The Effect of Ureteric Stent Tethers on Patient Symptoms, Stent Bacterial Colonization and Urinary Tract Infection

Two of the main issues surrounding the use of ureteral stents are stent related symptoms and bacterial colonization/urinary tract infection (UTI). To be useful, stent tethers must decrease the morbidity associated with stent removal and the cost to the health care system, while not increasing stent related symptoms or UTI. To our knowledge, the effect of leaving a stent tether on stent symptoms and bacterial colonization of the stent and urine has not been previously studied.

This is a single-centre, prospective, randomized, controlled trial. Patients eligible for recruitment into the study based on the inclusion and exclusion criteria will be provided with a consent form at the time of their initial appointment, when their ureteroscopy is being booked. Once consent is obtained, patients will be randomized (using random number table look-up) to receive either double-J stent placement with a tether (the Treatment Group) or double-J stent placement without a tether (the Control Group) following ureteroscopy. Randomization will occur prior to the commencement of ureteroscopy.

Patients will either have a double J-stent placed with or without a long tether attached. The double-J stents used in the treatment and control groups will be otherwise identical. All stents will be 6 French in diameter and 22-26 cm in length based on the patients' height. Sizing of stent length will be performed uniformly in the treatment and control group and will involve measuring ureteric length from the ureteropelvic junction to ureterovesical junction with a marked ureteral catheter. All patients will receive a single preoperative dose of prophylactic antibiotics (i.e., Ampicillin and Gentamicin or Ciprofloxacin).All patients will have a urine sample collected for culture and sensitivity at the start of the procedure.

Blinding will not be feasible during this trial due to the nature of the intervention. The urologist performing the procedure will clearly be aware of whether a tether is left on the stent. Similarly, patients will also be aware of whether a string tether is protruding from their urethral meatus or not. However, assessors of the compiled data and questionnaires will be blinded to the intervention.

Once enrolled in the study, patients will be given the Ureteral Stent Symptoms Questionnaire 1 (Pre Stent) to complete prior to undergoing ureteroscopy and stent insertion. This will allow us to establish baseline lower urinary tract symptoms.