Evaluating Postoperative Pain After Ureterorenoscopy. (STENTIMENT)

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.

Study Overview

• Status: Recruiting
• Conditions: Ureteral Stones
• Intervention / Treatment: Other: No Double-J catheter insertion; Procedure: Double-J catheter

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • Kantonsspital Baden AG
    • Contact: Céline Carole Kurt; Phone Number: +41 56 486 30 83; Email: celine.kurt@ksb.ch
    • Contact: Lukas John Hefermehl, PD Dr. med.; Phone Number: +41 56 486 30 92; Email: lukas.hefermehl@ksb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No-Stent Group; No postoperative double-J catheter following ureterorenoscopy.	Other: No Double-J catheter insertion; Ureterorenoscopy without consecutive DJ-stent insertion.
Active Comparator: Stent Group; Routine postoperative double-J catheter insertion following ureterorenoscopy.	Procedure: Double-J catheter; Transurethral catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	up to 4 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay [days]	Time from surgery to discharge in days [d]	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]	pre-/peri-/postoperative
Pain Management	Documentation of pain management [according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment]	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]	up to 4 weeks postoperative
Procedure related readmissions	Readmission that can be linked to the URS, binary [Yes/No]	up to 4 weeks postoperative
Procedure related reoperations	Reoperation that can be linked to the URS, binary [Yes/No]	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)]	up to 4 weeks postoperative

Collaborators and Investigators

• Sponsor: Lukas J Hefermehl
• Collaborators: Kantonsspital Baden
• Investigators: Principal Investigator: Lukas John Hefermehl, PD Dr. med., Kantonsspital Baden AG

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain assessment; ureterorenoscopy; pain app evaluation; double-J catheter
• Other Study ID Numbers: 2025-00665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that will be recorded in this study will be available on reasonable request from the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No