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

NCT06979583 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-009000
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retrograde Intra-renal Surgery; Ureteral Stent-Related Symptom

Outcome Measures

Primary Outcomes (1)

• Pain score post ureteroscopy procedure until stent removal determined by the primary operating team. Stent will be on a string

  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.

  Starting post-operatively, daily, until stent is removed (estimated 7-14 days)

Secondary Outcomes (1)

• Volume of post-operative correspondence between patients and medical system.

  14 days

Study Arms (2)

Group A: 4.8 Fr Ureteral stents

EXPERIMENTAL

Device: 4.8 Fr Ureteral stents

Group B: 7 Fr Ureteral stents

EXPERIMENTAL

Device: 7 Fr Ureteral stents

Interventions

7 Fr Ureteral stents DEVICE

After surgery, patients will have the Bard 7 Fr ureteral stent placed.

Group B: 7 Fr Ureteral stents

4.8 Fr Ureteral stents DEVICE

After surgery, patients will have the Boston Scientific 4.8 Fr ureteral stent placed.

Group A: 4.8 Fr Ureteral stents

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Meghan A. Cooper, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)