Real-World Study of Obstructive Upper Urinary Tract Stones and Acute Pyelonephritis

NCT07816991 | Not Yet Recruiting

• 1 other identifier: 20260830
• Study Type: observational
• Target: 1,650
• Locations: 0 countries
• Sites: N/A

Brief Summary

Upper urinary tract stone obstruction complicated by acute pyelonephritis is a critical urological emergency requiring urgent decompression and infection control, yet real-world clinical decisions regarding the choice between retrograde ureteral stenting, percutaneous nephrostomy, or initial antibiotic therapy often vary based on physician experience and resource availability. This prospective, multi-center, observational study aims to enroll 1,650 patients across more than 30 hospitals in China to systematically evaluate the technical success rates, infection control efficacy, and safety profiles of these different management strategies. By analyzing natural clinical cohorts without intervening in routine practice, the study seeks to define the optimal application boundaries for retrograde stenting, evaluate the role of nephrostomy as a primary or salvage treatment, and establish risk models to predict the failure of conservative antibiotic therapy, ultimately providing high-level evidence for individualized and precise clinical decision-making.

Conditions

Urolithiasis; Strategy Training; Observation; Pyelonephritis Acute

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate of Retrograde Ureteral Stenting

  Defined as successful retrograde placement of a ureteral stent into the renal pelvis, verified by postoperative imaging for correct positioning.

  Perioperative/Periprocedural

Secondary Outcomes (12)

• Time to Clinical Stability

  from the initiation of the assigned treatment until all the following criteria are met and maintained for a period of 24 hours

• Incidence of Major Complications:

  within 30 days

• Proportion of Salvage Treatment

  Day 1 After Initial Medical Therapy

• Failure of Initial Medical Therapy

  Day 1 After Initial Medical Therapy

• Total length of hospital stay

  From admission to discharge (up to 30 days)

Study Arms (3)

Ureteral Stent (RUS) Group

Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction

Procedure: Ureteral Stent

Percutaneous Nephrostomy (PCN) Group

Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction.

Procedure: Percutaneous Nephrostomy

Initial Medical Therapy Group

Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.

Drug: Initial Medical Therapy

Interventions

Ureteral Stent PROCEDURE

Retrograde placement of a ureteral stent via the transurethral approach to relieve the obstruction.

Ureteral Stent (RUS) Group

Percutaneous Nephrostomy PROCEDURE

Placement of a nephrostomy tube via percutaneous access to provide drainage and relieve the obstruction.

Percutaneous Nephrostomy (PCN) Group

Initial Medical Therapy DRUG

Conservative management with initial antimicrobial therapy to control infection, without immediate surgical drainage.

Initial Medical Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients presenting to emergency or urology departments with acute pyelonephritis secondary to unilateral upper urinary tract stone obstruction. This group represents a clinically high-risk population in the real-world setting, characterized by the presence of both mechanical urinary obstruction (confirmed by imaging) and systemic inflammatory responses. By including patients with symptoms ranging from localized flank pain to systemic markers such as SIRS or qSOFA abnormalities, the cohort encompasses the full clinical spectrum of obstructive pyelonephritis, from early-stage infection to the initial signs of urosepsis. The population reflects real-world clinical practice where urgent decisions must be made between retrograde stenting, percutaneous nephrostomy, or initial conservative medical management.

You may qualify if:

• Informed consent has been obtained from the patient.
• Unilateral upper urinary tract stone obstruction (accompanied by dilatation of the renal pelvis and/or ureter) confirmed by non-contrast CT (NCCT).
• Presence of fever (body temperature ≥38.0°C) and/or chills.
• Meet at least one of the following conditions:
• SIRS Criteria: Meeting at least two of the following: heart rate \>90 bpm; respiratory rate \>20 breaths/min; white blood cell count \>12×10⁹/L or \<4×10⁹/L.
• Flank or Abdominal Pain: Persistent dull pain or colic in the flank or upper abdomen on the affected side.
• qSOFA Abnormality: Meeting at least one of the following: altered mental status; systolic blood pressure \<100 mmHg; respiratory rate ≥22 breaths/min.

You may not qualify if:

• Pregnant or lactating women.
• Non-calculous obstruction (e.g., tumors, retroperitoneal fibrosis, congenital stenosis).
• Any form of drainage or surgical treatment performed on the affected kidney for the target stone prior to admission.
• Concurrent abdominal or pelvic emergency requiring urgent surgery.
• Non-functional affected kidney (preoperative imaging suggesting renal cortical thickness \<5 mm or clinical assessment of no renal function).

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Urolithiasis

Interventions

Nephrostomy, Percutaneous

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Ostomy; Surgical Procedures, Operative; Nephrotomy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Urinary Diversion

Central Study Contacts

Yi Shao

CONTACT

021-63240090; drshaoyi@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share