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Completed

NCT Number: NCT04384939

Feasibility of Magnetic-end Double-J Ureteral Stent Use in Children

Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.

To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.

The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker

Paris, 75015, France

About this study

First reported in 1967, ureteral stenting evolved fast until the introduction of the double-J ureteral stent (DJUS) in 1978. It has since become one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Many modifications have been introduced to Finney's double-J to reduce stent-related complications and disadvantages, one of which is its removal technique. Classically, DJUS are introduced and removed in the operation room (OR), under general anesthesia (GA), using a cystoscope. Efforts have been made to avoid the second procedure under GA. Preventing the patient from undergoing a second OR experience is not the only issue. For institutions, DJUS removal is time consuming and costly in terms of resources, OR occupancy, and staff. In children, the potential neurotoxicity of repeated exposures to GA, is also a major concern.

Alternatives to surgical removal of DJUS vary from basic solutions such as transurethral string, hook, or other tools, to more complex innovations such as the single use flexible cystoscope, and biodegradable stents. Moreover, some pediatric teams used the externalized pyeloureteral stent as an alternative to DJUS. Using magnet for ureteral stent retrieval was introduced in the early 80s. Difficulties related to its insertion, as well as its low retrieval success rate, minimized its acceptance. It wasn't until 2002 when Taylor and McDougall revisited the concept of magnetic retrieval of the ureteral stent. Since then, few teams have published their experience with magnetic-end DJUS.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop. Explanation of the retrieval method and its potential complications are given to the parents, and informed consent obtained prior to surgery. All of the stents are inserted under GA in the exact same manner as regular DJUS: antegrade, retrograde (cystoscopy insertion) or open surgery. The stent's length varies between 12 and 24 cm depending on the age and weight of the child. An abdominal plain X-Ray is routinely done after pyeloplasty to check the position of the DJUS distal loop (MEDJUS or not) in the bladder before waking up the child. A successful stent insertion is defined as having a good position of the distal end and its magnet in the bladder

To remove the magnetic-end Double-J ureteral stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip, lubricated with 2% lidocaine jelly, is inserted into the urethra by the surgeon with the patient breathing inhaled premixed nitrous oxide and oxygen for procedural sedation in the outpatient clinic. Both indwelling magnets connect and the catheter can be removed together with the MEDJUS. Success of magnetic retrieval are regarded as MEDJUS retrieval in outpatient clinic with no need of general anesthesia.

The aim is to demonstrate the feasibility and safety of the magnetic-end DJUS in children and perform a medico-economic study / cost-effectiveness study to evaluate the impact of the use of MEDJUS in children in terms of retrieval time and cost, as well as OR and staff occupancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child aged between 0 and 17 years and 10 months at the surgery
  • Child operated at the Necker hospital for an uropathy or kidney graft need the insertion of JJ ureteral stent
  • Parents or legal guardians signed the Informed consent form
  • Social insurance affiliation

Exclusion criteria

  • All clinical situation need an MRI
  • Contraindication with the experimental medical device (severe infections, obstruction, …)

For the medico-economic study, a comparative group will be constituted with patients treated with classic ureteral stent in the Necker hospital in the previous years.

This group will be matched with age (<5 years, 5-12 years and >13years), sex and surgery indication (kidney graft or other).

Treatment and study plan

magnetic-end Double-J ureteral stent

Device
  • Inserting the ureteral stent with magnet (same process as classic ureteral stent)
  • Removing the ureteral stent with magnet without general anaesthesia. Usually, the classic ureteral stent removed during a general anaesthesia.

Other names: No applied

Primary outcomes

  1. Successful removal of the Double-J ureteral stent with magnet

    Time frame: During the stent removal consultation, usually between 8 and 30 days after the surgery

    A successful removal is a removal of the Double-J (JJ) ureteral stent with the magnet removal system, without general anaesthesia - The measure is a binary criterion: success/ failure, evaluated by the surgeon

Secondary outcomes

  1. Successful insertion of the Double-J ureteral stent with magnet

    Time frame: 1 day

    A successful insertion is an insertion of the JJ ureteral stent with magnet in retrograde, antegrade process or open surgery - The measure is a binary criterion: success/ failure, evaluated by the surgeon

  2. Duration of hospitalization

    Time frame: At the end of the initial hospitalisation, at maximum 60 days

    Number of total days of hospitalization

  3. Costs of hospitalization after surgery

    Time frame: Until the stent removal consultation, usually between 8 and 30 days after the surgery

    Costs of hospitalization after surgery

  4. Pain score

    Time frame: At the end of the stent removal

    EVA or EVENDOL pain assessment on the child's age prior to, during, and subsequent to the removal

  5. Anxiety score

    Time frame: At the end of the stent removal

    Anxiety assessment using the mYPAS scale (modified-Yale Preoperative Anxiety Scale) consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent.- higher score indicating higher anxiety

  6. Satisfaction survey of parents

    Time frame: at the end of the stent removal and day 7 after

    A satisfaction survey that parents completed on D7 and at the end of the stent removal

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children

Acronym: EFUJA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 12, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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