NCT06045962

Brief Summary

The purpose of this study is to determine how soon ureteral stents can be safely removed following surgery.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
2 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2023Sep 2026

First Submitted

Initial submission to the registry

September 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 7, 2023

Last Update Submit

April 16, 2026

Conditions

Ureteral Stent

Outcome Measures

Primary Outcomes (1)

  • Change in Urinary Symptom Scores

    The urinary symptoms will be assessed using the self-reported Canadian Endourology Group Stent Symptom Score. Seven item questionnaire to assess urinary stent symptoms using a 5-point Likert scale; higher score indicated worse outcome.

    Post-operative day 2-3 and 2-3 days after stent removal

Secondary Outcomes (4)

  • Change in Pain Scores

    Post-operative day 2-3 and 2-3 days after stent removal

  • Change in Quality of life

    Post-operative day 2-3 and 2-3 days after stent removal

  • Return to work

    30 days

  • Complications

    30 days

Study Arms (2)

Uncomplicated Ureteroscopy and Stent Placement for 3-5 days

ACTIVE COMPARATOR

After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days

Device: Ureteral stent

Uncomplicated Ureteroscopy and Stent Placement for 7-9 days

EXPERIMENTAL

After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days

Device: Ureteral stent

Interventions

Ureteral stentDEVICE

Used to open the ureter and help the kidney drain

Uncomplicated Ureteroscopy and Stent Placement for 3-5 daysUncomplicated Ureteroscopy and Stent Placement for 7-9 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants undergoing unilateral stone treatment. Patients may have stones present bilaterally, but must only be having unilateral intervention.
  • The ureteroscopy must be uncomplicated
  • Patients undergoing semi-rigid ureteroscopy only, flexible ureteroscopy only, or a combination

You may not qualify if:

  • Pregnancy
  • A stent or nephrostomy tube placed prior to surgery
  • Complex ureteroscopy - ureteral injury, ureteral perforation, ureteral stricture, impacted stone
  • Infection or struvite stones
  • Recurrent Urinary Tract Infection (UTI): 2 culture proven UTI in 6 months or 3 culture proven UTIs in one year
  • No stone evident on ureteroscopic evaluation of ureter or kidney
  • Transplant kidney
  • Variant anatomy (horseshoe, pelvic kidney)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of Arizona

Tucson, Arizona, 85712, United States

Location

University of California San Diego

San Diego, California, 92122, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21206, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T1K2, Canada

Location

University of Montreal

Montreal, Quebec, H3C3J7, Canada

Location

Related Links

Study Officials

  • Karen Stern, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 21, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(9)