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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 7-10

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+11 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,346 Total Patients Enrolled

2 Trials studying Kidney Stones

284 Patients Enrolled for Kidney Stones

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,996,666 Total Patients Enrolled

1 Trials studying Kidney Stones

1,290 Patients Enrolled for Kidney Stones

Michigan Urological Surgery Improvement Collaborative (MUSIC)UNKNOWN

1 Previous Clinical Trials

356 Total Patients Enrolled

Media Library

Kidney Stones Research Study Groups: Randomized cohort- No stent placement, Randomized cohort- Stent placement, Observational participants - not randomized

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any possibilities to still join this research endeavor?

"According to clinicaltrials.gov, as of May 9th 2023 this medical trial is not recruiting participants. Although the study was initially posted on June 1st 2023 it has since been closed off and there are 92 other trials actively seeking volunteers in its stead."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative

Khurshid Ghani 2023. "Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05866081.

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