Hypothesis / aims of study
One-year post-pelvic fracture, symptoms of pelvic floor dysfunction (PFD) can persist (1), however, it is not standard care for acute hospital services to screen for PFD or refer for intervention. The aim of this study was to screen pelvic trauma patients 3 and 12-months after their injury and evaluate the uptake of nested randomisation to physiotherapy or usual care when PFD was identified.
Study design, materials and methods
Multi-site observational and nested randomised control trial (RCT). Adults sustaining ≥1 pelvic fracture (except isolated acetabulum) were recruited from two major trauma hospitals. Preceding hospital discharge, a demographics questionnaire, the Australian Pelvic Floor Questionnaire (APFQ)(2) and simplified International Index of Erectile Function (IIEF-5(3), males) were completed as baseline pre-injury pelvic floor function. Instruments were repeated at 3 and 12-months; additionally, EQ-5D-5L was completed at both time points. Recruitment target for observational study was 484 (205 female, 279 male) assuming 94% and 69% of women and men respectively would have PFD (1). Participants scoring an increase of ≥1 on the APFQ or ≤21 on the IIEF-5 at 3-months were deemed to have developed PFD since pelvic injury and were enrolled in the RCT. Randomization considered site, sex and surgical vs non-surgical intervention. The intervention group were offered referral for pelvic floor physiotherapy and the control group received standard care. All participants were reassessed at 12-months. Data were analysed descriptively (SPSSV28).
Results
Over 28 months 1278 potential participants were screened for inclusion, 236 of 806 eligible declined. Overall, 59% received non-operative management for pelvic fracture, 78% sustained concurrent injuries, 6.5% urinary tract damage, 4% genital injury, 13% abdominal, while 62% continued to receive orthopaedic rehabilitation. To date 479 (178 female, mean age 49.5 (17.9) years; 301 male, mean age 51.9 (18.4) years) were recruited (99% of target). Currently 429/479 have reached 3-month reassessment; 14 have declined, 3 died and 20 responded to email but failed to return data despite reminders. As per Table 1, new PFD post-fracture was reported in 228/355; 60% males (median [IQR] APFQ 7.0 [2.0-12.0]; IIEF-5 20.0 [9.0-24.0) and 72% of females (median [IQR] APFQ 12.0 [6.0-24.8]). Two thirds participants had never been asked about PFD and 90% never offered treatment.
At 12-months 29.9% of the cohort reported residual post-fracture issues; 29.5% had not returned to pre-injury work hours due to pain, weakness or fatigue. Prevalence of ongoing PFD was 53%. Of the participants who did not complete follow-up measures (24 females, 47 males) 14 females and 38 males had concurrent injuries and 1/3 were discharged to inpatient rehabilitation. Items in the IIEF-5 were often not relevant at the timepoint of recovery. Figure 1 demonstrates the on-going impact of pelvic fracture at 3 and 12 months.
Nested RCT: of the 127 males and 100 females, 72.6% have completed 12-month follow-up measures to date. Only 54% of intervention group accepted a referral to pelvic rehabilitation; 32% declined as PFD was not considered a priority and 13% were already receiving some form of pelvic healthcare. At 12-months referrals for PFD management were made for 44% of the control group.
Interpretation of results
Screening for PFDs after pelvic trauma is important but problematic, particularly since people with multi-trauma do not routinely prioritise symptoms of PFD. Sub-group analysis may direct targeted screening. The IIEF-5 was not fit-for-purpose in the male pelvic fracture population; the APFQ domains of prolapse and sexual function were minimally relevant to female participants.