Differences in Postoperative Symptoms With Four Ureteral Stents
ConditionUrinary Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.
Disqualifiers
Pregnant patients
Patients with transplant kidneys
Patients with irreversible coagulopathy
Patients with known ureteral stricture disease
Trial design
Design model
Parallel
Treatments tested in this trial
6Fr Percuflex ureteral stents
DeviceThe Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
6Fr Tria ureteral stents
DeviceThe 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.
4.8Fr Tria ureteral stents
DeviceThe 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.
4.8Fr Percuflex ureteral stents
DeviceThe Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy.
Treatment groups
272 Participants
are divided into 4 treatment groupsGroup A: 6Fr Percuflex ureteral stentsActive comparator 1 intervention
Group B: 6Fr Tria ureteral stentsActive comparator 1 intervention
Group C: 4.8Fr Tria ureteral stentsActive comparator 1 intervention
Group D: 4.8Fr Percuflex ureteral stentsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 1-2 weeks after surgery (up to 4 weeks on study)2
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)3
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)4
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)Secondary outcomes
1
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)2
Number of Emergency Room Visits
Data collected from medical record.
Time frame
up to 10 weeks3
Number of Unscheduled Clinic Follow-Ups
Data collected from medical record.
Time frame
up to 10 weeks4
Summary of Additional Prescriptions for Stent-Related Symptoms
Data collected from medical record.
Time frame
up to 10 weeksSponsors and contacts
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Source ClinicalTrials.gov