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Trial registered on ANZCTR


Registration number
ACTRN12620000626965
Ethics application status
Approved
Date submitted
21/04/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring Urethral Pressure Injuries in Adults with Long-Term Urinary Catheters
Scientific title
Exploring the Prevalence of Urethral Catheter Associated Mucosal Pressure Injuries in the Darling Downs Hospital and Health Service (DDHHS) & West Moreton Hospital and Health Service (WMHHS) Districts: A Cross-Sectional Study
Secondary ID [1] 301082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urethral Pressure Injuries 317152 0
Long Term Indwelling Urinary Catheters 317153 0
Condition category
Condition code
Renal and Urogenital 315302 315302 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adults who have had an indwelling urinary catheter (IDC) in place for at least 4 weeks will be invited to complete a single survey. This survey will ask participants if they have been diagnosed with a pressure injury or ulcer while the IDC was in situ. The survey will also ask about common signs and symptoms of urethral pressure injury. It is anticipated that the survey will take 10-15 minutes to complete.

In addition, investigators will review the medical records of participants to:
1. Identify any documentation of urethral pressure injuries or ulcers in medical records
2. Record relevant demographic and medical data
Intervention code [1] 317392 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323545 0
Prevalence of urethral pressure injuries in adults with long term IDCs in situ. Prevalence will be measured by:
i. Data obtained from surveys completed by participants
ii. Documentation of urethral pressure injuries or ulcers in medical records
Timepoint [1] 323545 0
Within 12 months of initial IDC insertion.
Secondary outcome [1] 382193 0
Age at time of IDC insertion. This will be collected from participant's medical records.
Timepoint [1] 382193 0
Age (at time of IDC insertion) will be collected from participant's medical records within 12 months of IDC insertion.
Secondary outcome [2] 382194 0
Sex (i.e. Male or Female). This will be collected from participant's medical records.
Timepoint [2] 382194 0
Sex (i.e. Male or Female) will be collected from participant's medical records within 12 months of IDC insertion.
Secondary outcome [3] 382195 0
Date of initial IDC insertion. This will be collected from participant's surveys and medical records.
Timepoint [3] 382195 0
Date of initial IDC insertion will be collected at survey completion within 12 months of IDC insertion.
Secondary outcome [4] 382196 0
Number of IDC changes. This will be collected from participant's surveys and medical records.
Timepoint [4] 382196 0
Number of IDC changes will be collected at survey completion within 12 months of IDC insertion.
Secondary outcome [5] 382197 0
Time (i.e. weeks) in between IDC changes. This will be collected from participant's surveys and medical records.
Timepoint [5] 382197 0
Time (i.e. weeks) in between IDC changes will be collected at survey completion within 12 months of IDC insertion.
Secondary outcome [6] 382198 0
Total duration of IDC insertion (i.e. months, weeks, and days). This will be collected from participant's surveys and medical records.
Timepoint [6] 382198 0
Total duration of IDC insertion (i.e. months, weeks, and days) will be collected at survey completion within 12 months of IDC insertion.
Secondary outcome [7] 382199 0
IDC material. This will be collected from participant's medical records.
Timepoint [7] 382199 0
IDC material will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [8] 382200 0
IDC size. This will be collected from participant's medical records.
Timepoint [8] 382200 0
IDC size will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [9] 382201 0
BMI at initial IDC insertion. This will be collected from participant's medical records.
Timepoint [9] 382201 0
BMI (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [10] 382202 0
Mobility status at initial IDC insertion (i.e. Independent, Supervision, Stand by assistance, Moderate assistance, or Maximal assistance). This will be collected from participant's medical records.
Timepoint [10] 382202 0
Mobility status (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [11] 382203 0
Smoking status at initial IDC insertion. This will be collected from participant's medical records.
Timepoint [11] 382203 0
Smoking status (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [12] 382204 0
Urological procedures (e.g. flexible cystoscopy, rigid cystoscopy, ureteric stent insertion, TURP, etc) that have been performed before AND/OR after initial IDC insertion. This will be collected from participant's medical records within 12 months of IDC insertion.
Timepoint [12] 382204 0
Urological procedures (i.e. that have been performed before AND/OR after initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [13] 382205 0
ICU admission during time when IDC was in-situ. This will be collected from participant's medical records within 12 months of IDC insertion.
Timepoint [13] 382205 0
ICU admission (i.e. during time when IDC was in-situ) will be collected from medical records within 12 months of IDC insertion.
Secondary outcome [14] 382206 0
Co-morbidities (i.e. Urological, Neurological, Cardiovascular, Respiratory, Metabolic, Immunological/Autoimmune, Cognitive, Oncological) during the time when the IDC was in-situ. This will be collected from participant's medical records within 12 months of IDC insertion.
Timepoint [14] 382206 0
Co-morbidities (i.e. during the time IDC was in-situ) will be collected from medical records within 12 months of IDC insertion.

Eligibility
Key inclusion criteria
In order to be eligible to participate in this project, candidates must fulfil all of the following criteria:
• >18 years of age
• Have capacity to consent
• Had an IDC in-situ for > 4 weeks between January 2019 and June 2020
• Provide written consent via signature of the Participant Consent Form
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria:
• <18 years of age
• Lack capacity to consent
• Do not provide written consent via signature of the Participant Consent Form

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data will be analysed with assistance from a statistician. Descriptive statistics will be performed to illustrate trends and observations within the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16513 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [2] 16514 0
St Vincent's Hospital - Toowoomba
Recruitment hospital [3] 16515 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 30071 0
4305 - Ipswich
Recruitment postcode(s) [2] 30070 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 305520 0
Self funded/Unfunded
Name [1] 305520 0
Dr Devang Desai
Address [1] 305520 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country [1] 305520 0
Australia
Funding source category [2] 305820 0
Hospital
Name [2] 305820 0
Toowoomba Hospital
Address [2] 305820 0
154 West Street
Toowoomba
QLD
4350
Country [2] 305820 0
Australia
Primary sponsor type
Individual
Name
Dr Devang Desai
Address
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country
Australia
Secondary sponsor category [1] 305926 0
None
Name [1] 305926 0
Address [1] 305926 0
Country [1] 305926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305832 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305832 0
Cossart House
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Ethics committee country [1] 305832 0
Australia
Date submitted for ethics approval [1] 305832 0
03/03/2020
Approval date [1] 305832 0
17/04/2020
Ethics approval number [1] 305832 0
HREA/2020/QTDD/62452

Summary
Brief summary
1. Background
The use of urinary catheters is common in hospitals, rehabilitation facilities, nursing homes, and the community. Catheters are mostly used for short-term bladder drainage, but sometimes they need to be used for longer. Serious illness, chronic inability to urinate, and incontinence are some of the reasons for long-term insertion of a urinary catheter.

People who have urinary catheters inserted for a long time can develop complications. These problems include pain, trauma, urinary tract infections, and urethral pressure injuries. The severity of a pressure injury can range from a mild erosion up to an ulcer or even cleavage of the urethra.

There has been little research into urethral pressure injuries occurring in people with long-term catheters. We want to find out how common urethral pressure injuries are. We also want to find out if urethral pressure injuries are more common in some people.

To do this, we will collect some information, like age and medical problems, from the medical records of participants. We will also ask participants to complete a survey about their experience with a urinary catheter. By doing this, we will better understand how common urethral pressure injuries are.

2. Aims
The primary aim of this study is to measure the prevalence of urethral pressure injuries in adults with long-term urinary catheters.

The secondary aim is to explore any association between any demographic variables (e.g. sex, age) or medical conditions (e.g. mobility issues, neurological conditions) and the occurrence of urethral pressure injuries.

3. Hypothesis
A proportion of adults with long-term urinary catheters will develop urethral pressure injuries. Certain demographic variables and medical conditions may be associated with development of a urethral pressure injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101750 0
Dr Devang Desai
Address 101750 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101750 0
Australia
Phone 101750 0
+61 0408154889
Fax 101750 0
Email 101750 0
ddesai@toowoombaurology.com.au
Contact person for public queries
Name 101751 0
Dr Devang Desai
Address 101751 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101751 0
Australia
Phone 101751 0
+61 0408154889
Fax 101751 0
Email 101751 0
ddesai@toowoombaurology.com.au
Contact person for scientific queries
Name 101752 0
Dr Devang Desai
Address 101752 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101752 0
Australia
Phone 101752 0
+61 0408154889
Fax 101752 0
Email 101752 0
ddesai@toowoombaurology.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results