Hypothesis / aims of study
There is growing evidence that pre-operative pelvic floor muscle training (PFMT) may reduce the severity and longevity of post-prostatectomy incontinence (PPI) [1, 2]. However, attention has yet to be paid to pre-operative PFMT with functional integration. This study not only responds to a call for greater contributions to the body of literature in this area of clinical practice, but addresses a novel area of practice that has not yet been investigated . The primary and secondary aims of the study include: 1) to assess the feasibility of a study exploring whether functional PFMT provides greater improvements in PPI outcomes when compared with standard strength training and 2) to provide a preliminary indication regarding the effectiveness of functional PFMT.
Study design, materials and methods
This study was an un-blinded prospective, single-centre pilot randomised controlled trial (RCT) conducted at a single metropolitan institution between December 2016 and July 2018. Patients were included if they had a scheduled date for radical prostatectomy (RP) at the participating organisation or if they were undergoing RP with a private urological consultant affiliated with the organisation. Patients from a non-English speaking background (NESB), pre-existing urinary incontinence (UI) and cognitive or functional deficits inhibiting participation were excluded from the study. Patients were screened for their eligibility during their pre-operative physiotherapy assessment which occurs as per the organisation’s standard care pathway. Due to the use of a pilot design study, a sample of convenience of 30 participants was used. Each participant was randomised to the control or intervention group by a computer-generated number sequence. Figure 1. represents the study pathway. An independent-samples t-test was conducted to compare post-operative UI measures between groups. Pearson’s correlation coefficient assessed for relationships between each variable of age, body mass index and time between physiotherapy assessment and surgery against each PPI outcome measure at 4 and 12 weeks post-operatively. All analysis was conducted using the SPSS statistical software package.
30 out of 60 (46 English speaking/14 NESB) potential participants were recruited, with 15 allocated to each group. 80% (24) completed the study (control (12), intervention (12)) with themes of withdrawal including cancellation of surgery, distress of diagnosis, failure to participate in the pre-operative program and failure to attend the 26-week review. There were no adverse events as a result of participation. Baseline characteristics were similar between groups. Between group characteristics were homogenous (age p=0.19, body mass index (BMI) p=0.50, days between physiotherapy assessment and surgery p=0.45 and number of physiotherapy sessions attended p=.10). Post-operative significance was reached between groups in the 26-week ICIQ-UISF total score with the intervention group demonstrating a more favourable outcome (Mean Difference=3.67, p=0.02). Using Pearson’s correlation coefficient, associations between each variable of age, body mass index and days between surgery were not significant at the p<0.05 level when compared with each of the post-operative variables. Table 1. demonstrates the univariate descriptive statistics and t-test outcomes between groups.
Interpretation of results
Functional PFMT may not have a significant impact on UI outcomes in the early phases of recovery but may have better long-term impact on UI, particularly in the areas of self-perceived incontinence and bother. Homogeneity of group characteristics contributes towards profiling of patients undergoing RP for prostate cancer. Age, BMI and the amount of time between the initial physiotherapy assessment and surgery did not demonstrate significant correlation with post-operative outcomes, indicating that UI may be associated with external factors requiring further exploration. A lack of cultural and linguistic validation of the pad weight record excluded recruitment of patients from NESB. This requires further attention given that 24% of patients who underwent RP at the host organisation in 2017 were of NESB. Patient distress at implementation of physiotherapy intervention is also a consideration that needs further exploration regarding self-efficacy and patient engagement.