Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Quality of life with a modified Double-J ureteral stent

Official title: Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.

Run by St. Luke's Clinical Hospital, Russia · NCT07275879 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorSt. Luke's Clinical Hospital, Russia
Academic / other
Locations1 site (Saint Petersburg, Outside U.S./Canada)
StatusRecruiting
StartedDecember 28, 2025
Main results expectedApril 1, 2026
Study endsApril 2026
Registry record updatedDecember 10, 2025
Trial IDNCT07275879 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • St. Luke's Clinical Hospital
    Saint Petersburg, Outside U.S./Canada, Russia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.