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Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): A randomised controlled trial

Hashim, Hashim; Worthington, Jo; Abrams, Paul; Young, Grace; Taylor, Hilary; Noble, Sian M.; Brookes, Sara T.; Cotterill, Nikki; Page, Tobias; Swami, K. Satchi; Lane, J. Athene

Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): A randomised controlled trial Thumbnail


Authors

Hashim Hashim

Jo Worthington

Paul Abrams

Grace Young

Hilary Taylor

Sian M. Noble

Sara T. Brookes

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N Nikki Cotterill Nikki.Cotterill@uwe.ac.uk
Professor of Long Term Conditions (Continence Care)

Tobias Page

K. Satchi Swami

J. Athene Lane



Abstract

Background: Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction. Methods: In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389. Findings: Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means −3·12, 95% CI −5·79 to −0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, −0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication. Interpretation: TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed. Funding: UK National Institute for Health Research Health Technology Assessment Programme.

Citation

Hashim, H., Worthington, J., Abrams, P., Young, G., Taylor, H., Noble, S. M., …Lane, J. A. (2020). Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): A randomised controlled trial. Lancet, 396(10243), 50-61. https://doi.org/10.1016/S0140-6736%2820%2930537-7

Journal Article Type Article
Acceptance Date Feb 26, 2020
Online Publication Date Jul 2, 2020
Publication Date Jul 4, 2020
Deposit Date Mar 27, 2020
Publicly Available Date Jul 3, 2020
Journal The Lancet
Print ISSN 01406736
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 396
Issue 10243
Pages 50-61
DOI https://doi.org/10.1016/S0140-6736%2820%2930537-7
Keywords lower urinary tract symptoms, therapeutic intervention, prostatic obstruction, urinary retention
Public URL https://uwe-repository.worktribe.com/output/5653847
Publisher URL https://www.thelancet.com/journals/lancet/home

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