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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urethral Pressure Injuries

Long Term Indwelling Urinary Catheters

Condition category

Condition code

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Within 12 months of initial IDC insertion.

Secondary outcome [1]

Age at time of IDC insertion. This will be collected from participant's medical records.

Timepoint [1]

Age (at time of IDC insertion) will be collected from participant's medical records within 12 months of IDC insertion.

Secondary outcome [2]

Sex (i.e. Male or Female). This will be collected from participant's medical records.

Timepoint [2]

Sex (i.e. Male or Female) will be collected from participant's medical records within 12 months of IDC insertion.

Secondary outcome [3]

Date of initial IDC insertion. This will be collected from participant's surveys and medical records.

Timepoint [3]

Date of initial IDC insertion will be collected at survey completion within 12 months of IDC insertion.

Secondary outcome [4]

Number of IDC changes. This will be collected from participant's surveys and medical records.

Timepoint [4]

Number of IDC changes will be collected at survey completion within 12 months of IDC insertion.

Secondary outcome [5]

Time (i.e. weeks) in between IDC changes. This will be collected from participant's surveys and medical records.

Timepoint [5]

Time (i.e. weeks) in between IDC changes will be collected at survey completion within 12 months of IDC insertion.

Secondary outcome [6]

Total duration of IDC insertion (i.e. months, weeks, and days). This will be collected from participant's surveys and medical records.

Timepoint [6]

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]

IDC material. This will be collected from participant's medical records.

Timepoint [7]

IDC material will be collected from medical records within 12 months of IDC insertion.

Secondary outcome [8]

IDC size. This will be collected from participant's medical records.

Timepoint [8]

IDC size will be collected from medical records within 12 months of IDC insertion.

Secondary outcome [9]

BMI at initial IDC insertion. This will be collected from participant's medical records.

Timepoint [9]

BMI (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.

Secondary outcome [10]

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]

Mobility status (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.

Secondary outcome [11]

Smoking status at initial IDC insertion. This will be collected from participant's medical records.

Timepoint [11]

Smoking status (i.e. at initial IDC insertion) will be collected from medical records within 12 months of IDC insertion.

Secondary outcome [12]

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]

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]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2020

Actual

Date of last participant enrolment

Anticipated

31/08/2020

Actual

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Toowoomba Hospital - Toowoomba

Recruitment hospital [2]

St Vincent's Hospital - Toowoomba

Recruitment hospital [3]

Ipswich Hospital - Ipswich

Recruitment postcode(s) [1]

4350 - Toowoomba

Recruitment postcode(s) [2]

4305 - Ipswich

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Devang Desai

Address [1]

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Toowoomba Hospital

Address [2]

154 West Street
Toowoomba
QLD
4350

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Darling Downs Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Cossart House
Toowoomba Hospital
154 West Street
Toowoomba
QLD 
4350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/03/2020

Approval date [1]

17/04/2020

Ethics approval number [1]

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

Dr Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Contact person for public queries

Name

Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Contact person for scientific queries

Name

Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Catheter-associated meatal pressure injuries (CAMPI) in patients with long-term urethral catheters—a cross-sectional study of 200 patients	2024	https://doi.org/10.21037/tau-23-445

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically