Optimal Stent Duration After Ureteroscopy

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06045962
• Collaborator: (none)
• Enrollment: 172
• Locations: 11
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site: 15.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ureteral Stent	Device: Ureteral stent	N/A

Detailed Description

The rationale for this study is to determine if there is a difference in symptoms or complications among patients undergoing uncomplicated ureteroscopy for stone removal with shorter indwelling stent duration. Currently there are only a few small studies exploring the optimal duration of stent placement after stent placement and no multicenter randomized control trials. Our aim is to determine if earlier ureteral stent removal will reduce urinary symptoms after stent removal and improve quality of life without increasing risk of negative side effects. Using questionnaires for stent related symptoms we will assess stent indwelling time effect on patient reported side effects.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Three vs Seven Day Ureteral Stent Removal After Ureteroscopy on Stent Related Symptoms
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Uncomplicated Ureteroscopy and Stent Placement for 3-5 days After standard of care ureteroscopic procedure stents will be left indwelling for 3-5 days	Device: Ureteral stent; Used to open the ureter and help the kidney drain
Experimental: Uncomplicated Ureteroscopy and Stent Placement for 7-9 days After standard of care ureteroscopic procedure stents will be left indwelling for 7-9 days	Device: Ureteral stent; Used to open the ureter and help the kidney drain

Outcome Measures

Primary Outcome Measures

1. Change in Urinary Symptom Scores [Post-operative day 2-3 and 2-3 days after stent removal]

   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.

Secondary Outcome Measures

1. Change in Pain Scores [Post-operative day 2-3 and 2-3 days after stent removal]

   Pain score as indicated in the self-reported Candian Endourology Group Stent Symptom Score questionnaire with a scale of 0-10 (10 being the worst)

2. Change in Quality of life [Post-operative day 2-3 and 2-3 days after stent removal]

   Change as calculated using the Wisconsin "Living With Kidney Stones" Questionnaire, which is a validated document assessing the quality of life of kidney stone patients. Likert scale 1-5 on 28 items, with a lower score being associated with a lower quality of life.

3. Return to work [30 days]

   Number of days participants return to work

4. Complications [30 days]

   Number of subjects to experience complications assessed by telephone, epic messages, ER visits related to procedure, unanticipated provider visits, and hospitalizations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• 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

Exclusion Criteria

• 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 (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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	University of Arizona	Tucson	Arizona	United States	85712
3	University of California San Diego	San Diego	California	United States	92122
4	Johns Hopkins University	Baltimore	Maryland	United States	21206
5	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905
6	Montefiore Medical Center	Bronx	New York	United States	10467
7	University of North Carolina	Chapel Hill	North Carolina	United States	27514
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	Vanderbilt University	Nashville	Tennessee	United States	37203
10	University of British Columbia	Vancouver	British Columbia	Canada	V6T1K2
11	University of Montreal	Montréal	Quebec	Canada	H3C3J7

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Karen Stern, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Karen L. Stern, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06045962
• Other Study ID Numbers: 22-011586
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Sep 21, 2023