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NCT Number: NCT07616505

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Upper urinary tract calculi

Procedure

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.

Other names: Double-J stent indwelling for 1 week postoperatively, Double-J stent indwelling for 2 weeks postoperatively

Primary outcomes

  1. Incidence of postoperative complications

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.