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Safety Study of Ureteral Stents with Strings

Safety Evaluation of Ureteral Stents with Strings after Ureteroscopic/Flexible Ureteroscopic Lithotripsy: A Single-center Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127148
Enrollment
Unknown
Registered
2026-06-25
Start date
2026-06-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Urinary Tract Calculi

Interventions

Research group (2 weeks):A string-attached ureteral stent was indwelled postoperatively and removed two weeks after surgery.
control group(4 weeks):A conventional ureteral stent is indwelled postoperatively and removed via cystoscopy four weeks after surgery.
control group(2 weeks):A conventional ureteral stent is indwelled postoperatively and removed via cystoscopy two weeks after surgery.
Research group (4 weeks):A string-attached ureteral stent was indwelled postoperatively and removed four weeks after surgery.

Sponsors

The Fifth Affiliated Hospital Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients who have voluntarily signed the informed consent form. 2.Patients aged over 18 years old with full capacity for civil conduct. 3.Patients who have been standardly diagnosed with upper urinary tract calculi (including ureteral calculi and/or renal calculi) in accordance with the Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases in China, and are scheduled to undergo ureteroscopic lithotripsy or flexible ureteroscopic lithotripsy.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled urinary tract infections (UTIs) who meet the following criteria: (1) Patients with urinary tract symptoms: Clean-catch midstream urine culture: colony count >= 10^5 CFU/mL (single pathogenic bacterium); OR centrifuged sediment of clean-catch midstream urine: leukocyte esterase (+) or urine leukocyte count >= 10 cells/HPF (high-power field), plus urine culture colony count >= 10^3 CFU/mL (single pathogenic bacterium). (2) Patients without urinary tract symptoms: Two consecutive clean-catch midstream urine cultures showing the same single pathogenic bacterium, with colony count >= 10^5 CFU/mL in both tests. 2. Patients with absolute contraindications to ureteroscopic/flexible ureteroscopic surgery. 3. Patients who are unable to understand or cooperate with the conduct of the trial. 4. Patients requiring percutaneous nephrolithotomy (PCNL). 5. Patients who need long-term indwelling ureteral stents for more than 4 weeks and 2 days after surgery. 6. Patients with any other conditions that the investigators believe may increase risks to the participants or interfere with the clinical trial.

Design outcomes

Primary

MeasureTime frame
Postoperative urinary tract infection rate;

Secondary

MeasureTime frame
complete blood count(white blood cell count etc.);Ureteral stent symptom ;Adverse event rate; Overactive Bladder Symptom Score (OABSS);Lower urinary tract symptoms;visual analogue scale;Procalcitonin;

Countries

China

Contacts

Public ContactYinghao Yin

The Fifth Affiliated Hospital Sun Yat sen University

yinyh25@mail.sysu.edu.cn+86 756 252 8679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026