Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001101673
Ethics application status
Approved
Date submitted
21/09/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
After Pelvic Trauma: Investigating the prevalence and severity of pelvic floor dysfunction post pelvic trauma.
Scientific title
After Pelvic Trauma: Investigating the prevalence and severity of pelvic floor dysfunction post pelvic trauma.
Secondary ID [1] 310659 0
Nil known
Universal Trial Number (UTN)
U1111-1298-1207
Trial acronym
APT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Floor Dysfunction 331557 0
Condition category
Condition code
Injuries and Accidents 328294 328294 0 0
Fractures
Renal and Urogenital 328295 328295 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
This multi-centre observational trial will involve adults (18 years of age and over) who are admitted to either The Royal Melbourne Hospital or The Alfred Hospital under an orthopaedic or trauma bed card with at least one pelvic fracture or traumatic changes (e.g. diastasis) on imaging (managed either non-operatively or operatively).

Acute orthopaedic and trauma ward physiotherapists, doctors and in-charge nurses, as well as Trauma Clinical Nurse Consultants, will be responsible for identifying newly admitted patients with at least one pelvic fracture. In order to determine eligibility, the recruitment physiotherapists will complete the Screening Form for all potentially eligible patients admitted to the acute inpatient orthopaedic or trauma wards, using details obtained from the patient’s hospital record, liaising with the multidisciplinary team and/or conducting a verbal subjective examination face-to-face at the patient’s bedside or via telehealth.

Once eligibility is confirmed, participants will be approached by the recruitment physiotherapist either face-to face at the bedside or via telehealth and provided with a verbal overview of the study procedures and commitment. Patients who are eligible and interested in participating in the study will then be provided with the Participant Informed Consent Form. The study physiotherapist will return either that afternoon (minimum 4 hours) or the following day and consenting participants will be required to confirm that they have read and understood the Participant Informed Consent Form (PICF) by signing and dating this document.

The Initial Data Collection Form will be used to collect patient demographic details and other baseline data for all enrolled participants. These details will be obtained by study team members during the acute inpatient admission on the orthopaedic or trauma ward by utilising hospital records, liaising with the multidisciplinary team and/or by questioning the participant.

All enrolled participants will complete the Australian Pelvic Floor Questionnaire (APFQ), with males who report being sexually active in the four weeks prior to their injury also required to complete the International Index of Erectile Function (IIEF-5). These questionnaires will be administered at baseline during the acute hospital admission independently via a smart device, verbally at the patient’s bedside, or via telehealth, with an electronic link to the study emailed to them. If the patient is not confident in using the smart device, they will be given the option of a paper copy. The APFQ and IIEF-5 (for males) will be re-administered at the 3-month time point for all participants either independently at home via a smart device or assisted via telehealth by either the recruitment physiotherapists or independent study staff (other physiotherapists within the acute orthopaedic and trauma teams at both study sites) whom are not involved in data analysis. All scores will be entered and saved electronically in a custom-built REDCap database.

3-months post-injury, patients will be sent the questionnaire to complete again via email, with both an email and text message reminder after one week; and a phone call reminder one week later. Where multiple efforts to contact the participant fail, the study team will contact the participant’s Next of Kin to request a suitable time for follow-up. Attempts at making contact will cease after 6-weeks from the initial follow-up due date. The Follow Up Data Collection Form will also be administered at the 3-month time point via a weblink or telehealth using the same methods as above. This includes questions pertaining to ongoing issues or treatment of an orthopaedic nature, any assessment or treatment which has been sought or provided for PFD independent of this study, return to work status and any change to marital status.


All participants recruited to the observational study will also be contacted at the 12 month time point and asked to complete both the questionnaires and Follow Up Data Collection Form via REDCap.


Intervention code [1] 327065 0
Not applicable
Comparator / control treatment
No control group - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336146 0
The prevalence of Pelvic Floor Dysfunction in an adult pelvic trauma population at 3 and 12 months post injury.
Timepoint [1] 336146 0
Baseline, 3 months and 12 months post injury.
Primary outcome [2] 336147 0
The severity of Pelvic Floor Dysfunction in an adult pelvic trauma population at 3 and 12 months post injury.
Timepoint [2] 336147 0
Baseline, 3 and 12 months post injury.
Secondary outcome [1] 428072 0
Nil
Timepoint [1] 428072 0
Nil

Eligibility
Key inclusion criteria
Admitted patient with at least one pelvic fracture (that is either non-operatively or operatively managed) under an orthopaedic or trauma bedcard.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Isolated acetabulum fracture;
2. Residing in a care facility;
3. Pre-existing cognitive impairment;
4. Currently undergoing Post Traumatic Amnesia (PTA) assessment;
5. Acute brain injury confirmed on imaging;
6. New or existing spinal cord injury;
7. Active cancer; and/or
8. Currently being treated with sedatives for alcohol withdrawal and/or
9. Admitted under the Mental Health Act.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
205 female and 279 male (total 484) patients with at least one pelvic fracture will be recruited into this observational study. Based upon previous admission rates, we believe this to be a feasible number of participants to recruit, taking approximately one year to recruit and an additional year to complete follow up of all participants.

Data analysis will be performed using Stata version 16.
To estimate the prevalence of PFD among patients with at least one pelvic fracture, the proportion of patients experiencing PFD at 3 months and 12 months will be calculated for all participants. Logistic regression analysis will be conducted to examine any associations between patient characteristics and the odds of developing PFD at 3 months post injury.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
484
Accrual to date
113
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25574 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 25575 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41397 0
3004 - Melbourne
Recruitment postcode(s) [2] 41396 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 314878 0
Government body
Name [1] 314878 0
Traffic Accident Commission
Country [1] 314878 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan St Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 316876 0
None
Name [1] 316876 0
Address [1] 316876 0
Country [1] 316876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313876 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 313876 0
300 Grattan St Parkville VIC 3050
Ethics committee country [1] 313876 0
Australia
Date submitted for ethics approval [1] 313876 0
23/01/2021
Approval date [1] 313876 0
13/04/2021
Ethics approval number [1] 313876 0
66244

Summary
Brief summary
Previous research shows that 12 months post pelvic fracture, women commonly experience issues with their bladder, bowel and sexual function, collectively known as pelvic floor dysfunction (PFD). This preliminary study also highlighted that men experienced significant sexual dysfunction post-pelvic fracture, but not bladder or bowel dysfunction. In the current study, eligible patients will be asked a series of questions pertaining to their normal bladder, bowel and sexual function during their acute hospital admission. Three months after their discharge from hospital, we will contact them via email or phone and these questions will be re-administered in order to detect any symptoms of PFD (such as pain or incontinence). At 12 months post injury, all patients will again be asked the same series of questions to determine whether their symptoms have changed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129634 0
Ms Carly McConnell
Address 129634 0
The Royal Melbourne Hospital, 300 Grattan St Parkville VIC 3050
Country 129634 0
Australia
Phone 129634 0
+61425449390
Fax 129634 0
Email 129634 0
carly.mcconnell@mh.org.au
Contact person for public queries
Name 129635 0
Ms Carly McConnell
Address 129635 0
The Royal Melbourne Hospital, 300 Grattan St Parkville VIC 3050
Country 129635 0
Australia
Phone 129635 0
+61 425449390
Fax 129635 0
Email 129635 0
carly.mcconnell@mh.org.au
Contact person for scientific queries
Name 129636 0
Ms Carly McConnell
Address 129636 0
The Royal Melbourne Hospital, 300 Grattan St Parkville VIC 3050
Country 129636 0
Australia
Phone 129636 0
+61 425449390
Fax 129636 0
Email 129636 0
carly.mcconnell@mh.org.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20446Study protocol    To be confirmed
20447Statistical analysis plan    To be confirmed
20448Clinical study report    To be confirmed



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.