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A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi

A Comparative Study of Three Ureteral Stenting Strategies After Ureteroscopic Lithotripsy for Upper Urinary Tract Calculi

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07616505
Enrollment
90
Registered
2026-06-01
Start date
2026-05-12
Completion date
2026-12-31
Last updated
2026-06-01

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

Conditions

Upper Urinary Tract Calculi

Keywords

tubeless, ureteroscopic lithotripsy, Upper urinary tract calculi

Brief summary

In recent years, with the widespread popularization of the enhanced recovery after surgery (ERAS) concept, tubeless ureteroscopic lithotripsy (URL) has gradually become a research hotspot. Multiple studies have indicated that tubeless management may be safe and feasible for strictly selected low-risk patients, and can prevent stent-related complications. Nevertheless, high-quality three-arm controlled trial evidence is still lacking regarding whether complete tubeless management is applicable to all patients with conventional urolithiasis, and whether an optimal time window exists to balance safety and comfort when ureteral stenting is mandatory. Most existing studies only compare stenting versus non-stenting, or long-term versus short-term stenting, without systematic comparison of tubeless management, short-term stenting (1-week indwelling) and conventional stenting (2-week indwelling) within a unified framework. In summary, although URL techniques have matured, numerous uncertainties remain in postoperative ureteral stent management strategies. Rigorously designed prospective studies are urgently needed in clinical practice to comprehensively evaluate differences in complication control, patient quality of life (assessed by the Ureteral Stent Symptom Questionnaire \[USSQ\]), unplanned readmission rates and health-economic costs among three management modalities: tubeless approach, stent removal at postoperative 1 week and stent removal at postoperative 2 weeks. This study aims to fill this evidence gap, provide high-level evidence-based medical references for urologists to develop individualized and precise postoperative ureteral stent management protocols, and ultimately achieve dual optimization of patients' recovery speed and quality of life.

Interventions

PROCEDUREUpper urinary tract calculi

Group A (Tubeless Group): No Double-J stent is placed after confirming no severe injury or significant residual calculi upon surgery completion. Postoperative routine anti-inflammatory treatment and fluid infusion are administered. Group B (1-Week Stent Group): A 4.7Fr or 6Fr Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 7 (±1 day). Group C (2-Week Stent Group): The same type of Double-J stent is indwelled postoperatively. Stent removal is performed via outpatient cystoscopy at postoperative day 14 (±2 days). Standardization: All operations are performed by the same team of senior attending physicians with identical brand laser devices and stents. Perioperative medication regimens are consistent across all groups.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Aged ≥18 years; diagnosed with unilateral upper urinary tract calculi (ureteral calculi or renal pelvic/calyceal calculi, diameter ≤2 cm) by computed tomography (CT) or ultrasonography. Scheduled for ureteroscopic lithotripsy (URL), including rigid or flexible ureteroscopy.

Exclusion criteria

* Patients undergoing bilateral surgery. Pregnant or lactating women. Patients with pre-existing ureteral stents at the time of ureteroscopy. Patients with anatomical abnormalities (e.g., horseshoe kidney, pelvic kidney, solitary kidney) or renal transplant recipients. Patients with systemic infectious manifestations. Patients unable to provide informed consent. Patients with uncontrolled coagulopathy, severe preoperative hydronephrosis or pyonephrosis. Patients with incomplete clearance of stone fragments during primary ureteroscopic lithotripsy (URSL).

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative complications1 month

Contacts

CONTACTHong He
zrhh@zju.edu.cn+8613757118231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026