Urinary CathetersNCT06893562
Evaluating Nine-Year Sustainability After Implementing Evidence-Based Practices to Prevent Urinary Tract Infections and Overfilling of the Bladder in Patients With Hip Fracture
An observational study of Urinary Catheters and Urinary Retention, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
This study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Catheters, Urinary Retention, Adherence
- What is being tested?
- Safe Hands and Safe Bladder intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 750 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older undergoing hip fracture surgery at a university hospital in Sweden.
Who may be able to join
- -Hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards.
Who cannot join
- -No catheterisation during hospital stay
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska Academy, Sahlgrenska University hospital/Mölndal
Mölndal, Västra Götaland County, 43180
About this study
Official title: Nine-Year Sustainability After Implementing Measures to Prevent Catheter- Associated Urinary Tract Infections and Bladder Distension in Patients With Hip Fracture
This study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. The intervention, which included two key innovations-a urinary catheter certificate and a nurse-driven urinary catheter protocol, was implemented between 2015 and 2020 and successfully reduced urinary tract infections and bladder distension, previously published. However, due to the pandemic, the initiative was paused and had to be reintroduced in 2022. Now, the study aims to assess the effectiveness of these preventive measures 9 years after their initial implementation. The research will analyze changes in the incidence of urinary tract infections, bladder distension, catheterisation methods, and documentation practices in patients aged 65 and older. The findings will help inform healthcare policies and may have broader implications for preventing adverse events in other surgical patient groups
- Conditions
- Urinary Catheters, Urinary Retention, Adherence, Documentation Skill, Sustainability of Innovations, Hip Fracture
- Being tested
- Safe Hands and Safe Bladder intervention
- Keywords
- Sustainability of Innovations, Hip fracture, Urinary Retention, Catheter Associated Urinary Tract Infection
- Medical subject headings
- Urinary Retention, Hip Fractures, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Hands and Safe Bladder interventionBehavioural
Evaluating changes in urinary tract infections and bladder distension nine-year after implementing preventive measures
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing hip fracture surgery year nine after the intervention started. | Not described Receives: Behavioral: Safe Hands and Safe Bladder intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe changes in the incidence of in-hospital urinary catheter-associated infections; Year 9 will be compared with previously published data from Years 1-5
Definition: Urinary tract infection with onset on day 3 after admission with prior urinary catheterisation. A physician prescribed antimicrobial agents for a urinary tract infection during the hospital stay. Data will be collected from patients' medical records.
Logistic regression analysis will be performed
Measured: For one year
Secondary outcomes (4)
Changes in the incidence of in-hospital acquired bladder distension will be compared; Year 9 will be compared to previously published data from Years 1-5.
Definition: Bladder distension is defined according to the national marker for point prevalence measurement when assessing adverse events. Bladderscan volume from patients' medical records.
Measured: For one year.
Changes in urine volume of 500ml and more during hospital stay. Year nine will be compared yera 1-5, previous published data
Bladderscan volume from patients' medical records.
Measured: For one year
Changes in catheterization methods during the hospital stay will be compared, with data from Year 9 compared to previously published data from Years 1-5
Data will be collected from patients' medical records.
Measured: For one year
Changes in urinary catheter-related documentation in Year 9 will be compared to previously published data from Years 1-5.
Catheter-related documentation will be collected from patients' medical records.
Measured: For one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start5 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maria frödin, Sahlgrenska University Hospital
- Investigators
- Annette Erichsen, Associate Professor, Principal investigator, Gothenburg University, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893562
- Sponsor's protocol ID
- 2025-00397-01
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erichsen Andersson A, Gillespie BM, Karlsson M, Malchau H, Nellgard B, Wikstrom E, Rogmark C, Tillander J. Reduction of early surgical site and other care related infections in 3553 hip fracture patients: lessons learned from the 5-year Safe Hands project. Antimicrob Resist Infect Control. 2022 Sep 5;11(1):113. doi: 10.1186/s13756-022-01153-4.
PubMed 36064457Wikstrom E, Dellenborg L, Wallin L, Gillespie BM, Erichsen Andersson A. The Safe Hands Study: Implementing aseptic techniques in the operating room: Facilitating mechanisms for contextual negotiation and collective action. Am J Infect Control. 2019 Mar;47(3):251-257. doi: 10.1016/j.ajic.2018.08.024. Epub 2018 Nov 16.
PubMed 30449454Erichsen Andersson A, Frodin M, Dellenborg L, Wallin L, Hok J, Gillespie BM, Wikstrom E. Iterative co-creation for improved hand hygiene and aseptic techniques in the operating room: experiences from the safe hands study. BMC Health Serv Res. 2018 Jan 4;18(1):2. doi: 10.1186/s12913-017-2783-1.
PubMed 29301519Frodin M, Nellgard B, Rogmark C, Gillespie BM, Wikstrom E, Andersson AE. A co-created nurse-driven catheterisation protocol can reduce bladder distension in acute hip fracture patients - results from a longitudinal observational study. BMC Nurs. 2022 Oct 12;21(1):276. doi: 10.1186/s12912-022-01057-z.
PubMed 36224550Frodin M, Ahlstrom L, Gillespie BM, Rogmark C, Nellgard B, Wikstrom E, Erichsen Andersson A. Effectiveness of implementing a preventive urinary catheter care bundle in hip fracture patients. J Infect Prev. 2022 Mar;23(2):41-48. doi: 10.1177/17571774211060417. Epub 2022 Feb 15.
PubMed 35340925
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nine-Year Sustainability After Implementing Measures to Prevent Catheter- Associated Urinary Tract Infections and Bladder Distension in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT06893562
- Acronym / sponsor ID
- 2025-00397-01
- Conditions
- Urinary Catheters, Urinary Retention, Adherence, Documentation Skill, Sustainability of Innovations, Hip Fracture
- Keywords
- Sustainability of Innovations, Hip fracture, Urinary Retention, Catheter Associated Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. The intervention, which included two key innovations-a urinary catheter certificate and a nurse-driven urinary catheter protocol, was implemented between 2015 and 2020 and successfully reduced urinary tract infections and bladder distension, previously published. However, due to the pandemic, the initiative was paused and had to be reintroduced in 2022. Now, the study aims to assess the effectiveness of these preventive measures 9 years after their initial implementation. The research will analyze changes in the incidence of urinary tract infections, bladder distension, catheterisation methods, and documentation practices in patients aged 65 and older. The findings will help inform healthcare policies and may have broader implications for preventing adverse events in other surgical patient groups
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hip fracture surgery year nine after the intervention started. | – | Behavioral: Safe Hands and Safe Bladder intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older undergoing hip fracture surgery at a university hospital in Sweden.
Key inclusion criteria (1 listed)
- -Hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards.
Key exclusion criteria (1 listed)
- -No catheterisation during hospital stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Hands and Safe Bladder interventionEvaluating changes in urinary tract infections and bladder distension nine-year after implementing preventive measures | Behavioural | Patients undergoing hip fracture surgery year nine after the intervention started. |
Primary outcome
Describe changes in the incidence of in-hospital urinary catheter-associated infections; Year 9 will be compared with previously published data from Years 1-5
Time frame: For one year
Definition: Urinary tract infection with onset on day 3 after admission with prior urinary catheterisation. A physician prescribed antimicrobial agents for a urinary tract infection during the hospital stay. Data will be collected from patients' medical records. Logistic regression analysis will be performed
4 secondary outcomes
Changes in the incidence of in-hospital acquired bladder distension will be compared; Year 9 will be compared to previously published data from Years 1-5.
Time frame: For one year.
Changes in urine volume of 500ml and more during hospital stay. Year nine will be compared yera 1-5, previous published data
Time frame: For one year
Changes in catheterization methods during the hospital stay will be compared, with data from Year 9 compared to previously published data from Years 1-5
Time frame: For one year
Changes in urinary catheter-related documentation in Year 9 will be compared to previously published data from Years 1-5.
Time frame: For one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 36064457Erichsen Andersson A, Gillespie BM, Karlsson M, Malchau H, Nellgard B, Wikstrom E, Rogmark C, Tillander J. Reduction of early surgical site and other care related infections in 3553 hip fracture patients: lessons learned from the 5-year Safe Hands project. Antimicrob Resist Infect Control. 2022 Sep 5;11(1):113. doi: 10.1186/s13756-022-01153-4.
- Background: PubMed 30449454Wikstrom E, Dellenborg L, Wallin L, Gillespie BM, Erichsen Andersson A. The Safe Hands Study: Implementing aseptic techniques in the operating room: Facilitating mechanisms for contextual negotiation and collective action. Am J Infect Control. 2019 Mar;47(3):251-257. doi: 10.1016/j.ajic.2018.08.024. Epub 2018 Nov 16.
- Background: PubMed 29301519Erichsen Andersson A, Frodin M, Dellenborg L, Wallin L, Hok J, Gillespie BM, Wikstrom E. Iterative co-creation for improved hand hygiene and aseptic techniques in the operating room: experiences from the safe hands study. BMC Health Serv Res. 2018 Jan 4;18(1):2. doi: 10.1186/s12913-017-2783-1.
- Background: PubMed 36224550Frodin M, Nellgard B, Rogmark C, Gillespie BM, Wikstrom E, Andersson AE. A co-created nurse-driven catheterisation protocol can reduce bladder distension in acute hip fracture patients - results from a longitudinal observational study. BMC Nurs. 2022 Oct 12;21(1):276. doi: 10.1186/s12912-022-01057-z.
- Background: PubMed 35340925Frodin M, Ahlstrom L, Gillespie BM, Rogmark C, Nellgard B, Wikstrom E, Erichsen Andersson A. Effectiveness of implementing a preventive urinary catheter care bundle in hip fracture patients. J Infect Prev. 2022 Mar;23(2):41-48. doi: 10.1177/17571774211060417. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Erichsen, Associate Professor principal investigator
Gothenburg University, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Catheters and Urinary Retention, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe changes in the incidence of in-hospital urinary catheter-associated infections; Year 9 will be compared with previously published data from Years 1-5 (time frame: For one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893562, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.