Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial

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

doi:10.1016/S0140-6736(20)30537-7

Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial

Hashim Hashim^*, Jo Worthington, Paul Abrams, Grace Young, Hilary Taylor, Sian M Noble, Sara T Brookes, Nikki Cotterill, Tobias Page, Kuchibhotla S Swami, J. Athene Lane

^*Corresponding author for this work

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Abstract

Background
Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery.

Methods
In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389).

Findings
Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively.

Interpretation
TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed.

Original language	English
Pages (from-to)	50-61
Number of pages	12
Journal	Lancet
Volume	396
Issue number	10243
DOIs	https://doi.org/10.1016/S0140-6736(20)30537-7
Publication status	Published - 4 Jul 2020

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BTC (Bristol Trials Centre)
BRTC
HEHP@Bristol

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Professor Athene Lane
- Athene.Lanebristol.acuk
- Bristol Medical School (PHS) - Professor of Trials Research
- Bristol Population Health Science Institute
- Cancer
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Hashim, H., Worthington, J., Abrams, P., Young, G., Taylor, H., Noble, S. M., Brookes, S. T., Cotterill, N., Page, T., Swami, K. S., & Lane, J. A. (2020). Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial. Lancet, 396(10243), 50-61. https://doi.org/10.1016/S0140-6736(20)30537-7

@article{4f9daafb9bb14b7f8e6897a0889d089e,

title = "Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial",

abstract = "Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery. Methods In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389). Findings Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively. Interpretation TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed. ",

author = "Hashim Hashim and Jo Worthington and Paul Abrams and Grace Young and Hilary Taylor and Noble, {Sian M} and Brookes, {Sara T} and Nikki Cotterill and Tobias Page and Swami, {Kuchibhotla S} and Lane, {J. Athene}",

year = "2020",

month = jul,

day = "4",

doi = "10.1016/S0140-6736(20)30537-7",

language = "English",

volume = "396",

pages = "50--61",

journal = "Lancet",

issn = "0140-6736",

publisher = "Lancet Publishing Group",

number = "10243",

}

Hashim, H, Worthington, J, Abrams, P, Young, G, Taylor, H, Noble, SM, Brookes, ST, Cotterill, N, Page, T, Swami, KS & Lane, JA 2020, 'Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial', Lancet, vol. 396, no. 10243, pp. 50-61. https://doi.org/10.1016/S0140-6736(20)30537-7

Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial. / Hashim, Hashim; Worthington, Jo; Abrams, Paul et al.
In: Lancet, Vol. 396, No. 10243, 04.07.2020, p. 50-61.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction

T2 - A randomised controlled trial

AU - Hashim, Hashim

AU - Worthington, Jo

AU - Abrams, Paul

AU - Young, Grace

AU - Taylor, Hilary

AU - Noble, Sian M

AU - Brookes, Sara T

AU - Cotterill, Nikki

AU - Page, Tobias

AU - Swami, Kuchibhotla S

AU - Lane, J. Athene

PY - 2020/7/4

Y1 - 2020/7/4

N2 - Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery. Methods In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389). Findings Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively. Interpretation TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed.

AB - Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. ThuVARP was compared to TURP in men suitable for BPO surgery. Methods In this randomised, controlled, blinded, parallel group, pragmatic equivalence trial, men with bothersome Lower Urinary Tract Symptoms (LUTS) or Urinary Retention (UR) secondary to BPO were randomised (1:1) at the point of surgery, in seven UK hospitals, to receive ThuVARP or TURP. Patients were blinded until follow-up completion. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS), 12-months post-surgery. Equivalence was defined as a difference of ≤2·5 points for IPSS and ≤4ml/s for Qmax. Secondary outcomes included surgical, functional and quality of life (QoL) measures, and complications. Analysis was by intention to treat. Registered with the ISRCTN registry (ISRCTN00788389). Findings Between June 2014 and December 2016, 410 men were randomised, 205 per arm. TURP was superior for Qmax (means of 23·2ml/s (TURP, n=199) and 20·2ml/s (ThuVARP, n=197); adjusted difference in means -3·12 and 95% CI: -5·79, -0·45). Equivalence was demonstrated for IPSS (means of 6·3 (TURP, n=199) and 6·4 (ThuVARP, n=197); adjusted difference in means 0·28 and 95% CI: -0·92, 1·49). Mean hospital stay was 48hrs in both arms. Other functional, QoL and surgical outcomes (including blood transfusions) were comparable. 45% (91/204) versus 47% (96/203) of men experienced at least one complication for TURP and ThuVARP respectively. Interpretation TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS), 12-months post surgery, whilst TURP was superior for Qmax. Anticipated laser benefits of reduced hospital stay and complications were not observed.

U2 - 10.1016/S0140-6736(20)30537-7

DO - 10.1016/S0140-6736(20)30537-7

M3 - Article (Academic Journal)

C2 - 32622397

SN - 0140-6736

VL - 396

SP - 50

EP - 61

JO - Lancet

JF - Lancet

IS - 10243

ER -

Hashim H, Worthington J, Abrams P, Young G, Taylor H, Noble SM et al. Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial. Lancet. 2020 Jul 4;396(10243):50-61. doi: 10.1016/S0140-6736(20)30537-7

Thulium laser transurethral VApoResection of the Prostate (ThuVARP) versus TransUrethral Resection of the Prostate (TURP) in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction: A randomised controlled trial

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