Hans-Peter Schmid - Daniel S Engeler

Fuente: https://link.springer.com/







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