Back to resultsThe Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Primary Purpose
Ureteroscopy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement of ureteral stent
Sponsored by
About this trial
This is an interventional treatment trial for Ureteroscopy
Eligibility Criteria
Inclusion Criteria:
- Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.
Exclusion Criteria:
- Stone size greater than 1.5 cm on preoperative imaging
- Pregnancy
- Stent placement prior to ureteroscopy ("pre-stented patients")
- Patients with solitary kidney
Sites / Locations
- BAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stent
No stent
Arm Description
Outcomes
Primary Outcome Measures
Postoperative complications
ED returns, Unplanned OR returns, admissions, UTIs
Secondary Outcome Measures
Subjective patient symptom scores
symptom questionnaires
Full Information
NCT ID
NCT03130907
First Posted
April 24, 2017
Last Updated
June 1, 2020
Sponsor
San Antonio Uniformed Services Health Education Consortium
1. Study Identification
Unique Protocol Identification Number
NCT03130907
Brief Title
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Official Title
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Antonio Uniformed Services Health Education Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent
Arm Type
Active Comparator
Arm Title
No stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Placement of ureteral stent
Intervention Description
will randomize groups to either receive a postoperative ureteral stent or not.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
ED returns, Unplanned OR returns, admissions, UTIs
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Subjective patient symptom scores
Description
symptom questionnaires
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.
Exclusion Criteria:
Stone size greater than 1.5 cm on preoperative imaging
Pregnancy
Stent placement prior to ureteroscopy ("pre-stented patients")
Patients with solitary kidney
Facility Information:
Facility Name
BAMC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
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