Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain

Not Applicable

Not yet recruiting

• Conditions: Ureteral Stent-Related Symptom; Retrograde Intra-renal Surgery

• Registration Number: NCT06979583
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to determine if post-operative stent size impacts stent-related pain and discomfort.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06
• Primary Completion: 2026-04
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing a retrograde intra-renal surgery (RIRS) (only patients undergoing the procedure for stone treatment will be included) who will require post-operative indwelling ureteral stent placement on a string at the conclusion of the procedure.

Exclusion Criteria

• Patients with intra-operative ureteral injury who will require ureteral stent for extended time (more than 10 days, in that case a stent without a string will be used).
• Patient undergoing ureteroscopy for any indication other than stone extraction.
• Patients who are currently pregnant as determined by clinical presurgical screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string	Starting post-operatively, daily, until stent is removed (estimated 7-14 days)	Post-operatively, patient will be contacted by study coordinators every day until stent is removed (usually 7-14 days after the surgery) to scale their stent pain on a scale from 1-5 as following: No pain: 1; Mild pain with no need for additional medication: 2; Mild pain with need for additional medication (anticholinergics): 3; Moderate stent pain (requiring narcotics): 4; Severe stent pain (requiring ER visit): 5.

Secondary Outcome Measures

Name	Time	Method
Volume of post-operative correspondence between patients and medical system.	14 days	Total number of communications received from patient post-operatively.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States