Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): Study protocol for a randomised controlled trial

Lynda Constable, Nikki Cotterill, David Cooper, Cathryn Glazener, Marcus J. Drake, Mark Forrest, Chris Harding, Mary Kilonzo, Graeme MacLennan, Kirsty McCormack, Alison McDonald, Anthony Mundy, John Norrie, Robert Pickard, Craig Ramsay, Rebecca Smith, Samantha Wileman, Paul Abrams, The MASTER Study Group

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Abstract

Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.

Original languageEnglish
Article number131
Pages (from-to)1-17
Number of pages17
JournalTrials
Volume19
DOIs
Publication statusPublished - 21 Feb 2018

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Artificial Urinary Sphincter
Suburethral Slings
Urodynamics
Prostate
Randomized Controlled Trials
Stress Urinary Incontinence
Prostatectomy
Secondary Care Centers
Transurethral Resection of Prostate
Health Services Needs and Demand
Operative Surgical Procedures
Urethra
Cost-Benefit Analysis
Prostatic Neoplasms
Urinary Bladder
Quality of Life
Urine

Keywords

  • Artificial urinary sphincter
  • Male sling
  • Randomised controlled trial
  • Urinary incontinence

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER) : Study protocol for a randomised controlled trial. / Constable, Lynda; Cotterill, Nikki; Cooper, David; Glazener, Cathryn; Drake, Marcus J.; Forrest, Mark; Harding, Chris; Kilonzo, Mary; MacLennan, Graeme; McCormack, Kirsty; McDonald, Alison; Mundy, Anthony; Norrie, John; Pickard, Robert; Ramsay, Craig; Smith, Rebecca; Wileman, Samantha; Abrams, Paul; The MASTER Study Group.

In: Trials, Vol. 19, 131, 21.02.2018, p. 1-17.

Research output: Contribution to journalArticle

Constable, Lynda ; Cotterill, Nikki ; Cooper, David ; Glazener, Cathryn ; Drake, Marcus J. ; Forrest, Mark ; Harding, Chris ; Kilonzo, Mary ; MacLennan, Graeme ; McCormack, Kirsty ; McDonald, Alison ; Mundy, Anthony ; Norrie, John ; Pickard, Robert ; Ramsay, Craig ; Smith, Rebecca ; Wileman, Samantha ; Abrams, Paul ; The MASTER Study Group. / Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER) : Study protocol for a randomised controlled trial. In: Trials. 2018 ; Vol. 19. pp. 1-17.
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abstract = "Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8{\%} after radical prostatectomy and 2{\%} after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27{\%} and 6{\%} respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.",
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author = "Lynda Constable and Nikki Cotterill and David Cooper and Cathryn Glazener and Drake, {Marcus J.} and Mark Forrest and Chris Harding and Mary Kilonzo and Graeme MacLennan and Kirsty McCormack and Alison McDonald and Anthony Mundy and John Norrie and Robert Pickard and Craig Ramsay and Rebecca Smith and Samantha Wileman and Paul Abrams and {The MASTER Study Group}",
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T2 - Study protocol for a randomised controlled trial

AU - Constable, Lynda

AU - Cotterill, Nikki

AU - Cooper, David

AU - Glazener, Cathryn

AU - Drake, Marcus J.

AU - Forrest, Mark

AU - Harding, Chris

AU - Kilonzo, Mary

AU - MacLennan, Graeme

AU - McCormack, Kirsty

AU - McDonald, Alison

AU - Mundy, Anthony

AU - Norrie, John

AU - Pickard, Robert

AU - Ramsay, Craig

AU - Smith, Rebecca

AU - Wileman, Samantha

AU - Abrams, Paul

AU - The MASTER Study Group

N1 - This work is supported by a grant from the National Institute for Health Research Health Technology Assessment (HTA) Programme (Project Number 11/106/01). The Health Services Research Unit is funded by the Chief Scientists Office of the Scottish Government Health Directorates. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, the National Institute of Health Research, the National Health Service or the Department of Health. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of data, or writing of the report. A UK Collaborative Study funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme Project Number 11/106/01.

PY - 2018/2/21

Y1 - 2018/2/21

N2 - Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.

AB - Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.

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KW - Male sling

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KW - Urinary incontinence

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