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Ureteral Stents for Kidney Stones
N/A
Recruiting
Led By Stephen Nakada, MD, FACS, FRCS
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.
Be older than 18 years old
Must not have
Patients with transplant kidneys
Patients who have stent placed before surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative visit (baseline), the stent removal 1-2 weeks after surgery (up to 4 weeks on study), and one post-operative visit 3-6 weeks after surgery (up to 10 weeks on study)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests different types of stents after ureteroscopy to treat urinary stones, with 192 participants studied for up to 10 weeks.
Who is the study for?
This trial is for patients with kidney or ureteral stones needing endoscopic treatment and stent placement. It's not for pregnant individuals, those with transplant kidneys, irreversible coagulopathy, known ureteral strictures, planned staged procedures, or pre-surgery stents.
What is being tested?
The study compares postoperative symptoms from three types of ureteral stents after laser lithotripsy: a smaller 4.8Fr Tria stent and two larger ones - a 6Fr Percuflex and a 6Fr Tria. Participants are randomly assigned to one of these options.
What are the potential side effects?
Potential side effects may include discomfort while urinating, blood in urine, lower back pain due to the presence of the stent, urinary urgency or frequency, and possible infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a procedure for kidney or ureter stones that involves placing a stent.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a transplanted kidney.
Select...
I have had a stent placed before undergoing surgery.
Select...
I have a permanent blood clotting disorder.
Select...
I have a known condition of narrowed ureters.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index
+4 moreSecondary study objectives
Change in Quality of Life measured by WISQOL Scores
Number of Emergency Room Visits
Number of Unscheduled Clinic Follow-Ups
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Active Control
Group I: 4.8Fr Percuflex ureteral stentsActive Control1 Intervention
Group II: 6Fr Percuflex ureteral stentsActive Control1 Intervention
Group III: 6Fr Tria ureteral stentsActive Control1 Intervention
Group IV: 4.8Fr Tria ureteral stentsActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,707 Total Patients Enrolled
4 Trials studying Kidney Stones
3,680 Patients Enrolled for Kidney Stones
Stephen Nakada, MD, FACS, FRCSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
310 Total Patients Enrolled
1 Trials studying Kidney Stones
310 Patients Enrolled for Kidney Stones
Ali Antar, MDPrincipal InvestigatorUniversity of Wisconsin, Madison