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Stenting After Kidney Stone Removal

N/A

Recruiting

Led By Khurshid Ghani, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Planned bilateral ureteroscopy

Patients who use opiate medication daily for greater than 3 months to manage a painful condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 7-10

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess patient-reported outcomes and unplanned healthcare utilization after ureteroscopic treatment of kidney stones, with or without a stent. Patients will be randomized or surveyed & treated at doctor's discretion.

Who is the study for?

This trial is for individuals undergoing ureteroscopy and lithotripsy for kidney stones no larger than 10mm, who can communicate with the study team and complete surveys in English. It excludes those with certain anatomical abnormalities, chronic opiate users, pregnant women, or those with a solitary kidney.

What is being tested?

The trial examines patient outcomes after kidney stone removal by comparing two approaches: one where a stent is placed post-surgery versus one without stent placement. Participants will either be randomly assigned to a treatment or observed based on physician's choice.

What are the potential side effects?

Potential side effects may include discomfort from the stent if placed, pain at the surgical site, urinary symptoms like urgency or frequency, and possible need for unexpected medical care related to the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a procedure to examine both of my ureters.

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I have been using opiate medication daily for over 3 months for pain management.

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I have a unique kidney shape or position.

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I have a tube inserted in my kidney or ureter before surgery.

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I am scheduled for a follow-up procedure to examine my ureter.

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I have only one working kidney.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative, day 7-10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative, day 7-10

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, day 7-10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Wins from the Hierarchical Unplanned stone treatment related healthcare utilization Composite Rank Score

Patient Reported Outcomes Measurement Information System (PROMIS®) Pain Interference (Short Form 6b) change at Postoperative Day 7-10 compared to preoperative

Secondary study objectives

International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative 4-6 weeks

International Consultation on Incontinence - Satisfaction (ICIQ-S) treatment satisfaction scores at postoperative day 7-10

National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptom Index-10 urinary symptom scores change at postoperative 4-6 weeks compared to preoperative

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Randomized cohort- Stent placementExperimental Treatment2 Interventions

Participants that are eligible and consent for the randomization cohort trial will have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

Group II: Randomized cohort- No stent placementExperimental Treatment2 Interventions

Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed. If participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study. In randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.

Group III: Observational participants - not randomizedExperimental Treatment1 Intervention

Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.

0 / 6Eligibility criteria met