Abstract Background Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death. Prepare for Kidney Care aims to compare preparation for a renal dialysis pathway with preparation for a conservative kidney management pathway, in relation to quantity and quality of life in multimorbid, frail, older people with advanced CKD. Methods This is a two-arm, superiority, parallel group, non-blinded, individual-level, multi-centre, pragmatic trial, set in United Kingdom National Health Service (NHS) kidney units. Patients with advanced CKD (estimated glomerular filtration rate < 15 mL/min/1.73 m2, not due to acute kidney injury) who are (a) 80 years of age and over regardless of frailty or multimorbidity, or (b) 65–79 years of age if they are frail or multimorbid, are randomised 1:1 to ‘prepare for responsive management’, a protocolised form of conservative kidney management, or ‘prepare for renal dialysis’. An integrated QuinteT Recruitment Intervention is included. The primary outcome is mean total number of quality-adjusted life years during an average follow-up of 3 years. The primary analysis is a modified intention-to-treat including all participants contributing at least one quality of life measurement. Secondary outcomes include survival, patient-reported outcomes, physical functioning, relative/carer reported outcomes and qualitative assessments of treatment arm acceptability. Cost-effectiveness is estimated from (i) NHS and personal social services and (ii) societal perspectives. Discussion This randomised study is designed to provide high-quality evidence for frail, multimorbid, older patients with advanced CKD choosing between preparing for dialysis or conservative kidney management, and healthcare professionals and policy makers planning the related services. Trial registration ISRCTN, ISRCTN17133653 (https://doi.org/10.1186/ISRCTN17133653). Registered 31 May 2017.

Background Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design This was a two-arm cluster randomised controlled trial. Setting The trial was set in 30 NHS general practice sites in England. Participants Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons’ patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of –1.81 points, 95% confidence interval –2.66 to –0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of –£29.99, 95% confidence interval –£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval –0.011 to 0.014). Conclusions The intervention showed a small, sustained benefit for men’s lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration This trial is registered as ISRCTN11669964. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.

Objectives To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.Design Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon.Setting Thirty NHS general practice sites in England.Participants 1077 men aged 18 or older identified in primary care with bothersome LUTS.Interventions A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites.Measures Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated.Results 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs −£29.99 (95% CI −£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI −0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI −£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold.Conclusions Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost.Trial registration number ISRCTN11669964.

Abstract Objective To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. Design Cluster randomised controlled trial. Setting 30 National Health Service general practice sites in England. Participants Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). Intervention Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. Main outcome measures The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. Results Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference −1.81 points, 95% confidence interval −2.66 to −0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. Conclusions A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of −1.81 points (95% confidence interval −0.95 to −2.66) on the IPSS was less than the predefined target reduction of 2.0 points. Trial registration ISRCTN Registry ISRCTN11669964 .

Background: Many men prefer conservative treatment of lower urinary tract symptoms (LUTS) but education and self-help guidance are limited in primary care. Objective: To report qualitative interview findings for men reporting nocturia in a primary care setting for LUTS. Design, setting, and participants: TRIUMPH (Treating Urinary Symptoms in Men in Primary Healthcare) is a multicentre cluster randomised trial of standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS. The participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK. Intervention: Delivery of a LUTS self-management booklet by health care staff in comparison to usual care for men with LUTS. Outcome measurements and statistical analysis: The qualitative component included 58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care. Purposive sampling was used to select participants for interview. Results and limitations: Nocturia is a common driver for seeking health care and is perceived by men as relatively acceptable to discuss. Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake. The TRIUMPH LUTS intervention booklet offers explanations and self-management guidance. Men with long-term disruptive symptoms, a perception that the booklet content was novel or worthwhile, and a belief that self-management might help, were more receptive to the intervention. In follow-up, improvements in nocturia were related to successful implementation of several aspects of the guidance. Most men were willing to complete a bladder diary, but some found it inconvenient, especially men in employment. The characteristics of the trial population mean that the findings may not apply to all men.

Lower urinary tract symptoms (LUTS) constitute a substantial burden on males due to their high prevalence (up to 30% of males aged >65 years)1 and significant impact on quality of life.2 Prevalence and severity of LUTS increase with age; therefore, the burden on the NHS and primary care (where most males with LUTS are managed) is expected to grow, alongside population ageing. Yet a comparatively small proportion of affected males seek advice or treatment for their symptoms; reported as between 19% and 24% in studies conducted in Europe and the US.3,4 There is a perception among males that LUTS is a normal sign of ageing, which may be related to a lack of knowledge of the condition and available treatments.5 Indeed, qualitative research reported in the current issue of the BJGP suggests that GPs find it difficult to decide on the mechanism of LUTS in males.6 Remarkably, the situation is also problematic after referral for urological management, where incomplete discussions and misperceptions of LUTS and its treatment have also been identified.7 Unfortunately, this can lead to a situation where treatment seems to be a case of ‘trial and error’.6 When males do …

Background: Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a technique similar to TURP. The small amount of existing literature suggests that there may be potential advantages of ThuVARP over TURP. Objective: To determine whether or not the outcomes from ThuVARP are equivalent to the outcomes from TURP in men with BPO treated in the NHS. Design: A multicentre, pragmatic, randomised controlled parallel-group trial, with an embedded qualitative study and economic evaluation. Setting: Seven UK centres – four university teaching hospitals and three district general hospitals. Participants: Men aged ≥ 18 years who were suitable to undergo TURP, presenting with bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO. Interventions: Patients were randomised 1 : 1 to receive TURP or ThuVARP and remained blinded. Main outcome measures: Two co-primary outcomes – patient-reported International Prostate Symptom Score (IPSS) and clinical measure of maximum urine flow rate (Qmax) at 12 months post surgery. Results: In total, 410 men were randomised, 205 to each arm. The two procedures were equivalent in terms of IPSS [adjusted mean difference 0.28 points higher for ThuVARP (favouring TURP), 95% confidence interval (CI) –0.92 to 1.49 points]. The two procedures were not equivalent in terms of Qmax (adjusted mean difference 3.12 ml/second in favour of TURP, 95% CI 0.45 to 5.79 ml/second), with TURP deemed superior. Surgical outcomes, such as complications and blood transfusion rates, and hospital stay were similar for both procedures. Patient-reported urinary and sexual symptoms were also similar between the arms. Qualitative interviews indicated similar patient experiences with both procedures. However, 25% of participants in the ThuVARP arm did not undergo their randomised allocation, compared with 2% of participants in the TURP arm. Prostate cancer was also detected less frequently from routine histology after ThuVARP (65% lower odds of detection) in an exploratory analysis. The adjusted mean differences between the arms were similar for secondary care NHS costs (£9 higher for ThuVARP, 95% CI –£359 to £376) and quality-adjusted life-years (0.01 favouring TURP, 95% CI –0.04 to 0.01). Limitations: Complications were recorded in prespecified categories; those not prespecified were excluded owing to variable reporting. Preoperative Qmax and IPSS data could not be collected for participants with indwelling catheters, making adjustment for baseline status difficult. Conclusions: TURP was superior to ThuVARP in terms of Qmax, although both operations resulted in a Qmax considered clinically successful. ThuVARP also potentially resulted in lower detection rates of prostate cancer as a result of the smaller volume of tissue available for histology. Length of hospital stay after ThuVARP, anticipated to be a key benefit, was equal to that after TURP in this trial. Overall, both ThuVARP and TURP were effective procedures for BPO, with minor benefits in favour of TURP. Therefore, the results suggest that it may be appropriate that new treatment alternatives continue to be compared with TURP. Future work: Longer-term follow-up to assess reoperation rates over time, and research into the comparative effectiveness of ThuVARP and TURP in large prostates. Trial registration: Current Controlled Trials ISRCTN00788389. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 41. See the NIHR Journals Library website for further project information.

Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction. Methods In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2.5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389. Findings Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23.2 mL per s for TURP and 20.2 mL per s for ThuVARP; adjusted difference in means -3.12, 95% CI -5.79 to -0.45). Equivalence was shown for IPSS (mean 6.3 for TURP and 6.4 for ThuVARP; adjusted difference in means 0.28, -0.92 to 1.49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication. Interpretation TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed.

Aim The International Continence Society (ICS) has standardized quality control and interpretation of uroflowmetry and urodynamics. We evaluated traces from two large studies of male lower urinary tract symptoms (UPSTREAM and UNBLOCS) against ICS standards of urodynamic equipment and practice. Methods Ten percent of uroflowmetry and urodynamics traces were selected at random from hospital sites. A data capture template was designed from the ICS Fundamentals of Urodynamic Practice checklist. Two pretrained blinded assessors extracted the data, with a third assessor to arbitrate. Departmental records of calibration checks and equipment maintenance were scrutinized. Results Seven out of twenty-five (28%) departments reported no calibration checks. Four sites (16%) could not provide annual service records. In 32 out of 296 (10.8%) uroflowmetry traces, findings were affected by artifact. One hundred ten urodynamic study traces were reviewed; in 11 records (10%), key pressure traces were incompletely displayed. In 30 (27.2%), reference zero was not set to atmospheric pressure. Resting pressures were outside the expected range for 36 (32.7%). Pressure drift was seen in 18 traces (16.4%). At pressure-flow study commencement, permission to void was omitted in 15 (13.6%). Cough testing after voiding was done in 71.2%, but the resulting cough spikes were significantly different in 16.5%. Erroneous diagnosis of bladder outlet obstruction (BOO) was identified in six cases (5.5%). Conclusions Erroneous diagnosis of BOO is a serious error of interpretation, as it could lead to unnecessary surgery. Other errors of standardization, testing, and interpretation were identified with lower risk of adverse implications. Inconsistent documentation of service records mean equipment accuracy is uncertain.

Objective To determine the cost‐effectiveness of the current ‘gold standard’ operation of transurethral resection of the prostate (TURP) compared to the new laser technique of thulium laser transurethral vaporesection of the prostate (ThuVARP) in men with benign prostatic obstruction (BPO) within the UK National Health Service (NHS). Patients and Methods The trial was conducted across seven UK centres (four university teaching hospitals and three district general hospitals). A total of 410 men aged ≥18 years presenting with either bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO, and suitable for surgery, were randomised (whilst under anaesthetic) 1:1 to receive the TURP or ThuVARP procedure. Resource use in relation to the operation, initial inpatient stay, and subsequent use of NHS services was collected for 12 months from randomisation (equivalent to primary effectiveness outcome) using hospital records and patient questionnaires. Resources were valued using UK reference costs. Quality adjusted life years (QALYs) were calculated from the EuroQoL five Dimensions five Levels (EQ‐5D‐5L) questionnaire completed at baseline, 3‐ and 12‐months. Total adjusted mean costs, QALYs and incremental Net Monetary Benefit statistics were calculated: cost‐effectiveness acceptability curves and sensitivity analyses addressed uncertainty. Results The total adjusted mean secondary care cost over the 12 months in the TURP arm (£4244) was £9 (95% CI –£376, £359) lower than the ThuVARP arm (£4253). The ThuVARP operation took on average 21 min longer than TURP. The adjusted mean difference of QALYs (0.01 favouring TURP, 95% CI −0.01, 0.04) was similar between the arms. There is a 76% probability that TURP is the cost‐effective option compared with ThuVARP at the £20 000 per QALY willingness to pay threshold used by National Institute for Health and Care Excellence (NICE). Conclusion One of the anticipated benefits of the laser surgery, reduced length of hospital stay with an associated reduction in cost, did not materialise within the study. The longer duration of the ThuVARP procedure is important to consider, both from a patient perspective in terms of increased time under anaesthetic, and from a service delivery perspective. TURP remains a highly cost‐effective treatment for men with BPO.

OBJECTIVES:To evaluate the psychometric properties of a new patient-reported outcome measure (PROM), the International Consultation on Incontinence Questionnaire-Satisfaction (ICIQ-S), to assess satisfaction after urological surgery. SUBJECTS/PATIENTS AND METHODS:Following item development, the developmental ICIQ-S (dICIQ-S) was used within in a randomised control trial comparing two types of surgery for male prostatic obstruction at 1.5, 3, and 12 months after surgery. Reliability was assessed by Cronbach's α and construct validity by the correlation of scores with concurrently administered PROMs of known validity: ICIQ-Male Lower Urinary Tract Symptoms (LUTS), International Prostate Symptom Score, and the ICIQ-LUTS Quality of Life. RESULTS:A total of 410 men were included in the trial. Missing data was generally low for the dICIQ-S [mean (range) 1.6 (<1-3.1)%] except for the items 'complications' 6.8% and 'satisfaction with sex-life' 9.2%. High ceiling effects were found in all items. Factor analysis identified six items related to surgical outcomes (Cronbach's α 0.89), which have formed the scored part of the ICIQ-S, together with a standalone overall satisfaction item, scored 0-10. Seven additional unscored items, related to satisfaction with experiences and expectations, were also retained. As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs. CONCLUSION:The results support the validity and reliability of a scored six-item domain for evaluating satisfaction with surgical outcomes, together with a standalone scored overall satisfaction item. The further unscored seven standalone items are anticipated to be used as the basis for adaptation and further validation of the ICIQ-S in different patient populations.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (PD10)1 Apr 2019PD10-08 THULIUM LASER TRANSURETHRAL VAPORESECTION OF THE PROSTATE VERSUS TRANSURETHRAL RESECTION OF THE PROSTATE: RESULTS OF THE UNBLOCS RANDOMIZED CONTROLLED TRIAL Hashim Hashim, J Athene Lane*, Jo Worthington, Hilary Taylor, Grace Young, Sian Noble, Paul Abrams, Aideen Ahern, Sara Brookes, Nikki Cotterill, Lyndsey Johnson, Rafiyah Khan, Aida Moure Fernandez, Tobias Page, and Satchi Swami Hashim HashimHashim Hashim More articles by this author , J Athene Lane*J Athene Lane* More articles by this author , Jo WorthingtonJo Worthington More articles by this author , Hilary TaylorHilary Taylor More articles by this author , Grace YoungGrace Young More articles by this author , Sian NobleSian Noble More articles by this author , Paul AbramsPaul Abrams More articles by this author , Aideen AhernAideen Ahern More articles by this author , Sara BrookesSara Brookes More articles by this author , Nikki CotterillNikki Cotterill More articles by this author , Lyndsey JohnsonLyndsey Johnson More articles by this author , Rafiyah KhanRafiyah Khan More articles by this author , Aida Moure FernandezAida Moure Fernandez More articles by this author , Tobias PageTobias Page More articles by this author , and Satchi SwamiSatchi Swami More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555278.86701.97AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Transurethral resection of the prostate (TURP), using electro-cautery, is the commonest surgical procedure for benign prostatic obstruction (BPO). Thulium-laser transurethral vaporesection of the prostate (ThuVARP) is a relatively new technique which vaporises and resects the prostate similarly to TURP (e.g. resectoscope hand-movement) with histology also being available. The limited literature suggests advantages of laser techniques in terms of length of stay and bleeding. This NIHR-funded study aimed to determine whether ThuVARP is equivalent to TURP for BPO treatment. METHODS: This randomized controlled, parallel-group, blinded phase III trial was conducted in seven UK centres. Men presenting with voiding LUTS or urinary retention secondary to BPO were randomized to TURP or ThuVARP. The co-primary outcomes were the IPSS and maximum urinary flow rate (Qmax) at 12 months. Secondary outcomes included complications (Clavien-Dindo), healthcare costs and patient experiences. RESULTS: Overall, 410 men were randomized (205/arm). IPSS scores reduced equally for both procedures with a small benefit for TURP in Qmax (Table 1). Surgical complications, transfusion rates and hospital stay were similar for both procedures. Patient experiences (37 interviews) and urinary and sexual outcome measures were similar across treatments. Notably, only 75% of ThuVARP patients underwent their allocation versus 98% for TURP, mostly due to ThuVARP equipment failure (18/51). Prostate cancer was detected incidentally less frequently after ThuVARP (13% vs. 5%, odds ratio 0.35, 95% CI 0.16 to 0.75) in an exploratory analysis. The ThuVARP operation took 20 minutes on average longer than TURP. Costs were similar at £4,185 for TURP and £67 higher for ThuVARP (95% CI -£353 to £486). CONCLUSIONS: ThuVARP mostly demonstrated similar outcomes to TURP. TURP was superior for Qmax, although both were clinically successful. ThuVARP may also detect less prostate cancer incidentally. The anticipated benefits of length of stay and bleeding for ThuVARP were equal to TURP. Overall, ThuVARP and TURP are effective BPO treatments, with minor clinical benefits favouring TURP, suggesting that TURP remains the “gold standard” operation. Source of Funding: National Institute for Health and Research, Health Technology Assessment (HTA) programme. Bristol, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Newcastle, United Kingdom; Aberdeen, United Kingdom© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e161-e162 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hashim Hashim More articles by this author J Athene Lane* More articles by this author Jo Worthington More articles by this author Hilary Taylor More articles by this author Grace Young More articles by this author Sian Noble More articles by this author Paul Abrams More articles by this author Aideen Ahern More articles by this author Sara Brookes More articles by this author Nikki Cotterill More articles by this author Lyndsey Johnson More articles by this author Rafiyah Khan More articles by this author Aida Moure Fernandez More articles by this author Tobias Page More articles by this author Satchi Swami More articles by this author Expand All Advertisement PDF downloadLoading ...

BackgroundLower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care.MethodsTRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis.DiscussionIt is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

Transurethral resection of the prostate (TURP) has been the standard operation for benign prostatic obstruction (BPO) for 40 years, with approximately 25,000 procedures performed annually, and has remained largely unchanged. It is generally a successful operation, but has well-documented risks for the patient. Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a surgical technique similar to TURP. The small amount of study data currently available suggests that ThuVARP may have certain advantages over TURP, including reduced blood loss and shorter hospital stay, earlier return to normal activities, and shorter duration of catheterisation.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2016PD24-10 EVALUATION OF THE LEARNING CURVE FOR THULIUM LASER TRANSURETHRAL VAPORESECTION OF THE PROSTATE (THUVARP) Ala'a Sharaf, jo worthington, and Hashim Hashim Ala'a SharafAla'a Sharaf More articles by this author , jo worthingtonjo worthington More articles by this author , and Hashim HashimHashim Hashim More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1775AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Transurethral resection of the prostate (TURP) has been the standard operation for voiding LUTS for 40 years with very few changes. It is generally a very successful operation but has well documented risks for the patient. Various laser techniques have become available but none have become widely used in the National Health Service (NHS) because of lengthy training required for surgeons or inferior performance on clinical outcomes. The thulium laser technique (ThuVARP) vaporises and resects the prostate using a surgical technique similar to TURP, facilitating a potentially shorter training period for surgeons. A systematic review of laser technology recently recommended ThuVARP as an acceptable alternative to TURP for the treatment of symptomatic benign prostatic obstruction (BPO). For patients undergoing BPO surgery, NICE clinical guidelines recommended offering TURP or holmium laser enucleation (HoLEP). However, HoLEP is only used in a few centres due to the steep learning curve. The Objective was to assess the surgical learning curve of ThuVARP, as part of a prospective, randomised, multicentre, controlled trial to determine the clinical and cost effectiveness of ThuVARP versus TURP in the NHS (UNBLOCS trial). METHODS The UNBLOCS trial is funded by the NIHR HTA program. Consultant urologists were mentored to perform ThuVARP. All participating surgeons observed the chief investigator performing 1 to 2 cases. The lead surgeon then observed the principal investigators (PIs) performing 2 to 5 cases. The surgeons then performed cases without supervision. Competency was assessed with the Intercollegiate Surgical Curriculum Programme work-based assessments (ISCP-WBA) by an independent assessor and the PIs were signed off once the competency criteria were met. RESULTS A total of 9 surgeons were involved form 6 different centres (3 district general hospitals and 3 tertiary referral centres). All of the surgeons have performed at least 150 TURPs. A mean of 2.1 cases were observed by each surgeon and a mean of 2.2 cases were performed by each surgeon under supervision. A mean of 7 cases were performed by the PIs before being signed off as competent. CONCLUSIONS The study has shown that ThuVARP has a short learning curve not exceeding 12 cases for surgeons already experienced in performing TURPs. Results of the non-inferiority trial are awaited to see if outcomes are comparable to TURP, making it a feasible alternative with a short learning curve. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e515 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ala'a Sharaf More articles by this author jo worthington More articles by this author Hashim Hashim More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...