RecruitingACTRN12623001101673

After Pelvic Trauma: Investigating the prevalence and severity of pelvic floor dysfunction post pelvic trauma.


Sponsor

Royal Melbourne Hospital

Enrollment

484 participants

Start Date

Nov 1, 2022

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A broken pelvis is a serious injury, and its effects can extend well beyond the bones themselves. Research shows that pelvic fractures often lead to problems with bladder, bowel, and sexual function — collectively known as pelvic floor dysfunction — and these issues can persist for a year or more after the injury. This study is investigating how common and how severe these problems are in people who have sustained a pelvic fracture. Participants will be asked a series of questions about their bladder, bowel, and sexual function at three time points: during their hospital admission, three months after discharge, and twelve months after their injury. The questionnaires are designed to detect any changes over time and understand how symptoms evolve during recovery. You may be eligible if you are an adult admitted to hospital with a pelvic fracture (not just the hip socket) and do not have a pre-existing spinal cord injury or cognitive impairment. By tracking these outcomes, the study aims to ensure that patients receive the right support during rehabilitation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 c

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.


Locations(2)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

The Alfred - Melbourne

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623001101673


Related Trials