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A randomized, double-blind, parallel-controlled, multicenter clinical study on the prevention of urinary tract infection in patients with indwelling ureteral stents after lithotripsy for renal and ureteral calculi using Longqing Tablets

A randomized, double-blind, parallel-controlled, multicenter clinical study on the prevention of urinary tract infection in patients with indwelling ureteral stents after lithotripsy for renal and ureteral calculi using Longqing Tablets

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094783
Enrollment
Unknown
Registered
2024-12-27
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

urinary tract infection

Interventions

Test group:Longqing tablets, oral, 6 tablets/time, 2 times /d, course: 28 days +/-3 days (from the day of discharge to the day of extubation)
Control group:Longqing tablets analog tablets, oral, 6 tablets/time, 2 times /d, course: 28 days +/-3 days (from the day of discharge to the day of extubation)

Sponsors

Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent; 2. Age 18-65 years old (including boundary value), gender is not limited; 3. No symptoms of systemic infection such as fever (axillary temperature less than 37.3?) before randomization; 4. Single ureteral stent was indwelled after nephroureteral calculus lithotripsy; 5. Postoperative review showed no significant residual stones and the position of ureteral stent was normal.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy to the investigational drug used in this study; 2. Positive white blood cell abnormalities and/or urine culture in random pre-urine routine; 3. Complicated with ureteral stricture, urinary retention, urinary malformation, bladder outlet obstruction, neurogenic bladder, bladder stones and tumors, vesicoureteral reflux or other functional abnormalities, urine flow diversion, chemotherapy or radiation damage to urine patients with high risk of urinary tract infection such as epithelium; 4. Patients with diseases that affect immune function or systemic status, such as hypoproteinemia, diabetes, heart disease cerebrovascular, liver, kidney and hematopoietic diseases; 5. KUB abdominal plain film does not show stone patients, such as uric acid stone, cystine stone patients; 6. Special coating or special material (anti-pressure, anti-bacterial, anti-biofilm, etc.) for ureteral stent piping; 7. Patients with uncontrolled malignant tumors or mental illness; 8. Participate in clinical studies of other drugs or devices within 3 months before the screening period; 9. Those who are not considered suitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Pyuria incidence;

Secondary

MeasureTime frame
Fever incidence;Urinary tract irritation symptom score;Urodynia score;Low back pain score;Incidence of gross hematuria;Urine culture positive rate;Ureteral stent culture positive rate;Biofilm formation of ureteral stents;Formation of ureteral stent wall stones;

Countries

China

Contacts

Public ContactZhiqiang Chen

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

zhqchen8366@163.com+86 139 9551 2271

Outcome results

None listed

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