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

NCT ID: NCT06979583

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Ureteral Stent-Related Symptom Retrograde Intra-renal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A: 4.8 Fr Ureteral stents

Group Type EXPERIMENTAL

4.8 Fr Ureteral stents

Intervention Type DEVICE

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

Group B: 7 Fr Ureteral stents

Group Type EXPERIMENTAL

7 Fr Ureteral stents

Intervention Type DEVICE

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

Interventions

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4.8 Fr Ureteral stents

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

Intervention Type DEVICE

7 Fr Ureteral stents

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Meghan A. Cooper

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meghan A. Cooper, DO

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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24-009000

Identifier Type: -

Identifier Source: org_study_id

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