Study design, materials and methods
A Stratified Randomized Controlled Trial (by age and weight of pad test) with blinding assessor was administered for this study. The respondents participating in the study were randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment as the control.
The primary outcomes of the study were the amount and frequency of urine leakage measured by objective measures; 1-hour pad test and Bengali-ISI subjective questionnaire. In addition the secondary outcome of the study was the QoL of women with UI measured by KHQ. An Intention-to-Treat analysis was conducted and repeated measures ANOVA (2x2) with Bonferroni Post-hoc analysis was used to analyze the data.
A stratified randomized control trial with concealed allocation, assessor-blinded to groups of patient conducted at the Centre for the Rehabilitation of the Paralysed (CRP), Savar, Bangladesh. Recruitment of the patient was performed by the two physical therapists’ daily visited at the outpatient unit of CRP. Participants were asked about the presence of involuntary leakage of urine. After that the investigator was filled up the QUID diagnostic questionnaire to ensure the presence of stress urinary incontinence followed by inclusion and exclusion criteria to find out the sample population. Eligible patients were informed about the objectives and the study details. A written consent form was filled up by the patients and the patients were randomized into two groups including intervention and control group. This study was allocated the respondents with the 1:1 parallel ratio with opaque sealed envelopes that was used to achieve allocation sequence. A researcher who was not involved in the data collection and treatment was created a list of computer-generated random numbers, prepared and was sequentially numbered the opaque sealed envelopes. The participants were drawn one of pre-printed cards in opaque sealed envelopes from the boxes labeled “A” as the “Core stability with PFME” and “B” as the “PFME”. The respondents were arranged in the experimental and control groups according to the drawn of card.
For sample size estimation, it was based on the previous study by Burns et al (1999), the mean frequency of UI episodes between the control group (6.19 episodes per week) and the treatment group (3.3 episodes per week) with the moderate effect size of 0.37 was used in G*Power software program for power analysis. The power was set at the level of 0.80 with the p-value of 0.05, therefore a sample size of 41 participants was required to detect a significant difference between groups. To account for the dropout rate, extra numbers of participants (i.e.,20%) were added, so at least 50 participants’ were required. Participants for this study were consisted of 4 age ranges of women population. An equal number of women with pad weight severity ≥ 2 gram were balanced within each group.
Results
In this randomized Control trial (TCTR2020320004), combination of PFMT with core stability exercises were shown to be more effective than the PFMT in the women with stress urinary incontinence along with the low back pain.
At baseline, there were no significant differences between groups in terms of demographics and clinical characteristics (i.e., age, occupation, living place, education, and severity of SUI by pad test, frequency of urine leakages, quality of life. Twenty four respondents of the experimental group completed the intervention till 12th week.
The study findings illustrated that 84% (n=21) of experimental and 28% (n=27) of control group respondents were cured from the UI. The effects of treatment and time were assessed by a mixed model of 2-ways repeated measures ANOVA (2x4) with Bonferroni Post-hoc analysis at 4 different time points. The findings of one hour pad test demonstrated that both experimental group (PFMT+ Core stability exercise) group and control group (PFMT) after 12th weeks of intervention considering the level of significance less than p value ≤ 0.05 (experimental; p=0.001; and control; p=0.007), respectively. Mentionable, the amount of urine leakage significantly decreased in the experimental group (PFMT+ Core stability exercise) more than the control group (PFMT) after 12th weeks of intervention (p=0.004).
Another primary outcome of the study considered to measure the frequency of urinary incontinence; measured by the Bengali-translated incontinence frequency index (ISI) questionnaire. It is a two item questionnaire which was used at the baseline and at 12th week of intervention to measure the urinary incontinence frequency. Intention-to-treat analysis was conducted and mixed model of 2-ways repeated measures ANOVA (2x2) with Bonferroni Post-hoc analysis. The findings of this study revealed that there were statistical significant difference after 12th week of intervention within the groups (p=0.008) and (p=0.000), respectively. In addition, there were significant difference of frequency in between the experimental and control groups (p=0.014).
Furthermore, the study findings suggested that the QoL of both groups significantly improved after 12th weeks of intervention, however, the experimental group significantly improved in incontinence impact, physical limitation, severity measures and effect of bladder problem considering p=0.000 as per the KHQ.
Interpretation of results
The findings of the study revealed that both combined treatment group (PFMT+ Core Stability Exercise) and individual PFMT groups displayed significant improvements in primary and secondary outcomes of clinical efficacy. However, the comparisons among these two kinds of interventions favored more the experimental group both the objective parameters including cure of SUI and core stability and subjective cure of frequency and Quality of Life (QoL).
A previous study revealed the similar findings with the present study and stated that PFMT increased pelvic floor muscle strength (p<0.05) and significantly reduced the frequency and amount of urine leakage considering the (p=0.04) (Da Roza, et al., 2012).
The secondary outcome of the study considered to measure the QoL of women with urinary incontinence through King’s Health Questionnaire (KHQ). The present study found a significant difference within the groups after 12th weeks of intervention. In a previous study by Krhut (2018) stated weaker impact of stress urinary incontinence on the QoL than the mixed urinary incontinence.
The result of the present study is in line with the previous study mentioned with that there was a significant decrease in the mean scores of the domains assessed by the KHQ regarding the perception of health, impact of the incontinence, limitations of daily activities and measures of severity (Fitz, et al., 2012).