Abstract
Purpose:
To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system.
Patients and Methods:
The Clinical Research Office of the Endourological Society collected prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. The stone size and location were recorded and postoperative outcome and complications, graded according to the modified Clavien grading system, reported.
Results:
Between January 2010 and October 2012, 11,885 patients received URS at 114 centers in 32 countries; 1852 had only renal stones, 8676 had only ureteral stones, and 1145 patients had both types of stone. Fragmentation was performed principally using a laser device (49.0%) or a pneumatic device (30.3%); no device was used in 17.9% of the patients. A high stone-free rate (85.6%) was achieved. The large majority of patients did not receive any further treatment for renal or ureter stones (89.4%). The postoperative complication rate was low (3.5%). The most frequent complication was fever (1.8%); a blood transfusion was required in 0.2% of patients. The majority of complications were Clavien grade I or II (2.8% of patients).
Conclusion:
URS is an established minimal invasive treatment for urinary stones with a high success rate and low morbidity. Recent advances have expanded the indication for urinary stones, which now ranges from treatment of smaller sized distal ureter stones by semirigid URS to larger sized renal pelvis stones treated by flexible URS.
Introduction
N
The European Association of Urology (EAU) guidelines on urolithiasis report that 95% of stones up to 4 mm pass within 40 days and recommend that, in patients with newly diagnosed ureteral stones <10 mm and if active removal is not indicated, then observation with periodic evaluation should be conducted. 7 Appropriate medical therapy, such as an alpha-blocker, to facilitate stone removal should be offered. 7,8 The EAU guidelines state the indications for active removal of ureteral stones as being stones with a low likelihood of spontaneous passage, persistent pain despite adequate pain medication, persistent obstruction, and renal insufficiency. 7 Indications for active removal of kidney stones include stone growth, stones in high-risk patients for stone formation, obstruction caused by stones, infection, symptomatic stones (e.g., pain, hematuria), stones >15 mm, stones <15 mm if observation is not the option of choice, patient preference, comorbidity, social situation of the patient (e.g., profession, travelling), and >2–3 years stone persistence. 7
During the past 20 years, ureteroscopy (URS) has dramatically changed the management of ureteral calculi. Major technical improvements include endoscope miniaturization, enhanced optical quality and tools, and introduction of disposables. URS has had a great impact on active stone removal and is performed increasingly worldwide. The EAU guidelines specify that apart from general problems, for example, with general anesthesia or untreated urinary infections, URS can be performed in all patients without any specific contraindications. 7 Specific problems such as ureteral strictures may prevent successful retrograde stone management. Specific recommendations are made with regard to stone size and location. 7 The AUA/EAU joint guidelines describe that in patients for whom active stone removal is recommended, proximal stones <10 mm should be removed using SWL, while those >10 mm should be removed using URS or SWL. For distal ureter stones <10 mm, URS or SWL are recommended, while for stones >10 mm, URS is first choice treatment based on improved stone-free rates. 9
There are some fundamental (institutional) differences concerning indication for URS surgery, equipment used, and possible outcomes. 4 Moreover, specific factors may influence treatment-related morbidity. The clinical research office of the Endourological Society (CROES) initiated the URS Global Study to establish a prospective global database to examine these aspects. In this communication, we report the overall results for indications, complications, and outcomes in 11,885 patients reported by the centers participating in the CROES URS Global Study. This is the first in a series of articles that will be presented from the study.
Patients and Methods
This was a prospective, observational, international, multicenter study that involved the collection of data on consecutive patients treated at the participating centers over a 1-year period.
Study objectives
The primary study objectives were to assess the current indications for URS treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system.
Study organization
CROES launched the URS Global Study in January 2010. CROES invited the authors to form an International Representative Steering Committee that would be responsible for managing the CROES URS Global Study. The authors were members of the Endourological Society and their selection for the Steering Committee was due to their recognition as experts in URS treatment. Centers, specifically urology departments that had expertise in URS, were invited to participate in this prospective study. The invitation to each center was to include all consecutive patients who were treated over a 1-year period; the treatment of the first patient indicated the start of the study period at each site. The overall study period was from January 2010 to October 2012.
Inclusion criteria and treatment protocol
Patients eligible for inclusion were those who were candidates for URS, for ureter stones and renal stones, as a primary treatment or after failure of a previous treatment. No specific exclusion criteria were applied. For semirigid URS, guidewire and occasionally dilatation were employed; stone disintegration was conducted using the equipment locally available and might include laser and/or ballistic devices. For flexible URS, guidewire and access sheath were used depending on the local protocol. Stone removal was conducted using stone retrieval devices, with insertion of an internal drain postremoval depending on local protocols.
Patient follow-up
Patients were assessed postprocedure according to the local protocol, which included the kidneys, ureter, and bladder and/or ultrasound or computed tomography scan of the abdomen. The classification of a patient being stone free was based on the absence of stones or fragments larger than 1 mm. Intraoperative details and postoperative outcome were assessed, including complications graded according to the modified Clavien system. 10
Secondary treatment
Secondary treatment was considered necessary if significant remnant stones were present, if the upper urinary tract was obstructed by the remaining stones, or for other reasons, dependent on the clinical judgment of the treating physician. Secondary treatment involving repeated URS or SWL was selected based on clinical assessment.
Data collection
Data were collected electronically through a web-based website:
Data analysis
The data were analyzed using SPSS version 19.0. All data are descriptive and based on frequencies. The data collected did not represent 100% of patients. Where data were missing, the number of patients for whom the values were missing or not available was stated. Percentages were calculated based on the total cohort.
Results
Between January 2010 and October 2012, 11,885 patients received URS during a 1-year period at 114 centers in 32 countries. The number of participating centers and patients per country are shown in Table 1 and the Appendix.
URS=ureteroscopy.
Patient characteristics
The distribution of the cases according to age, gender, body mass index (BMI), and clinical details are presented in Table 2. The peak distribution of patients was in the age range 51–60 years with a predominance of males in the entire cohort 64.9%. With a mean BMI of 26.8 recorded, the study group was on average of normal weight. Almost one-third of the patients had the significant comorbidity of cardiovascular disease and 10.7% were diagnosed with diabetes mellitus. For the majority of patients (67.6%), this was their first-line treatment of their stone disorder. Previous stone treatments undertaken included percutaneous nephrolithotomy (PCNL), SWL, URS, ureterolithotomy, pyelolithotomy, or ureteropelvic junction pyeloplasty. A doubleJ stent had been placed previously in 2341 (19.7%) cases and 471 (4.0%) cases had a previous nephrostomy. There was a low incidence of anatomic kidney abnormalities (3.4%). The majority of patients had an American Society of Anesthesiologists (ASA) score of I or II (84.2%). In 827 (7.0%) patients, a positive urine culture was found preoperatively.
More than one treatment feasible.
SD=standard deviation; BMI=body mass index; DM=diabetes mellitus; PCNL=percutaneous nephrolithotomy; SWL=extracorporeal shockwave lithotripsy; URS=ureteroscopic stone removal; UPJ=ureteropelvic junction; ASA=American Society of Anesthesiologists.
Intraoperative characteristics
Of the total population of 11,885 patients, 1852 (15.6%) had only renal stones, 8676 (73.0%) had only ureteral stones, 1145 (9.6%) patients had both types of stone, of 199 (1.7%) patients, the stone location could not be indicated and of 13 (0.1%), the stone location was missing. Renal stones were located in the upper pole in 713 patients (6.0%), in the middle pole in 876 patients (7.4%), in the lower pole in 1688 patients (14.2%), and in the renal pelvis in 882 (7.4%) patients. The ureteral stones were located proximal in 3101 (26.1%) patients, middle in 2390 (20.1%) patients, and distal in 5020 (42.2%) patients. Antibiotics were given in only 82.2% of the patients. The semirigid URS was primarily used (73.9%), followed by the flexible URS (15.0%) or a combination of both techniques (10.7%). The flexible URS was never used in a quarter of the centers (28/114), probably because the flexible URS was not available. Access techniques used were predominantly through guide wire (62.0%), followed by a dilation technique (33.7%). Once access was obtained, fragmentation was performed principally using a laser device (49.0%) or a pneumatic device (30.3%); no device was used in 17.9% of the patients. Operative procedures were considered uneventful in the majority of patients (93.7%). There was a low incidence of significant bleeding (1.4%), perforation (1.0%), and failure to complete the operation (1.6%) (Table 3).
More than one complication feasible.
Postoperative outcomes
A summary of postoperative outcomes is shown in Table 4. A high stone-free rate (85.6%) was achieved, but stones were impacted in 27.2% of patients and the intraoperative migration rate was 9.5%. Ureteral stents were inserted in the majority of patients (81.4%). The large majority of patients did not receive any further treatment for renal or ureter stones (89.4%). The postoperative complication rate was low (3.5%). The most frequent complication was fever (1.8%); a blood transfusion was required in 0.2% of patients. The majority of complications were Clavien grade I or II (2.8% of patients). Five patients had a Clavien grade V; causes of death were sepsis, lung embolism, cardiac death, multiorgan dysfunction, and sudden death from arrhythmia. At 3 months, 8.4% of patients were readmitted to the hospital for a range of complications, including flank pain and ureteral stent discomfort.
More than one option feasible.
UTI=urinary tract infection; CVA=cerebrovascular accident; TIA=transient ischemic attack; MI=myocardial infarction; KUB=kidneys, ureter, and bladder; CT=computed tomography; IVU=intravenous urogram.
Discussion
According to the EAU guidelines on urolithiasis, URS can be used in all patients without specific contraindications to treat renal and ureteral stones. 7 Of the total population of 11,885 patients in the URS Global Study, 1852 (15.6%) had only renal stones, 8676 (73.0%) had only ureteral stones, and 1145 (9.6%) patients had both types of stone. In the case of renal stones, stones were evenly divided over all renal locations and similarly for the ureteral stones. The large majority of ureteroscopic procedures employed a semirigid device alone (73.9%) or with a flexible ureteroscope (10.7%), while a flexible ureteroscope alone was used in 15.0% of procedures. These figures mirror the data on stone location. These findings indicate that URS can be used with the semirigid and flexible ureteroscopes to treat stones in most locations for both ureteral and renal stones.
The mean and median values of BMI in treated patients in the study show that they were in the normal weight range. The high value of obese patients (16.7%) with an upper limit of range at 86.4 shows that URS was used in morbidly obese patients. Previous studies reveal successful treatment of such patients. Dash and colleagues 13 reported on the use of URS in obese patients with renal calculi and compared outcome with normal weight patients and found no difference in success rates. Andreoni and colleagues 14 also reported successful outcomes in obese and morbidly obese patients with renal stones up to 15 mm in size. Other patient characteristics in the current study indicate a high rate of morbidity due to diabetes mellitus (10.7%) and cardiovascular disease (25.2%); anticoagulant use was reported in 5.9% of patients. Previous stone treatment was reported in 31.4% of patients, which comprised primarily of SWL (18.9%) and URS (13.5%). The majority of patients had an ASA score of I and II (84.2%) and there was a low rate of renal abnormalities in the study cohort.
Stents were employed postoperatively in 84.1% of procedures. This contrasts with current literature, which reveals that for uncomplicated URS, there is no increased risk of obstruction or colic if the ureter is left unstented. 15 –18 A comprehensive review by Haleblian and colleagues 19 also reported that stenting was not mandatory after uncomplicated URS, with more bladder and lower urinary tract symptoms being reported when stents were placed. Nevertheless, the review showed that in certain patients at increased risk of complications, such as pregnant women, stenting was beneficial. The EAU 2012 guidelines also recommend that stenting is optional after uncomplicated URS. 7
The reported rate of intraoperative stone migration in the current study was 9.5%. A number of techniques have been introduced to reduce the rate of migration. These include the Accordion, 20,21 the Backstop, 22 the Dretler stone cone, 23,24 the Escape basket, 25 and the Ntrap. 26 In general, these devices act as a backstop during lithotripsy once deployed within the ureter and are connected to a guide wire or catheter. They also assist in extracting significant fragments after fragmentation.
In the majority of patients, stone fragmentation was achieved using lasers (49%) or pneumatic disruption (30.3%). According to the EAU guidelines, for flexible URS, the Ho:YAG laser is preferred. 7 The primary intraoperative complications reported were bleeding (1.4%) and perforation (1.0%); ureteral avulsion was reported in 0.1% of patients. Five patients died after URS. The perforation, avulsion, and bleeding rates are in line with those previously reported. 27,28 Antibiotics were administered at patient discharge in 73.8% of patients in accordance with the EAU guidelines, which recommend the administration of short-term antibiotic prophylaxis. 7
A stone-free rate of 85.6% overall, for renal and ureteral stones, was reported in the URS Global Study. Stone-free rates for ureteral stones using URS range from 81% to 97% according to the location of the stone (distal, mid, or proximal ureter) and size (<10 and >10 mm). 7 The highest rates reported were for stones in the distal ureter and sized <10 mm. For renal stones, evidence implies that no significant difference in stone-free rates exists between lower pole and nonlower pole renal stones. 29 –31 Again, with renal stones, the impact of large stone size on stone-free rates is well accepted with the stone size being inversely proportional to the stone-free rate. 32 In the current study, the success of the treatment is reflected in the observation that 89.4% of patients did not require retreatment. A retreatment rate of 2.2% for ureteral stones treated with URS has been reported. 33
The postoperative complication rate was low at 3.5%; fever was reported in 1.8% of patients and was comparable to that in other studies. 27 The rate of bleeding at 0.4% was lower than the 2% rate of persistent hematuria previously published. 27 Notably, 96% of patients had no reported complications (Clavien grade 0). The Clavien classification of complications post-semirigid URS was reported by Mandal and colleagues, 34 who showed a 30% complication rate at a resident training center; 98% of these were grade 1–3 and <2% were grade 4. A stricture rate of 0.3% resulted in hospital readmission. Again, ureteral stricture has previously been reported as a late complication in 0%–4% of cases, with comparable rates of <1% in the more recent studies, and may be due to ureteral trauma from instrumentation or calculus impaction. 28
Very few centers participating in the study enrolled fewer than 50 patients. Evidence suggests that optimal outcomes can be achieved in centers that focus on URS and provide a dedicated center for the procedure. 35 A recent review also shows that predictive factors for success or complications of URS include technological advancement and surgeon experience. 36
Conclusion
In URS, for urinary stones, semirigid URS is the dominant form of treatment. Recent advances in flexible instruments, however, have expanded the indications for urinary stone treatment. At present, the indications include treatment of smaller sized distal ureter stones by semirigid URS to larger sized renal pelvis stones treated by flexible URS. Widening of the indication for URS is at the cost of PCNL and SWL, as URS is a minimal invasive treatment for urinary stones with a high success rate and low morbidity.
Footnotes
Acknowledgment
The URS Global Study was supported by an unrestricted educational grant from Boston Scientific.
Disclosure Statement
No competing financial interests exist.
| Country | Center | Principal investigator |
|---|---|---|
| Argentina | Centro de Urologia-CDU | Barusso |
| Argentina | Hospital Italiano de Buenos Aires | Daels |
| Argentina | Urosalud | Labate |
| Australia | Westmead Hospital and University of Sydney | Bariol |
| Austria | Medical University of Vienna | Klingler a |
| Canada | McGill University Health Centre | Andonian |
| Canada | Western University, St. Joseph's Hospital | Razvi |
| Chile | Clinica Alemana de Santiago | Krebs |
| Chile | Clínica Las Condes Santiago | Zambrano |
| Chile | Hospital Militar de Santiago | Coz |
| Chile | Hospital San Borja Arriaran | Silva |
| Chile | University of Chili, Clinic Hospital Santiago | Marchant |
| China | Changhai Hospital | Sun |
| China | First Hospital of Tsinghua University | Li |
| China | Renji Hospital | Xue |
| Czech Republic | University Hospital Brno, Medical School Masaryk University | Pacik |
| Denmark | Århus University Hospital Skejby | Fuglsig |
| Denmark | Fredericia Hospital, University of Southern Denmark | Osther |
| Egypt | University of Tanta | El-Abd |
| Egypt | Urology and Nephrology Center, Mansoura University | EL-Nahas |
| France | Nouvel Hôpital Civil les Hôpitaux Universitaires | Saussine |
| France | University Pierre et Marie Curie Paris 6 | Traxer |
| Germany | Academic Hospital Braunschweig | Hammerer |
| Germany | Asklepios Hospital Barmbek | Knipper |
| Germany | Sindelfingen-Boblingen Medical Center | Wendt-Nordahl |
| Germany | SLK-Klinikum am Gesundbrunnen | Klein |
| Germany | University Medical Center Marburg | Olbert |
| Greece | Aristotle University of Thessaloniki | Toutziaris |
| Greece | General Hospital Of Veria | Sountoulidis |
| Greece | Laiko Hospital, University of Athens Medical School | Stravodimos |
| Greece | Athens Medical School, Sismanoglio Hospital | Skolarikos |
| Greece | University Hospital of Heraklion | Mamoulakis |
| Greece | University Hospital of Thessaly | Melekos |
| Greece | University of Patras | Liatsikos |
| India | Fortis Raheja Hospital | Shah b |
| India | Institute of Urology, Division of Tejnaksh Healthcare | Ashish Rawandale-Patil |
| India | Muljibhai Patel Urological Hospital | Desai |
| India | RG Stone Urology and Laparoscopy hospital Mumbai | Sodha |
| India | RG Stone Urology and Laparoscopy Hospital New Delhi | Varshney |
| India | Shyam Urosurgical Hospital | Parikh |
| India | Vedanayagam Hospital and Postgraduate Institute | Kandasami |
| Iran | Hasheminejad Hospital | Etemadian |
| Iran | Labbafinejad Hospital | Basiri |
| Israel | Hadassah Ein-Kerem University Hospital | Duvdevani |
| Israel | Rambam Medical Center | Meretyk |
| Italy | AOS Paolo Teaching Hospital, University of Milan | Montanari |
| Italy | Azienda Ospedaliero Universitaria di Parma | Frattini |
| Italy | Careggi Hospital, University of Florence | Crisci |
| Italy | Catholic University School of Medicine | D'Addessi |
| Italy | I.C. Humanitas, IRCCS | Giusti |
| Italy | San Bassiano Hospital | Celia |
| Italy | Second University Hospital Naples | De Sio |
| Italy | University of Cagliari | De Lisa |
| Italy | Vittorio Emanuele Hospital | Saita |
| Italy | University of Foggia | Cormio |
| Italy | University San Luigi Gonzaga | Scarpa |
| Japan | Hachinohe Heiwa Hospital | Miura |
| Japan | Kansai Medical University | Fukui |
| Lithuania | Vilnius university, Republic Vilnius University Hospital | Gaizauskas |
| Mexico | Centro Medico Puerta de Hierro and Nuevo Hospital Civil | Gutierrez-Aceves c |
| Mexico | Hospital Regional de Alta Especialidad del Bajío | Negrete |
| Poland | Central Railway Hospital | Dobruch |
| Romania | Emergency County Hospital | Mitroi |
| Romania | Oncological Institute Cluj-Napoca | Petrut |
| Romania | Prof Dr Th Burghele Hospital | Jinga |
| Romania | Saint John Emergency Clinical Hospital | Geavlete |
| Romania | Timisoara Clinical Emergency Hospital | Bucuras |
| Russia | Moscow City Urological Hospital | Martov |
| Russia | First City Hospital | Zenkov |
| Russia | Yekaterinburg City Hospital | Frank |
| Serbia | Clinical Centre of Vojvodina | Marusic |
| Spain | Clinica La Luz | Perez-Castro |
| Spain | Hospital Clínico Universitario “Lozano Blesa” | Zalabardo |
| Spain | Hospital Galdakao-Usansolo | Palacios-Ramos |
| Spain | Hospital General Royo Villanova | Rioja Sanz |
| Spain | Hospital Mateu Orfila | Bercowsky |
| Spain | Hospital Miguel Servet de Zaragoza | Rioja Zuazu |
| Sweden | Orebro University hospital | Popiolek |
| Switzerland | University of Bern, Inselspital | Thalmann |
| The Netherlands | Hospital Rijnstate | Roelofs |
| The Netherlands | AMC University Hospital | de la Rosette |
| The Netherlands | Atrium Medisch Centrum | Strijbos |
| Tunisia | Charles Nicolle Hospital | Bouzouita |
| Turkey | Akdeniz University Hospital | Erdogru d |
| Turkey | Cerahpasa School of Medicine Istanbul | Onal |
| Turkey | Ege University School of Medicine | Turna |
| Turkey | ESOGU Medical Faculty Urology | Baseskioglu |
| Turkey | Fatih University | Unal |
| Turkey | Gulhane Military Medical Academy | Ozgok |
| Turkey | Hacettepe University School of Medicine | Bilen |
| Turkey | Haseki Training and Research Hospital | Muslumanoğlu |
| Turkey | Istanbul Bilim University School Of Medicine | Kural e |
| Turkey | Istanbul Goztepe Training Hospital | Erkan f |
| Turkey | Kecioren Training and Research Hospital | Unsal |
| Turkey | Bahcesehir University, School of Medicine | Tefekli |
| Turkey | Necmettin Erbakan University, Meram School of Medicine | Guven |
| Turkey | Pamukkale University Faculty of Medicine | Tuncay |
| Turkey | Private Lokman Hekim Hospitals | Yildiz |
| Turkey | University of Cukurova | Aridogan |
| Turkey | Bülent Ecevit University School of Medicine | Mungan |
| UK | Barts and The London NHS Trust | Buchholz |
| UK | Forth Valley Royal Hospital | McIlhenny |
| UK | University Hospital Southampton NHS Trust | Somani |
| USA | Boston Medical Center, Boston University School of Medicine | Babayan |
| USA | Mayo Clinic | Krambeck |
| USA | Northwestern University Medical School | Nadler |
| USA | The University of Oklahoma Health Sciences Center | Wong g and Culkin |
| USA | The University of Texas Southwestern Medical Center | Pearle |
| USA | University of Arkansas for Medical Sciences | Eltahawy |
| USA | University of Pittsburgh Medical Center | Averch |
| USA | Urological Institute of Northeastern New York/Albany Medical Center | White |
| USA | Vanderbilt University Medical Center | Miller |
| USA | Wake Forest University | Assimos h |
| Venezuela | Instituto Medico La Floresta | Sotelo |
aDr. Klingler is currently affiliated to Wilhelminenspital Wiener KAV.
bDr. Shah is currently affiliated to Urolap Superspeciality Clinic.
cDr. Gutierrez-Aceves is currently affiliated to Wake Forest University.
dDr. Erdogru is currently affiliated to Memorial Istanbul Atasehir Hospital.
eDr. Kural is currently affiliated to Acibadem University Maslak Hospital.
fDr. Erkan is currently affiliated to Istanbul Egitim ve Arastirma Hastanesi.
gDr. Wong is currently affiliated to University Hospitals Ahuja Medical Center Beachwood; Southwest Urology.
hDr. Assimos is currently affiliated to UAB School of Medicine.
