Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001102662
Ethics application status
Approved
Date submitted
25/05/2023
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
Does a new screening and referral process for people with a pelvic fracture reduce the frequency and severity of them experiencing symptoms of bladder, bowel and sexual dysfunction?
Scientific title
Does a screening and referral process for pelvic trauma patients reduce the prevalence and severity of pelvic floor dysfunction?
Secondary ID [1] 309736 0
Nil known
Universal Trial Number (UTN)
U1111-1293-0572
Trial acronym
APT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Floor Dysfunction 330149 0
Condition category
Condition code
Injuries and Accidents 327027 327027 0 0
Fractures
Renal and Urogenital 327028 327028 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This multi-centre single blinded randomised control trial (RCT) 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). Due to the nature of the intervention in this study, it is not possible to blind participants however, the investigative team and data analysts will be blinded to the allocation of participants.

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 PICF details to patients that they will only be eligible for the RCT component if they present with PFD at 3 months post injury.

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 blinded independent study staff (other physiotherapists within the acute orthopaedic and trauma teams at both study sites) whom are not involved in treatment or 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 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.

Only participants with PFD at 3 months post injury will be eligible for inclusion in the RCT component of the study. Participants will be identified as having PFD 3 months post injury if they have either i) an increase in overall APFQ score of 3 or more from their in-hospital scores; ii) an increase in any APFQ domain score of 1 or more from their in-hospital scores; or iii) an IIEF-5 score of 21 or less. Participants with PFD will then be randomised via randomisation stratified by fracture management (non-operative vs operative); study site; and gender; using a pre-uploaded randomisation schedule in REDCap. Allocation will thus be independent of treating therapists and medical specialists.

All participants identified as having PFD will be required to use the iUFlow voiding bladder diary app or a paper bladder diary for 48- hours following randomisation at the 3-month mark and again within a 48-hour period leading up to their 12-month follow-up appointment. The information entered into this app automatically uploads to a database that is readily accessible to their treating clinician. Variables to be collected using this smart technology include frequency of micturition, severity of urinary urgency and episodes of urinary incontinence. All data entered into the iUFlow app can only be accessed by the study staff member (continence physiotherapist or urologist) whose contact details (email address) are entered into the app and cannot be accessed by a third party, thus there are no privacy concerns. The paper diary will be returned via email or post to study staff. This raw data will be entered into a separate confidential REDCap database, again using the participants unique study code (therefore will be de-identified) and provided to data analysts who will be blinded as to the allocation of the participants.

Participants allocated to the intervention group will receive equivalent care to that of the control group and in addition, will be offered a referral to a specialised continence or urology service associated with the institution at which their initial injury was managed (The Royal Melbourne Hospital or The Alfred Hospital) for assessment and management of their PFD symptoms. Participants who choose to take up this referral will have the option of either face-to-face or telehealth consultation(s) with a pelvic floor physiotherapist or urology doctor (for males with erectile dysfunction). If the patient is geographically distanced from this service, they may be referred to a local public specialised continence or urology service, as is seen fit by the treating health professional. Intervention choices and number of appointments scheduled will be determined by the treating health professional and will be individually tailored for each participant, including treatment techniques with high quality supporting evidence such as pelvic floor muscle retraining and/or behavioural interventions. This will enable the prevalence and severity of PFD to be compared between control and intervention groups at 12 months post injury; and ascertain the natural history and resolution rate of PFD without intervention. Additionally, this will allow us to assess the efficacy of screening and referring these patients to a sub-acute continence or urology service at 3 months; and determine whether there is a change in resolution rate compared with usual care or natural history.
Intervention code [1] 326194 0
Early detection / Screening
Intervention code [2] 326195 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will receive usual care (that is, orthopaedic management of their pelvic fracture(s) and standard acute inpatient and inpatient or outpatient sub-acute and/or community physiotherapy care) and will be asked to complete the same questionnaires again at 12 months. This time point was chosen as it is anticipated that most patients would have recovered from their pelvic injury within one year (Harvey-Kelly KF, Kanakaris NK, Eardley I, Giannoudis PV 2011. Sexual function impairment after high energy pelvic fractures: Evidence today. J Urol; 185:2027-2034.); and it is recommended that such a time frame would enable adequate assessment of long-term outcomes of PFD symptoms such as sexual function (Khanna P, Phan H, Hardy AH, Nolan T, Dong P, 2012. Multidisciplinary management of blunt pelvic trauma. Semin Intervent Radiol; 29(3):187-91.). Moreover, as spontaneous recovery of PFD is unlikely beyond 12 months post-injury (Khanna P, Phan H, Hardy AH, Nolan T, Dong P, 2012. Multidisciplinary management of blunt pelvic trauma. Semin Intervent Radiol; 29(3):187-91.), any patients presenting with PFD at this time point will be offered a cross-over to the intervention (that is, a referral to the sub-acute continence or urology service at the institution at which they were originally treated for their pelvic injuries, for specialised assessment and treatment). Participants in this group will also be asked whether they have had any assessment or management for PFD independent of this study.
Control group
Active

Outcomes
Primary outcome [1] 334895 0
Change in prevalence of pelvic floor dysfunction, as determined by score on the APFQ for females and the IIEF or APFQ for males.
Timepoint [1] 334895 0
Acute admission post injury, 3 months post injury, 12 months post injury
Primary outcome [2] 335211 0
Change in severity of pelvic floor dysfunction, as determined by APFQ and IIEF scores
Timepoint [2] 335211 0
Acute admission post injury, 3 months post injury and 12 months post injury
Secondary outcome [1] 423465 0
Nil
Timepoint [1] 423465 0
Nil

Eligibility
Key inclusion criteria
Patients who participated in the linked observational study and were determined to have pelvic floor dysfunction 3 months post injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who participate in the linked observational study who had no evidence of pelvic floor dysfunction 3 months post injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Women and men will be analysed separately as they have different total possible PFD symptoms and thus different APFQ scores. A sample size of 192 for each sex provides 80% power at a two-sided alpha of 0.05 to detect a minimum difference in mean APFQ score (primary outcome) of 5.3 (women) and 3.4 (men) between the treatment and control groups at 12 months follow-up. This is based on a standard deviation of 11.8 for women and 7.6 for men, found in our previous study. Given the lack of literature in this area, it is not clear what the minimum clinically important difference in means should be for women or men. Consultation with an expert women’s health physiotherapist indicated that a change of 5.3 in APFQ score would indicate the presence of new PFD symptoms in women and therefore this difference was chosen to be clinically meaningful. Furthermore, given that men complete only two of the four sections of the APFQ that women complete and hence, overall scores will be lower, it is appropriate to be able to detect a smaller difference in mean scores. These sample size calculations have allowed for a dropout rate of 20%.

Data analysis will be performed using Stata version 16. Linear regression models will be fitted to examine differences in mean APFQ and IIEF-5 scores at 12-months (where appropriate, depending on sex) by treatment allocation (standard care or referral) for patients who participated in the RCT, controlling for baseline scores and randomisation strata. Analyses will be conducted on an intention-to-treat basis according to the treatment to which the patient was randomised.

Prior to completion of the study, a full statistical analysis plan will be completed.

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
384
Accrual to date
78
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24806 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 24807 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 40451 0
3004 - Melbourne
Recruitment postcode(s) [2] 40450 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 313925 0
Government body
Name [1] 313925 0
Traffic Accident Commission
Country [1] 313925 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan StParkville VIC 3050
Country
Australia
Secondary sponsor category [1] 315787 0
None
Name [1] 315787 0
Address [1] 315787 0
Country [1] 315787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313071 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 313071 0
300 Grattan StParkville VIC 3050
Ethics committee country [1] 313071 0
Australia
Date submitted for ethics approval [1] 313071 0
23/01/2021
Approval date [1] 313071 0
13/04/2021
Ethics approval number [1] 313071 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). This will enable patients with PFD to be randomly assigned to either receive usual care or usual care plus onward referral to a sub-acute outpatient continence or urology service. 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 126890 0
Ms Carly McConnell
Address 126890 0
The Royal Melbourne Hospital300 Grattan StParkville VIC 3050
Country 126890 0
Australia
Phone 126890 0
+61 425 449 390
Fax 126890 0
Email 126890 0
carly.mcconnell@mh.org.au
Contact person for public queries
Name 126891 0
Ms Carly McConnell
Address 126891 0
The Royal Melbourne Hospital300 Grattan StParkville VIC 3050
Country 126891 0
Australia
Phone 126891 0
+61 3 93427000
Fax 126891 0
Email 126891 0
carly.mcconnell@mh.org.au
Contact person for scientific queries
Name 126892 0
Ms Carly McConnell
Address 126892 0
The Royal Melbourne Hospital300 Grattan StParkville VIC 3050
Country 126892 0
Australia
Phone 126892 0
+61 3 93427000
Fax 126892 0
Email 126892 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
19263Study protocol    To be confirmed
19264Statistical analysis plan    To be confirmed
19265Clinical 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.