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; Forrest, Mark; Harding, Chris; Kilonzo, Mary; MacLennan, Graeme; McCormack, Kirsty; McDonald, Alison; Mundy, Anthony R.; Norrie, John; Pickard, Robert; Ramsay, Craig R; Smith, Rebecca; Wileman, Samantha; Abrams, Paul

doi:10.1186/s13063-018-2501-2

Cited by 36 publications

(32 citation statements)

References 17 publications

(25 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It has been reported that 42% of men have impaired urinary function 5 years after radical prostatectomy (RP) ; 70% of men report some persisting urine leakage within this time frame . Urinary function after RP is a considerable postoperative concern for men with prostate cancer .…”

Section: Introductionmentioning

confidence: 99%

A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

et al. 2020

View full text Add to dashboard Cite

Objectives To consider the provision of post‐radical prostatectomy (RP) continence surgery in England. Materials and Methods Patients with an Office of Population Census and Surveys Classification of Interventions and Procedures, version 4 code for an artificial urinary sphincter (AUS) or male sling between 1 January 2010 and 31 March 2018 were searched for within the Hospital Episode Statistics (HES) dataset. Those without previous RP were excluded. Multivariable logistic regressions for repeat AUS and sling procedures were built in stata. Further descriptive analysis of provision of procedures was performed. Results A total of 1414 patients had received index AUS, 10.3% of whom had undergone prior radiotherapy; their median follow‐up was 3.55 years. The sling cohort contained 816 patients; 6.7% of these had received prior radiotherapy and the median follow‐up was 3.23 years. Whilst the number of AUS devices implanted had increased each year, male slings peaked in 2014/2015. AUS redo/removal was performed in 11.2% of patients. Patients in low‐volume centres were more likely to require redo/removal (odds ratio [OR] 2.23 95% confidence interval [CI] 1.02–4.86; P = 0.045). A total of 12.0% patients with a sling progressed to AUS implantation and 1.3% had a second sling. Patients with previous radiotherapy were more likely to require a second operation (OR 2.03 95% CI 1.01–4.06; P = 0.046). Emergency re‐admissions within 30 days of index operation were 3.9% and 3.6% fewer in high‐volume centres, for AUS and slings respectively. The median time to initial continence surgery from RP was 2.8 years. Increased time from RP conferred no reduced risk of redo surgery for either procedure. Conclusion There is a volume effect for outcomes of AUS procedures, suggesting that they should only be performed in high‐volume centres. Given the known impact of incontinence on quality of life, patients should be referred sooner for post‐prostatectomy continence surgery.

show abstract

Section: Introductionmentioning

confidence: 99%

A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

et al. 2020

View full text Add to dashboard Cite

show abstract

“…3 A history of prior prostate surgery, most commonly radical prostatectomy, is a major risk factor for the development of male SUI, and up to 20% of men undergoing these types of procedures ultimately undergo an intervention for SUI. [3][4][5][6] While a variety of interventions exist, the artificial urinary sphincter (AUS) is considered to be the gold standard definitive treatment for male SUI. [3][4][5][6][7][8] Though overall success rates and satisfaction are high, the AUS is a procedure with many known potential complications.…”

Section: Introductionmentioning

confidence: 99%

“…[3][4][5][6] While a variety of interventions exist, the artificial urinary sphincter (AUS) is considered to be the gold standard definitive treatment for male SUI. [3][4][5][6][7][8] Though overall success rates and satisfaction are high, the AUS is a procedure with many known potential complications. 5,9 Among the most severe of these complications are device infection and erosion, necessitating removal of the device in its entirety.…”

Section: Introductionmentioning

confidence: 99%

The Impact of Frailty on Artificial Urinary Sphincter Placement and Removal Procedures

Medendorp

Anger

Jin

et al. 2019

Urology

View full text Add to dashboard Cite

Objectives: To determine whether frailty is associated with increased odds of 30-day surgical complications among men undergoing both artificial urinary sphincter (AUS) placement and removal procedures and to determine whether frailty was associated with increased odds of having an AUS removal procedure. Methods: This is a retrospective cohort study of men undergoing AUS placement and removal procedures using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) from 2006-2013. Frailty was quantified using the NSQIP-FI (Frailty Index) and was applied to logistic regression models predicting 30-day complications (overall, major and minor) and the odds of having an AUS removal procedure (over an AUS placement procedure). Results: We identified a total of 624 and 147 men undergoing AUS placement and removal procedures, respectively. NSQIP-FI of ≥0.27, but not age, was associated with major complications (aOR 3.5, 95% CI 1.2-9.9), while age ≥85 years, but not NSQIP-FI, was associated with minor complications (aOR 7.9, 95% CI 1.4-45.6). Men undergoing AUS removal procedures tended to be more frail compared to men undergoing AUS placement procedures (12.9% vs 6.1% had NSQIP-FI of ≥0.27, p<0.01). Conclusions: Men undergoing AUS removal procedures are, on average, more frail compared to men undergoing AUS placement procedures. Frailty is associated with increased odds of major complications and with having an AUS removal procedure. These findings highlight the importance of incorporating measures of frailty, instead of age alone, into the perioperative decision-making process for adults considering these types of procedures.

show abstract

“…The majority (21/29), had an AUS inserted with the remaining patients having a sub‐urethral sling. From 1st January 2014 to 31st December 2017 our center was recruiting to the Male synthetic sling vs Artificial urinary Sphincter Trial: Evaluation by Randomized controlled trial (MASTER) . Median time from RARP to operation was 24 months (95% CI, 19.9‐28.1) with a median follow‐up post continence procedure of 25 months (95% CI, 19.4‐30.6).…”

Section: Resultsmentioning

confidence: 99%

“…From 1st January 2014 to 31st December 2017 our center was recruiting to the Male synthetic sling vs Artificial urinary Sphincter Trial: Evaluation by Randomized controlled trial (MASTER). 16 Median time from RARP to operation was 24 months (95% CI, 19.9-28.1) with a median follow-up post continence procedure of 25 months (95% CI, 19.4-30.6). Men with no urodynamic evidence of lower urinary tract dysfunction (10/64) were counseled about their results by the continence specialist team.…”

Section: Clinical Outcomes After Continence Team Reviewmentioning

confidence: 99%

Patient‐reported outcomes and urodynamic findings in men with persistent lower urinary tract symptoms following robot‐assisted radical prostatectomy

MacKenzie

Davis

Harding

et al. 2019

Neurourology and Urodynamics

View full text Add to dashboard Cite

Aims To evaluate the patient‐reported outcome measures (PROMs) and urodynamic findings in men seeking intervention for lower urinary tract symptoms (LUTS) after robotic‐assisted radical prostatectomy (RARP) in a regional referral center for continence surgery. Methods Consecutive men with post‐RARP LUTS, who were referred for specialist evaluation and urodynamics between December 2012 and October 2017, were evaluated. Men were invited to complete the International Consultation on Incontinence Questionnaire on Male Lower Urinary Tract Symptoms Long Form (ICIQ‐MLUTS) pre‐operatively and at 6, 12 and 18 months post‐RARP. Results In total 64/860 (7.4%) men post‐RARP were referred for specialist evaluation. There was a significant increase in total ICIQ‐MLUTS and bother scores at 6, 12 and 18 months compared with the baseline in these men (P < 0.001 and P < 0.05, respectively). Urodynamics identified 41/64 (64%) had urodynamic stress incontinence (USI) only, 2/64 (3%) had detrusor overactivity (DO) only and 11/64 (17%) had a combination of USI and DO. Of those referred to a continence specialist 29/64 (45%) underwent a continence procedure. Conclusions Patients with bothersome LUTS post‐RARP have higher baseline ICIQ‐MLUTs scores and significant worsening of total scores at all time points compared with the baseline. Routine use of PROMs may identify patients at risk of bothersome symptoms after RARP and prompt earlier referral for further management of their LUTS. Urodynamic evaluation revealed that the most common finding was pure stress incontinence but the range of urodynamic diagnoses highlights the need to perform urodynamics before making treatment decisions for men with LUTS post‐RARP.

show abstract

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

Cited by 36 publications

References 17 publications

A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

The Impact of Frailty on Artificial Urinary Sphincter Placement and Removal Procedures

Patient‐reported outcomes and urodynamic findings in men with persistent lower urinary tract symptoms following robot‐assisted radical prostatectomy

Contact Info

Product

Resources

About