Differences in Postoperative Symptoms With Three Ureteral Stents
Primary Purpose
Urinary Stone
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6Fr Percuflex ureteral stents
6Fr Tria ureteral stents
4.8Fr Tria ureteral stents
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stone
Eligibility Criteria
Inclusion Criteria: Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room. Exclusion Criteria: Pregnant patients Patients with transplant kidneys Patients with irreversible coagulopathy Patients with known ureteral stricture disease Non-English speaking, vulnerable patients such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled. Patients with planned staged procedures. Patients who have stent placed before surgery.
Sites / Locations
- University of Wisconsin School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
6Fr Percuflex ureteral stents
6Fr Tria ureteral stents
4.8Fr Tria ureteral stents
Arm Description
Outcomes
Primary Outcome Measures
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The General Health subscale score range from 6-28.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-28.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.
Secondary Outcome Measures
Change in Quality of Life measured by WISQOL Scores
WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 5-30. In the study, standardized total score is used. The range of the standardized total score is 0-100.
Number of Emergency Room Visits
Data collected from medical record.
Number of Unscheduled Clinic Follow-Ups
Data collected from medical record.
Summary of Additional Prescriptions for Stent-Related Symptoms
Data collected from medical record.
Summary of Stent Complications
Physician Evaluation of Stent: Survey Scores
Physicians will complete a one page survey at the end of the case evaluating the stent. Scores are from 0-5 where higher scores indicate a more positive evaluation.
Full Information
NCT ID
NCT06083051
First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT06083051
Brief Title
Differences in Postoperative Symptoms With Three Ureteral Stents
Official Title
Randomized Clinical Trial Evaluating Differences in Postoperative Symptoms With 6Fr Percuflex Ureteral Stents Versus 6Fr Tria Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 192 participants will be enrolled and will be on study for up to approximately 10 weeks.
Detailed Description
The investigators will compare Ureteral Stent Symptom Questionnaire (USSQ) scores with each ureteral stent. Laser lithotripsy is a surgical procedure performed during stone surgeries. The Percuflex ureteral stent and Tria ureteral stent are FDA approved and clinically used in the United States.
A total of 3 clinic visits (i.e., pre-operative visit, the stent removal 1-2 weeks after surgery, and one post-operative visit 3-6 weeks after surgery) in addition to the surgery will be needed for this study. The patient's demographic information and medical background data will be collected from the medical record.
The USSQ will be administered twice:
At the time of stent removal (1-2 weeks after surgery ) (This is standard of care)
At the first postoperative follow-up after stent removal (3-6 weeks) (This is the standard of care).
The following information will be collected as secondary outcomes:
WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit.
ER visits documented in patients chart
Unscheduled clinic follow-up documented in patient chart
Additional prescriptions for stent related symptoms documented by patient chart
Stent complications by fluoroscopy or image
Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6Fr Percuflex ureteral stents
Arm Type
Active Comparator
Arm Title
6Fr Tria ureteral stents
Arm Type
Active Comparator
Arm Title
4.8Fr Tria ureteral stents
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
6Fr Percuflex ureteral stents
Intervention Description
The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
Intervention Type
Device
Intervention Name(s)
6Fr Tria ureteral stents
Intervention Description
The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 6 Fr is the diameter.
Intervention Type
Device
Intervention Name(s)
4.8Fr Tria ureteral stents
Intervention Description
The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 4.8 Fr is the diameter.
Primary Outcome Measure Information:
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.
Time Frame
at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.
Time Frame
at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The General Health subscale score range from 6-28.
Time Frame
at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.
Time Frame
at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.
Time Frame
at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54.
Time Frame
at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37.
Time Frame
at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-28.
Time Frame
at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15.
Time Frame
at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Title
Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters
Description
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.
Time Frame
at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Secondary Outcome Measure Information:
Title
Change in Quality of Life measured by WISQOL Scores
Description
WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 5-30. In the study, standardized total score is used. The range of the standardized total score is 0-100.
Time Frame
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)
Title
Number of Emergency Room Visits
Description
Data collected from medical record.
Time Frame
up to 10 weeks
Title
Number of Unscheduled Clinic Follow-Ups
Description
Data collected from medical record.
Time Frame
up to 10 weeks
Title
Summary of Additional Prescriptions for Stent-Related Symptoms
Description
Data collected from medical record.
Time Frame
up to 10 weeks
Title
Summary of Stent Complications
Time Frame
up to 10 weeks
Title
Physician Evaluation of Stent: Survey Scores
Description
Physicians will complete a one page survey at the end of the case evaluating the stent. Scores are from 0-5 where higher scores indicate a more positive evaluation.
Time Frame
up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.
Exclusion Criteria:
Pregnant patients
Patients with transplant kidneys
Patients with irreversible coagulopathy
Patients with known ureteral stricture disease
Non-English speaking, vulnerable patients such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
Patients with planned staged procedures.
Patients who have stent placed before surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Li
Phone
608.263.8336
Email
lis@urology.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nakada, MD, FACS, FRCS
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Differences in Postoperative Symptoms With Three Ureteral Stents
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