Turning the tip of the stent upside down may ease urinary symptoms
| ISRCTN | ISRCTN17937257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17937257 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Gebze Medical Park Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 15/10/2024
- Registration date
- 22/10/2024
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study aims to find out if changing the direction of a double-j stent placed in the ureter can reduce the uncomfortable urinary symptoms that patients often experience. The researchers want to see if turning the tip of the stent outward instead of inward makes a difference.
Who can participate?
Patients who have undergone a procedure called ureteroscopy for kidney or ureteral stones and have had a double-j stent inserted can participate in this study.
What does the study involve?
Participants will be divided into two groups based on the direction of their ureteral stent. They will fill out a questionnaire about their symptoms before and after the treatment. The researchers will compare the results to see if there is a difference between the two groups.
What are the possible benefits and risks of participating?
The possible benefit of participating is that it may help identify a better way to place stents that reduces urinary symptoms. The risks are minimal and are mainly related to the standard procedure of having a stent placed.
Where is the study run from?
The study is being conducted at Medical Park Gebze Hospital Urology Clinic (Turkey)
When is the study starting and how long is it expected to run for?
May 2023 to September 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr. Goksel Bayar, goxelle@yahoo.com
Contact information
Public, Scientific, Principal investigator
Guzelller mah kavak cad medical park hastanesi
Kocaeli
34363
Türkiye
 ORCID ID |
0000-0003-1506-9732 |
|---|---|
| Phone | +90 5315849749 |
| goksel.bayar@medicalpark.com.tr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized controlled |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reverse placement of a double J ureteral stent improve lower urinary tract symptoms |
| Study objectives | If we place the tip of the stent upside down, we can reduce contact with the bladder trigone. In this way, the patient's complaints can be reduced. |
| Ethics approval(s) |
Approved 01/06/2024, Istinye university local ethics committee (Hamidiye, Kâğıthane, İstanbul, 34408, Türkiye; +90 8502836000; info@istinye.edu.tr), ref: 24-120 |
| Health condition(s) or problem(s) studied | Improve lower urinary tract symptoms on patients that inserted double-j stent |
| Intervention | At the end of ureteroscopy, double-j stent was inserted as normal in control group and reverse in study group. Follow-up duration was until removed stent from kidney about a month. Randomisation was performed online on website:https://clincalc.com/stats/samplesize.aspx) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Ureteral stent symptoms questionnaire score before stent removal |
| Key secondary outcome measure(s) |
Pain measured as use of painkiller or not, measured by interview before stent removal |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 140 |
| Total final enrolment | 116 |
| Key inclusion criteria | Patient underwent ureteroscopy and inserted double-j stent |
| Key exclusion criteria | 1. Bilateral operation performed 2. Have previous lower urinary tract symptoms (etc. prostate hyperplasia, overactive bladder) 3. Pregnant |
| Date of first enrolment | 05/06/2024 |
| Date of final enrolment | 05/08/2024 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Kocaeli
41400
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/02/2025 | 25/02/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/02/2025: Publication reference added.
17/10/2024: Trial's existence confirmed by Istinye university local ethics committee.
