Focused UTUC pathways with a risk-stratified approach to diagnostic ureteroscopy: is it the need of the hour? A retrospective cohort analysis.

INTRODUCTION: Upper urinary tract urothelial cancer is a rare, aggressive variant of urinary tract cancer. There is often delay to diagnosis and management for this entity in view of diagnostic and staging challenges needing additional investigations and risk stratifications for improved outcomes. In this article, we share our experience in developing a dedicated diagnostic and treatment pathway for UTUC and assess its impact on time lines to radical nephroureterectomy (RNU). We also evaluate the impact of diagnostic ureteroscopy (DUR) on UTUC care pathways timelines. MATERIALS AND METHODS: A prospective database was maintained for all patients who underwent a RNU from January 2015 to August 2022 in a high-volume single tertiary care centre in the UK. In 2019, a Focused UTUC pathway (FUP) was implemented at the centre to streamline diagnostic and RNU pathways. A retrospective analysis of the database was conducted to compare time lines and diagnostic trends between the pre-FUP and FUP cohorts. Primary outcome measures were time to RNU from MDT. Secondary outcome measures were: impact of DUR on time to RNU from MDT and negative UTUC rates between DUR and non-DUR cohorts. Differences in continuous variables across categories were assessed using the independent sample t test. Categorical variables between cohorts were analysed using the chi-square (χ2). Statistical significance in this study was set as p < 0.05. RESULTS: A total of 500 patients with complete data were included in the analysis. The pre-FUP and FUP cohorts consisted of 313 patients and 187 patients, respectively. The overall cohort had a mean age (SD) of 70 years (9.3). 66% of the overall cohort were males. The median time to RNU from MDT in the FUP was significantly lower compared to the pre-FUP cohort; 62 days (IQR 59) vs. 48 days (IQR 41.5), p < 0.0001. The median time to RNU from MDT in patients who underwent a diagnostic URS in the FUP cohort was significantly lower compared to the pre-FUP cohort; 78.5 days (IQR 54.8) vs. 68 days (IQR 48), p-NS. The non-UTUC rates in the DUR and non-DUR cohorts were 6/248 (2.4%) and 14/251 (5.6%), respectively (NS). CONCLUSION: In this series, we illustrate the effectiveness of integrating a multidisciplinary approach with specialised personnel, ring-fenced clinics, efficient diagnostic assessment and optimised theatre capacity. By adopting a risk-stratified approach to diagnostic ureteroscopy, we have achieved a significant reduction in time to RNU.

Calyceal Diverticula Disease: Diagnosis and Management Options in the Era of Non-Contrast CT Scan.

INTRODUCTION: Calyceal diverticula (CD) are traditionally diagnosed by contrast studies. However, non-contrast CT is the standard imaging modality for kidney stones. Therefore, we aimed to determine if the lack of contrast imaging affected outcomes of the management of symptomatic CD with stone. MATERIALS AND METHODS: This is a retrospective study of patients diagnosed with CD with intracalyceal stone from 2000 to 2017 analyzing demographics, clinical data, and success of different treatment options. The timing of CD diagnosis is correlated to the success of the first treatment. RESULTS: Forty-eight patients were found. CD was diagnosed prior to intervention in 20 (42%) cases and intraoperatively during flexible ureteroscopy in 17 (35%) and 11 (23%) cases were diagnosed after failed intervention, mainly ESWL. We found that the success rate of treatment was highly affected by the timing and modality of diagnosis. Preoperative diagnosis of CD was associated with 69% success rate of the first intervention. In contrast, there was a 0% success rate of first treatment if CD was not diagnosed with contrast imaging. Furthermore, univariate analysis showed no significant association between sociodemographics and clinical variables and success treatment (p > 0.05). CONCLUSIONS: The delay in diagnosing CD with stone contributes significantly to the success rate and the number of treatments.

Renal cryoablation: Multidisciplinary, collaborative and perspective approach.

Renal cryoablation is becoming an established treatment option for small renal masses. It allows preservation of renal function without compromising cancer control. The technique has evolved considerably since it was first reported using liquid nitrogen over 20 years ago. We describe the modern technique for both laparoscopic and image guided renal cryoablation. Renal cryoablation is performed either laparoscopically or percutaneously depending on tumour characteristics. Common features include biopsy of the mass, protection of adjacent organs, and the use of compressed argon gas for freezing and helium for thawing. Dynamic monitoring is used to ensure adequate treatment. The shape of the iceball can be modified by adding extra needles or changing their positions. A double freeze/thaw is necessary for confident ablation of all cancer cells. The laparoscopic approach includes exposure of the tumour and may involve extensive mobilisation of the kidney. Laparoscopic ultrasound is essential for correct localisation of the tumour, needle placement, and monitoring the treatment. A Temperature probe is placed at the edge of the tumour to record treatment temperature. The percutaneous approach is typically performed with CT guidance. Adjacent organs can be protected by injecting saline or carbon dioxide. Early imaging is helpful to detect or rule out incomplete treatment. Post-operative follow-up is structured at specific intervals (e.g. 3, 6, 12 months then annually) and perhaps tailored or modified based on the degree of suspicion of inadequate treatment.

Laparoscopic heminephrectomy for duplex system: observed difference in outcomes between upper and lower pole resections.

INTRODUCTION: Renal duplication is a relatively common congenital abnormality of the urinary tract, but symptomatic duplex kidney is a rare presentation in adults. Traditionally, the treatment of choice for poorly functioning moiety has been heminephrectomy. There is extensive literature detailing the outcomes of minimally invasive upper pole heminephrectomy, but comparatively little published regarding lower pole resection, especially in adult patients. We present a series of 13 patients who underwent minimally invasive heminephrectomy for duplex kidney. MATERIALS AND METHODS: Over a 6 year period (2011-2017) 13 patients at a single center underwent laparoscopic heminephrectomy for symptomatic duplex kidney with a poorly functioning moiety. A retrospective review of case notes and imaging was undertaken. RESULTS: Eight and 5 patients underwent upper and lower pole heminephrectomies, respectively. Laparoscopic transperitoneal approach was utilized in all cases. Median length of stay was 2 days (range 1 to 16 days). In the upper pole cohort, one patient had a postoperative infection requiring IV antibiotics. In the lower pole cohort by contrast, there were three major complications (60%). Conversion to complete nephrectomy was necessary in one case; one patient had urinary leakage requiring selective embolization and one patient required a second operation to resect remnant calyces. Furthermore, two patients (40%) developed late recurrence of symptoms. CONCLUSIONS: Symptomatic duplex kidney is a rare presentation in adults. In our experience, heminephrectomy for non-functioning renal unit is safe and reproducible in experienced hands with no major complications and resolution of symptoms in the majority of patients. We have, however, observed a higher complication rate in those undergoing resection of a lower pole moiety. Alternative management such as uretero-ureterostomy should be considered in these cases.

Heminephrectomy in Adults: A Systematic Review with Cumulative Analysis.

INTRODUCTION: Duplex collecting system of the kidney is a relatively common abnormality, with the majority of symptomatic cases discovered in childhood. Treatment is commonly a heminephrectomy of the affected moiety. We aimed to conduct a systematic review of the literature to provide the best available evidence for heminephrectomy for duplex kidneys in the adult population. MATERIALS AND METHODS: A literature search was conducted in September 2017 with no limitations being placed on language, region, date or publication type. Data were represented numerically and analysed cumulatively. RESULTS: Seven retrospective studies with 66 patients were included. Of which, 56/66 operations were performed laparoscopically, 5/66 were robot-assisted and 5/66 were open procedures. Complete resolution of symptoms was reported in 53/55 (96.4%) of patients in five studies providing outcome data. Of the 6 studies reporting complications, there were a total of 9 complications (9/62, 14.5%), however 5 of these were found to be in one study alone. CONCLUSIONS: This review emphasises the scarcity of evidence for heminephrectomy in adults. Nonetheless, it has been shown that this operation may be effective in alleviating patients' symptoms in addition to being safe in experienced hands.

Upper Urinary Tract Carcinoma In Situ: Current Knowledge, Future Direction.

PURPOSE: Carcinoma in situ of the urinary tract is a high grade form of nonmuscle invasive urothelial cancer. Our understanding of this entity in the upper tract is poor, and case management remains challenging due to knowledge gaps regarding the definition, diagnosis, treatment options and followup of the disease. We reviewed the available literature for similarities and differences between bladder and upper tract carcinoma in situ, and herein summarize the best available data. MATERIALS AND METHODS: We reviewed PubMed® and MEDLINE™ databases from January 1976 through September 2014. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement was used to screen publications. All authors participated in the development of a consensus definition of disease. RESULTS: A total of 61 publications were found suitable for this review. All studies were retrospective. Compared to bladder carcinoma in situ, upper tract carcinoma in situ appears to have lower progression rates and improved survival. All available studies demonstrate topical therapy to be effective in treating upper tract carcinoma in situ, with decreased recurrence rates compared to bladder carcinoma in situ. Highlighted areas of current knowledge gaps include variable definitions of disease, methods of drug delivery and ideal treatment course. Improving methods for detection may allow easier diagnosis and more effective treatment. CONCLUSIONS: Based on the available data, organ preserving therapy with topical agents is an alternative to radical surgery in select patients with upper tract carcinoma in situ, although this method has not been evaluated in prospective trials. A paradigm shift regarding detection and treatment is needed to improve care and allow better renal preservation. A consensus definition of the disease is offered, and several areas of major knowledge gaps and opportunities for future research are identified.

Partial vs radical nephrectomy for T1 renal tumours: an analysis from the British Association of Urological Surgeons Nephrectomy Audit.

OBJECTIVES: To analyse and compare data from the British Association of Urological Surgeons Nephrectomy Audit for perioperative outcomes of partial (PN) and radical nephrectomy (RN) for T1 renal tumours. PATIENTS AND METHODS: UK consultants were invited to submit data on all patients undergoing nephrectomy between 1 January and 31 December 2012 to a nationally established database using a standard pro forma. Analysis was made on patient demographics, operative technique, and perioperative data/outcome between PN and RN for T1 tumours. RESULTS: Overall, data from 6 042 nephrectomies were reported of which 1 768 were performed for T1 renal tumours. Of these, 1 082 (61.2%) were RNs and 686 (38.8%) were PNs. The mean age of patients undergoing PN was lower (PN 59 years vs RN 64 years; P < 0.001) and so was the WHO performance score (PN 0.4 vs RN 0.7; P < 0.001). PN for the treatment of T1a tumours (≤4 cm) accounted for 55.6% of procedures, of which 43.9% were performed using a minimally invasive technique. For T1b tumours (4-7 cm), 18.9% of patients underwent PN, in 33.3% of which a minimally invasive technique was adopted. The vast majority of RNs for T1 tumours were performed using a minimally invasive technique (90.3%). Of the laparoscopic PNs, 30.5% were robot-assisted. There was no significant difference in overall intraoperative complications between the RN and PN groups (4% vs 4.3%; P = 0.79). However, PN accounted for a higher overall postoperative complications rate (RN 11.3% vs PN 17.6%; P < 0.001). RN was associated with a markedly reduced risk of severe surgical complications (Clavien Dindo classification grade ≥3) compared with PN even after adjusting for technique (odds ratio 0.30; P = 0.002). Operation time between RN and PN was comparable (141 vs 145 min; P = 0.25). Blood loss was less in the RN group (mean for RN 165 vs PN 323 mL; P < 0.001); however, transfusion rates were similar (3.2% vs 2.6%; P = 0.47). RN was associated with a shorter length of stay (median 4 vs 5 days; P < 0.001). A direct comparison between robot-assisted and laparoscopic PN showed no significant differences in operation time, blood loss, warm ischaemia time, and intraoperative and postoperative complications. CONCLUSIONS: PN was the method of choice for treatment of T1a tumours whereas RN was preferred for T1b tumours. Minimally invasive techniques have been widely adopted for RN but not for PN. Despite the advances in surgical technique, a substantial risk of postoperative complications remains with PN.

Perioperative outcomes of 6042 nephrectomies in 2012: surgeon-reported results in the UK from the British Association of Urological Surgeons (BAUS) nephrectomy database.

OBJECTIVE: To present the perioperative outcomes from the British Association of Urological Surgeons (BAUS) nephrectomy dataset for 2012, the first year of public reporting of individual surgeon outcomes in the UK. PATIENTS AND METHODS: All nephrectomies performed in the year 2012 and recorded in the database were analysed. These were divided into simple nephrectomy (SN), partial nephrectomy (PN), radical nephrectomy (RN), and nephroureterectomy (NU). The estimated capture rate for nephrectomy was 80%. The outcomes measured were 30-day mortality (30-DM), Clavien-Dindo complications grade ≥III, blood transfusion, conversion to open, and length of stay. RESULTS: The overall 30-DM was 0.55% (SN 0.53%; PN 0.10%; RN 0.52%; NU 1.27%). Clavien-Dindo complications grade ≥III were recorded in 3.9% of nephrectomies (SN 4.3%; PN 5.4%; RN 3.1%; NU 4.5%). Blood transfusion was required during surgical admission for 8.4% of nephrectomies (SN 5.2%; PN 3.4%; RN 11.1%; NU 8.3%). Conversion to open was carried out in 5.5% of minimally invasive nephrectomies (SN 6.1%; PN 4.0%; RN 5.5%; NU 5.6%). Open nephrectomy patients remained in hospital for a median of 6 days (SN 7; PN 5; RN 7; NU 8 days), which was higher than the median 4-day stay (SN 3; PN 4; RN 4; NU 5 days) for minimally invasive surgery. CONCLUSIONS: Nephrectomy in 2012 was a safe procedure with morbidity and mortality rates comparable with or less than published series. The collection of surgeon-specific data should be iterative with further refinement of data categories, support for the collection process and independent validation of results.

The management of secondary pelvi-ureteric junction obstruction - a comparison of pyeloplasty and endopyelotomy.

OBJECTIVE: To review our experience in the management of secondary pelvi-ureteric junction obstruction (PUJO) comparing endopyelotomy with pyeloplasty. PATIENTS AND METHODS: We retrospectively analysed our database of 58 patients having undergone operative management of PUJO after failed primary management, including 41 with failed pyeloplasty and 17 failed endopyelotomy. Outcomes included mercapto-acetyltriglycine (MAG3) drainage capacity, symptomatic control and need for further intervention. Success was defined as freedom from failure in all three. RESULTS: Patients undergoing secondary pyeloplasty had better outcomes than endopyelotomy for symptomatic success (87.5% vs 74%), resolution of obstruction on MAG3 renography (96% vs 74%), and no need for further intervention (96% vs 71%). Overall success was 87.5% for pyeloplasty compared with 44% after secondary endopyelotomy. CONCLUSION: Outcomes of pyelopasty for secondary PUJO were superior when compared with endopyelotomy.

Renal Function After CT-Guided Cryoablation of Small Renal Tumours in Patients with Solitary Kidney: An Analysis of European Multinational Prospective EuRECA Registry.

PURPOSE: Treatment of renal cell carcinoma (RCC) in patients with solitary kidneys remains challenging. The purpose of this multicentre cohort study was to explore how renal function is affected by percutaneous image-guided cryoablation in patients with solitary kidneys. MATERIAL AND METHODS: Data from the European Registry for Renal Cryoablation database were extracted on patients with RCC in solitary kidneys treated with image-guided, percutaneous cryoablation. Patients were excluded if they had multiple tumours, had received previous treatment of the tumour, or were treated with more than one cryoablation procedure. Pre- and post-treatment eGFR (within 3 months of the procedure) were compared. RESULTS: Of 222 patients with solitary kidneys entered into the database, a total of 70 patients met inclusion criteria. The mean baseline eGFR was 55.8 ± 16.8 mL/min/1.73 m2, and the mean 3-month post-operative eGFR was 49.6 ± 16.5 mL/min/1.73 m2. Mean eGFR reduction was - 6.2 mL/min/1.73 m2 corresponding to 11.1% (p = 0.01). No patients changed chronic kidney disease group to severe or end-stage chronic kidney disease (stage IV or V). No patients required post-procedure dialysis. CONCLUSION: Image-guided renal cryoablation appears to be safe and effective for renal function preservation in patients with RCC in a solitary kidney. Following cryoablation, all patients had preservation of renal function without the need for dialysis or progression in chronic kidney disease stage despite the statistically significant reduction in eGFR. LEVEL OF EVIDENCE 3: Observational study.

Multi-length or 24 cm ureteric stent? A multicentre randomised comparison of stent-related symptoms using a validated questionnaire.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: One of the suggested factors for stent-related symptoms is that excess distal intravesical stent mass may cause bladder irritation. There is a lack of studies investigating this in a randomised controlled fashion using a validated questionnaire. This study compared two of the most commonly used length of stents (a 30 cm multi-length vs a 24 cm long stent) and showed no significance difference in stent-related symptoms in patients with either of these stents. OBJECTIVE: To investigate whether excessive redundant intravesical stent component contributes to the severity of stent-related symptoms in patients with a ureteric stent. We compared stent-related symptoms in patients who had either a standard 24 cm or multi-length ureteric stent. PATIENTS AND METHODS: In all, 162 patients with upper urinary tract calculi requiring ureteric stent insertion were randomised to receive either a 6 F × 24 cm Contour(TM) or multi-length 6 F × 22-30 cm Contour VL(TM) stent. Patients were requested to complete the validated Bristol Ureteric Stent Symptom Questionnaire (USSQ) at 1 and 4 weeks after stent insertion and 4 weeks after removal. The mean scores for each domain of the USSQ for both groups were compared using the Student's t-test. Any adverse events, e.g. stent migration, early removal of stent due to stent-related symptoms and failure of stent insertion, were also recorded. RESULTS: In all, 153 patients who had successful stent insertion were requested to complete the USSQ and 74% of patients returned at least the week 1 questionnaire. At 1 and 4 weeks with the stent in situ, comparison of the mean scores showed no significant difference in urinary symptoms, pain, general health, work performance, sexual dysfunction and number of days patients stayed in bed or reduced their routine activities. Three (2%) patients had their stent removed early due to stent-related symptoms and five (3%) had failed stent insertion. CONCLUSIONS: This study did not find any difference in symptoms between the 24 cm or multi-length Contour stents. However, the study was not powered to detect small differences particularly for the pain symptom domain. Stents should only be used sparingly and the stent dwell-time should be minimised.

Laparoscopic partial nephrectomy without ischemia.

The warm ischaemia time appears the most prominent modifiable risk factor for the development of renal impairment following laparoscopic partial nephrectomy. Historically, hilar clamping was the 'gold standard' technique, but now we are pushing our techniques to achieve the ultimate: 'zero ischaemia' approach. Results from 'early unclamping' techniques reinforced the importance of 'every minute counts' (28). Subsequent techniques in non-hilar clamping demonstrated that this approach was indeed feasible, but at the expense of higher bleeding, positive margins, and collecting system breach rates. With the advancement of technology, through the use of robotic assistance, improved haemostatic agents, as well as various imaging modalities (laparoscopic ultrasound, CT angiography), the surgeon can now potentially perform Nephron Sparing Surgery (NSS) in a more precise manner. Specifically, with the use of superselective clamping of the feeding vessel(s) to the tumour, the remaining healthy renal parenchyma should be less compromised, with associated low bleeding rates. NSS in the form of laparoscopic partial nephrectomy is clearly evolving, with increasing demands on the surgeon, requiring more expertise and experience, with the added assistance from other specialties (anaesthetists, radiologists etc). To be able to regularly perform Laparoscopic Partial Nephrectomy (LPN) without ischaemia safely, the laparoscopist must develop his / her experience in a stepwise fashion, perhaps commencing with artery-only clamping, leading on to early declamping, and then 'on demand' clamping. When moving on to LPN without ischaemia, patient selection is paramount. The ideal patient would harbour a single small, polar, exophytic renal mass with a normal functioning contralateral kidney. Although currently the techniques and outcomes laparoscopic partial nephrectomy without ischaemia published are limited to a few authors, with no current long term results to prove its full worth and reproducibility, early results are very encouraging. The pursuit of acquiring 'zero ischaemia' is clearly worthwhile, but needs to be measured against the potential risks of increased morbidity and positive margin rates.

Yo-Yo Reflux Into a Blind-Ending Branch of a Bifid Ureter: A Case Report.

A bifid ureter is an uncommon congenital anomaly. It develops through abnormal branching of the ureteric bud in utero and represents incomplete duplication of the collecting system. However, a bifid ureter with a blind-ending branch is a rare variant. We present the case of a 26-year-old female who presented with recurrent urinary tract infections and an episode of pyelonephritis. Radiological imaging revealed a blind-ending branch of a bifid ureter with Yo-Yo reflux. This report demonstrates laparoscopic evidence of the reflux and management of this rare congenital anomaly.

Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi.

BACKGROUND: Ureteral stones frequently cause renal colic, and if left untreated, can lead to obstructive uropathy. Extracorporeal shock wave lithotripsy (ESWL) and ureteroscopy, with or without intracorporeal lithotripsy, are the most common interventions used to treat ureteral stones. ESWL treatment is less invasive than ureteroscopy, but has some limitations such as a high retreatment rate, and is not available in all centres. Recent advances in ureteroscopy have increased success rates and reduced complication rates. OBJECTIVES: To examine evidence from randomised controlled trials (RCTs) on the outcomes of ESWL or ureteroscopy in the treatment of ureteric calculi. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL in The Cochrane Library Issue 2, 2011), MEDLINE (1966 to March 2011), EMBASE (1980 to March 2011), CINAHL, Clinicaltrials.gov, Google Scholar, reference lists of articles and abstracts from conference proceedings, all without language restriction. SELECTION CRITERIA: RCTs that compared ESWL with ureteroscopic retrieval of ureteric stones were included in this review. Study participants were adults with ureteric stones requiring intervention. Published and unpublished sources were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three authors independently assessed study quality, risk of bias, and extracted data. Statistical analyses were performed using the random-effects model. Results were expressed as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous data, both with 95% confidence intervals (CI). MAIN RESULTS: Seven RCTs (1205 patients) were included in the review. Stone-free rates were lower in patients who underwent ESWL (7 studies, 1205 participants: RR 0.84, 95% CI 0.73 to 0.96) but re-treatment rates were lower in ureteroscopy patients (6 studies, 1049 participants: RR 6.18, 95% CI 3.68 to 10.38. ESWL-treated patients had less need for auxiliary treatment (5 studies, 751 participants: RR 0.43, 95% CI 0.25 to 0.74; fewer complications (7 studies, 1205 participants: RR 0.54, 95% CI 0.33 to 0.88); and shorter length of hospital stay (2 studies, 198 participants: MD -2.55 days, 95% CI -3.24 to -1.86).Three studies adequately described the randomisation sequence, three studies were unclear on how they randomised, while one study had a high risk of selection bias. All the studies had an unclear risk of performance bias and detection bias, while all had a low risk of attrition bias, reporting bias, or other sources of bias identified. AUTHORS' CONCLUSIONS: Compared with ESWL, ureteroscopic removal of ureteral stones achieves a greater stone-free state, but with a higher complication rate and longer hospital stay.

Shockwave lithotripsy compared with ureteroscopic stone treatment for adults with ureteric stones: the TISU non-inferiority RCT.

BACKGROUND: Urinary stone disease affects 2-3% of the general population. Ureteric stones are associated with severe pain and can have a significant impact on a patient's quality of life. Most ureteric stones are expected to pass spontaneously with supportive care; however, between one-fifth and one-third of patients require an active intervention. The two standard interventions are shockwave lithotripsy and ureteroscopic stone treatment. Both treatments are effective, but they differ in terms of invasiveness, anaesthetic requirement, treatment setting, number of procedures, complications, patient-reported outcomes and cost. There is uncertainty around which is the more clinically effective and cost-effective treatment. OBJECTIVES: To determine if shockwave lithotripsy is clinically effective and cost-effective compared with ureteroscopic stone treatment in adults with ureteric stones who are judged to require active intervention. DESIGN: A pragmatic, multicentre, non-inferiority, randomised controlled trial of shockwave lithotripsy as a first-line treatment option compared with primary ureteroscopic stone treatment for ureteric stones. SETTING: Urology departments in 25 NHS hospitals in the UK. PARTICIPANTS: Adults aged ≥ 16 years presenting with a single ureteric stone in any segment of the ureter, confirmed by computerised tomography, who were able to undergo either shockwave lithotripsy or ureteroscopic stone treatment and to complete trial procedures. INTERVENTION: Eligible participants were randomised 1 : 1 to shockwave lithotripsy (up to two sessions) or ureteroscopic stone treatment. MAIN OUTCOME MEASURES: The primary clinical outcome measure was resolution of the stone episode (stone clearance), which was operationally defined as 'no further intervention required to facilitate stone clearance' up to 6 months from randomisation. This was determined from 8-week and 6-month case report forms and any additional hospital visit case report form that was completed by research staff. The primary economic outcome measure was the incremental cost per quality-adjusted life-year gained at 6 months from randomisation. We estimated costs from NHS resources and calculated quality-adjusted life-years from participant completion of the EuroQol-5 Dimensions, three-level version, at baseline, pre intervention, 1 week post intervention and 8 weeks and 6 months post randomisation. RESULTS: In the shockwave lithotripsy arm, 67 out of 302 (22.2%) participants needed further treatment. In the ureteroscopic stone treatment arm, 31 out of 302 (10.3%) participants needed further treatment. The absolute risk difference was 11.4% (95% confidence interval 5.0% to 17.8%); the upper bound of the 95% confidence interval ruled out the prespecified margin of non-inferiority (which was 20%). The mean quality-adjusted life-year difference (shockwave lithotripsy vs. ureteroscopic stone treatment) was -0.021 (95% confidence interval 0.033 to -0.010) and the mean cost difference was -£809 (95% confidence interval -£1061 to -£551). The probability that shockwave lithotripsy is cost-effective is 79% at a threshold of society's willingness to pay for a quality-adjusted life-year of £30,000. The CEAC is derived from the joint distribution of incremental costs and incremental effects. Most of the results fall in the south-west quadrant of the cost effectiveness plane as SWL always costs less but is less effective. LIMITATIONS: A limitation of the trial was low return and completion rates of patient questionnaires. The study was initially powered for 500 patients in each arm; however, the total number of patients recruited was only 307 and 306 patients in the ureteroscopic stone treatment and shockwave lithotripsy arms, respectively. CONCLUSIONS: Patients receiving shockwave lithotripsy needed more further interventions than those receiving primary ureteroscopic retrieval, although the overall costs for those receiving the shockwave treatment were lower. The absolute risk difference between the two clinical pathways (11.4%) was lower than expected and at a level that is acceptable to clinicians and patients. The shockwave lithotripsy pathway is more cost-effective in an NHS setting, but results in lower quality of life. FUTURE WORK: (1) The generic health-related quality-of-life tools used in this study do not fully capture the impact of the various treatment pathways on patients. A condition-specific health-related quality-of-life tool should be developed. (2) Reporting of ureteric stone trials would benefit from agreement on a core outcome set that would ensure that future trials are easier to compare. TRIAL REGISTRATION: This trial is registered as ISRCTN92289221. 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. 26, No. 19. See the NIHR Journals Library website for further project information.

Approximately 1 in 20 people suffers from kidney stones that pass down the urine drainage tube (ureter) into the urinary bladder and cause episodes of severe pain (ureteric colic). People with ureteric colic attend hospital for pain relief and diagnosis. Although most stones smaller than 10 mm eventually reach the bladder and are passed during urination, some get stuck and have to be removed using telescopic surgery (called ureteroscopic stone treatment) or shockwave therapy (called shockwave lithotripsy). Ureteroscopic stone treatment involves passing a telescope-containing instrument through the bladder and into the ureter to fragment and/or remove the stone. This is usually carried out under general anaesthetic as a day case. For shockwave lithotripsy, the patient lies flat on a couch and the apparatus underneath them generates shockwaves that pass through the skin to the ureter and break the stones into smaller fragments, which can be passed naturally in the urine. This involves using X-ray or ultrasound to locate the stone, but can be carried out on an outpatient basis and without general anaesthetic. Telescopic surgery is known to be more successful at removing stones after just one treatment, but it requires more time in hospital and has a higher risk of complications than shockwave lithotripsy (however, shockwave lithotripsy may require more than one session of treatment). Our study, the Therapeutic Interventions for Stones of the Ureter trial, was designed to establish if treatment for ureteric colic should start with telescopic surgery or shockwave therapy. Over 600 NHS patients took part and they were split into two groups. Each patient had an equal chance of their treatment starting with either telescopic surgery or shockwave lithotripsy, which was decided by a computer program (via random allocation). We counted how many patients in each group had further procedures to remove their stone. We found that telescopic surgery was 11% more effective overall, with an associated slightly better quality of life (10 more healthy days over the 6-month period), but was more expensive in an NHS setting. The finding of a lack of any significant additional clinical benefit leads to the conclusion that the more cost-effective treatment pathway is shockwave lithotripsy with telescopic surgery used only in those patients in whom shockwave lithotripsy is unsuccessful.

New ureteral stent design does not improve patient quality of life: a randomized, controlled trial.

PURPOSE: Ureteral stents result in significant morbidity in many patients. Manufacturers have altered stent design and composition to minimize symptoms. The Polaris™ stent is made of a Percuflex® combination, providing a firm proximal aspect with a softer distal aspect to minimize symptoms. In this prospective, randomized study we compared symptoms and quality of life after stent insertion to determine whether this stent is better tolerated than the InLay® stent. MATERIALS AND METHODS: Between September 2002 and September 2006 we randomized 159 patients requiring stent insertion for stone disease to receive the InLay or the Polaris ureteral stent. Patients were asked to complete the validated Ureteral Stent Symptom Questionnaire 2 weeks after stent insertion and 1 week after removal. RESULTS: A total of 98 patients completed and returned each questionnaire, including 45 with the InLay and 53 with the Polaris. There were no significant differences between the groups on any health domain assessed. In the InLay and Polaris groups 91% and 94% of patients experienced pain with the stent in situ, which decreased to 40% and 43%, respectively, after stent removal. The urinary symptom score with the stent in situ was equal in the 2 groups (32, maximum 55). Of the InLay and Polaris groups 60% and 66% of patients, respectively, would be against receiving a further stent due to symptoms (p = 0.79). CONCLUSIONS: The Polaris stent, designed with the specific aim of improving urinary symptoms and pain associated with ureteral stents, continues to have a significant detrimental effect on patient quality of life.

Predictors of morbidity in patients with indwelling ureteric stents: results of a prospective study using the validated Ureteric Stent Symptoms Questionnaire.

OBJECTIVE: To assess the predictors of morbidity in patients with indwelling ureteric stents using a validated questionnaire. PATIENTS AND METHODS: Eighty-six consecutive patients with indwelling double-J ureteric stent of different length and size enrolled at an Italian tertiary academic centre were prospectively evaluated with the Italian-validated Ureteric Stent Symptoms Questionnaire (USSQ), which explores the stent-related symptoms in six domains. Ureteric stents were placed for benign ureteric obstruction or after uncomplicated ureterorenoscopy, and were all removed after 28 days. The questionnaire was administered on days 7 and 28 after stent placement and on day 28 after removal. A plain abdominal X-ray was performed on days 7 and 28 after placement to determine stent location. Univariable and multivariable analyses tested the association of patient age, sex and body mass index (BMI), and stent side, length, calibre and distal loop location, with the index score of the various domains on days 7 and 28. RESULTS: All patients completed the study. At multivariable analysis, on day 7, sex, BMI and stent calibre were significantly associated with one domain (general health, body pain and work performance, respectively), while location of stent distal loop was significantly associated with five domains (urinary symptoms, body pain, general health, work performanc, and sexual matters). On day 28, body mass index was significantly associated with two domains (body pain and general health), while location of stent distal loop remained significantly associated with the same five domains (urinary symptoms, body pain, general health, work performance and sexual matters). CONCLUSION: Location of stent distal loop with respect to midline had the strongest association with most domains of the USSQ on both days 7 and 28 after stent placement. The visualization of stent distal loop crossing the midline may therefore identify patients at higher risk of post-procedural morbidity requiring early management.

Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi.

BACKGROUND: Ureteral stones frequently cause renal colic, and if left untreated, can lead to obstructive uropathy. Extracorporeal shock wave lithotripsy (ESWL) and ureteroscopy, with or without intracorporeal lithotripsy, are the most common interventions used to treat ureteral stones. ESWL treatment is less invasive than ureteroscopy, but has some limitations such as a high retreatment rate, and is not available in all centres. Recent advances in ureteroscopy have increased success rates and reduced complication rates. OBJECTIVES: To examine evidence from randomised controlled trials (RCTs) on the outcomes of ESWL or ureteroscopy in the treatment of ureteric calculi. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL in The Cochrane Library Issue 2, 2011), MEDLINE (1966 to March 2011), EMBASE (1980 to March 2011), CINAHL, Clinicaltrials.gov, Google Scholar, reference lists of articles and abstracts from conference proceedings, all without language restriction. SELECTION CRITERIA: RCTs that compared ESWL with ureteroscopic retrieval of ureteric stones were included in this review. Study participants were adults with ureteric stones requiring intervention. Published and unpublished sources were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three authors independently assessed study quality, risk of bias, and extracted data. Statistical analyses were performed using the random-effects model. Results were expressed as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous data, both with 95% confidence intervals (CI). MAIN RESULTS: Seven RCTs (1205 patients) were included in the review. Stone-free rates were lower in patients who underwent ESWL (7 studies, 1205 participants: RR 0.84, 95% CI 0.73 to 0.96) but re-treatment rates were lower in ureteroscopy patients (6 studies, 1049 participants: RR 6.18, 95% CI 3.68 to 10.38. ESWL-treated patients had less need for auxiliary treatment (5 studies, 751 participants: RR 0.43, 95% CI 0.25 to 0.74; fewer complications (7 studies, 1205 participants: RR 0.54, 95% CI 0.33 to 0.88); and shorter length of hospital stay (2 studies, 198 participants: MD -2.55 days, 95% CI -3.24 to -1.86).Three studies adequately described the randomisation sequence, three studies were unclear on how they randomised, while one study had a high risk of selection bias. All the studies had an unclear risk of performance bias and detection bias, while all had a low risk of attrition bias, reporting bias, or other sources of bias identified. AUTHORS' CONCLUSIONS: Compared with ESWL, ureteroscopic removal of ureteral stones achieves a greater stone-free state, but with a higher complication rate and longer hospital stay.