Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Stone Ureter; Stone, Kidney; Stone;Renal

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 Type: Observational
• Enrollment (Actual): 2348

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University and Guangdong Key Laboratory of Urology
  • Ningbo, China
    • Ningbo First Hospital, The Affiliated Hospital of Ningbo University
  • Shanghai, China
    • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Shanghai, China
    • Shanghai Changhai Hospital, Second Military Medical University
  • Wuhan, China
    • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Second Provincial General Hospital, The Third Clinical Medical College of Southern Medical University
• Greece
  • Athens, Greece
    • Aretaieion Hospital
  • Athens, Greece
    • Sismanoglio General Hospital
  • Heraklion, Greece
    • University of Crete, Department of Urology
  • Larissa, Greece
    • Department of Urology, University Hospital of Larissa
  • Thessaloníki, Greece
    • 1st Department of Urology, Aristotle University
• India
  • Pune, India
    • Kulkarni Reconstructive Urology Center
  • Rajasthan
    • Ajmer, Rajasthan, India
      • Jawahar Lal Nehru (JLN) Medical College
• Indonesia
  • Bandung, Indonesia
    • Department of Urology, Hasan Sadikin Hospital/Padjadjaran University
  • Denpasar, Indonesia
    • Department of Urology, Sanglah Hospital/Udayana University
  • Jakarta, Indonesia
    • Department of Urology, Cipto Mangunkusumo Hospital/University of Indonesia
  • Malang, Indonesia
    • Department of Urology, Saiful Anwar Hospital/Brawijaya University
  • Surabaya, Indonesia
    • Department of Urology, Dr. Soetomo Hospital/Airlangga University
  • Yogyakarta, Indonesia
    • Department of Urology, Sardjito Hospital/Gadjah Mada University
• Iran, Islamic Republic of
  • Hamadan, Iran, Islamic Republic of
    • Shahid Beheshti Hospital, Hamadan University of Medical Sciences
• Iraq
  • Basra, Iraq
    • University of Basra, College of Medicine, Urology Department
• Kenya
  • Mombasa, Kenya
    • Pandya Memorial Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center
• Malaysia
  • Batu Caves, Malaysia
    • Selayang Hospital
  • Kajang, Malaysia
    • Serdang Hospital
  • Kuala Lumpur, Malaysia
    • University of Malaya
  • Kuala Lumpur, Malaysia
    • Kuala Lumpur Hospital
  • Kuching, Malaysia
    • Sarawak General Hospital
• Romania
  • Bucharest, Romania
    • Department of Urology, St. John Clinical Hospital of Emergency
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Abdulaziz University
  • Jeddah, Saudi Arabia
    • International Medical Center
  • Riyadh, Saudi Arabia
    • Prince Sultan Military Medical City
• South Africa
  • Ga-Rankuwa, South Africa
    • Sefako Makgatho Health Sciences University
• Taiwan
  • Kaohsiung, Taiwan
    • Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung
  • New Taipei City, Taiwan
    • Department of Urology, Cardinal Tien Hospital
  • New Taipei City, Taiwan
    • Department of Urology, En Chu Kong Hospital
  • Taipei, Taiwan
    • Department of Urology, National Taiwan University Hospital
• Turkey
  • Adana, Turkey
    • Department of Urology, Cukurova University, Adana
  • Ankara, Turkey
    • Baskent University, Faculty of Medicine, Department of Urology
  • Ankara, Turkey
    • Department of Urology, Gazi University
  • Ankara, Turkey
    • Department of Urology, Hacettepe University
  • Istanbul, Turkey
    • Cerrahpasa School of Medicine Istanbul University
  • Istanbul, Turkey
    • Department of Urology, University of Health Sciences, Bağcılar Hospital
  • Istanbul, Turkey
    • Istanbul Medipol University, Department of Urology
  • Konya, Turkey
    • Konya Meram Education & Research Hospital
  • Konya, Turkey
    • Necmettin Erbakan University, Meram Medical School
  • Konya, Turkey
    • Selcuk University Selcuklu Medical School
  • Zonguldak, Turkey
    • Department of Urology, Bulent Ecevit University
  • İzmir, Turkey
    • Department of Urology, 9 Eylul University
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients >18 years old with a ureter or renal stone that are planned for ureteroscopic treatment are eligible for this registry.

Description

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

Exclusion Criteria:

• Patient <18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	6 months
Duration of the internal drain indwelling time as indicated by the surgeon [days]	Calculated as number of days.	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.	6 months
Incidence of use of flexible instruments for stent removal following ureteroscopy.	As indicated by treating surgeon [Yes/No response].	6 months

Collaborators and Investigators

• Sponsor: Société Internationale d'Urologie
• Investigators: Principal Investigator: Joyce Baard, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Study Chair: Mihir Desai, MD, University of Southern California, United States; Study Director: Jean de la Rosette, MD, Istanbul Medipol University, Istanbul, Turkey

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: stenting; ureteral stent; stone disease; ureteroscopy treatment; stent placement; postoperative ureteral stenting; Société Internationale d'Urologie; uCARE
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: uCARE 2018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No