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NCT Number: NCT07283003

Evaluating Postoperative Pain After Ureterorenoscopy.

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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Key information

Conditions

Ureteral Stones

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Double-J catheter insertion

Other

Ureterorenoscopy without consecutive DJ-stent insertion.

Double-J catheter

Procedure

Transurethral catheter insertion

Primary outcomes

  1. 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].

Secondary outcomes

  1. Length of stay [days]

    Time frame: During the hospital stay, on average 2 days

    Time from surgery to discharge in days [d]

  2. Pain Assessment

    Time frame: pre-/peri-/postoperative

    Assessment of pain level via Visual Analogue Scale (VAS), scale [1-10, higher scores indicates greater pain]

  3. Pain Management

    Time frame: pre-/peri-/postoperative

    Documentation of pain management [according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment]

  4. Secondary need of double-J catheter

    Time frame: 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]

  5. Procedure related readmissions

    Time frame: up to 4 weeks postoperative

    Readmission that can be linked to the URS, binary [Yes/No]

  6. Procedure related reoperations

    Time frame: up to 4 weeks postoperative

    Reoperation that can be linked to the URS, binary [Yes/No]

  7. Comprehensive Complication Index

    Time frame: up to 4 weeks postoperative

    Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]

Sponsors and collaborators

Lead sponsor

Lukas J Hefermehl

Other

Collaborators

  • Kantonsspital Baden

Registry information

Official study title

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

Acronym: STENTIMENT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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