Clinical trial NCT06083051: Differences in Postoperative Symptoms With Four 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 Percuflex Ureteral Stents Versus 4.8Fr Tria Ureteral Stents After Laser Lithotripsy of Renal and Ureteral Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Stone
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
timeFrame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index
timeFrame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
timeFrame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
timeFrame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters
timeFrame: at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms
timeFrame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index
timeFrame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health
timeFrame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance
timeFrame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
measure: Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters
timeFrame: at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study)
Secondary outcomes:
measure: Change in Quality of Life measured by WISQOL Scores
timeFrame: 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)
measure: Number of Emergency Room Visits
timeFrame: up to 10 weeks
measure: Number of Unscheduled Clinic Follow-Ups
timeFrame: up to 10 weeks
measure: Summary of Additional Prescriptions for Stent-Related Symptoms
timeFrame: up to 10 weeks
measure: Summary of Stent Complications
timeFrame: up to 10 weeks
measure: Physician Evaluation of Stent: Survey Scores
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ali Antar, MD
role: PRINCIPAL_INVESTIGATOR
References: