Randomized Clinical Trial Evaluating Differences in Postoperative Symptoms With 6Fr Percuflex Ureteral Stents Versus 6Fr Tria Ureteral Stents Versus 4.8Fr Percuflex Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 272
- Locations
- 2
- Primary Endpoint
- Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
Study Overview
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, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
4.8Fr Percuflex ureteral stents
Intervention: 4.8Fr Percuflex ureteral stents (Device)
6Fr Percuflex ureteral stents
Intervention: 6Fr Percuflex ureteral stents (Device)
6Fr Tria ureteral stents
Intervention: 6Fr Tria ureteral stents (Device)
4.8Fr Tria ureteral stents
Intervention: 4.8Fr Tria ureteral stents (Device)
Outcomes
Primary Outcomes
Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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-Pain index
Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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-Pain Index
Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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-Urinary symptoms
Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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-Sexual Matters
Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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-General Health
Time Frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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-Sexual matters
Time Frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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 Outcomes
- Change in Quality of Life measured by WISQOL Scores(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))
- Number of Unscheduled Clinic Follow-Ups(up to 10 weeks)
- Summary of Additional Prescriptions for Stent-Related Symptoms(up to 10 weeks)
- Summary of Stent Complications(up to 10 weeks)
- Physician Evaluation of Stent: Survey Scores(up to 10 weeks)
- Number of Emergency Room Visits(up to 10 weeks)