Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855787
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
MaineHealth
Université de Montréal
University of California, Davis
University of California, San Diego
Indiana University
Information provided by (Responsible Party):
Ryan Hsi, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE February 24, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date March 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2019)
Total number of complications [ Time Frame: 30 days after ureteroscopy ]
Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2019)
  • PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This survey assesses self-reported consequences of pain on relevant aspects of one's life, including engagement with social, cognitive, emotional, physical, and recreational activities. There are 6 questions on the survey. The survey score uses at T-score metric with a mean of 50 and a standard deviation of 10 in a referent population. A higher score denotes greater pain interference in one's life.
  • WISQOL (Wisconsin Stone Quality of Life Questionnaire) [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This is a disease specific quality-of-life instrument designed to assess the impact on patients of stones in the urinary tract. The survey is a 28-item instrument with a 5-point LIkert scale for each item. There are a total of 140 points total, and a difference of 10 points can be considered clinically significant.
  • Cumulative opiate morphine equivalent dosing (MED) [ Time Frame: baseline to 5-10 days after ureteroscopy ]
    This will be the calculated morphine equivalent dosage of all opiate medications that are prescribed after surgery to follow-up at 5-10 days.
  • % return to work [ Time Frame: 5-10 days after ureteroscopy ]
    This is the number of participants that have returned to work at the time of follow-up at 5-10 days divided by the total participants in the group.
  • Number of participants with symptomatic urinary tract infection (UTI) [ Time Frame: Baseline 5-10 days after ureteroscopy ]
    This will be defined as a urine culture positivity (50,000 cfu/mL or more) with urinary symptoms.
  • Number of participants with abnormal imaging findings [ Time Frame: 4-8 weeks after ureteroscopy ]
    Hydronephrosis, hematoma, urinoma on routine postop imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Official Title  ICMJE Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Brief Summary The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.
Detailed Description

Kidney stones affect 9% individuals within the United States, and the prevalence is increasing. Over the last few decades, ureteroscopy has become the most commonly performed stone procedure. However the complication rate after ureteroscopy is not insignificant. Reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization.

A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. The rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. On the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. Additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use.

The clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. Prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed ~15 years ago. Surgical techniques and device innovations have changed the procedure since that time. To date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. In addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Calculi
Intervention  ICMJE Procedure: Ureteroscopy
Ureteroscopy for 1.5cm or less renal stones.
Other Name: Flexible ureteroscopy
Study Arms  ICMJE
  • Active Comparator: Ureteral stent group
    A ureteral stent will be placed after ureteroscopy.
    Intervention: Procedure: Ureteroscopy
  • Active Comparator: No ureteral stent group
    A ureteral stent will not be placed after ureteroscopy.
    Intervention: Procedure: Ureteroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 11, 2023
Estimated Primary Completion Date March 11, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy

Exclusion Criteria:

  • age < 18 years
  • pregnancy status
  • ureteral stone
  • preoperative hydronephrosis
  • indwelling nephrostomy tube
  • planning bilateral ureteroscopy or subsequent staged ureteroscopy
  • solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater)
  • variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Participant eligibility is based on self-representation of gender identity.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ryan Hsi, MD 615-343-2036 ryan.hsi@vumc.org
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03855787
Other Study ID Numbers  ICMJE URSSTONE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ryan Hsi, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE
  • MaineHealth
  • Université de Montréal
  • University of California, Davis
  • University of California, San Diego
  • Indiana University
Investigators  ICMJE
Principal Investigator: Ryan Hsi, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP