Double J Stent
Conditions
Keywords
DJ stent, Double J stent, ureteric stent, Biofilm, Mucolytic, Linezolid
Brief summary
Indwelling Double J (DJ) ureteral stents are commonly used following lithotripsy to ensure adequate urinary drainage and prevent obstruction. However, stent-related biofilm formation remains a significant clinical problem, contributing to infection, encrustation, patient discomfort, and stent failure. Biofilms consist of microbial communities embedded within an extracellular polymeric substance (EPS), which protects microorganisms from host defenses and antimicrobial agents. Antibiotic therapy alone may be insufficient to eradicate established biofilms due to poor penetration into the EPS matrix. Linezolid is a potent antibiotic with activity against gram-positive organisms commonly implicated in urinary tract colonization and penetrate and effectively act against bacterial biofilms. Mucolytic agents, by disrupting the biofilm matrix, may enhance antimicrobial penetration and reduce biofilm burden. The combination of an antibiotic with a mucolytic agent may therefore provide superior biofilm reduction compared to either approach alone or no treatment.
Interventions
DRUGLinezolid (LZD)
Linezolid 600 mg, oral, twice daily, for 7 days.
N-Acetyl cysteine 600 mg, oral, once daily, for 30 days.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years). * Undergoing lithotripsy (FURS, URS or PCNL) with DJ stent insertion. * Stone free status. * Planned stent indwelling time of 1 month. * Negative preoperative urine culture.
Exclusion criteria
* Known allergy or contraindication to linezolid or the selected mucolytic agent. * Chronic kidney disease. * Immunocompromised patients (e.g., chemotherapy, long-term steroid use). * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm bacterial load | 1 month | Biofilm bacterial load, defined as the quantity of bacteria within a biofilm, measured by culture of a swab taken off Double J stent after removal and expressed in numbers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary tract infection rate | 1 month | urinary tract infection, defined as presence of positive urine culture after double J stent insertion, expressed in numbers. |
| Double J related symptoms | 1 month | Double J related symptoms, defined as lower urinary tract symptoms that patient expeirence after double J stent insertion, measured using the ureteral stent symptom questionnaire (USSQ), expressed in numbers. |
Countries
Egypt
Contacts
Primary ContactAmmar Alorabi
Outcome results
None listed