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.
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: 1. At the time of stent removal (1-2 weeks after surgery ) (This is standard of care) 2. 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: 1. WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit. 2. ER visits documented in patients chart 3. Unscheduled clinic follow-up documented in patient chart 4. Additional prescriptions for stent related symptoms documented by patient chart 5. Stent complications by fluoroscopy or image 6. Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
272
The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
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.
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.
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
RECRUITINGUreteral 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.
Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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.
Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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.
Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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.
Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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.
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The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
Time frame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
Time frame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
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.
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)
Number of Emergency Room Visits
Data collected from medical record.
Time frame: up to 10 weeks
Number of Unscheduled Clinic Follow-Ups
Data collected from medical record.
Time frame: up to 10 weeks
Summary of Additional Prescriptions for Stent-Related Symptoms
Data collected from medical record.
Time frame: up to 10 weeks
Summary of Stent Complications
Time frame: up to 10 weeks
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.
Time frame: up to 10 weeks