Protocol for the TRANSLATE prospective, multicentre, randomised clinical trial of prostate biopsy technique.

OBJECTIVES: Primary objectives: to determine whether local anaesthetic transperineal prostate (LATP) biopsy improves the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥2 disease (i.e., any Gleason pattern 4 disease), compared to transrectal ultrasound-guided (TRUS) prostate biopsy, in biopsy-naïve men undergoing biopsy based on suspicion of csPCa. SECONDARY OBJECTIVES: to compare (i) infection rates, (ii) health-related quality of life, (iii) patient-reported procedure tolerability, (iv) patient-reported biopsy-related complications (including bleeding, bruising, pain, loss of erectile function), (v) number of subsequent prostate biopsy procedures required, (vi) cost-effectiveness, (vii) other histological parameters, and (viii) burden and rate of detection of clinically insignificant PCa (ISUP Grade Group 1 disease) in men undergoing these two types of prostate biopsy. PATIENTS AND METHODS: The TRANSLATE trial is a UK-wide, multicentre, randomised clinical trial that meets the criteria for level-one evidence in diagnostic test evaluation. TRANSLATE is investigating whether LATP biopsy leads to a higher rate of detection of csPCa compared to TRUS prostate biopsy. Both biopsies are being performed with an average of 12 systematic cores in six sectors (depending on prostate size), plus three to five target cores per multiparametric/bi-parametric magnetic resonance imaging lesion. LATP biopsy is performed using an ultrasound probe-mounted needle-guidance device (either the 'Precision-Point' or BK UA1232 system). TRUS biopsy is performed according to each hospital's standard practice. The study is 90% powered to detect a 10% difference (LATP biopsy hypothesised at 55% detection rate for csPCa vs 45% for TRUS biopsy). A total of 1042 biopsy-naïve men referred with suspected PCa need to be recruited. CONCLUSIONS: This trial will provide robust prospective data to determine the diagnostic ability of LATP biopsy vs TRUS biopsy in the primary diagnostic setting.

Suprapubic catheterisation: a study of 1000 elective procedures.

OBJECTIVES: To investigate the risks and long-term outcomes of suprapubic catheter (SPC) insertion in a population predominantly with spinal cord injury. MATERIALS AND METHODS: We used the theatre database at the National Spinal Injuries Centre in Stoke Mandeville Hospital to identify 1000 consecutive SPC insertions from 1998 to 2015. We retrospectively analysed all records for these patients. RESULTS: Follow-up ranged from 4 weeks to 16.45 years (median 3.3 years). Either cystoscopy-guided suprapubic puncture (Lawrence Add-a-Cath trochar) or a direct incision onto a urethral sound (Lowsley retractor) followed by cystoscopy was used for 98% of insertions. Complications graded as Clavien-Dindo IIIb or higher occurred in 0.6% of patients. Return to theatre was necessary in 0.4%, including three laparotomies due to bleeding or misplacement of the catheter, but no bowel injuries occurred. One death occurred within 30 days due to pulmonary embolism. There were no significant differences in outcomes between insertion methods. Tolerance of long-term suprapubic catheterisation was high, despite 59% of cases experiencing mostly minor complications. Tract losses during routine community change and variability in antibiotic prescribing highlighted areas for educational development which could improve patient outcomes. CONCLUSIONS: This study supports the view that the risk of major complications from SPC insertion is lower than previously reported. Minor complications related to the catheter are common in the long term but are generally well tolerated.

Litigation in the management of urinary stone disease.

OBJECTIVE: To present common technical and non-technical issues leading to medicolegal litigation, illustrated by a series of 54 cases, with the aim of using these examples to prevent harm to patients and to prevent surgeons from having to experience the stress of litigation. METHODS: A series of 78 medicolegal litigation cases reviewed by a single expert witness over 13 years from 2008 to 2021 was analysed by two reviewers. Twenty-nine cases were identified as having a non-technical learning point and 25 were identified as having a technical learning point. These are discussed using illustrative examples and the steps that could have avoided these issues are considered. RESULTS: All major issues and themes are illustrated with cases demonstrating the errors that lead to litigation and the often-simple steps that can be taken to avoid them. Out of 29 non-technical issues, 13 involved consent issues (45%), eight involved delays in treatment (28%) and eight involved failure to provide adequate safeguarding advice (28%). Out of 25 technical issues, 13 cases involved intra-operative problems (52%) including nine ureteric injuries, eight involved errors or omissions in the immediate preoperative period (32%) and four resulted from decisions around emergency decompression of the obstructed infected kidney. These emergency cases featured complications of amputation (two out of four) and death (one out of four). These decisions are complex and there are many subtleties to these cases, which are discussed in detail. CONCLUSION: We hope that this case series highlights the potentially catastrophic outcomes of even small errors of judgement, and allows careful stone surgeons to learn from the experiences of those unfortunate others without having to encounter these situations themselves.

The meaning of words - closing the gap in understanding between doctors and patients in 21st century consent.

'When I use a word' Humpty Dumpty said, in a rather scornful tone, 'it means just what I choose it to mean, neither more nor less'. 'The question is' said Alice 'whether you can make words mean so many different things'. Through the Looking-Glass, Lewis Carroll, 1872.

Shock wave lithotripsy (SWL): outcomes from a national SWL database in New Zealand.

OBJECTIVES: To present the national outcomes for New Zealand of over 9000 stone cases treated with SWL at 21 centres over a 20 year period. SUBJECTS/PATIENTS AND METHODS: Stone cases treated with SWL on board the Mobile Medical Technology (MMT) vehicle between 19 June 1995 and 1 December 2014 were identified, and data collection undertaken prospectively for patient, stone and treatment characteristics, and retrospectively for treatment outcomes. The primary outcome was treatment success, defined as complete stone clearance or clinically insignificant residual fragments (CIRFs) of ≤4 mm. Secondary outcomes were stone free rate, complications and auxiliary procedures, and all statistical analyses were descriptive. RESULTS: 9538 stone cases (7769 patients) were included. The overall, cumulative success rate was 58.7%; this included 45.1% that were stone free and 13.5% in which there were CIRFs ≤4 mm. Success rates varied widely by stone size and location. Overall rates of urinary tract infection, perinephric haematoma, hospital admission and ureteral stent placement were 1.1%, 0.2%, 6.8% and 4.1%, respectively. Variations in SWL protocols across centres limits the overall reliability of our findings. CONCLUSION: SWL remains a low morbidity management option requiring careful patient selection. This study provides valuable data for patient counseling and the formation of evidence based guidelines in SWL. The MMT SWL service has demonstrated that is it possible to deliver a high volume specialist stone service without requiring patients to travel further for treatment.

Diet and risk of kidney stones in the Oxford cohort of the European Prospective Investigation into Cancer and Nutrition (EPIC).

The lifetime prevalence of kidney stones is around 10 % and incidence rates are increasing. Diet may be an important determinant of kidney stone development. Our objective was to investigate the association between diet and kidney stone risk in a population with a wide range of diets. This association was examined among 51,336 participants in the Oxford arm of the European Prospective Investigation into Cancer and Nutrition using data from Hospital Episode Statistics in England and Scottish Morbidity Records. In the cohort, 303 participants attended hospital with a new kidney stone episode. Cox proportional hazards regression was performed to calculate hazard ratios (HR) and their 95 % confidence intervals (95 % CI). Compared to those with high intake of meat (>100 g/day), the HR estimates for moderate meat-eaters (50-99 g/day), low meat-eaters (<50 g/day), fish-eaters and vegetarians were 0.80 (95 % CI 0.57-1.11), 0.52 (95 % CI 0.35-0.8), 0.73 (95 % CI 0.48-1.11) and 0.69 (95 % CI 0.48-0.98), respectively. High intakes of fresh fruit, fibre from wholegrain cereals and magnesium were also associated with a lower risk of kidney stone formation. A high intake of zinc was associated with a higher risk. In conclusion, vegetarians have a lower risk of developing kidney stones compared with those who eat a high meat diet. This information may be important to advise the public about prevention of kidney stone formation.

Trends in urological stone disease.

OBJECTIVE: To summarize the changes in prevalence and treatment of upper urinary tract stone disease in the UK over the last 10 years. METHODS: Data from the Hospital Episode Statistics (HES) website (http://www.hesonline.nhs.uk) were extracted, summarized and presented. RESULTS: The number of upper urinary tract stone hospital episodes increased by 63% to 83,050 in the 10-year period. The use of shock wave lithotripsy (SWL) for treating all upper tract stones increased from 14,491 cases in 2000-2001 to 22,402 cases in 2010 (a 55% increase) with a 69% increase in lithotripsy for renal stones. There was a 127% increase in the number of ureteroscopic stone treatments from 6,283 to 14,242 cases over the 10-year period with a 49% increase from 2007/2008 to 2009/2010. There was a decline in open surgery for upper tract stones from 278 cases in 2000/2001 to 47 cases in 2009/2010 (an 83% reduction). Treatment for stone disease has increased substantially in comparison with other urological activity. In 2009/2010, SWL was performed almost as frequently as transurethral resection of the prostate or transurethral resection of bladder tumour, ureteroscopy for stones was performed more frequently than nephrectomy, radical prostatectomy and cystectomy combined, and percutaneous nephrolithotomy was performed more frequently than cystectomy. CONCLUSIONS: The present study highlights the increase in prevalence and treatment of stone disease in the UK over the last 10 years. If this trend continues it has important implications for workforce planning, training, service delivery and research in the field of urolithiasis.

Lack of effectiveness of botulinum neurotoxin A on isolated detrusor strips and whole bladders from mice and guinea-pigs in vitro.

OBJECTIVE: To differentiate between the effects of parasympathetic and sensorimotor stimulation of isolated mouse and guinea-pig bladders in vitro by measuring the pressure increases to electrical field stimulation (EFS) and then comparing the effects of botulinum neurotoxin A (BoNT-A) applied either to the lumen or to the external bathing medium. MATERIALS AND METHODS: Isolated mouse and guinea-pig bladders and detrusor strips were exposed to EFS in vitro before and after the addition of BoNT-A. The rationale of this method was that BoNT-A applied to the outside of the bladder would first affect the parasympathetic nerves before diffusing inwards to affect the sensorimotor innervation. BoNT-A applied intravesically would first reach the sensorimotor nerves and only later the parasympathetic nerves. Initial experiments on strips of detrusor were conducted to establish the correct dosage and application time of BoNT-A. RESULTS: Contrary to our expectations, BoNT-A application failed to produce any significant effects on either the detrusor strips or whole bladders. CONCLUSIONS: Our experimental design failed to show any effect of BoNT-A on the contractility of detrusor muscle strips or whole bladders from mice and guinea-pigs. The reason for this is unclear, but may be related to tissue spending inadequate time incubated with BoNT-A under physiological conditions.

Impact of Case Volume on Shock Wave Lithotripsy Outcomes: Data from the National Shock Wave Lithotripsy Database of New Zealand.

Purpose: To assess the impact of individual operator case volume on shock wave lithotripsy (SWL) treatment outcomes in more than 9000 stone cases over a 20-year period in New Zealand. Materials and Methods: Stone cases treated with SWL on the Mobile Medical Technology (MMT) vehicle between June 19, 1995, and December 1, 2014, were identified. Data collection was undertaken prospectively for patient, stone, and treatment characteristics, and retrospectively for treatment outcomes. Multivariate analysis using binary logistic regression was undertaken to assess whether radiographer stone case volume (stones/year) was an independent predictor of SWL success (stone free or clinically insignificant residual fragments ≤4 mm at follow-up). Results: Sixteen radiographers delivered treatment to the included cohort (9039 stone cases), with a median case volume (stones/year) of 73 (range: 37-197) and median total of 425 stones treated (range: 71-1721). The two radiographers with highest case volumes achieved the highest success rates. Radiographer case volume (stones/year) was independently associated with SWL success (odds ratio [OR]: 1.004, 95% confidence interval [CI]: 1.003-1.005, p < 0.0001) and reduced need for post-SWL hospital admission (OR: 0.997, 95% CI: 0.994-1.000, p = 0.028), but there was no associated decrease in post-SWL urosepsis (OR: 0.999, 95% CI: 0.974-1.025, p = 0.941), perinephric hematoma (OR: 1.003, 95% CI: 0.985-1.020, p = 0.778), or need for auxiliary procedures (OR: 1.000, 95% CI: 0.998-1.002, p = 0.871). Conclusions: SWL success rates can be improved by increasing the frequency of cases performed by individual operators. In this multicenter cohort of more than 9000 stone cases treated over a 20-year period, the best outcomes were seen for those radiographers performing >150 cases per year.

Routine Antibiotic Prophylaxis Is Not Required for Patients Undergoing Shockwave Lithotripsy: Outcomes from a National Shockwave Lithotripsy Database in New Zealand.

PURPOSE: To assess the effectiveness of routine prophylactic antibiotics in the prevention of urinary tract infection (UTI) after extracorporeal shockwave lithotripsy (SWL) and identify predictors of UTI development in a multicenter series of over 10,000 stone cases treated in New Zealand over a 20-year period. MATERIALS AND METHODS: Patients treated with SWL on the Mobile Medical Technology vehicle between June 19, 1995 and December 1, 2014 were identified. Data collection was undertaken prospectively for patient, stone and treatment characteristics, and, retrospectively, for treatment outcomes. The primary outcome was clinical UTI, defined as development of UTI symptoms requiring antibiotic therapy. Secondary outcomes included urinary sepsis, need for hospital admission due to infectious complications, and length of hospital stay. Multivariate analysis was undertaken to identify factors independently associated with the development of post-SWL UTI. RESULTS: Antibiotic prophylaxis was used in 62.1% (n = 6710) of cases. On comparing patients who received prophylactic antibiotics to those in whom antibiotics were withheld, no significant differences were observed in terms of post-SWL UTI (1.1% vs 1.3%, p = 0.335) or urinary sepsis (0.04% vs 0.15%, p = 0.075). The use of prophylactic antibiotics was not independently associated with post-SWL UTI (OR: 1.269, 95% CI: 0.886-1.818, p = 0.194). Female gender, larger stone size, and higher number of delivered shocks were predictive of UTI development, but antibiotic prophylaxis did not appear to offer any benefit in this subgroup. CONCLUSIONS: Routine antibiotic prophylaxis was not associated with a reduction in clinical UTI after SWL in this cohort of over 10,000 stone cases in New Zealand.

Consent information leaflets - readable or unreadable?

OBJECTIVE: The objective of this article is to assess the readability of leaflets about urological procedures provided by the British Association of Urological Surgeons (BAUS) to evaluate their suitability for providing information. METHODS: Information leaflets were assessed using three measures of readability: Flesch Reading Ease, Flesch-Kincaid and Simple Measure of Gobbledygook (SMOG) grade formulae. The scores were compared with national literacy statistics. RESULTS: Relatively good readability was demonstrated using the Flesch Reading Ease (53.4-60.1) and Flesch-Kincaid Grade Level (6.5-7.6) methods. However, the average SMOG index (14.0-15.0) for each category suggests that the majority of the leaflets are written above the reading level of an 18-year-old. Using national literacy statistics, at least 43% of the population will have significant difficultly understanding the majority of these leaflets. CONCLUSIONS: The results suggest that comprehension of the leaflets provided by the BAUS is likely to be poor. These leaflets may be used as an adjunct to discussion but it is essential to ensure that all the information necessary to make an informed decision has been conveyed in a way that can be understood by the patient.