Hypothesis / aims of study
The quality of life (QoL) of women with urinary incontinence (UI) is affected in different proportions, depending on the type and severity of symptoms. UI can cause serious medical, social, psychological and economic implications (1). It is expected that conservative and surgical interventions can improve the QoL of patients with UI. Pelvic floor muscle training (PFMT) is recognized as a conservative treatment, presenting level 1 and degree of evidence A for the treatment of stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) (2). Currently, gametherapy is a new therapeutic approach that has been used associated with PFMT. This modality can add to the treatment as a motivational and amused factor (3). However, there are still few publications about this new modality for UI treatments. Therefore, the aim of this study was to compare QoL in women with MUI before and after two conservative interventions: PFMT isolated and associated with gametherapy.
Study design, materials and methods
Randomized, blinded clinical trial study was performed. 32 women with MUI were divided equally into two groups: PFMT (pelvic floor muscle training group – n=16) and GG+PFMT (gametherapy + pelvic floor muscle training group – n=16). The study included women aged between 45 and 70 years, who did not have an intact hymen, did not perform PFMT, did not use hormone replacement therapy (HRT) for at least three months and did not have a diagnosis of diabetes, neurological disorders or a previous history of epilepsy. The research was carried out in four stages: (1) Evaluation 1 (baseline): the evaluation form was used including sociodemographic information, life habits, urogynecological, obstetric and sexual history. Pelvic floor function was assessed using the modified Oxford scale and manometry. The quality of life was measured by the World Health Organization Quality of Life – bref (WHOQOL-bref) questionnaire. The questionnaire has 26 questions, two about general QoL and the other 24 divided into four domains: physical, psychological, social relationships and environment. (2) Intervention: The training was performed twice a week for eight consecutive weeks, during 40 minutes per session. all interventions were performed individually in both groups. PFMT consisted of three modalities: breathing exercises, abdominal exercises and pelvic mobility exercises. Each exercise was performed associated with the contraction of the pelvic floor muscle (PFM). There were progressions throughout the training in each modality.Gametherapy used a video game by Nintendo® brand, Wii®, with Wii Balance Board® that it is responsible for the interface between the machine and participant. Wii Fit Plus® games from the balance segment were used: Lotus Focus and Peguin Slide and from the aerobic segment: Step Basic and Hula Hoop. Each game was performed associated with the contraction of the PFM. All volunteers received educational content on the location and function of the PFM, types of UI, bladder and bowel functioning, as well as guidance on risk factors. (3) Evaluation 2: It was performed after 8 sessions; (4) Evaluation 3: It was performed after 16 sessions. The evaluator was blinded.This project was approved by the Ethics Committee in Research and registered on the Brazilian Registry of Clinical Trials – ReBEC virtual platform. For sample size calculation, the g*power software (Universität Düsseldorf: Psychologie) was used. Means and standard deviation of the World Health Organization Quality of Life – bref (WHOQOL-bref) of 13 patients with MUI were used, with a sample size proposed with a confidence level of 95% and power of 80%. Data normality distributions were evaluated using the Kolmogorov-Smirnov test. Data were presented as mean and standard deviation for quantitative data, while categorical variables were described in absolute and relative frequency. An ANOVA test with repeated measures was used for the time factor (evaluations 1, 2 and 3) and for the group factor (PFMT and GG+PFMT), followed by a Bonferroni post hoc. The level of statistical significance adopted was p<0.05. Analyzes were performed using SPSS® version 22.0 software.
Results
The mean age of the sample was 50.12 ± 8.62 in PFMT and 54.43 ± 9.96 in GG + PFMT, most had more than eight years of schooling, had children, did not have regular menstrual cycles, were sexually active, were overweight and sedentary. There was a difference between the times (evaluation 1, 2 and 3) for the Whoqol question 2 (p = 0.024). The time x group comparison, there was a difference in the psychological domain (p = 0.001). There was a difference between groups in the domains: psychological (p = 0.007); social relationships (p = 0.008); and environment (p = 0.006). Comparing the groups individually by time, there was a difference for the psychological domain between the groups at baseline (p = 0.0001) and evaluation 2 (p = 0.03); for the domain social relationships occurred at baseline (p = 0.003) and for the domain environment was at baseline (p = 0.0001) and evaluation 3 (p = 0.011).
Interpretation of results
It is possible to find several questionnaires to evaluate the quality of life, some of them specific for urinary incontinence, others for lower urinary tract symptoms and others generic as WHOQOL.
It is observed to improve the QoL of women with UI, which is an important determinant of their physical, mental, and social functioning. The literature shows that PFMT is an effective non-surgical treatment for UI in women. The duration of PFMT should not be shorter than 6 weeks and it is advised to perform supervised PFMT. PFMT can be used isolated or combined with other therapy for the treatment of UI in women as gametherapy (4). Possibly, our findings resulted in an improvement in QoL considering that the intervention protocol followed the previously proven scientific findings on the effectiveness of the PFMT.
According to Dumoulin et al. (2014), women treated with any type of training for PFMs are more likely to report cure or improvement of symptoms, have fewer episodes of urinary leakage per day and less urine leakage based on the 1h pad-test. These findings have a positive impact on quality of life and justify our data.
Both intervention showed good acceptance, with no no dropout, easy applicability and has been shown to reduce the urinary symptoms. The gametherapy is similar to the PFMT intervention in terms of clinical improvement and QoL. Thus, it can be said that this technique can bring good results in clinical practice in urogynecology, in populations similar to that of this study.
Our data also showed significant differences in three WHOQL domains. However, comparison with other studies becomes difficult due to the different types of questionnaires to assess UI and QoL. Thus, it is essential that future clinical trials use valid measures for QoL (5).