Abstract
Objective:
To verify whether pelvic floor muscle training (PFMT) associated with game therapy (GT) can potentiate improvements in PFM pressure, urinary loss, and perception of improvement in women with mixed urinary incontinence (MUI).
Materials and Methods:
A randomized and blinded trial was conducted with 32 women aged between 45 to 70 years presenting diagnosis of MUI. They were randomly divided into two groups: PFMT group and PFMT+GT group. Interventions occurred twice a week during 8 weeks. Primary outcome was PFM pressure, assessed by manometry, and secondary outcomes were 1-hour pad-test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and patients global impression of improvement for incontinence (PGI-I). Two-way analysis of variance and post hoc Tukey analysis were performed.
Results:
Initially, no significant difference between groups was found in variables of age, body mass index, educational level, marital status, gynecological and obstetric variables, life habits, and sexual activity. Besides, at baseline clinical variables also showed similar results between groups for PFM pressure, 1-hour pad-test, and ICIQ-SF. Time–group interaction did not present statistically significant differences for PFM pressure (P = 0.56), 1-hour pad-test (P = 0.75), and ICIQ-SF (P = 0.30) in intergroup analysis. All women reported being “much better or better,” considering the comparison of urinary complaints in the beginning and end of treatment.
Conclusion:
There were no statistically significant differences between groups for PFM pressure, 1-hour pad-test, and ICIQ-SF. However, both treatments proved to be effective for MUI symptoms. Perception of improvement was highly improved, according to women's report.
Introduction
Mixed urinary incontinence (MUI) has presented higher rates in middle aged and elderly individuals. 1 The physiological mechanism has been associated with intra-abdominal pressure increase and inadequate urethral closure, causing a high vesical pressure and consequently favoring urinary losses. 2 Besides, another condition that has caused urinary dysfunction is urgency incontinence, consequence of involuntary contractions of the detrusor muscle.1,2
According to the International Continence Society, pelvic floor muscle training (PFMT) presents evidence level 1 and grade A for treatment of mixed and stress Urinary incontinence (UI). 3 This intervention aims to strength fast and slow fibers to provide a greater support of pelvic organs and encourage urethral closure. 3
UI symptoms improvement has been reported in pregnant women, 4 female stroke patients, 5 and women with loss of urine 6 by using PFMT. 7 This treatment improves muscle power, function, and quality of life. 7 It is important to mention that strengthening of pelvic floor muscle (PFM) favors a conscious and effective contraction in moments of increased intra-abdominal pressure by improving tone and transmission of urethral pressure, thus avoiding urinary losses. 8
Game therapy (GT) has been suggested as a new conservative modality for UI treatments.9,10 This intervention is a form of virtual reality used to create an interface between people and machine that allows the users to interact with the elements within this simulated scenario.11,12 GT approach has shown several advantages, such as activation of different muscle groups, boosting participation and motivation. 13
There are still few studies that have investigated PFMT associated with GT9,10 and only one study that associates virtual reality with PFM contraction, simultaneously. 9 It is important to note that pelvic floor dysfunctions, such as UI, are conditions that do not threat life, but cause significant comorbidities. The presence of urinary symptoms can strongly affect patients' quality of life and promote physical, social, occupational, and sexual limitations.7,14 Therefore, new approaches are necessary that encourage, motivate, and be part of movement routine to help improvements of UI. We hypothesized that PFMT associated with GT can promote better PFM pressure and decrease urinary loss than PFMT isolated. According to these assumptions, this study aims to verify whether PFMT associated with GT can potentiate improvements in PFM pressure, urinary loss, and perception of improvement in women with MUI.
Methods
Trial design
A randomized double blinded trial was conducted from July 2016 to July 2017, according to the Consolidated Standards of Reporting Trials (CONSORT) recommendations. 15 The study was performed at the Laboratório Multiprofissional de Pesquisas Clínica e Epidemiológica from Onofre Lopes University Hospital, Natal. It was submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte, approved under the protocol number 1.438.219 and registered on virtual platform Brazilian Clinical Trials Registry (ReBEC) under the protocol RBR-6y7m8z. All participants signed the informed consent and the study was conducted in accordance with the principles of the Declaration of Helsinki.
Participants
The sample consisted of 32 women who were selected to participate in the study according to the following criteria: age between 45 and 70 years, do not have intact hymen, do not perform exercises for PFM, do not use hormone replacement therapy for at least 3 months, to present MUI, do not present loss of 1 g or less in the 1-hour pad-test, do not present null value in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 16 do not present level III or IV prolapse, according to the graduation system halfway (Baden-Walker), 17 to be able to understand simple verbal commands, not fail to contract PFM isolated without contraction of abdominal hip adductors and glutes muscles, do not report unbearable pain during gynecological evaluation, do not present diagnosis of diabetes, neurological diseases, or history of epilepsy. Those who presented vaginal or urinary infection, got pregnant, or started taking medicines, which could influence in muscle performance, were excluded. It is important to mention that initially all women were taught about the correct way to perform muscle contractions during the evaluation. Up to three attempts were made, and if the volunteer did not adequately perform them, she would be excluded.
Interventions
Two sessions per week were performed during 8 consecutive weeks in both groups, each session lasted 40 minutes (PFM warmup during 5 minutes and exercise strengthening during 35 minutes). All the protocol is in accordance with studies that treated and assessed UI dysfunctions. 18 Interventions were performed individually and the patients received educational guidance once a week about location and function of pelvic floor, bladder, and bowel physiological functioning, types of UI and general information about risk factors for pelvic floor, and onset of UI.
Treatment of the PFMT group was composed of three modalities: breathing, abdominal, and pelvic mobility exercises. All exercises were associated with PFM contraction and progressions were performed throughout training. Each exercise modality presented two sets of eight replicates in the first 4 weeks, and three sets of eight replicates in the last 4 weeks. The rest time between each exercise was 1 minute (Table 1).
Pelvic Floor Muscle Training Protocol
+, associated with; PFMs, pelvic floor muscles; PFMT, pelvic floor muscle training.
Interventions using GT+PFMT were performed by using the Wii Balance Board®. Initially, the scale captured information about weight and mass center, and along with other information previously provided, such as height and age, associations were made to recreate the patient in a virtual environment. For this study, we used balance segments of the Wii Fit Plus® games: Lotus Focus and Penguin Slide; and aerobic segments: Basic Step and Hula Hoop. All the performances were associated with PFM contractions and pelvic mobilizations (Table 2).
Game Therapy Associated with Pelvic Floor Muscle Training Group Protocol
Outcomes
Data collections were performed before interventions (initial evaluation) and after last intervention (final evaluation). During initial evaluation, information about sociodemographic data, pre-existing diseases, use of medication in the last 3 months, life habits, urogynecology, obstetric, and sexual history was collected. The height and weight were measured on physical examination. Besides, manometry of PFM, 1-hour pad-test, and ICIQ-SF were applied. In final evaluation, manometry of PFM, ICIQ-SF, 1-hour pad-test, and patients global impression of improvement for incontinence (PGI-I) were performed.
Primary outcome was PFM pressure that was assessed by the manometry, Peritron™ model 9300AV. To perform it, the patients were, initially, instructed to empty their bladder, then lithotomy position was adopted. A conical sensor (probe) was introduced into the vaginal canal 9 to 10 centimeters to measure pressure generated by the PFM, in cmH2O. After, they were instructed to perform three maximum contractions of the PFM, with a 30-second interval between them, without contraction of the abdominal, hip adductors, and gluteal muscles. The maximum value between the three trials was registered. 19
Secondary outcomes were 1-hour pad-test, ICIQ-SF, and PGI-I. The 1-hour pad-test was performed to quantify urinary losses through a pad (previously weight). After placing it, close to the external urethral meatus, individuals ingested 500 mL of water at rest. After 15 minutes, volunteers performed some actions simulating activities of daily living (walk for 30 minutes, go up and down stairs [14 steps], sit and get up 10 times, cough 10 times, pick up objects on the floor five times, run in the same place for 1 minute, and wash the hands in running water for 1 minute). 20 Finally, the pad was removed and reweighed on a precision scale. Urinary loss was evaluated and classified according to the following criteria: 1 g or less, insignificant; between 1 and 10 g, mild loss; between 11 and 50 g, moderate loss; and >50 g, severe loss. 20
ICIQ-SF is a simple, brief, and self-administered questionnaire that classifies urinary loss. It was translated and validated into the Portuguese language by Tamanini et al. 21 It consists of three questions that evaluate the frequency, severity, and impact of UI over quality of life. 21
PGI-I is a global index that assesses a condition after intervention and is considered a simple scale that presents clinical applicability about intervention perception. This instrument was composed of a single question about the current urinary condition compared with the period before treatment, ranging from 1 (much better) to 7 (very much worse). 22
Sample size
Sample size was the result of a probabilistic sampling procedure performed by Miot 23 formula, using an α error of 1.96 (5%), β error of 0.84 (20%), and the minimum difference between the means was given through a pilot study developed in the urology clinic of University Hospital, which used manometry of the PFM as primary outcome, generating an amount of 13 patients per group.
Randomization and blinding
Women who followed eligibility criteria were randomized equally (1:1) into two groups: PFMT or PFMT+GT (pelvic floor muscle training associated with GT), by platform randomization.org. All assessments and interventions were performed by a blind researcher who was trained to accomplish it.
Statistical analysis
Sample data were analyzed through Statistical Package for the Social Science (SPSS 20.0) software. Komolgorov–Smirnov's test was used, to test normality of the data, and Levene's test to analyze the homogeneity of the variances. Descriptive statistics were used to characterize sociodemographic, clinical, anthropometric, gynecological, obstetric, and PGI-I variables. In addition, independent t-test evaluated the difference between the groups at initial evaluation.
The mixed variance (two-way analysis of variance) and post hoc Tukey analysis were performed to evaluate time–group interaction, and inter/intragroup differences for manometry, pad-test, and ICIQ-SF. The independent fixed variables were time (baseline and after intervention), group of stimulation (PFMT and PFMT+GT), and the interaction term. Sphericity was tested using Mauchly test and Greenhouse–Geisser correction was used when necessary. Statistical significance was set at P ≤ 0.05. Cohen f2 effect size was calculated to identify the clinical practice impact on subgroup analyses when there was statistical significance. The effect of the clinical practice was rated as a small effect (f = 0.1), medium effect (f = 0.25), and large effect (d = 0.4). Statistical significance was set at P ≤ 0.05.
Results
Two hundred fourteen women were assessed; however, 182 did not meet inclusion criteria. Thirty-two people participated in the study and were included for analysis. Study process is represented in Figure 1.

Study flow diagram according to CONSORT 10. CONSORT, Consolidated Standards of Reporting Trials; GT, game therapy; PFMT, pelvic floor muscle training.
Sociodemographic profile, gynecological and obstetric characteristics, and life habits results are presented in Table 3. There were no statistical differences between groups before intervention. Most women did not present a regular menstrual cycle, were considered overweight, sedentary, and reported to be sexually active (Table 3).
Sociodemographic, Gynecological, Obstetric, and Lifestyle Characteristics of the Sample
PFMT+GT, PFMT associated with game therapy group.
There was no statistically significant difference between groups in the initial evaluation for manometry of PFM (P = 0.56), ICIQ-SF (P = 0.30), and 1-hour pad-test (P = 0.75). In addition, it was observed that there was no time–group interaction or even statistically significant intergroup differences after interventions for PFM manometry, 1-hour pad-test, and ICIQ-SF analysis (P > 0.05). Regarding intragroup analysis (both groups), statistical difference was observed in the PFM manometry (F1.30 = 19.874; P = 0.000; f = 0.80; Power = 0.99), in 1-hour pad-test (F1.30 = 45.531; P = 0.000; f = 1.29; Power = 1.00), and ICIQ-SF (F1.30 = 25.285; P = 0.000; f = 0.93; Power = 0.99). When compared before and after treatment, 93.8% of patients in PFMT group reported being “much better or better,” whereas 81.3% of patients in the PFMT+GT group reported being “much better or better” (Table 4).
Pelvic Floor Muscle Pressure and Urinary Loss Before and After Interventions
ICIQ-SF, International Consultation on Incontinence Questionnaire-Short Form.
Discussion
This study aimed to compare the efficacy of PFMT isolated and associated with GT in the treatment of MUI. The results showed that both interventions improved PFM pressure, intervention perception, and decrease urinary loss. However, no statistically significant differences were found in the variables between groups. Although there were no significant intergroup differences, a significant improvement in intragroup analysis (both groups) for PFM manometry was found. The PFMT group showed an increase in muscle pressure of 28.75% and PFMT+GT increased 16.74% after interventions.
The authors presented for the first time a classification scale with standard values of manometry of PFM by Peritron equipment. 24 According to the proposed scale, values of pressure in cmH2O between 7.5 and 14.5 correspond to very weak; 14.6 to 26.5 correspond to weak; 26.6 to 41.5 correspond to moderate; 41.6 to 60.5 correspond to good; and >60.6 correspond to strong pressure. 24 In this study, we observed that interventions performed by both groups changed from weak to moderate PFM pressure.
Urinary losses also decreased in intragroup evaluation. Women from both groups obtained a final mean of <1 g, which according to the ICS is considered as continent. 25 Thus, it is suggested that both protocols can be used to treat and improve MUI. Oliveira et al. 26 showed in the systematic review that training programs from 8 to 12 weeks seem to reduce the amount of urine leakage, and/or to increase PFM strength. Some authors suggest that PFM strengthening is an effective treatment strategy for women with UI to promote the reduction of urogynecology symptoms due to increase of urethral closure pressure and pelvic organ support.27–29 It is emphasized that both interventions proposed in this study aimed to strengthen PFM by training fast and slow fibers. Training both types of fibers is important for the maintenance of urinary continence and should be present in PFM rehabilitation programs. 30 The histological composition of PFM is composed of 70% of type I fibers with the function of maintaining the pelvic organs and 30% of type II fibers that are responsible for urethral closure during activities that trigger intra-abdominal pressure increase. 31
The ICIQ-SF showed that urinary losses decreased 89.97% and 92.36% in PFMT and PFMT associated with GT, respectively. This information showed that both groups reduced from 5 to 7 points in the ICIQ-SF final score. Nystrom et al. 32 evaluated 214 women with stress UI, before and after PFMT, and found 2.5 as a minimum clinically relevant difference in the total ICIQ-SF score.
Our data showed that PFMT isolated and associated with GT presented similar results. The effects of PFMT are known in the literature 18 ; however, information about GT is somewhat new in PFM rehabilitation. Botelho et al. 29 found that isolated GT (without PFMT) was able to increase PFM contractility and decrease urinary symptoms in 27 postmenopausal women with MUI. Moreover, Elliott et al. 9 associated virtual reality with PFMT and home exercises in 24 elderly women and the results showed a reduction of urinary loss. According to Dumoulin et al., 18 women treated with any type of strengthening approach for PFM are more likely to report cure, to have better quality of life or symptoms improvements, fewer episodes of urinary loss per day, and less urine loss based on 1-hour pad-test. This information corroborates the findings of this study, which showed improvements in pressure, urinary loss, and acceptance in both groups.
It is important to note that both interventions in this study requested PFM contractions associated with active contraction of transverse abdominal muscle. Junginger et al. 33 reported that attempts to coordinate actions between abdominal muscles and PFM in rehabilitation processes should be encouraged to increase awareness and perception of PFM. This study further demonstrated that exercises with a focus on the abdominal and pelvic cavity can promote strengthening of PFM by improving its functionality. Kamel et al. 34 also found a significant improvement in vaginal pressure, justifying that abdominal muscles can generate secondary activations of PFM, keeping their organization, sustenance, endurance, and muscular strength. 35 It is also added that recruitment of the transverse abdominal and internal oblique muscles leads to an activation of PFM, acting as part of an integrated abdominal pelvic unit. 36
This article has some limitations that deserve to be known. It was not a urodynamic study, instead diagnosis of MUI was performed by a urologist based on clinical signs and symptoms. Another point is a lack of bladder diary that could infer additional data about loss of urine. We believe that the educational level of the participants made it difficult.
Conclusion
PFMT associated with GT did not show better improvements than PFMT isolated in PFM pressure and urinary loss. Both interventions proved to be effective for the treatment of women with MUI. Treatments proposed in this study showed good acceptance, no withdrawal, and easy applicability, and demonstrated to be effective.
Footnotes
Authors' Contributions
L.O.B., M.C.E.O., H.K.V.S., and G.F.M.O. had full access to all of the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design were carried out by L.O.B., M.C.E.O., and M.T.A.B.C.M. Acquisition of data was by L.O.B., M.C.E.O., H.K.V.S., and G.F.M.O. Analysis and interpretation of data were done by L.O.B., E.M.S.F., R.P., and M.T.A.B.C.M. Drafting of the article was performed by L.O.B., E.M.S.F., and M.T.A.B.C.M. Critical revision of the article for important intellectual content was carried out by A.K.S.G. and R.P. Study was supervised by M.T.A.B.C.M.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) - Finance Code 001.
