Skip to content

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

Assessment of intermittent rinsing of pouches with sterile sodium chloride (NaCl) 0.9% solution or tap water in patients with continent catheterizable ileal pouch after cystectomy in terms of incidence of nitrite-positive days and urinary tract infections, quality of life and costs in a cross-over study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000618055
Enrollment
26
Registered
2010-07-28
Start date
2005-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Continent catheterizable ileal pouches must be regularly rinsed to reduce the risk of urinary tract infections (UTI). The aim of this study is to compare the standard method of "aseptic ISC and rinsing with NaCl 0.9% solution" to "hygienic ISC and rinsing with tap water" to assess whether UTI rate, quality of life (QoL), and costs differ. The hypothesis is a lower UTI rate, better QoL and lower costs with the method with tap water.

Interventions

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, t

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.

Sponsors

Department of Urology, Inselspital Bern
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Continent catheterizable ileal pouch since 2 weeks or more

Exclusion criteria

Chronical urinary tract infection

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 29, 2026