Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent

Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent: a Prospective Study

The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

Study Overview

• Status: Completed
• Conditions: Bacterial Colonization in Double J Ureteral Stent
• Intervention / Treatment: Device: Double J stent

Detailed Description

This was a hospital-based prospective observational study performed at a tertiary academic center from March 2022 to August 2023.

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively with aseptic precaution under local anesthesia (2% lignocaine jelly) with the help of a 30-degree Karl Storze scope with cystoscope sheath 19/21 and alligator forceps following the standard technique. The equipment was sterilized with a 2.45% Cidex solution for 12 minutes prior to all DJS removal. Then the patient was positioned in the lithotomy position, with proper cleaning of the external genitalia with povidone-iodine 10%, complete separation of the labia in the female, and proper cleaning of the prepuce and glans in the male. Then sterile xylocaine jelly 2% was instilled in the urethra, a cystoscope was inserted into the bladder, alligator forceps were inserted, and a DJS was removed. After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation.

The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Colonization is defined as the growth of microorganisms in the tip culture of either end or both ends of DJS. All the demographic data with other study variables were recorded in proforma. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Institute of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively.

Description

Inclusion Criteria:

- Patients undergoing DJ stent placement

Exclusion Criteria:

• Positive urine culture before stenting
• Taking antibiotics during DJS removal
• Presence of yeasts in urine culture
• Declining informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing DJ stent; All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures	Device: Double J stent; Double J ureteral catheter has been used to prevent upper urinary tract obstructions or strictures and to facilitate stone clearance after procedures such as percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and ureteroscopic lithotripsy (URSL).; Other Names: Ureteral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated with bacterial colonization of DJS.	Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.	After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation. The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.	4 weeks

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Risk factors; Colonization; Urinary tract infection; Double J stent
• Other Study ID Numbers: 510 (6-11)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Individual Participant Data (IPD) to be shared for registration on ClinicalTrials.gov will include demographic details (age, sex), preoperative characteristics (hemoglobin levels, albuminuria), procedural information (stent type, duration), microbiological findings (bacterial species, drug sensitivity), and clinical outcomes (complications, mortality). These data will facilitate analysis of risk factors for bacterial colonization in patients with double J ureteral stents and guide future research and clinical practice.
• IPD Sharing Time Frame: Data will be made available after publication of manuscript in the journal.
• IPD Sharing Access Criteria: Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No