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

NCT03567421 | Completed DMC

• 1 other identifier: uCARE 2018-001
• Study Type: observational
• Target: 2,348
• Locations: 14 countries
• Sites: 49

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of patients requiring secondary interventions [N]

  6 months

• Number of patients requiring pain medication at discharge [N]

  6 months

• Duration of the actual internal drain indwelling time [days]

  6 months

• Duration of the internal drain indwelling time as indicated by the surgeon [days]

  6 months

• % of patients who required anaesthesia for stent removal [Yes/No]

  6 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient \>18 years old
• Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy

You may not qualify if:

• Patient \<18 years old

Sponsors & Collaborators

• Société Internationale d'Urologie: lead

Study Sites (50)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Guangdong Second Provincial General Hospital, The Third Clinical Medical College of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou Medical University and Guangdong Key Laboratory of Urology

Guangzhou, China

Location

Ningbo First Hospital, The Affiliated Hospital of Ningbo University

Ningbo, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Location

Shanghai Changhai Hospital, Second Military Medical University

Shanghai, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Aretaieion Hospital

Athens, Greece

Location

Sismanoglio General Hospital

Athens, Greece

Location

University of Crete, Department of Urology

Heraklion, Greece

Location

Department of Urology, University Hospital of Larissa

Larissa, Greece

Location

1st Department of Urology, Aristotle University

Thessaloniki, Greece

Location

Jawahar Lal Nehru (JLN) Medical College

Ajmer, Rajasthan, India

Location

Kulkarni Reconstructive Urology Center

Pune, India

Location

Department of Urology, Hasan Sadikin Hospital/Padjadjaran University

Bandung, Indonesia

Location

Department of Urology, Sanglah Hospital/Udayana University

Denpasar, Indonesia

Location

Department of Urology, Cipto Mangunkusumo Hospital/University of Indonesia

Jakarta, Indonesia

Location

Department of Urology, Saiful Anwar Hospital/Brawijaya University

Malang, Indonesia

Location

Department of Urology, Dr. Soetomo Hospital/Airlangga University

Surabaya, Indonesia

Location

Department of Urology, Sardjito Hospital/Gadjah Mada University

Yogyakarta, Indonesia

Location

Shahid Beheshti Hospital, Hamadan University of Medical Sciences

Hamadan, Iran

Location

University of Basra, College of Medicine, Urology Department

Basra, Iraq

Location

Pandya Memorial Hospital

Mombasa, Kenya

Location

Selayang Hospital

Batu Caves, Malaysia

Location

Serdang Hospital

Kajang, Malaysia

Location

Kuala Lumpur Hospital

Kuala Lumpur, Malaysia

Location

University of Malaya

Kuala Lumpur, Malaysia

Location

Sarawak General Hospital

Kuching, Malaysia

Location

Department of Urology, St. John Clinical Hospital of Emergency

Bucharest, Romania

Location

International Medical Center

Jeddah, Saudi Arabia

Location

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Prince Sultan Military Medical City

Riyadh, Saudi Arabia

Location

Sefako Makgatho Health Sciences University

Ga-Rankuwa, South Africa

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Division of Urology, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung

Kaohsiung City, Taiwan

Location

Department of Urology, Cardinal Tien Hospital

New Taipei City, Taiwan

Location

Department of Urology, En Chu Kong Hospital

New Taipei City, Taiwan

Location

Department of Urology, National Taiwan University Hospital

Taipei, Taiwan

Location

Department of Urology, Cukurova University, Adana

Adana, Turkey (Türkiye)

Location

Baskent University, Faculty of Medicine, Department of Urology

Ankara, Turkey (Türkiye)

Location

Department of Urology, Gazi University

Ankara, Turkey (Türkiye)

Location

Department of Urology, Hacettepe University

Ankara, Turkey (Türkiye)

Location

Cerrahpasa School of Medicine Istanbul University

Istanbul, Turkey (Türkiye)

Location

Department of Urology, University of Health Sciences, Bağcılar Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Medipol University, Department of Urology

Istanbul, Turkey (Türkiye)

Location

Department of Urology, 9 Eylul University

Izmir, Turkey (Türkiye)

Location

Konya Meram Education & Research Hospital

Konya, Turkey (Türkiye)

Location

Necmettin Erbakan University, Meram Medical School

Konya, Turkey (Türkiye)

Location

Selcuk University Selcuklu Medical School

Konya, Turkey (Türkiye)

Location

Department of Urology, Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 28321499 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi; Ureterolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Study Officials

• Joyce Baard, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Mihir Desai, MD

  University of Southern California, United States

  STUDY CHAIR

• Jean de la Rosette, MD

  Istanbul Medipol University, Istanbul, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 25, 2018
• Study Start: June 7, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

MY (5); IN (2); IR (1); GR (5); ID (6); TU (12); SA (3); US (1); CN (6); KE (1); RO (1); ZA (1); KR (1); TW (4)