Hypothesis / aims of study
The primary objective of this study was to evaluate the long-term effectiveness of a supervised pelvic floor muscle training (PFMT) intervention for urinary incontinence (UI) in women 60 and over, by comparing the number of urinary leakages/day prior to and at 8-years post-treatment. Secondary objectives were to compare UI symptoms and UI-specific quality-of-life questionnaire results prior to and at 8-years.
Study design, materials and methods
This was an 8-year follow-up of a non-inferiority RCT conducted between July 2012 and June 2023. Women who completed the 1-year evaluation were invited to participate in the 8-year follow-up.[1] In the initial RCT, both interventions included a sequence of PFM exercises, structured into one-hour weekly sessions over 12 weeks, complemented by pelvic floor muscle (PFM) exercises to be done five days/week, at home. Upon completing the program, participants were asked to continue the PFM home exercises three days/week.
The primary outcome was the average number of leakage episodes/day as measured by a 7-day bladder diary.[2] Secondary outcomes included the ICIQ-UI-SF, ICIQ-N and ICIQ-LUTSqol. Measurements were taken prior to (baseline) and 8 years post-intervention.
For the statistical analysis, the data from both interventions (group and individual) were combined due to the absence of a significant difference in the primary outcome one-year post-intervention. Descriptive statistics included demographic and clinical characteristics. Analyses relied on the nonparametric paired Wilcoxon rank sum test with the 25th and 75th interquartile range (IQR) to compare the outcomes between two different times.
Results
Between March 2022 and June 2023, 231/319 (72.4%) participants who completed the one-year follow-up consented to participate in the 8-year follow-up. Baseline clinical and demographic characteristics were similar between participants who dropped out and those who completed the trial. Table 1 presents the demographic and clinical characteristics of the participants at the 8-year follow-up.
Since completing the 12-week PFM physiotherapy program, few participants requested further treatment; 6/230 (2.6%) participants had undergone UI surgery and 8/230 (3.5%) had been prescribed medication to treat UI.
The median (IQR) daily leakage episodes were 1.43 (0.86, 2.32) at baseline, 0.43 (0.14, 1.00) at 12-weeks, 0.43 (0.14, 1.00) at 1 year and 0.57 (0.29,1.29) at 8 years. A comparison between the 8-year follow-up and baseline revealed a significant reduction in the median number of daily UI episodes, with a median decrease of 0.86 episodes per day at 8 years: 0.86 (-1.00; -0.71); p<0.01. Overall, at 8 years’ post-intervention, 51.7% of participants experienced a decrease in leakage episodes of more than 50% compared to baseline.
Further, our results showed that improvements in symptoms and quality of life were statistically significant 8 years after the intervention. There was a meaningful improvement in the severity and impact of UI symptoms, as measured by the ICIQ-UI SF: –5 points (–6; –4), p < 0.00001. The frequency and bother of nocturia episodes, measured by the ICIQ-N, also improved: –1 point (–1; 0), p < 0.00001. Similarly, the impact of urinary symptoms on quality of life (QoL), as assessed by the ICIQ-LUTSqol, also improved: –5 points (–7; –4), p < 0.00001.
Interpretation of results
This is one of a few long-term follow-up studies (>2 years) evaluating the effect of a supervised PFMT on UI in older women. Among women participating in the 1-year follow-up, three-quarter participated in the 8-year follow-up. Eight years after the initial PFMT intervention, very few participants required more invasive interventions. Our results demonstrated that the reduction in urinary leakage episode, UI symptoms and the improvement in QoL were still significant 8 years post-intervention.