Simple, safe and economical: In patients with continent catheterizable ileal pouch after cystectomy, sterile solution for rinsing of pouches can safely be replaced by tap water

Category Primary study
Registry of TrialsANZCTR
Year 2010
INTERVENTION: Patients with continent catheterizable ileal pouch are prospectively randomized in a two‐arm crossover study. One study arm is "aseptic intermittent self catheterisation (ISC) and rinsing with sodium bicarbonate (NaCl) 0.9% solution". This study arm lasts 90 days. Every morning a dipstick urine test is done by the patient to check nitrite in urine. After that, the umbilicus is cleaned with aseptic solution. Then the pouch is catheterized with a sterile single‐use catheter. After catheterizing, the poch is rinced with 3 times 60 milliliters of sterile NaCl 0.9% solution. In case of nitrite‐negativity, the same procedure is repeated next morning. In case of nitrite‐positivity, the same procedure is repeated at the next catheterization 4 hours later. The entire procedure takes about 15 minutes. In monthly intervals urine cultures are collected. In case of symptomatic urinary tract infection (UTI) an antibiotic therapy is prescribed. Evaluation of quality of life and costs by questionnaire. There is washout period is one day between the two study arms of the cross‐over study. CONDITION: Bladder cancer Continent catheterizable ileal pouches Urinary tract infection PRIMARY OUTCOME: quality of life by questionnaire The amount of nitrite‐positive urine study days. Every study day with at least one nitrite‐positive urine dipstick test is counted as "nitrite‐positive". A study day with a negative nitrite‐test in the morning is negative. urinary tranct infection by urine culture SECONDARY OUTCOME: The amount and the duration of every prescribed antibiotic treatments for a symptomatic urinary tract infection (UTI) is evalutated. A symptomatic UTI is defined as a nitrite‐positive urine dipstick with fever and/or abdominal pain. costs per month of the used material of each patient are evaluated. costs include catheters, syringes, rinsing solution, aseptic solution. Not included are costs for tap water, shipment of the material and waste disposal. INCLUSION CRITERIA: Continent catheterizable ileal pouch since 2 weeks or more
Epistemonikos ID: 0b28ae46b4393be65336e67d5bf14e55cab6fbce
First added on: Aug 25, 2024