Ureteral Double-J StentNCT07275879
Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent
A study testing Ureteric stent insertion in people with Ureteral Double-J Stent and Urolithiasis, run by St. Luke's Clinical Hospital, Russia at 1 site in Russia.
Trial summary
Double-J (DJ) stents are commonly inserted after ureteroscopy. There are several complications associated with the presence of DJ stent: urinary tract infection, stent encrustation, stent migration, and stent-related symptoms (SRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Double-J Stent, Urolithiasis, Quality of Life
- What is being tested?
- Ureteric stent insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 28 Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older
- Patients with kidney stones
- Patients with ureteral stones
Who cannot join
- Congenital anomalies of the urinary tract
- Urinary tract infections
- Upper urinary tract obstruction
- Complicated ureteroscopy (e.g., ureteral perforation)
- Pregnancy
- Pre-stented patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
St. Luke's Clinical Hospital
Saint Petersburg, Outside U.S./Canada
Dmitriy Sytnik, +7 931 367 78 58, doc.dmitriysytnik@gmail.com
About this study
Official title: Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.
Double-J (DJ) stents are commonly inserted after ureteroscopy. There are several complications associated with the presence of DJ stent: urinary tract infection, stent encrustation, stent migration, and stent-related symptoms (SRS).
SRS occur in up to 80% of patients and include pain, hematuria, and dysuria, all of which negatively impact the patient's quality of life.
Physicians proposed the distal end of the ureteral stents might involve in SRS by over-simulating the trigone of bladder. The design of the distal end, made with a thinner loop than that of a standard DJ stent, is intended to mitigate SRS and reduce urine reflux.
Read the detailed description
Study Design:
Prospective, randomized, open-label, controlled trial with two parallel arms.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
All patients should not be prestented and should have no ureteral obstruction. 40 patients, divided into four equal groups of 20 people each:
Group I (standard DJ stent):
Group II (modified DJ stent)
Procedure for evaluation:
After surgery ( RIRS, ureteroscopy) reflux is assessed (gravity-filling cystogram). After stenting, the presence of post-stent reflux is assessed.
In the postoperative period, patients complete the USSQ (1st day, 7th day and before stent removal).
Statistics method:
The results are presented as the median and interquartile range (IQR) for continuous variables, and as frequencies (n with percentage %) for categorical variables. Statistical comparisons of all primary and secondary outcome measures between different treatment groups were conducted using the Mann-Whitney U test for continuous data. Meanwhile, categorical variables were analyzed using either Pearson's chi-square (χ²) test or Fisher's exact test, where appropriate. Thenthreshold for statistical significance was established at 5%, implying that a p-value less than 0.05 (p < 0.05) was considered statistically significant for all tests performed.
- Conditions
- Ureteral Double-J Stent, Urolithiasis, Quality of Life
- Being tested
- Ureteric stent insertion
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteric stent insertionProcedure or surgery
Ureteric stent insertion is the procedure to place a thin, flexible plastic tube that is temporarily in the ureter to help urine drain. They are placed with cystoscopic and X-ray guidances in an operating room setting
| Study group | Role | What they receive |
|---|---|---|
| Group I (DJ stent) | Active comparator | Non-prestented patients who will insert a standard DJ stent after surgery Receives: Procedure: Ureteric stent insertion |
| Group II (modified DJ stent) | Experimental | Non-prestented patients who will insert a modified DJ stent after surgery Receives: Procedure: Ureteric stent insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ureteral reflux
Injection of raradiopaque dye using gravity- filling cystogram followed by X-ray imaging. If contrast entered or not entered the ureter and kidney, ureteral reflux was considered positive or not, respectively.
Measured: Intraoperative
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)
Ureteral stent symptom questionnaire (USSQ) a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents.
USSQ contains 38 questions and 2 visual analog scales (VAS), allowing assessment of the severity of SRS and their impact on the patient's quality of life. The questions are grouped into 6 domains:
Urinary symptoms Pain General health Work performance Sexual matters Additional problems For each domain, a score index is calculated as the sum of the points from all questions in that domain. The scale scores range from 1 to 10, with higher values indicating more severe SRS and lower quality of life.
Measured: Postoperative: 1st and 7th day, before stent removal
Secondary outcomes (5)
Patient's height
The patient's height is measured in centimeters.
Measured: Preoperative
Patient's weight
The patient's weight is measured in centimeters.
Measured: Preoperative
Body mass index (BMI)
Body mass index (BMI) is a value derived from the mass (weight) and height of a person.
BMI = kg/m2
Measured: Preoperative
Operative time
total operative time in minutes
Measured: Intraoperative (measured from start to end of procedure)
Surgery
Type of surgery: ureteroscopy or retrograde intrarenal surgery or stenting
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start28 Dec 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Double-J StentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Clinical Hospital, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikheev Yury, St. Luke's Clinical Hospital, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275879
- Sponsor's protocol ID
- 21/4
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07275879
- Acronym / sponsor ID
- 21/4
- Conditions
- Ureteral Double-J Stent, Urolithiasis, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Luke's Clinical Hospital, RussiaUniversity, hospital or other
- Study start
- 28 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-J (DJ) stents are commonly inserted after ureteroscopy. There are several complications associated with the presence of DJ stent: urinary tract infection, stent encrustation, stent migration, and stent-related symptoms (SRS).
SRS occur in up to 80% of patients and include pain, hematuria, and dysuria, all of which negatively impact the patient's quality of life.
Physicians proposed the distal end of the ureteral stents might involve in SRS by over-simulating the trigone of bladder. The design of the distal end, made with a thinner loop than that of a standard DJ stent, is intended to mitigate SRS and reduce urine reflux.
Detailed description
Study Design:
Prospective, randomized, open-label, controlled trial with two parallel arms.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
All patients should not be prestented and should have no ureteral obstruction. 40 patients, divided into four equal groups of 20 people each:
Group I (standard DJ stent):
Group II (modified DJ stent)
Procedure for evaluation:
After surgery ( RIRS, ureteroscopy) reflux is assessed (gravity-filling cystogram). After stenting, the presence of post-stent reflux is assessed.
In the postoperative period, patients complete the USSQ (1st day, 7th day and before stent removal).
Statistics method:
The results are presented as the median and interquartile range (IQR) for continuous variables, and as frequencies (n with percentage %) for categorical variables. Statistical comparisons of all primary and secondary outcome measures between different treatment groups were conducted using the Mann-Whitney U test for continuous data. Meanwhile, categorical variables were analyzed using either Pearson's chi-square (χ²) test or Fisher's exact test, where appropriate. Thenthreshold for statistical significance was established at 5%, implying that a p-value less than 0.05 (p < 0.05) was considered statistically significant for all tests performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (DJ stent) | Active comparator | Procedure: Ureteric stent insertionNon-prestented patients who will insert a standard DJ stent after surgery |
| Group II (modified DJ stent) | Experimental | Procedure: Ureteric stent insertionNon-prestented patients who will insert a modified DJ stent after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and older
- Patients with kidney stones
- Patients with ureteral stones
Key exclusion criteria (6 listed)
- Congenital anomalies of the urinary tract
- Urinary tract infections
- Upper urinary tract obstruction
- Complicated ureteroscopy (e.g., ureteral perforation)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteric stent insertionUreteric stent insertion is the procedure to place a thin, flexible plastic tube that is temporarily in the ureter to help urine drain. They are placed with cystoscopic and X-ray guidances in an operating room setting | Procedure or surgery | Group I (DJ stent), Group II (modified DJ stent) |
Primary outcome
ureteral reflux
Time frame: Intraoperative
Injection of raradiopaque dye using gravity- filling cystogram followed by X-ray imaging. If contrast entered or not entered the ureter and kidney, ureteral reflux was considered positive or not, respectively.
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)
Time frame: Postoperative: 1st and 7th day, before stent removal
Ureteral stent symptom questionnaire (USSQ) a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. USSQ contains 38 questions and 2 visual analog scales (VAS), allowing assessment of the severity of SRS and their impact on the patient's quality of life. The questions are grouped into 6 domains: Urinary symptoms Pain General health Work performance Sexual matters Additional problems For each domain, a score index is calculated as the sum of the points from all questions in that domain. The scale scores range from 1 to 10, with higher values indicating more severe SRS and lower quality of life.
5 secondary outcomes
Patient's height
Time frame: Preoperative
Patient's weight
Time frame: Preoperative
Body mass index (BMI)
Time frame: Preoperative
Operative time
Time frame: Intraoperative (measured from start to end of procedure)
Surgery
Time frame: Preoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteric stent insertion in people with Ureteral Double-J Stent and Urolithiasis, run by St. Luke's Clinical Hospital, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitriy Sytnik (+7 931 367 78 58, doc.dmitriysytnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ureteral reflux (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.