Stone;RenalNCT03567421
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
An observational study of Stone;Renal and Stone, Kidney, run by Société Internationale d'Urologie at 50 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stone;Renal, Stone, Kidney, Stone Ureter
- How many people
- 2,348 participants
- Where
- 50 sitesin 15 countries
- Study dates
- 7 Jun 2018to 31 Aug 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry.
Who may be able to join
- Patient >18 years old
- Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy
Who cannot join
- Patient <18 years old
Trial locations and contacts
50 sites in 15 countries.
50 sites in 15 countries
Turkey (Türkiye)12 sites
Department of Urology, Cukurova University, Adana
Adana
Baskent University, Faculty of Medicine, Department of Urology
Ankara
Department of Urology, Gazi University
Ankara
Department of Urology, Hacettepe University
Ankara
Cerrahpasa School of Medicine Istanbul University
Istanbul
Department of Urology, University of Health Sciences, Bağcılar Hospital
Istanbul
Istanbul Medipol University, Department of Urology
Istanbul
Department of Urology, 9 Eylul University
Izmir
Konya Meram Education & Research Hospital
Konya
Necmettin Erbakan University, Meram Medical School
Konya
Selcuk University Selcuklu Medical School
Konya
Department of Urology, Bulent Ecevit University
Zonguldak
China6 sites
Guangdong Second Provincial General Hospital, The Third Clinical Medical College of Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou Medical University and Guangdong Key Laboratory of Urology
Guangzhou
Ningbo First Hospital, The Affiliated Hospital of Ningbo University
Ningbo
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Shanghai Changhai Hospital, Second Military Medical University
Shanghai
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Indonesia6 sites
Department of Urology, Hasan Sadikin Hospital/Padjadjaran University
Bandung
Department of Urology, Sanglah Hospital/Udayana University
Denpasar
Department of Urology, Cipto Mangunkusumo Hospital/University of Indonesia
Jakarta
Department of Urology, Saiful Anwar Hospital/Brawijaya University
Malang
Department of Urology, Dr. Soetomo Hospital/Airlangga University
Surabaya
Department of Urology, Sardjito Hospital/Gadjah Mada University
Yogyakarta
Greece5 sites
Aretaieion Hospital
Athens
Sismanoglio General Hospital
Athens
University of Crete, Department of Urology
Heraklion
Department of Urology, University Hospital of Larissa
Larissa
1st Department of Urology, Aristotle University
Thessaloniki
Malaysia5 sites
Selayang Hospital
Batu Caves
Serdang Hospital
Kajang
Kuala Lumpur Hospital
Kuala Lumpur
University of Malaya
Kuala Lumpur
Sarawak General Hospital
Kuching
Taiwan4 sites
Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung
Kaohsiung City
Department of Urology, Cardinal Tien Hospital
New Taipei City
Department of Urology, En Chu Kong Hospital
New Taipei City
Department of Urology, National Taiwan University Hospital
Taipei
Saudi Arabia3 sites
International Medical Center
Jeddah
King Abdulaziz University
Jeddah
Prince Sultan Military Medical City
Riyadh
India2 sites
Jawahar Lal Nehru (JLN) Medical College
Ajmer, Rajasthan
Kulkarni Reconstructive Urology Center
Pune
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Iran1 site
Shahid Beheshti Hospital, Hamadan University of Medical Sciences
Hamadan
Romania1 site
Department of Urology, St. John Clinical Hospital of Emergency
Bucharest
About this study
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.
Read more
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.
Read the detailed description
BACKGROUND AND RATIONALE
The majority of patients with stones receive an indication for its active removal by ureteroscopy. In the last two decades, endourological treatment techniques have evolved with several technological advances through miniaturisation of ureteroscopes, digital improvements, and optical imaging enhancement techniques leading to a better image quality, and the development of different disposables such as single-use digital ureteroscopes. This advancement has led to an increased number of indications for ureteroscopic treatment. Aside from this, there are no specific contraindications for ureteroscopic treatment, apart from general problems such as being unfit for anaesthesia or the presence of urinary tract infections, according to the EAU guidelines.
The indications for active stone removal of ureteral stones include persistent pain or obstruction, renal insufficiency, and in cases when spontaneous passage is less likely. The indications for active removal of renal stones include stone growth, stone formation in patients who are at high risk for stone formation, symptomatic patients, infection, obstruction, stones larger than 15 mm and the comorbidity profile, social situation and preference of the patient.
The procedure can be performed using semi-rigid instruments, mainly for ureter stones, and/or by flexible ureteroscopes, for complete inspection and treatment of the upper tract.
The exit strategy after stone treatment varies depending on patient characteristics and comorbidity, residual stone load, per-operative details and complications, and surgeons' preference. Stent placement is recommended by the EAU guidelines in case of increased postoperative complications; in cases of residual fragments, bleeding, perforation, pregnancy or urinary tract infections; as well as in all doubtful cases to avoid stressful emergencies.
Postoperative stenting increases postoperative morbidity and urologists should carefully balance the pros and cons of postoperative stenting in each individual case. The ideal stent duration is not known. Ureteral stents are usually removed 1-day postoperatively and most urologists will remove double Js 1-2 weeks postoperatively.
It remains a matter of debate whether to stent a patient postoperatively after a ureteroscopic procedure despite the EAU guidelines statement that routine stenting after an uncomplicated procedure with complete stone removal is not necessary.
STUDY OBJECTIVES
The aim of this registry is to review current clinical practice on postoperative ureteral stenting after ureteroscopy for stone treatment. The investigators will explore the answers to the following questions: What are the indications, predictors and outcomes for stent placement? What types of stents are used and what is the duration for stent placement? Hence, the investigators will assess in what setting the stents are being removed, looking at instrumentation, anaesthetics, and location.
- Conditions
- Stone;Renal, Stone, Kidney, Stone Ureter
- Keywords
- stone disease, ureteral stent, stenting, ureteroscopy treatment, stent placement, postoperative ureteral stenting, Société Internationale d'Urologie, uCARE
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Ureterolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy
This number will be reported as a % of the total patients enrolled.
Measured: 6 months
Secondary outcomes (6)
Number of patients requiring secondary interventions [N]
Post-operative secondary interventions include JJ placement, ureter splint placement, nephrostomy tube placement, reURS, clot removal, pharmacological intervention, or other.
Measured: 6 months
Number of patients requiring pain medication at discharge [N]
Pain defined as that requiring additional therapy or pain medication, or prolonged hospital stay due to pain.
Measured: 6 months
Duration of the actual internal drain indwelling time [days]
This number is auto-calculated based from the date of surgery, and date of stent removal or post-operative visit (if no stent was used)
Measured: 6 months
Duration of the internal drain indwelling time as indicated by the surgeon [days]
Calculated as number of days.
Measured: 6 months
% of patients who required anaesthesia for stent removal [Yes/No]
This intraoperative information will be provided by surgeon to indicate whether anesthesia was required during stent removal. Data to be reported as % of total patients.
Measured: 6 months
Incidence of use of flexible instruments for stent removal following ureteroscopy.
As indicated by treating surgeon [Yes/No response].
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start7 Jun 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stone;RenalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,348 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Société Internationale d'Urologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce Baard, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Mihir Desai, MD, Study chair, University of Southern California, United StatesJean de la Rosette, MD, Study director, Istanbul Medipol University, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567421
- Sponsor's protocol ID
- uCARE 2018-001
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28321499ICH 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
- ClinicalTrials.gov ID
- NCT03567421
- Acronym / sponsor ID
- uCARE 2018-001
- Conditions
- Stone;Renal, Stone, Kidney, Stone Ureter
- Keywords
- stone disease, ureteral stent, stenting, ureteroscopy treatment, stent placement, postoperative ureteral stenting, Société Internationale d'Urologie, uCARE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,348 participants (actual)
- Lead sponsor
- Société Internationale d'UrologieUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND AND RATIONALE
The majority of patients with stones receive an indication for its active removal by ureteroscopy. In the last two decades, endourological treatment techniques have evolved with several technological advances through miniaturisation of ureteroscopes, digital improvements, and optical imaging enhancement techniques leading to a better image quality, and the development of different disposables such as single-use digital ureteroscopes. This advancement has led to an increased number of indications for ureteroscopic treatment. Aside from this, there are no specific contraindications for ureteroscopic treatment, apart from general problems such as being unfit for anaesthesia or the presence of urinary tract infections, according to the EAU guidelines.
The indications for active stone removal of ureteral stones include persistent pain or obstruction, renal insufficiency, and in cases when spontaneous passage is less likely. The indications for active removal of renal stones include stone growth, stone formation in patients who are at high risk for stone formation, symptomatic patients, infection, obstruction, stones larger than 15 mm and the comorbidity profile, social situation and preference of the patient.
The procedure can be performed using semi-rigid instruments, mainly for ureter stones, and/or by flexible ureteroscopes, for complete inspection and treatment of the upper tract.
The exit strategy after stone treatment varies depending on patient characteristics and comorbidity, residual stone load, per-operative details and complications, and surgeons' preference. Stent placement is recommended by the EAU guidelines in case of increased postoperative complications; in cases of residual fragments, bleeding, perforation, pregnancy or urinary tract infections; as well as in all doubtful cases to avoid stressful emergencies.
Postoperative stenting increases postoperative morbidity and urologists should carefully balance the pros and cons of postoperative stenting in each individual case. The ideal stent duration is not known. Ureteral stents are usually removed 1-day postoperatively and most urologists will remove double Js 1-2 weeks postoperatively.
It remains a matter of debate whether to stent a patient postoperatively after a ureteroscopic procedure despite the EAU guidelines statement that routine stenting after an uncomplicated procedure with complete stone removal is not necessary.
STUDY OBJECTIVES
The aim of this registry is to review current clinical practice on postoperative ureteral stenting after ureteroscopy for stone treatment. The investigators will explore the answers to the following questions: What are the indications, predictors and outcomes for stent placement? What types of stents are used and what is the duration for stent placement? Hence, the investigators will assess in what setting the stents are being removed, looking at instrumentation, anaesthetics, and location.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry.
Key inclusion criteria (2 listed)
- Patient >18 years old
- Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy
Key exclusion criteria (1 listed)
- Patient <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy
Time frame: 6 months
This number will be reported as a % of the total patients enrolled.
6 secondary outcomes
Number of patients requiring secondary interventions [N]
Time frame: 6 months
Number of patients requiring pain medication at discharge [N]
Time frame: 6 months
Duration of the actual internal drain indwelling time [days]
Time frame: 6 months
Duration of the internal drain indwelling time as indicated by the surgeon [days]
Time frame: 6 months
% of patients who required anaesthesia for stent removal [Yes/No]
Time frame: 6 months
Incidence of use of flexible instruments for stent removal following ureteroscopy.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- BackgroundTürk 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
- Background: PubMed 28321499Legemate 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.
- BackgroundICH 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Baard, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mihir Desai, MD study chair
University of Southern California, United States
Jean de la Rosette, MD study director
Istanbul Medipol University, Istanbul, Turkey
50 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stone;Renal and Stone, Kidney, run by Société Internationale d'Urologie at 50 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Turkey (Türkiye), China, Indonesia, Greece, Malaysia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567421, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.