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

BACKGROUND: Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. OBJECTIVE: We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. DESIGN: This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. SETTING: The trial was set in 28 UK urological centres in the NHS. PARTICIPANTS: Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. INTERVENTIONS: We compared male synthetic sling with artificial urinary sphincter. MAIN OUTCOME MEASURES: The clinical primary outcome measure was men's reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). RESULTS: In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference -0.034, 95% confidence interval -0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of -15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months' follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. LIMITATIONS: Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. CONCLUSIONS: Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. FUTURE WORK: Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. TRIAL REGISTRATION: This trial is registered as ISRCTN49212975. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Leakage of urine associated with physical exertion (e.g. sporting activities, sneezing or coughing) is common in men who have undergone prostate surgery, but it is difficult to improve. Many men still leak urine 12 months after their prostate surgery and may continue to wear protective pads or sheaths. The most common operation to improve incontinence is implantation of an artificial urinary sphincter. An artificial urinary sphincter is an inflatable cuff that is placed around the urethra, the tube that drains urine from the bladder. The cuff is inflated and compresses the urethra to prevent leaking. When the man needs to pass urine, he must deflate the cuff by squeezing a pump placed in his scrotum, which releases the compression on the urethra and allows the bladder to empty. Recently, a new device, the male sling (made from non-absorbable plastic mesh), has been developed. The sling, which is surgically inserted under the urethra, supports the bladder, but, in contrast to the artificial sphincter, it does not need to be deactivated by a pump and, therefore, the patient does not need to do anything to operate it. A sling is also easier for the surgeon to insert than a sphincter. However, in some men, the sling does not provide enough improvement in incontinence symptoms and another operation, to place an artificial urinary sphincter, is needed. The aim of this study was to determine if the male sling was as effective as the artificial urinary sphincter in treating men with bothersome incontinence after prostate surgery. The study took the form of a randomised controlled trial (the gold standard and most reliable way to compare treatments) in which men were randomised (allocated at random to one of two groups using a computer) to either a male sling or an artificial urinary sphincter operation. We asked men how they got on in the first 2 years after their operation. Regardless of which operation they had, incontinence and quality of life significantly improved and complications were rare. A small number of men did require another operation to improve their incontinence, and it was more likely that an artificial urinary sphincter was needed, rather than another sling operation, if a male sling was not successful. Satisfaction was high in both groups, but it was significantly higher in the artificial urinary sphincter group than in the male sling group. Those who received a male sling were less likely than those who received an artificial urinary sphincter to say that they would recommend their surgery to a friend.

The development of the Cystectomy-Pathway Assessment Tool (C-PAT): a concise tool to assess the quality of care in the cystectomy pathway.

OBJECTIVES: To develop and test the psychometric properties of a concise, patient-reported questionnaire, designed to assess key aspects of the radical cystectomy (RC) patient pathway that are important to both patients and clinicians. PATIENTS AND METHODS: Draft items were developed by a consultation with a 13-member expert clinical panel, and the in-depth qualitative analysis of 14 semi-structured interviews with patients who had received RC within the previous 18 months. A further nine cognitive interviews with patients refined the items and ensured they were easy to complete. Pilot testing in 122 patients recruited from five hospitals in England tested the properties of validity and reliability of the resulting 17-item questionnaire. RESULTS: Patients and clinicians identified the following aspects as important for the delivery of quality patient care. These included timely referral and initial test results; an explanation of risk/benefits of treatment; access to a cancer nurse specialist; training and support in stoma management; timely surgery, surgical complications, and timely follow-up. Pilot testing showed missing data was low (≤3% for all items), and between 73% and 89% of the responses to items were the most positive about their care (indicating ceiling effects). Five items were identified using factor analysis as being statistically related (Cronbach's α 0.76, intraclass correlation coefficient test-retest reliability of 0.95) and formed the scored part of the tool 'care and support', scored 0-16. There was insufficient evidence at this stage to show the tool was capable of measuring differences between cancer centres. CONCLUSION: We have developed a questionnaire that captures aspects of quality of care within the RC patient pathway. The results support the validity and reliability of the 17-item Cystectomy-Pathway Assessment Tool (C-PAT). We envisage the tool can be the basis for audit of the patient reported assessment of the quality of care for individual cancer centres.

Definition and symptoms of underactive bladder.

Underactive bladder (UAB) is a symptom syndrome reflecting the urodynamic observation of detrusor underactivity (DU), a voiding contraction of reduced strength and/or duration, leading to prolonged or incomplete bladder emptying. An International Continence Society Working Group has described UAB as characterised by a slow urinary stream, hesitancy and straining to void, with or without a feeling of incomplete bladder emptying and dribbling, often with storage symptoms. Since DU often coexists with bladder outlet obstruction, or storage dysfunction (detrusor overactivity or incontinence), the exact contribution of the DU to the presenting complaints can be difficult to establish. The presence of voiding and post voiding lower urinary tract symptoms (LUTS) is implicitly expected in UAB, but a reduced sensation of fullness is reported by some patients, and storage LUTS are also an important factor in many affected patients. These may result from a postvoid residual, but often they do not. The storage LUTS are often the key driver in leading the patient to seek healthcare input. Nocturia is particularly common and bothersome, but what the role of DU is in all the range of influences on nocturia has not been established. Qualitative research has established a broad impact on everyday life as a result of these symptoms. In general, people appear to manage the voiding LUTS relatively well, but the storage LUTS may be problematic.

Qualitative Exploration of the Patient Experience of Underactive Bladder.

BACKGROUND: Underactive bladder (UAB) is considered the symptom complex associated with the urodynamic diagnosis of detrusor underactivity. OBJECTIVE: The aim of this research was to investigate the patient reported experience of the symptoms, signs, and impact of UAB. This research is also part of the initial qualitative phase for the development of a new patient reported outcome measure for the assessment of UAB. DESIGN, SETTING, AND PARTICIPANTS: Qualitative methods were used to understand the experience of UAB from a patient perspective, in a purposive sample of male (n=29) and female (n=15) patients aged 27-88 yr (mean: 64 yr), diagnosed with a primary diagnosis of detrusor underactivity, with or without coexisting urological conditions. Semistructured interviews were conducted in Bristol, UK. RESULTS: Male and female patients reported a variety of lower urinary tract symptoms and associated impact on quality of life. Storage symptoms of nocturia, increased daytime frequency, and urgency, and the voiding symptoms of slow stream, hesitancy, and straining were reported by over half of the patients. A sensation of incomplete emptying and postmicturition dribble were also frequently described. Most had a post void residual >30ml (n=34, 77%, median: 199ml) with many reporting urinary tract infections, a history of self-catheterisation, and some experiencing occasional acute retention episodes. These symptoms and signs can have a broad impact on quality of life including having to plan their daily activities around the location of toilets, disruption to sleep, social life, and associated effect on family and friends. CONCLUSIONS: Knowledge of the lived experience of UAB obtained in the current study will be used for the development of a new patient reported outcome measure and help inform the current working definition of UAB. PATIENT SUMMARY: The symptoms, signs, and impact on quality of life of underactive bladder are described by patients with the condition.