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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]

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

Condition category

Condition code

Injuries and Accidents

Fractures

Renal and Urogenital

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]

Early detection / Screening

Intervention code [2]

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]

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]

Acute admission post injury, 3 months post injury, 12 months post injury

Primary outcome [2]

Change in severity of pelvic floor dysfunction, as determined by APFQ and IIEF scores

Timepoint [2]

Acute admission post injury, 3 months post injury and 12 months post injury

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3050 - Parkville

Recruitment postcode(s) [2]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Traffic Accident Commission

Address [1]

TACPO Box 742Geelong, VIC 3220

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Melbourne Hospital

Address

300 Grattan StParkville VIC 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Hospital HREC

Ethics committee address [1]

300 Grattan StParkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/01/2021

Approval date [1]

13/04/2021

Ethics approval number [1]

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

Ms Carly McConnell

Address

The Royal Melbourne Hospital300 Grattan StParkville VIC 3050

Country

Australia

Phone

+61 425 449 390

Fax

[email protected]

Contact person for public queries

Name

Carly McConnell

Address

The Royal Melbourne Hospital300 Grattan StParkville VIC 3050

Country

Australia

Phone

+61 3 93427000

Fax

[email protected]

Contact person for scientific queries

Name

Carly McConnell

Address

The Royal Melbourne Hospital300 Grattan StParkville VIC 3050

Country

Australia

Phone

+61 3 93427000

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?

Doc. No.	Type	Other Details
19263	Study protocol	To be confirmed
19264	Statistical analysis plan	To be confirmed
19265	Clinical 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.

Trial Review

Documents added manually

Documents added automatically