Quality of life with a modified Double-J ureteral stent
Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.
This trial tests whether a modified Double-J stent with a thinner bladder-end loop reduces stent-related symptoms and improves quality of life for adults having ureteroscopy for kidney or ureteral stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Luke's Clinical Hospital, Russia Academic / other |
| Locations | 1 site (Saint Petersburg, Outside U.S./Canada) |
| Trial ID | NCT07275879 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label controlled trial at St. Luke's Clinical Hospital in Saint Petersburg comparing a standard Double-J ureteral stent to a modified stent with a thinner distal loop. Forty adults undergoing ureteroscopy or RIRS for kidney or ureteral stones who are not pre-stented will be randomly assigned to one of the two stent types. Postoperative reflux is measured by gravity-filling cystogram and patient symptoms are tracked using the Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7, and before stent removal. Outcomes will be compared between groups using nonparametric tests for continuous data and chi-square or Fisher's exact test for categorical data.
Who should consider this trial
Good fit: Adults (18+) with kidney or ureteral stones undergoing ureteroscopy/RIRS who are not pre-stented and have no urinary tract infection or upper urinary tract obstruction are ideal candidates.
Not a fit: Patients with urinary tract infections, upper urinary tract obstruction, congenital urinary tract anomalies, pregnancy, pre-stented status, or complicated ureteroscopy (e.g., ureteral perforation) are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the modified stent could cause fewer stent-related symptoms (pain, hematuria, dysuria) and improve patient quality of life after ureteroscopy.
How similar studies have performed: Some prior smaller device and design studies have suggested that distal stent modifications can reduce stent-related symptoms, but published results are mixed and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years and older * Patients with kidney stones * Patients with ureteral stones Exclusion Criteria: * Congenital anomalies of the urinary tract * Urinary tract infections * Upper urinary tract obstruction * Complicated ureteroscopy (e.g., ureteral perforation) * Pregnancy * Pre-stented patients
Where this trial is running
Saint Petersburg, Outside U.S./Canada
- St. Luke's Clinical Hospital — Saint Petersburg, Outside U.S./Canada, Russia (Recruiting)
Study contacts
- Study coordinator: Dmitriy Sytnik
- Email: doc.dmitriysytnik@gmail.com
- Phone: +7 931 367 78 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.