Evaluating Postoperative Pain After Ureterorenoscopy.

NCT07283003 | Recruiting

• 1 other identifier: 2025-00665
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ureteral Stones

Keywords

pain app evaluation; ureterorenoscopy; double-J catheter; pain assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Length of stay [days]

  During the hospital stay, on average 2 days

• Pain Assessment

  pre-/peri-/postoperative

• Pain Management

  pre-/peri-/postoperative

• Secondary need of double-J catheter

  up to 4 weeks postoperative

• Procedure related readmissions

  up to 4 weeks postoperative

Study Arms (2)

No-Stent Group

ACTIVE COMPARATOR

No postoperative double-J catheter following ureterorenoscopy.

Other: No Double-J catheter insertion

Stent Group

ACTIVE COMPARATOR

Routine postoperative double-J catheter insertion following ureterorenoscopy.

Procedure: Double-J catheter

Interventions

Double-J catheter PROCEDURE

Transurethral catheter insertion

Stent Group

No Double-J catheter insertion OTHER

Ureterorenoscopy without consecutive DJ-stent insertion.

No-Stent Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lukas J Hefermehl: lead
• Kantonsspital Baden: collaborator

Study Sites (1)

Kantonsspital Baden AG

Baden, 5404, Switzerland

RECRUITING

Study Officials

• Lukas John Hefermehl, PD Dr. med.

  Kantonsspital Baden AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)