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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03567421




Registration number
NCT03567421
Ethics application status
Date submitted
26/04/2018
Date registered
25/06/2018
Date last updated
13/04/2021

Titles & IDs
Public title
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Scientific title
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Secondary ID [1] 0 0
uCARE 2018-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stone;Renal 0 0
Stone, Kidney 0 0
Stone Ureter 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Number of patients requiring secondary interventions [N]
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Number of patients requiring pain medication at discharge [N]
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Duration of the actual internal drain indwelling time [days]
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Duration of the internal drain indwelling time as indicated by the surgeon [days]
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
% of patients who required anaesthesia for stent removal [Yes/No]
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Incidence of use of flexible instruments for stent removal following ureteroscopy.
Timepoint [6] 0 0
6 months

Eligibility
Key inclusion criteria
- Patient >18 years old

- Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by
semi-rigid and/or flexible ureteroscopy
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patient <18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2019
Sample size
Target
Accrual to date
Final
2348
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Guangzhou
Country [4] 0 0
China
State/province [4] 0 0
Ningbo
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
China
State/province [6] 0 0
Wuhan
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Heraklion
Country [9] 0 0
Greece
State/province [9] 0 0
Larissa
Country [10] 0 0
Greece
State/province [10] 0 0
Thessaloníki
Country [11] 0 0
India
State/province [11] 0 0
Rajasthan
Country [12] 0 0
India
State/province [12] 0 0
Pune
Country [13] 0 0
Indonesia
State/province [13] 0 0
Bandung
Country [14] 0 0
Indonesia
State/province [14] 0 0
Denpasar
Country [15] 0 0
Indonesia
State/province [15] 0 0
Jakarta
Country [16] 0 0
Indonesia
State/province [16] 0 0
Malang
Country [17] 0 0
Indonesia
State/province [17] 0 0
Surabaya
Country [18] 0 0
Indonesia
State/province [18] 0 0
Yogyakarta
Country [19] 0 0
Iran, Islamic Republic of
State/province [19] 0 0
Hamadan
Country [20] 0 0
Iraq
State/province [20] 0 0
Basra
Country [21] 0 0
Kenya
State/province [21] 0 0
Mombasa
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Malaysia
State/province [23] 0 0
Batu Caves
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kajang
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kuala Lumpur
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kuching
Country [27] 0 0
Romania
State/province [27] 0 0
Bucharest
Country [28] 0 0
Saudi Arabia
State/province [28] 0 0
Jeddah
Country [29] 0 0
Saudi Arabia
State/province [29] 0 0
Riyadh
Country [30] 0 0
South Africa
State/province [30] 0 0
Ga-Rankuwa
Country [31] 0 0
Taiwan
State/province [31] 0 0
Kaohsiung
Country [32] 0 0
Taiwan
State/province [32] 0 0
New Taipei City
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
Turkey
State/province [34] 0 0
Adana
Country [35] 0 0
Turkey
State/province [35] 0 0
Ankara
Country [36] 0 0
Turkey
State/province [36] 0 0
Istanbul
Country [37] 0 0
Turkey
State/province [37] 0 0
Izmir
Country [38] 0 0
Turkey
State/province [38] 0 0
Konya
Country [39] 0 0
Turkey
State/province [39] 0 0
Zonguldak

Funding & Sponsors
Primary sponsor type
Other
Name
Société Internationale d'Urologie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Background: The exit strategy after ureteroscopy for stone treatment remains a topic for
discussion. Current EAU guidelines on urolithiasis state that postoperative stenting is
indicated in patients at increased risk of postoperative complications. Stenting is not
considered necessary in all other cases, and after uncomplicated procedures.

Objective: To analyse the postoperative ureteral stenting strategy in clinical practice
looking at the indication, type of stents used and the duration of stenting after
ureteroscopy for stone treatment. Furthermore, the investigators will examine in what setting
the stents are being removed postoperatively.

Study design: This study is a prospective, observational, international, multicentre registry
study executed by uCARE.

Study population: All patients >18 years with a ureter or renal stone who are planned for
ureteroscopic treatment by semi-rigid and/or flexible ureteroscopy are eligible for this
study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03567421
Trial related presentations / publications
Türk C, Knoll T, Petrik A, et al. EAU Guidelines on Urolithiasis 2016. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-Urolithiasis-2016-1.pdf
Legemate JD, Wijnstok NJ, Matsuda T, Strijbos W, Erdogru T, Roth B, Kinoshita H, Palacios-Ramos J, Scarpa RM, de la Rosette JJ. Characteristics and outcomes of ureteroscopic treatment in 2650 patients with impacted ureteral stones. World J Urol. 2017 Oct;35(10):1497-1506. doi: 10.1007/s00345-017-2028-2. Epub 2017 Mar 20.
ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R2). Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed March 25, 2018.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Joyce Baard, MD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03567421