Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT

Lynda Constable; Paul Abrams; David Cooper; Mary Kilonzo; Nikki Cotterill; Christopher K.  Harding; Marcus J Drake; Megan N  Pardoe; Alison McDonald; Rebecca Smith; John Norrie; Kirsty McCormack; Craig Ramsay; Alan  Uren; Tony  Mundy; Cathryn Glazener; Graeme MacLennan

doi:10.3310/TBFZ0277

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT

Lynda Constable^* (Corresponding Author), Paul Abrams, David Cooper, Mary Kilonzo, Nikki Cotterill, Christopher K. Harding, Marcus J Drake, Megan N Pardoe, Alison McDonald, Rebecca Smith, John Norrie, Kirsty McCormack, Craig Ramsay, Alan Uren, Tony Mundy, Cathryn Glazener, Graeme MacLennan

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background
Stress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.
Objective
To compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.
Design
A multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.

Original language	English
Article number	184
Journal	Health Technology Assessment
Volume	26
Issue number	36
DOIs	https://doi.org/10.3310/TBFZ0277
Publication status	Published - Aug 2022

Keywords

post-prostatectomy incontinence
male incontinence
artificial urinary sphincter
male sling
randomised controlled tria

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Constable, L., Abrams, P., Cooper, D., Kilonzo, M., Cotterill, N., Harding, C. K., Drake, M. J., Pardoe, M. N., McDonald, A., Smith, R., Norrie, J., McCormack, K., Ramsay, C., Uren, A., Mundy, T., Glazener, C., & MacLennan, G. (2022). Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT. Health Technology Assessment, 26(36), [184]. https://doi.org/10.3310/TBFZ0277

Constable, L, Abrams, P, Cooper, D , Kilonzo, M, Cotterill, N, Harding, CK, Drake, MJ, Pardoe, MN, McDonald, A, Smith, R, Norrie, J, McCormack, K , Ramsay, C, Uren, A, Mundy, T, Glazener, C & MacLennan, G 2022, 'Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT', Health Technology Assessment, vol. 26, no. 36, 184. https://doi.org/10.3310/TBFZ0277

@article{7013b9a032c24d6cbad2dcac884bac97,

title = "Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT",

abstract = "BackgroundStress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.ObjectiveTo compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.DesignA multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference. ",

keywords = "post-prostatectomy incontinence, male incontinence, artificial urinary sphincter, male sling, randomised controlled tria",

author = "Lynda Constable and Paul Abrams and David Cooper and Mary Kilonzo and Nikki Cotterill and Harding, {Christopher K.} and Drake, {Marcus J} and Pardoe, {Megan N} and Alison McDonald and Rebecca Smith and John Norrie and Kirsty McCormack and Craig Ramsay and Alan Uren and Tony Mundy and Cathryn Glazener and Graeme MacLennan",

note = "Funding Boards Policy Group, HTA General Board and HTA Post-board, Funding Teleconference; the NIHR Clinical Trials Unit Standing Advisory Committee; the NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board; and the Pre-exposure Prophylaxis Impact Review Panel. Acknowledgements The authors wish to thank the men who participated in MASTER. We also thank Fiona Cherry, Lara Mitchell, Georgia Mannion-Krase, Denise Will, Rebecca Bruce, Margery Heath, Maria Ntessalen, Andrea Fraser, Dianne Dejean and Janice Cruden for their secretarial support and data management; Kirsty Shearer, Caroline Peet, Lynda Constable, Karen Campbell and Elerita Flammini for the Trial Management; Graeme MacLennan (CHaRT Director (from 2017)), the programming team in CHaRT, led by Gladys McPherson (to 2016) and Mark Forrest (2016-present), members of the PMG for their ongoing support and advice, Cynthia Fraser (HSRU) for literature searches, Nikki Cotterill, Megan Pardoe, Alan Uren and Rafiyah Khan for the qualitative research carried out in MASTER, Marcus Jepson, Jenny Donovan and the Quintet team for exploring surgeon equipoise, and the independent members of the TSC and DMC, and the staff at the recruiting sites (listed below) who facilitated recruitment, treatment and follow up of trial participants. ",

year = "2022",

month = aug,

doi = "10.3310/TBFZ0277",

language = "English",

volume = "26",

journal = "Health Technology Assessment",

issn = "1366-5278",

publisher = "National Co-ordinating Centre for HTA",

number = "36",

}

TY - JOUR

T1 - Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery

T2 - the MASTER non-inferiority RCT

AU - Constable, Lynda

AU - Abrams, Paul

AU - Cooper, David

AU - Kilonzo, Mary

AU - Cotterill, Nikki

AU - Harding, Christopher K.

AU - Drake, Marcus J

AU - Pardoe, Megan N

AU - McDonald, Alison

AU - Smith, Rebecca

AU - Norrie, John

AU - McCormack, Kirsty

AU - Ramsay, Craig

AU - Uren, Alan

AU - Mundy, Tony

AU - Glazener, Cathryn

AU - MacLennan, Graeme

N1 - Funding Boards Policy Group, HTA General Board and HTA Post-board, Funding Teleconference; the NIHR Clinical Trials Unit Standing Advisory Committee; the NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board; and the Pre-exposure Prophylaxis Impact Review Panel. Acknowledgements The authors wish to thank the men who participated in MASTER. We also thank Fiona Cherry, Lara Mitchell, Georgia Mannion-Krase, Denise Will, Rebecca Bruce, Margery Heath, Maria Ntessalen, Andrea Fraser, Dianne Dejean and Janice Cruden for their secretarial support and data management; Kirsty Shearer, Caroline Peet, Lynda Constable, Karen Campbell and Elerita Flammini for the Trial Management; Graeme MacLennan (CHaRT Director (from 2017)), the programming team in CHaRT, led by Gladys McPherson (to 2016) and Mark Forrest (2016-present), members of the PMG for their ongoing support and advice, Cynthia Fraser (HSRU) for literature searches, Nikki Cotterill, Megan Pardoe, Alan Uren and Rafiyah Khan for the qualitative research carried out in MASTER, Marcus Jepson, Jenny Donovan and the Quintet team for exploring surgeon equipoise, and the independent members of the TSC and DMC, and the staff at the recruiting sites (listed below) who facilitated recruitment, treatment and follow up of trial participants.

PY - 2022/8

Y1 - 2022/8

N2 - BackgroundStress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.ObjectiveTo compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.DesignA multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.

AB - BackgroundStress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.ObjectiveTo compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.DesignA multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.

KW - post-prostatectomy incontinence

KW - male incontinence

KW - artificial urinary sphincter

KW - male sling

KW - randomised controlled tria

UR - https://doi.org/10.3310/nihrevidence_58018

U2 - 10.3310/TBFZ0277

DO - 10.3310/TBFZ0277

M3 - Article

VL - 26

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 36

M1 - 184

ER -

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT

Abstract

Keywords

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