Comparison of standard JJ stents to magnetic JJ stents with regard to stent placement and removal discomfort and cost analysis
| ISRCTN | ISRCTN11897665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11897665 |
| Secondary identifying numbers | ECM 4 (c) 07/07/2020 |
- Submission date
- 15/01/2021
- Registration date
- 22/01/2021
- Last edited
- 16/10/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English summary of protocol
Background and study aims
For over 40 years ureteric stents have been used in urology and the placement of a ureteral stent is the most frequent urological intervention performed. Modern ureteric stents are thin, flexible plastic tubes which are curled at both ends to avoid damaging the kidney and urinary bladder and to prevent it from dislocating.
There are certain reasons for stent placement, for example after kidney stone removal. Unfortunately up to 80% of patients complain about irritative voiding (urinating) symptoms after stent implantation. Usually, the stent is removed after 7‐14 days. The standard procedure to remove a stent is by cystoscopy.
The cystoscopic removal of stents can be unpleasant and needs specific preparation for up to 30 minutes. The idea to remove a stent by using two magnets has been tried to be implemented for over 10 years and only recently have magnetic stents been available. Despite the wide adoption of magnetic stents worldwide, there is a relative lack of data to support their use compared to non-magnetic stents.
The aim of this study is to assess the effectiveness of a magnetic stent that allows for removal without cystoscopy. The impact on patient’s quality of life in terms of stent and stent removal related symptoms, as well as the stent removal, will especially be addressed.
Who can participate?
All patients who had a short term (<6 weeks) stent placed, either magnetic or conventional
What does the study involve?
When it is time to place a stent at the end of a ureteroscopy procedure, participants are randomly allocated to have either a magnetic stent or a conventional ureteric stent placed. When the patients return to have their stent removed, they will undergo a quality of life assessment with a symptom questionnaire. After the stent is removed, the discomfort caused by the removal is recorded. Patients will be followed up for a minimum of 6 months.
What are the possible benefits and risks of participating?
There is no direct benefit to participants. However, there is a benefit to society, as participating in this study will increase knowledge about which type of stent is more comfortable for patients and which removal method is least painful. Participants may require a stent regardless of being in the study. Both types of stents are commonly used already and participating in this study has no risk.
Where is the study run from?
Mercy University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
July 2020 to February 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Derek Hennessey
dhennessey@muh.ie
Contact information
Public
14 Rosefield
Model Farm Road
Cork
T12 VKP1
Ireland
| Phone | +353 (0)830333325 |
|---|---|
| dhennessey@muh.ie |
Study information
| Study design | Prospective randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN11897665_PIS.docx |
| Scientific title | A prospective single-centre randomised control trial of magnetic DJ stents versus conventional DJ stents |
| Study objectives | That magnetic DJ stents are superior to conventional DJ stents with regard to removal discomfort and cost. |
| Ethics approval(s) | Approved 22/09/2020, Clinical Research Ethics Committee Of the Cork Teaching Hospitals (Lancaster Hall, 6 Little Hanover Street, Cork, Ireland; +353 (0)21 4901901; crec@ucc.ie), ref: ECM 4 (c) 07/07/2020, ECM 3 (z) 20/10/2020 |
| Health condition(s) or problem(s) studied | Post ureteroscopy renal drainage with a DJ stent |
| Intervention | When it is time to place a ureteric stent at the end of a ureteroscopy procedure, a random number generator will be used to generate a number. When an even number is generated, a magnetic ureteric stent will be placed, and an odd number meaning a conventional ureteric stent will be placed. When the patients return to have their stent removed, they will undergo a quality of life assessment with a ureteral symptom questionnaire (USSQ). After the stent is removed, a visual analogue scale (VAS) will be used to document the discomfort caused by the D J‐removal. Patients will be followed up for a minimum of 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Quality of life assessed using ureteral symptom questionnaire (USSQ) immediately prior to JJ stent removal 2. Stent removal pain assessed using a visual analogue scale (VAS) after JJ stent removal |
| Secondary outcome measures | Cost of each type of stent, including removal, measured using Total Resource Use Index after data collection is complete |
| Overall study start date | 01/07/2020 |
| Completion date | 02/02/2024 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | All patients who had a short term (<6 weeks) JJ stent placed, either magnetic or conventional |
| Key exclusion criteria | 1. Patients aged under 18 years 2. Pregnant women 3. Sheltered patients 4. Patients taking alpha-blockers or anticholinergics |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 02/02/2024 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Cork
T12 WE28
Ireland
Sponsor information
Hospital/treatment centre
Grenville Place
Cork
T12 WE28
Ireland
| Phone | +353 (0)21 427 1971 |
|---|---|
| enquiries@muh.ie | |
| Website | https://www.muh.ie/ |
"ROR" |
https://ror.org/017q2rt66 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To publish the results in an international journal and present data at national and international conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/02/2021 | No | Yes | ||
| Protocol file | 04/02/2021 | No | No |
Additional files
- ISRCTN11897665_PROTOCOL.docx
- uploaded 04/02/2021
- ISRCTN11897665_PIS.docx
- uploaded 04/02/2021
Editorial Notes
16/10/2024: The following changes were made to the trial record:
1. The study was stopped due to poor recruitment.
2. The participant level data sharing statement was changed from Available on request to Not expected to be made available.
12/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2021 to 31/10/2024.
2. The overall end date was changed from 02/02/2022 to 02/02/2024.
3. The intention to publish date was changed from 02/02/2021 to 02/02/2024.
4. The plain English summary was updated to reflect these changes.
01/03/2021: Due to unexpected circumstances, the trial sponsor has to be changed. A new sponsor is being sought. No recruitment has taken place and is on hold until this issue is resolved.
15/02/2021: The overall trial end date was changed from 02/02/2021 to 02/02/2022.
04/02/2021: The following changes were made to the trial record:
1. The participant information sheet was uploaded as an additional file.
2. Uploaded protocol (not peer reviewed) Version n/a, no date.
21/01/2021: Trial's existence confirmed by the Clinical Research Ethics Committee Of the Cork Teaching Hospitals.
