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

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ClinicalTrials.gov Identifier: NCT03567421
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Société Internationale d'Urologie

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.


Condition or disease
Stone;Renal Stone, Kidney Stone Ureter

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of patients requiring secondary interventions [N] [ Time Frame: 6 months ]
    Post-operative secondary interventions include JJ placement, ureter splint placement, nephrostomy tube placement, reURS, clot removal, pharmacological intervention, or other.

  2. Number of patients requiring pain medication at discharge [N] [ Time Frame: 6 months ]
    Pain defined as that requiring additional therapy or pain medication, or prolonged hospital stay due to pain.

  3. Duration of the actual internal drain indwelling time [days] [ Time Frame: 6 months ]
    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)

  4. Duration of the internal drain indwelling time as indicated by the surgeon [days] [ Time Frame: 6 months ]
    Calculated as number of days.

  5. % of patients who required anaesthesia for stent removal [Yes/No] [ Time Frame: 6 months ]
    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. Incidence of use of flexible instruments for stent removal following ureteroscopy. [ Time Frame: 6 months ]
    As indicated by treating surgeon [Yes/No response].



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567421


Contacts
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Contact: Joyce Baard, MD +31612635264 joyce.baard@siu-urology.org
Contact: Christine Albino, MSc. +1 514-875-5665 ext 35 christine.albino@siu-urology.org

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Sponsors and Collaborators
Société Internationale d'Urologie
Investigators
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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

Additional Information:

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
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.

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Responsible Party: Société Internationale d'Urologie
ClinicalTrials.gov Identifier: NCT03567421     History of Changes
Other Study ID Numbers: uCARE 2018-001
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Société Internationale d'Urologie:
stone disease
ureteral stent
stenting
ureteroscopy treatment
stent placement
postoperative ureteral stenting
Société Internationale d'Urologie
uCARE
Additional relevant MeSH terms:
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Kidney Calculi
Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi