Ureteral StonesSTENTIMENTNCT07283003
Evaluating Postoperative Pain After Ureterorenoscopy.
A study testing No Double-J catheter insertion and Double-J catheter in people with Ureteral Stones, run by Lukas J Hefermehl at 1 site in Switzerland.
Trial summary
Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stones
- What is being tested?
- No Double-J catheter insertion and Double-J catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jan 2026to Sep 2027
- 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
- Age 18 years or older
- Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal
- Previous pre-stenting
- Informed Consent as documented
Who cannot join
- Complex ureteral conditions (e.g., known ureteral strictures)
- Impacted stones
- Solitary kidney
- Patients with significant renal stones (>3mm)
- Previous ureteral surgeries (except endoscopic stone treatments)
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baden AG
Baden, 5404
Céline Carole Kurt, +41 56 486 30 83, celine.kurt@ksb.ch
Lukas John Hefermehl, PD Dr. med., +41 56 486 30 92, lukas.hefermehl@ksb.ch
About this study
Official title: Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.
Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.
Read the detailed description
After a ureteroscopy (URS) for the removal of ureteral stones, a double-J stent is routinely placed. Among other measures, this is intended to prevent pain caused by ureteral swelling, small residual fragments, blood clots, and potential drainage obstructions, which could lead to colic or fever. However, the evidence supporting the benefit of this practice is limited. At the same time, many patients report discomfort due to the stent (e.g., flank pain, dysuria, frequent urination, hematuria), which can significantly impact their quality of life.
- Conditions
- Ureteral Stones
- Being tested
- No Double-J catheter insertion, Double-J catheter
- Keywords
- pain app evaluation, ureterorenoscopy, double-J catheter, pain assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Double-J catheter insertionOther
Ureterorenoscopy without consecutive DJ-stent insertion.
Double-J catheterProcedure or surgery
Transurethral catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| No-Stent Group | Active comparator | No postoperative double-J catheter following ureterorenoscopy. Receives: Other: No Double-J catheter insertion |
| Stent Group | Active comparator | Routine postoperative double-J catheter insertion following ureterorenoscopy. Receives: Procedure: Double-J catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment
Assessment of postoperative pain will be conducted using the Visual Analogue Scale (VAS) and the study-specific mobile application HEATMAP (Byldr GmbH, Switzerland). The primary outcome is the difference between the pain scores recorded by the VAS and those recorded by the HEATMAP application at predefined postoperative time points [both measured on a scale from 1-10, with higher scores indicating greater pain].
Measured: up to 4 weeks postoperative
Secondary outcomes (7)
Length of stay [days]
Time from surgery to discharge in days [d]
Measured: During the hospital stay, on average 2 days
Pain Assessment
Assessment of pain level via Visual Analogue Scale (VAS), scale [1-10, higher scores indicates greater pain]
Measured: pre-/peri-/postoperative
Pain Management
Documentation of pain management [according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment]
Measured: pre-/peri-/postoperative
Secondary need of double-J catheter
(Please note, this applies only for patients that where in the intervention group.)
Patient received a double-J catheter, binary [yes/no]
Measured: up to 4 weeks postoperative
Procedure related readmissions
Readmission that can be linked to the URS, binary [Yes/No]
Measured: up to 4 weeks postoperative
Procedure related reoperations
Reoperation that can be linked to the URS, binary [Yes/No]
Measured: up to 4 weeks postoperative
Comprehensive Complication Index
Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]
Measured: up to 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start8 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StonesStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lukas J Hefermehl
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor-investigator, Lukas J Hefermehl, Kantonsspital Baden
- Investigators
- Lukas John Hefermehl, PD Dr. med., Principal investigator, Kantonsspital Baden AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283003
- Sponsor's protocol ID
- 2025-00665
- Other IDs
- 2025
- Acronym
- STENTIMENT
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that will be recorded in this study will be available on reasonable request from the PI
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.
- ClinicalTrials.gov ID
- NCT07283003
- Acronym / sponsor ID
- STENTIMENT / 2025-00665
- Conditions
- Ureteral Stones
- Keywords
- pain app evaluation, ureterorenoscopy, double-J catheter, pain assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lukas J HefermehlUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 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.
Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.
Detailed description
After a ureteroscopy (URS) for the removal of ureteral stones, a double-J stent is routinely placed. Among other measures, this is intended to prevent pain caused by ureteral swelling, small residual fragments, blood clots, and potential drainage obstructions, which could lead to colic or fever. However, the evidence supporting the benefit of this practice is limited. At the same time, many patients report discomfort due to the stent (e.g., flank pain, dysuria, frequent urination, hematuria), which can significantly impact their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Stent Group | Active comparator | Other: No Double-J catheter insertionNo postoperative double-J catheter following ureterorenoscopy. |
| Stent Group | Active comparator | Procedure: Double-J catheterRoutine postoperative double-J catheter insertion following ureterorenoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal
- Previous pre-stenting
- Informed Consent as documented
Key exclusion criteria (6 listed)
- Complex ureteral conditions (e.g., known ureteral strictures)
- Impacted stones
- Solitary kidney
- Patients with significant renal stones (>3mm)
- Previous ureteral surgeries (except endoscopic stone treatments)
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 |
|---|---|---|
| No Double-J catheter insertionUreterorenoscopy without consecutive DJ-stent insertion. | Other | No-Stent Group |
| Double-J catheterTransurethral catheter insertion | Procedure or surgery | Stent Group |
Primary outcome
Postoperative pain assessment
Time frame: up to 4 weeks postoperative
Assessment of postoperative pain will be conducted using the Visual Analogue Scale (VAS) and the study-specific mobile application HEATMAP (Byldr GmbH, Switzerland). The primary outcome is the difference between the pain scores recorded by the VAS and those recorded by the HEATMAP application at predefined postoperative time points [both measured on a scale from 1-10, with higher scores indicating greater pain].
7 secondary outcomes
Length of stay [days]
Time frame: During the hospital stay, on average 2 days
Pain Assessment
Time frame: pre-/peri-/postoperative
Pain Management
Time frame: pre-/peri-/postoperative
Secondary need of double-J catheter
Time frame: up to 4 weeks postoperative
Procedure related readmissions
Time frame: up to 4 weeks postoperative
Procedure related reoperations
Time frame: up to 4 weeks postoperative
Comprehensive Complication Index
Time frame: up to 4 weeks postoperative
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 17 Feb 2026.
- Individual participant dataSharing planned: No. The data that will be recorded in this study will be available on reasonable request from the PI
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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.
Lukas John Hefermehl, PD Dr. med. principal investigator
Kantonsspital Baden AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Double-J catheter insertion and Double-J catheter in people with Ureteral Stones, run by Lukas J Hefermehl at 1 site in Switzerland.
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 4 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 17 Feb 2026. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment (time frame: up to 4 weeks postoperative). 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 17 Feb 2026.