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A Prospective Randomized Controlled Study on the Efficacy of Triangular Prism-shaped Ureteral Stent in the Treatment of Complex Upper Urinary Tract Stones by Transurethral Flexible Ureteroscopic Lithotripsy

A Prospective Randomized Controlled Study on the Efficacy of Triangular Prism-shaped Ureteral Stent in the Treatment of Complex Upper Urinary Tract Stones by Transurethral Flexible Ureteroscopic Lithotripsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110608
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Patients with complex upper urinary tract stones

Interventions

Test Group:Placement of triangular prism-shaped ureteral stent (F4.8, Guangdong Tianyou Medical Device Technology Development Co., Ltd.)
Control Group:Placement of conventional circular ureteral stent (F4.8, Shenzhen Kangyibo Technology Development Co., Ltd.)

Sponsors

Qingbaijiang District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–70 years, regardless of gender; 2. Diagnosed with complex upper urinary tract calculi by imaging examinations (CT urography/CTU or kidney-ureter-bladder radiography/KUB), meeting any of the following criteria: (1) Renal calculi or upper ureteral calculi with a diameter of >=2 cm; (2) Multiple renal or ureteral calculi (>=2 stones); (3) Impacted upper ureteral calculi accompanied by obvious obstruction; (4) Renal lower calyceal calculi with an infundibulopelvic angle (IPA) of 3 cm); (6) Presence of ureteral urinary diversion or abnormal renal anatomy (ectopic kidney, horseshoe kidney, calyceal diverticulum, etc.); 3. American Society of Anesthesiologists (ASA) physical status classification I–III, and able to tolerate flexible ureteroscope surgery; 4. Signed the informed consent form and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of severe urological malformations or malignant tumors of the urinary system; 2. Presence of severe infection that is poorly controlled; 3. Presence of severe hepatic or renal dysfunction, or coagulation disorders; 4. Allergy to perioperative medications or stent materials; 5. Pregnant or lactating women; 6. Presence of psychiatric disorders or inability to comply with follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Postoperative 2-week VAS pain score;Ureteral stent symptom score;

Secondary

MeasureTime frame
Renal function recovery;Ureteral stent indwelling time;Stone - free rate;

Countries

China

Contacts

Public ContactQilei Jia

Chengdu Qingbaijiang District People's Hospital

2455325477@qq.com+86 189 0807 9103

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026