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Evaluating Postoperative Pain After Ureterorenoscopy.

NCT07283003 — Not applicable, Recruiting, 60 participants, Lukas J Hefermehl

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Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.

RegistryNCT07283003, acronym STENTIMENT
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment60 (Estimated)
SponsorLukas J Hefermehl (Other); collaborators: Kantonsspital Baden
ConditionsUreteral Stones
InterventionsNo Double-J catheter insertion, Double-J catheter (Other, procedure)
Datesstart 2026-01-08, primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2025-12-15, last updated 2026-02-17
Locations1 site in Switzerland

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-Summary

Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
No-Stent GroupActive comparatorOther: No Double-J catheter insertionNo postoperative double-J catheter following ureterorenoscopy.
Stent GroupActive comparatorProcedure: Double-J catheterRoutine postoperative double-J catheter insertion following ureterorenoscopy.
  • No Double-J catheter insertion (Other): Ureterorenoscopy without consecutive DJ-stent insertion.
  • Double-J catheter (Procedure): Transurethral catheter insertion

+Outcome measures

Primary outcomes

  • Postoperative pain assessment [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 \[both measured on a scale from 1-10, with higher scores indicating greater pain\].

Secondary outcomes

  • Length of stay [days] [During the hospital stay, on average 2 days]: Time from surgery to discharge in days \[d\]
  • Pain Assessment [pre-/peri-/postoperative]: Assessment of pain level via Visual Analogue Scale (VAS), scale \[1-10, higher scores indicates greater pain\]
  • Pain Management [pre-/peri-/postoperative]: Documentation of pain management \[according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment\]
  • Secondary need of double-J catheter [up to 4 weeks postoperative]: (Please note, this applies only for patients that where in the intervention group.) Patient received a double-J catheter, binary \[yes/no\]
  • Procedure related readmissions [up to 4 weeks postoperative]: Readmission that can be linked to the URS, binary \[Yes/No\]
  • Procedure related reoperations [up to 4 weeks postoperative]: Reoperation that can be linked to the URS, binary \[Yes/No\]
  • Comprehensive Complication Index [up to 4 weeks postoperative]: Any complication that occurred within 30 days post surgery, Scale \[from 0 (no complication) to 100 (death)\]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age 18 years or older
* Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal
* Previous pre-stenting
* Informed Consent as documented

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
Kantonsspital Baden AGBadenSwitzerlandRecruiting

+Investigators

+Funding

NIH grants: 2025

My Notes