Bladder irrigation with tap water to reduce antibiotic treatment for catheter-associated urinary tract infections
| ISRCTN | ISRCTN16005365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16005365 |
- Submission date
- 17/04/2024
- Registration date
- 17/04/2024
- Last edited
- 13/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Catheter-associated urinary tract infection (CAUTI) is a common complication among patients performing clean intermittent catheterization (CIC) or with an indwelling catheter (IDC) and is often treated with antibiotics. With increasing rates of antibiotic resistance and healthcare costs, it is necessary to explore alternatives for antibiotic treatment of CAUTIs which are cost-effective, well tolerated by patients and lead to less antibiotic resistance. This is the first study to prospectively evaluate the safety and effectiveness of bladder irrigation (BI) with tap water to reduce antibiotic use for the treatment of CAUTIs in patients with urinary catheters in the community setting. In addition, health-related quality of life (QoL) and treatment satisfaction are evaluated.
Who can participate?
Patients aged 18 years old and over with an indwelling catheter performing CIC and recurrent CAUTI symptoms
What does the study involve?
Bladder irrigation (BI) with tap water is prescribed for patients experiencing recurrent catheter-associated urinary tract infection (CAUTI) symptoms, excluding systemic symptoms like fever, flank pain, or delirium. Symptoms include cloudy or strong-smelling urine, hematuria, dysuria/pain during catheterization, urinary frequency, urinary urgency, and suprapubic pain. Patients will receive BI instructions from continence nurses at the outpatient clinic. For the procedure, a 50 ml catheter-tip syringe filled with tap water at body temperature is used. The bladder is actively irrigated by flushing and drawing back on the plunger to reduce bacterial concentration. This process repeats until the outgoing solution is clear, indicating a lack of contamination. A tapering schedule is employed for BI, resumed upon recurrent CAUTI symptoms. Patients are advised to contact their physician and halt BI if systemic symptoms arise. Antibiotics are prescribed when BI is infeasible, insufficient in relieving symptoms, or for CAUTI with systemic symptoms.
What are the possible benefits and risks of participating?
The possible benefits to participation are less antibiotic use and fewer CAUTIs. The possible risks include performing time-consuming procedures (BI) and more CAUTIs.
Where is the study run from?
Erasmus University Medical Center
When is the study starting and how long is it expected to run for?
November 2021 to February 2024
Who is funding the study?
Erasmus University Medical Center
Who is the main contact?
Mrs Felice van Veen, f.vanveen@erasmusmc.nl
Contact information
Public, Scientific, Principal Investigator
Dr. Molewaterplein 40, 3015 GD Rotterdam
Room Na-1524
Rotterdam
3000 CA
Netherlands
 ORCID ID |
0000-0003-0947-052X |
|---|---|
| Phone | +316 25 67 73 37 |
| f.vanveen@erasmusmc.nl |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community, Hospital |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Bladder irrigation with tap water to reduce antibiotic treatment for catheter-associated urinary tract infections: a prospective observational study |
| Study acronym | TAP-UTI |
| Study hypothesis | This study aims to evaluate patient-reported outcomes on the safety and effectiveness of BI with tap water to reduce antibiotic use for the treatment of CAUTI in patients performing clean intermittent catheterization (CIC) or with an indwelling catheter (IDC) in the community setting. Additionally, the study will look at the quality of life and treatment satisfaction of BI with tap water. It is hypothesized that BI with tap water helps reduce the use of antibiotics in the treatment of CAUTIs while not increasing the risk of developing a CAUTI with systemic symptoms. |
| Ethics approval(s) |
Approved 06/12/2021, METC Erasmus MC (Dr. Molewaterplein 40, Rotterdam, 3015 GD, Netherlands; +31 (010) 704 0 704; metc@erasmusmc.nl), ref: EMC-2021-0855 |
| Condition | Bladder irrigation (BI) with tap water to reduce antibiotic use for the treatment of catheter-associated urinary tract infection (CAUTI) in patients with urinary catheters in the community setting |
| Intervention | Bladder irrigation (BI) with tap water will be prescribed to patients with recurrent catheter-associated urinary tract infection (CAUTI) symptoms and is used for the treatment of CAUTIs without systemic symptoms (e.g. fever, flank pain or delirium). CAUTI symptoms include cloudy or strong-smelling urine, hematuria, dysuria/pain during catheterization, urinary frequency, urinary urgency and suprapubic pain. Patients will receive BI instructions from our continence nurses at the outpatient clinic. For the BI procedure, a 50 ml catheter-tip syringe is used, which is filled with tap water (at body temperature) from a clean, non-sterile container. The bladder is actively irrigated by flushing in and drawing back on the plunger to reduce the concentration of bacteria in the bladder. This procedure is repeated until the outgoing solution is clear, and thus without contamination. A tapering schedule is used for BI, which is resumed upon recurrent CAUTI symptoms. Patients are instructed to contact their physician and discontinue BI in the presence of systemic symptoms. Antibiotics are prescribed when BI is not feasible, does not sufficiently relieve CAUTI symptoms or in case of a CAUTI with systemic symptoms. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The number of self-reported antibiotic treatments for catheter-associated urinary tract infections (CAUTIs) during 3 months, measured using a self-developed questionnaire at baseline and 3-months follow-up |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline and 3-months follow-up: 1. Number of self-reported CAUTIs during 3 months measured using a self-developed questionnaire 2. Health-related quality of life measured using the EuroQoL EQ-5D-5L 3. Treatment satisfaction measured using the Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) |
| Overall study start date | 01/11/2021 |
| Overall study end date | 25/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 58 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Patients with an indwelling catheter performing CIC 2. Recurrent CAUTI symptoms for which BI started |
| Participant exclusion criteria | 1. Received BI with tap water solely for other reasons, such as prevention of catheter blockage or bladder stones, or treatment of hematuria 2. A history of surgical bladder reconstruction |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 20/02/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
3015 GD
Netherlands
Sponsor information
Hospital/treatment centre
Erasmus University Medical Center
Dr. Molenwaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 10 704 0704 |
|---|---|
| b.blok@erasmusmc.nl | |
| Website | https://www.erasmusmc.nl/nl-nl/ |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Erasmus MC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewd journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Mrs Felice van Veen, f.vanveen@erasmusmc.nl. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/10/2024 | 13/03/2025 | Yes | No |
Editorial Notes
13/03/2025: Publication reference added.
17/04/2024: Study's existence confirmed by the Medical Ethical Review Committee of Erasmus Medical Center.
