Ureteral Stent-Related Symptom
Conditions
Brief summary
Placement of a ureteral stent at the end of ureteroscopy is commonly performed in endourology. The purpose of this study is to determine whether ureteral stents whose lengths are calibrated to a participant's specific ureteral length based on imaging are better tolerated than one-size-fits-all variable length ureteral stents. The investigators hypothesize that ureteral stent lengths calibrated to the ureteral length of each participant will be better tolerated.
Interventions
DEVICEVariable length ureteral stent
Placement of variable length ureteral stent at the end of ureteroscopy. The variable length stent is a one-size-fits-all stent that measures 22-30cm.
DEVICEImage-informed length ureteral stent
Placement of image-informed length ureteral stent at the end of ureteroscopy. The length will be 22cm, 24cm, or 26cm depending on the distance of the renal vein to ureterovesical junction on imaging.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female age 18-80 years 2. Urolithiasis requiring ureteroscopic management with ureteral stent placement 3. CT scan showing evidence of upper tract urolithiasis 4. Negative pre-operative urine culture 5. No symptoms of urinary tract infection
Exclusion criteria
1. Known urinary tract anatomical abnormality, reconstructed urinary system, or congenital anomaly 2. Ureteral stent inserted within the last 31 days 3. History of peptic ulcer disease, symptomatic benign prostatic hyperplasia, interstitial cystitis, chronic pelvic pain syndrome, neurogenic lower urinary tract dysfunction, ureteral stricture disease 4. Chronic narcotic use 5. Allergy to non-steroidal anti-inflammatory medications 6. Documentation of urinary tract infection within the last 31 days 7. Pregnant 8. Surgery being performed on transplanted kidney 9. Unable to understand the questionnaire 10. Requiring metallic stent placement 11. Requiring bilateral or long-term stent insertion 12. Requiring stent insertion after open or percutaneous renal procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in scores as measured by the USSQ between the two treatment arms. | 5 hours post-surgery | The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the rate of adverse events between the two treatment arms. | From enrollment until 30 days after end of treatment, an average of 5 weeks. | Adverse events include but are not limited to early stent removal due to stent-related symptoms, stent migration, and failure of stent insertion. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
PRINCIPAL_INVESTIGATORLuay Alshara, MD
Weill Medical College of Cornell University
Outcome results
None listed