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Ongoing Projects > URS Study

URS- A prospective international observational study on indications and perioperative outcomes

During the past years there has been an increased interest in flexible and semirigid Ureteroscopy (URS) as primary treatment for ureter stones and smaller sized (lower pole) renal stones. URS is truly on the rise, most probably due to technical refinements of the (flexible) endoscopic equipment and because of more realism about the efficacy of the SWL therapy.

There are some fundamental (institutional) differences, however, concerning indication for surgery, equipment used and maybe outcomes. Moreover specific factors may influence treatment related morbidity. In this prospective work, the Endourological Society, through CROES, will study on a global basis the indications and outcomes of both flexible and semirigid URS. Each centre or site participating in this project will enter data on all patients undergoing ureteroscopy during the study period of one year at their site.

Download the URS protocol

 

 

Primary study objective:

To assess the current indications for URS and the treatment outcomes in terms of the stone free rate.


Secondary study objectives:

To assess the peri-operative morbidity (30 days), including SAE, and translate them in the Clavien score.

To define risk factors for the development of peri-operative morbidity after URS.


The following variables will be included to correlate in a logistic regression and uni/multivariate analysis:

The use of antibiotics and incidence of infections

The type of ureteral access used (balloon dilatation, access sheet) and the possible differences in morbidity.

Specific medical conditions (age, BMI, DM, anticoagulants, CVD) versus outcome and morbidity.

The success of URS treatment following prior failed SWL.

Outcomes in complicated cases (mono-kidney, renal congenital anomalies, neurogenic problems).

To study preferences in intra-operative technique (device for fragmentation, use of ureteral stents, device to avoid intra-operative stone migration).

To study differences between lower and higher volume sites.

 

  • Inclusion of patients for a one-year period

  • Study initiated from each site once the first patient is enrolled

  • There is no minimum or maximum of number of sites participating in this study, however, all sites must receive prior approval of the CROES council

  • Subject to the approval of the CROES council, the lead investigator at study sites must be a member of the Endourological Society and in good standing. Subject to the approval of the CROES council, study sites may be proposed by the Sponsor, the members from the Steering committee or on recommendation from a third party

  • Electronic database will be maintained at the central data collection site selected by the CROES council and shall be updated on a regular basis as determined by the CROES council. A manager, selected by the CROES council, at the central data collection site will maintain and coordinate the data collection

  • Prior to approval of the site by the CROES council, for quality assurance, either an IRB approval or a letter from the principal investigator of the study site assuring the quality and ethical standards of data collection will be provided

  • The members of the study group will receive feedback on the data collected on a regular basis, as determined by the CROES council

  • The data analysis shall be the responsibility of the Steering committee for the study group

  • The Steering committee shall be comprised of 8-10 international members and a chairman. A representative of the CROES council will be a member of the Steering committee. A liaison from the Sponsor can attend the Steering committee meetings by invitation of the Steering committee

Jean de la Rosette (the Netherlands)
Olivier Traxer (France)
Frank Keeley (UK)
Petrisor Geavlete (Romania)
Margaret Pearle (USA)
Glenn Preminger (USA)
Tadashi Matsuda (Japan)
John Denstedt (Canada)

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

Wilhelminenspital Wiener KAV

Klingler

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

Rassweiler

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

Urolap Superspeciality Clinic

Shah

India

Institute of Urology, Division of Tejnaksh Healthcare

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

Wake Forest University

Gutierrez-Aceves

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

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

Baykara

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

Acibadem University Maslak Hospital

Kural

Turkey

Istanbul Egitim ve Arastirma Hastanesi  

Erkan

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 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

UAB School of Medicine

Assimos

Venezuela

Instituto Medico La Floresta

Sotelo

Mr. Dave Dyer
Mr. Evan Brasington
Mr. John Pedersen

Our Commitment to You

For over 20 years Boston Scientific has been a leader in developing minimally invasive stone products designed for safety, efficacy and helping to improve procedural efficiency. But innovating Stone Management products isn’t the only thing we care about…we also support the following:

  • Education programs, including physician to physician training, to enhance physician skills in flexible ureteroscopy and PCNL procedures
  • Continuing Medical Education programs for OR nursing and staff to help advance their skills and knowledge
  • Support for resident education
  • Investment in local and national societies to help urology professionals achieve research and educational goals
  • Investment in research and educational grants to fund Urology fellowships
  • A reimbursement help line and current coding and payment information offered by our Health Economics & Reimbursement group

Our Commitment to Product Innovation

Each year Boston Scientific invests millions of dollars in R&D with the goal of developing new, clinically superior products for the treatment of stone disease. This commitment has produced the full product line offering that we have today. 20 years later and after hundreds of products launched to support Stone management surgical care, we continue to strive to develop new, safe, minimally invasive devices to help improve efficacy of these procedures.

Boston Scientific invests in quality initiatives to provide unparalleled products and services for Urologists and their patients. This commitment to quality is a significant part of the culture at Boston Scientific. You should feel confident in the products that you use for the treatment of stone disease….you should feel confident in using Boston Scientific products.

www.bostonscientificstone.com

MANUSCRIPTS PUBLISHED/IN PREPARATION

1) The Clinical Research Office of the Endourological Society Ureteroscopy global study: indications, complications, and outcomes in 11885 patients

de la Rosette, Denstedt, Geavlete, Keeley, Matsuda, Pearle, Preminger, Traxer

Published Journal of Endourology 2014:28(2):131-139

2) Differences in Ureteroscopic Stone Treatment and Outcomes for Distal-, Mid, Proximal-, or Multiple Ureter Locations: The Clinical Research Office of the Endourological Society Ureteroscopy Global Study

Perez Castro,Osther, Jinga, Razvi, Stravodimos, Parikh, Kural, de la Rosette

Published European Urology 2014: 66(1):102-9

3) Impact of Case Volume on Outcomes of Ureteroscopy for Ureteral Stones: the Clinical Research Office of the Endourological Society URS Global Study

Kandasami, Mamoulakis, EL-Nahas, Averch, Tuncay, Rawandale-Patil, Cormio, de la Rosette

Published European Urology 2014 Dec;66(6):1045-51

4) Age-Related Prevalence of Diabetes Mellitus, Cardiovascular Disease and Anticoagulation Therapy Use in a Urolithiasis Population and Their Effect on Outcomes: The Clinical Research Office of The Endourological Society Ureteroscopy Global Study

Daels, Gaizauskas, Rioja , Varshney, Erkan, Ozgok, Melekos , de la Rosette

Published World Journal of Urology 2015 Jun;3396):859-64

5) Post-Operative Infection Rates in Patients With a Negative Baseline Urine Culture Undergoing Ureteroscopic Stone Removal: A Matched Case Control Analysis on Antibiotic Prophylaxis From The CROES URS Global Study

Martov, Gravas, Etemadian, Unsal, Barusso, D’Addessi, Krambeck, de la Rosette

Published Journal of Endourology 2015;29(2):171-80

6) Differences in renal stone treatment and outcomes for patients treated with flexible ureteroscopy with or without access sheath: The Clinical Research Office of the Endourological Society Ureteroscopy Global Study

Traxer, Wendt Nordal, Sodha, Rassweiler, Meretyk, Tefekli, Coz, de la Rosette

Published World Journal of Urology 2015 Dec;33(12):2137-44

7) Management and outcomes of flexible ureteroscopy for a large solitary renal stone in the Clinical Research Office of Endourological Society URS Global study

Skolarikos, Gross, Krebs, Unal, Bercowsky, Eltahawy, Somani, de la Rosette

Published Journal of Urology 2015;194(1):137-43

8) Preoperative JJ stent placement in ureteric and renal stone treatment:results from the CROES URS Study

Assimos, Crisci, Culkin, Wei, Roelofs, Duvdevani, Desai, de la Rosette

Published BJU International 2016;117(4):648-654

9) Ureteroscopy in children in different age groups: data from the Clinical Research Office of the Endourological Society (CROES) Ureteroscopy Global Study

Guven, Basiri, Varshney, Aridogan, Miura, White, Kilinc, de la Rosette

Published Urology 2017;101:31-37

10) Risks and Benefits of Postoperative Double-J Stent Placement After Ureteroscopy (URS): Results From the Clinical Research Office of Endourological Society URS Global Study 

Muslumanoglu, Fuglsig, Frattini, Labate, Nadler, Martov, Wong, de la Rosette

In press Journal of Endourology

11) The URS global study: classification of complications

Somani, Giusti, Sun, Osther, Frank, De Sio, Turna, de la Rosette

Published World Journal of Urology 2017;35(4):675-681

12)The CROES ureteroscopy global study: the influence of body mass index on outcome

Krambeck, Wijnstok, Olbert, Mitroi, Bariol, Shah, El-Abd, Onal, de la Rosette

Published Journal of Endourology 2016;31(1):20-26

13) Outcomes of ureterorenoscopic stone treatment in 301 patients with a solitary kidney

Legemate, Marchant, Bouzouita, Li, McIlhenny, Miller, Saita, de la Rosette

Submitted

14) Worldwide use of anti-retropulsive techniques: observations from the CROES URS Global Study

Saussine, Andonian, Pacik, Popiolek, Celia, Buchholz, Sountoulides, Petrut, de la Rosette

In preparation

15) Ureteroscopic treatment for impacted ureteral stones: characteristics, efficacy and complications in 2650 patients

Legemate, Wijnstok, Matsuda, Strijbos, Erdogru, Roth, Kinoshita, Palacios-Ramos, Scarpa, de la Rosette

In press World Journal of Urology

16) Ureteroscopy and chronic kidney disease: results from the CROES URS Global Study

  *The proposed authors are nominated by the steering committee of the URS study according to the CROES guidelines for publication. The list is not final and can be amended by the steering committee

 

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