A PILOT STUDY TO ESTABLISH ROLE OF ANTIBIOTIC WASHED DOUBLE J STENT IN PREVENTING COLONISATION OF THE DOUBLE J STENT AND URINARY TRACT INFECTION IN ELECTIVE UROLOGICAL INTERVENTIONS AT A TERTIARY CARE HOSPITAL- A RANDOMISED CONTROLLED STUDY

Ureteral double-J (DJ) stents are extensively used in the management of upper urinary tract obstruction and prevention of complications after endoscopic or open urological operations. DJ stents are also used to reduce the obstruction risk due to stone fragments after extracorporeal shock-wave lithotripsy in patients with large kidney stones (1). However, their use is associated with some morbidity, such as dysuria, hematuria, and lumbar or suprapubic pain (2). More serious complications include stent migration, fragmentation, encrustation and infection which may lead to bacteremia, pyelonephritis, renal deterioration and even death due to sepsis (3,4,5). Infection and encrustation of DJ stent occur frequently because of its direct contact with urine. Furthermore, internal ureteral stents also offer an ideal surface for bacterial colonization and biofilm formation (6,7). Bacterial colonization with biofilm formation on the stent plays an essential role in the pathogenesis of stent-associated infections (7). Previous studies have demonstrated a poor correlation between urine culture (UC) and stent culture (SC) results (8,9). Stent-related urinary tract infections (UTIs) are often asymptomatic and resolve without any treatment, while only about 3% to 5% develop symptomatic UTI necessitating antimicrobial treatment (10,11).

Despite controversial evidence, there have been few studies advocating use of low dose continuous antibiotic prophylaxis (CAP) in patients with indwelling DJ stents with the intention of preventing stent related symptoms and febrile UTIs [14]. While evidence in support of continuous antibiotic prophylaxis is at best controversial, there is ongoing search for new modalities to reduce the incidence of stent related complications. Some authors have shown that anti-adherence agents, such as cranberry juice and d-mannose prevent adherence of bacteria to uroepithelial cells [15].

Upon literature search, till date no study has been done to qualify the role of antibiotic washed stent in preventing colonisation of the DJ stent and symptomatic UTI.

Case definition†A PILOT STUDY TO ESTABLISH ROLE OF ANTIBIOTIC WASHED DOUBLE J STENT IN PREVENTING COLONISATION OF THE DOUBLE J STENT AND URINARY TRACT INFECTION IN ELECTIVE UROLOGICAL INTERVENTIONS AT A TERTIARY CARE HOSPITAL- A RANDOMISED CONTROLLED STUDYâ€

In this study, we aim  to establish role of antibiotic washed D J stent in preventing colonisation and UTI.

This study will enable us to determine the risk factors for D J stent colonisation and feasibility of using antibiotic washed DJ stent to prevent UTI.

METHODOLOGY

Approval from the Institutional Ethics Committee  obtained and written informed consent from the patients undergoing Double J Stenting will be taken.

 We will enroll 150 registered patients of all age group, presenting with indication for Double J stenting, for this study.

 The study will be carried out at a tertiary care center in India.

 Randomization will be done by a computer-generated chart based on the serial number of the cases where patients will be allocated to one of the two groups i.e. group A receiving the  antibiotic (Gentamicin 80 mg) washed Double J stent and group B receiving Double J stent without being washed..

 After the patient is brought into operating room, standard American Society of Anesthesiologists monitoring would be applied.

           INTERVENTION: -

Group A

This group will receive cystoscope-guided antibiotic (Gentamicin 80 mg) washed DJ Stent.

 Patients will be placed in the lithotomy position. After part preparation and draping a cystoscope will be inserted through the urethra and into bladder; visualizing the ureteric orifice, a guide wire will be guided through the cystoscope, up the ureter into the kidney. The stent will be inserted over the wire. A fluoroscope will be used to position the stent.

 Group B

This group will receive cystoscope-guided DJ Stent without being washed with antibiotic.

Patients will be placed in the lithotomy position. After part preparation and draping a cystoscope will be inserted through the urethra and into bladder; visualizing the ureteric orifice, a guide wire will be guided through the cystoscope, up the ureter into the kidney. The stent will be inserted over the wire. A fluoroscope will be used to position the stent

Temperature, Urine routine examination, Urine Culture, complete blood count of each individual of both the groups will be recorded before stenting and before stent removal.

 Patients will be discharged and will be called back for Stent removal after 4 weeks. He/she will be asked to inform whenever he/she develops some UTI related symptoms. Tip of the stent will be sent for culture for all.

 Assessment of success of antibiotic (Gentamicin) washed Double J stent in preventing colonisation of the DJ Stent and UTI will be done based on above investigations.

Data collection and analysis: All the data will be recorded and tabulated. The data will be analyzed using appropriate statistical technique.

Final result: Symptomatic urinary tract infection / Colonisation of D J Stent/ No infection and colonisation.