Assessment of the Possibility of Using Ultrasound Imaging in the Treatment of Stress Urinary Incontinence in Women

doi:10.21203/rs.3.rs-2607613/v1

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Assessment of the Possibility of Using Ultrasound Imaging in the Treatment of Stress Urinary Incontinence in Women

https://doi.org/10.21203/rs.3.rs-2607613/v1

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The number of people suffering from urinary incontinence increases every year. Along with it, the knowledge of the society increases that there are various methods of eliminating this ailment.. Both patients and researchers are constantly looking for new treatments for urinary incontinence. One of the new solutions is sonofeedback of the pelvic floor muscles, which may help to strengthen them and thus reduce the problem. The aim of this study was to evaluate the effectiveness of sonofeedback and transvaginal electrostimulation in increasing the bioelectrical activity of pelvic floor muscles in postmenopausal women with stress urinary incontinence. Sixty women with stress urinary incontinence were enrolled in the study. The patients were divided into two groups: A - where sonofeedback was used and B - where electrostimulation of the pelvic floor muscles was performed with biofeedback training. In patients, the resting bioelectrical activity of the pelvic floor muscles was assessed using an electromyograph. The assessment of the resting bioelectrical activity of the pelvic floor muscles was performed before the therapy, after the 5th training and after the therapy. It was observed that after the end of the therapy, the average bioeltrical potential increased by 1.1 µV compared with baseline in group A. It can be suggested that the sonofeedback method is comparatively effective in reducing symptoms that are associated with urinary incontinence as a electrostimulation method with biofeedback training.

electrostimulation

sonofeedback

stress urinary incontinence

Urinary incontinence is an extremely common problem affecting postmenopausal women. This condition adversely affects numerous aspects of life [1,2]. Urinary incontinence (UI) is characterized as involuntary leakage of urine due to dysfunction of the urethral sphincters which control the outflow of urine [3]. According to the International Continence Society (ICS), it is also the cause of hygienic difficulties leading to social problems. UI mainly concerns older women, which concerns 10–20% of all women. The latest data show that this problem occurs in as many as 77% of women living in nursing homes [4]. Despite the increase in public awareness of UI, there are still many people who believe that urination is natural and closely correlated with old age [5,6]. These data show that UI should be considered a social disease, as it affects more than 5% of the population, regardless of ethnic or cultural differences [7].

The incidence of urinary incontinence increases with age. In addition, chronic diseases and low economic status predispose to incontinence. Numerous researchers state that this problem is most commonly seen in menopausal and postmenopausal women [8–10]. According to US researchers, UI affects as many as 50% of women over the age of 65 [11].

One of the important risk factors predisposing the occurrence of UI is menopause. It is caused by a significant decrease of estrogen in the blood, which contributes to the lowering of the urethra and shortening it to 1–2 cm, as a result, it can cause frequent urination. In addition, in menopausal women, the detrusor muscle and those responsible for urine excretion are also very often too weak [12].

Urinary incontinence can also be caused by part of the aging process [13]. Changes in the bladder, pelvic structure, and comorbidities that can interfere with continence mechanisms are major contributors to the onset of incontinence, and often occur in older adults. The comorbidities include above all diabetes, disability or cognitive impairment. Numerous studies have been published showing the relationship between age and incontinence [14].

At present, women are becoming more and more aware of the health problems that affect them. Nevertheless, many still believe that UI is natural and incurable. People with this condition often withdraw from professional and social life, effectively contributing to a decrease in their quality of life [15]. As the population in Poland is aging, it can be assumed that the number of patients will continue to increase. According to the forecasts presented by the Statistics Poland (Polish: Główny Urząd Statystyczny), the number of people over 80 years of age in 2030 will be doubled compared to nowadays, and will reach more than 2 million [16]. The fight against urinary incontinence will require the development of effective treatment standards and tailored medical care provided by an interdisciplinary team of specialists from different fields [17]. Conservative treatment is recommended in the presence of I or II degree urinary incontinence. Surgical treatment should only be considered in the case of advanced disease or the presence of disturbances in pelvic floor stability [18,19]. Modern physiotherapeutic methods are able to reduce the symptoms of urinary incontinence and prevent the occurrence of adverse effects, such as psychological, social, and societal disorders [20]. Physiotherapy treatments can often constitute an alternative to surgical treatment or pharmacotherapy [21,22]. Conservative treatment methods primarily include physiotherapy [23]. Properly selected physiotherapy methods ensure improvement or complete resolution of symptoms. In case of incomplete symptom reduction, physiotherapy increases the chance of success for the applied surgical treatment [24,25]. Conservative treatment includes: physiotherapy (pelvic floor muscle exercises, biological feedback – biofeedback, sonofeedback, pelvic floor muscle electrostimulation, bladder training, magnetic field stimulation); mechanical measures (pessaries, cones, intravaginal balls - Kegel balls); lifestyle changes; pharmacotherapy [26].

Currently, the common conservative treatment is electrostimulation of the pelvic floor muscles (PFM). This method is primarily used for patients who are unable to contract these muscles on their own. The cause of pelvic floor muscle weakness is most often due to impaired conduction of nerve impulses through the pudendal nerve. The purpose of using electrical stimulation is to restore the ability of muscles exhibiting partial denervation to contract [27,28]. The electrical impulses sent by the electrostimulation device cause the muscles to contract, which results in their passive reinforcement. The procedure can be performed as a direct stimulation using a special vaginal electrode, indirect stimulation using surface electrodes or as functional electrostimulation using both types of electrodes simultaneously [29,30].

Another method that can be used in the treatment of stress urinary incontinence is sonofeedback. This method uses biological feedback and, as shown in the studies presented in the available literature, can be used to strengthen the pelvic floor muscles [31–33].

Sonofeedback allows you to observe muscle activity in real time. This enables the therapist to teach the patient how to tense and relax the muscles correctly [34]. Sonofeedback is gaining increasing interest [35]. The sonofeedback method is used by physiotherapists to treat a variety of conditions. It is also referred to as rehabilitative ultrasound imaging. With this innovative method, pelvic floor muscle reinforcement is achieved in patients with urinary incontinence. Furthermore, ultrasound allows the physical therapist to evaluate some of the functions in these muscles.

Ultrasound examination also allows the physiotherapist to assess the function of the pelvic floor muscle. Thanks to the examination, the physiotherapist can assess, among others, the urethra, bladder neck or the pubic symphysis [36]. The methodology is standardized and must be the same for all measurements [37, 38].

The aim of study was to evaluate the effectiveness of sonofeedback and transvaginal electrostimulation in increasing the bioelectrical activity of pelvic floor muscles in women.

Study Questions:

• Will the use of sonofeedback training increase the bioelectric activity of the PFM in the study group?

• Is training with the use of the sonofeedback method as effective in the treatment of SUI as electrostimulation with biofeedback training?

This project was carried out at the Gynecology Department of a hospital in Wrocław, Poland. The research was approved by the Bioethics Committee and took place between February and June 2019.

60 women diagnosed with stress urinary incontinence were qualified for the project. Before the therapy, each patient underwent a medical history and physical examination. The obtained data are presented in Table 1. To participate in the study, the patients had to meet strictly defined inclusion and exclusion criteria. They are presented in Table 2.

Table 1

Characteristics of patients.
Number of people		n = 60
Age [years]	Min-max Mean Standard deviation Median	45–65 57.33 6.26 57.5
Body height [m]	Min-max Mean Standard deviation Median	1.49–1.72 1.61 0.05 1.62
Body weight [kg]	Min-max Mean Standard deviation Median	48–100 69.94 11.65 69.5
BMI [kg/m²] Number of births Type of delivery Comorbidities The circumstances of the appearance of the first symptoms of SUI	Min-max Mean Standard deviation Median Min-max Mean Standard deviation Median birth by the forces of nature caesarean section Yes No after delivery after gynecological surgery after menopause the patient is unable to give the circumstances	17.63–38.86 27.07 4.69 26.74 1–4 2,10 0,71 2 55 (91,67%) 5 (8,33%) 49 (81,67%) 11(18,33%) 3 (5%) 22 (36,67%) 26 (43,33%) 9 (15%)

Table 2

Study inclusion and exclusion criteria.
Inclusion criteria	Exclusion criteria
- grade II SUI confirmed by a gynecologist; - age 45–65; - postmenopausal age; - no health contraindications to the use of therapy; - SUI occurrence for more than 5 years; - obtaining informed written consent from the patient.	- an implanted pacemaker; - lower urinary tract infections; - decreased nerve excitability; - difficulty cooperating with the studied person; - organ prolapse; - previous pelvic surgery; - SUI pharmacological treatments, - other conservative treatments for SUI.

The patients were randomly assigned to three groups. Simple randomization was used. Sonofeedback training was performed in group A. In group B electrostimulation of the pelvic floor muscles was performed, combined with biofeedback training. Group C was the control group which did not receive the therapy. Patients were recommended not to exercise the PFM between sessions.

In all subjects the bioelectrical activity of the pelvic floor muscles was tested three times: before, after the 5th, and after the therapy. The measurement was performed with a MyoPlus 4 Pro Electromyograph. Resting EMG levels were examined for 60 seconds. Changes in mean resting bioelectrical activity of the PFM were evaluated. During the examination, the patients were in the supine position on a stable therapy table. The electrodes were placed equally in each subject – an endovaginal electrode in the vagina.

Different management was applied to the patients, depending on the enrollment to a specific group. In patients from group A, sonofeedback training of the pelvic floor muscles was performed. After enrollment to the group, patients were trained to perform sonofeedback training correctly. The ability to perform the training correctly was a requirement for participation. The correctness of the training was evidenced by the displacement of the bladder, which both the patient and the therapist could observe on the ultrasound screen. The training was conducted in accordance with the literature guidelines [39].

There were two images on the monitor screen during the sonofeedback training. One showed the lesser pelvis in the resting phase, while the other image was a real image in which the displacement of structures during muscle contraction was observed. Differences in bladder base position between the two images were measured using vectors that could be determined on an ultrasound machine. The contraction time was 5 seconds each time, whereas the relaxation time was twice as long. The patient repeated this activity 10 times in each of the 10 series, with a rest time of 30 seconds between each series.

Training was performed by assessing the change in bladder base location during normal pelvic floor muscle tone [40]. General Electric's Voluson E10 ultrasound device was used for the therapy. The therapies took place every day from Monday to Friday and lasted 2 weeks. All treatments were performed by one therapist.

Patients from group B underwent electrostimulation of the pelvic floor muscles. The treatments were performed in the supine position on a couch with the lower limbs placed on a set of wedges. The electrostimulation was performed with the use of electrodes placed in the patients' vagina. Treatments were performed using Kegel Plus Professional electrostimulation. Each of the 10 treatments lasted 30 minutes. The parameters for the procedure were consistent with those reported in the literature as the most effective in the treatment of stress urinary incontinence [41].

After electrostimulation, the patients underwent a five-minute biofeedback training. The patients were to perform the contractions and relaxation of the pelvic floor muscles on their own when the game installed on the training device (MyoPlus 4 Pro Electromyograph) required from them. Using an endovaginal electrode receiving muscle signal, the pelvic floor muscle tension was imaged on the screen of the device in real time as a displayed electromyogram. During properly generated muscle tension, the indicator moved upward, whereas it did not change its position in the absence of tension, and when the strength of contraction decreased before the indicated time, it decreased. The contraction time was 5 seconds. This was followed by a 10-second pause. The duration of a single training was 5 minutes.

In patients from group C, no therapy was implemented, only the control measurements were the same as those in groups A and B.

The results of the study were collected in an Excel spreadsheet and then statistically analyzed using R Project [42]. The following was calculated as a part of primary descriptive characteristics for measurable properties. Before starting the statistical analysis of the obtained results, the conformity of their distribution with the normal distribution was assessed using the Shapiro-Wilk test. Due to non-compliance using Kruskal-Wallis nonparametric analysis of variance. The significance level was p < 0.05.

75 women were included in the study. Ultimately, only 60 met all of the inclusion and exclusion criteria for the project. Figure 1 is shown the flow chart of the patients at each stage on the study. After the end of therapy, both in the group A - subjected to sonofeedback training and in the group B, in which pelvic floor muscle electrostimulation with biofeedback training was used, there was an upward trend observed in the bioelectrical activity of pelvic floor muscles evaluated during electromyography. Nevertheless, the results were not statistically significant, which may have been due to insufficient.

Table 3

Intergroup comparisons of resting PFM bioelectrical activity measured by EMG before, after 5 treatments, and after therapy and also the p-value between groups also at different times
		EMG [µV]					P-value
		Before therapy		After 5 therapies	After therapy		Kruskal-Wallis test
SONOFEEDBACK (A)
n		20		20	20
median		3.70		4.05	4.45
minimum		1.20		1.70	1.60		0.8584
maximum		6.10		9.40	10.40
v		39		45	46
ELECTROSTIMULATION (B)
n		20		20	20
median		3.65		3.75	4.00
minimum		1.20		1.20	1.60		0.8617
maximum		7.90		7.50	6.90
v		46		45	38
CONTROL (C)
n		20		20	20
median		3.95		4.00	3.75
minimum		1.40		1.70	1.20		0.9899
maximum		10.70		12.20	8.70
v		57		61	46
P-value
Kruskal-Wallis test	0.7563		0.8879			0.9410

n = number of observations, SD = standard deviation, v = coefficient of variation.

The results in all three groups before treatment, after 5 interventions, and at the end of treatment were not statistically significantly different. In the sonofeedback group, the final value increased by 1.1 µV compared to the initial value. After 10 interventions, the minimum value in this measurement increased by 0.40 µV, while the maximum value increased by 4.30 µV from the initial values. There were no statistically significant differences in resting muscle bioelectrical activity in this group.

In the group that received pelvic floor muscle electrostimulation with biofeedback training (group B), the final value increased by 0.55 µV compared to the initial value. After a series of 10 interventions, the minimum value increased by 0.40 µV, while the maximum value decreased by 1.00 µV from the initial values. There were no statistically significant differences in resting muscle bioelectrical activity in this group.

Changes in pelvic floor muscle bioelectrical activity occurring in the control group (group C) showed that the final value decreased by 0.43 µV compared to the initial value. In the third measurement, the minimum value decreased by 0.20 µV while the maximum value decreased by 2.00 µV from the initial values. There were no statistically significant differences in resting muscle bioelectrical activity in this group.

The effect of incontinence on quality of life depends largely on the severity of symptoms. In cases of significant discomfort, the performance of basic activities of daily living is impaired. In his study, Hunskaar estimated that patients with symptoms of severe incontinence suffer from depressive symptoms in as many as 80% of cases, and with a low degree of incontinence, the number of such women oscillates around 40% [43]. Irwin et al. have shown that patients with urinary incontinence very often have a sense of losing control over their bodies, which further increases their psychological discomfort and reduces their activities of daily living [44].

According to the latest data, conservative treatment is effective in 80% of patients with I degree SUI and 50% of patients with II degree SUI. In patients with stage III, it helps to reduce the severity of symptoms and improves their quality of life. Properly performed PFM training is therefore extremely important for many women with SUI. Before starting it, patients should be instructed how to perform it. The most common mistake is to tighten the abdominal muscles instead of PFM. According to Moroni et al., training should consist of maximal contraction of the PFM for 5–10 seconds, and the daily number of repetitions can be as high as 300 [45].

Latest guidelines of the International Continence Society shows that using electrostimulation of the PFM aimed at reinforcing these muscles is an integral part of physiotherapy training [44]. In the available literature, there is a wide variety in terms of the parameters of electrical current, electrode type and their placement. The effectiveness of electrostimulation in the treatment of UI has been evaluated by many authors. Jha et al. compared electrostimulation with traditional PFM training, a study they performed on 114 female patients with urinary incontinence. They found that both forms of physiotherapy had a beneficial effect on the urinary incontinence treatment, but did not conclude which was more effective [47]. On the other hand, Ma and Liu, conducted a meta-analysis in which they compared the effectiveness of electrostimulation and electrostimulation combined with muscle training in patients with urinary incontinence. They showed that electrostimulation with muscle training is a more effective treatment method [48].

This form of therapy was also shown to be effective in our study. Although not showing significant changes in the bioelectrical activity of the PFM, the electrostimulation treatments with biofeedback training still demonstrate positive upward trend. This was confirmed by electromyographic findings. After treatment, the mean resting potential of the pelvic floor muscles increased by 0.55 µV from the initial value. However, the resulting changes were not statistically significant.

Ultrasonography is a single technique that has found application in the treatment of SUI. Thanks to ultrasonography, it has become possible to monitor muscle activity and thus improve muscle function. This therapy is referred to as sonofeedback. According to recent literature, sonofeedback allows reinforcement of the PFM [49]. Using this method seems to be an alternative to electrostimulation, especially since many women, despite its numerous advantages, resign from this treatment form. The most common cause is concern over the type of physical agent being used – electricity. Patients drop out of therapy equally often due to experiencing irritating and unpleasant sensations during the procedure.

Ultrasound imaging enables biofeedback assessment, as it provides real-time images of changes in PFM tone. This allows it to be a tool for PFM re-education in people with incontinence problems. Sonofeedback is particularly beneficial in patients with uncoordinated contractions of the PFM, with their excessive tension, and with an impaired ability to initiate movement in a conscious manner. This information is particularly relevant in the context of the study by Liebergall-Wischnitzer et al., who showed that exercise effectiveness decreases with age. After the age of 45, only 20% of patients perform them correctly. Biofeedback allows learning to consciously modify muscle tone by receiving auditory, visual, and sensory stimuli [50].

In their study, Morkved et al. enrolled 103 pregnant nulliparous women who were 20 weeks pregnant and had known stress urinary incontinence. They applied biofeedback training to all women. During therapy, they assessed pelvic floor muscle thickness gain and vaginal compression pressure. After the project, the researchers found 19 to 25 percent improvement in PFM function scores. They concluded that, as a source of biofeedback, ultrasound imaging provides information about the direction of PFM movement during contraction and functional tasks, and thus is an effective form of treatment. The researchers also emphasized that it is important to prevent the patient from using abdominal, thoracic, and lower extremity muscle tension during training [51]. Dietz et al. enrolled 212 women in their study, and found that 26% of the patients were unable to perform a proper PFM contraction, while up to 57% of them were able to perform the task after 5 minutes of biofeedback ultrasound training. In addition, they found that 62% of the studied women lowered their pelvic floor when attempting to perform a strong contraction of the PFM, but performed the training correctly as early as after one biofeedback session. As with any type of biofeedback, the testing protocol must be carefully established [30].

Our own studies also support the effectiveness of sonofeedback in postmenopausal women with SUI. Although the results did not show statistically significant changes in the bioelectrical activity of the PFM, a positive upward trend can be noted, as confirmed by the results obtained from the electromyography test. After therapy, the mean resting potential increased by 1.1 µV from the initial value. In comparison, this change was 0.55 µV in the electrostimulation treatment group with biofeedback training.

It is necessary to search for effective treatment methods, as the number of women with the problem of incontinence is predicted to increase every year. The results obtained in this study indicate that sonofeedback may be one of them. This method increased the bioelectrical activity of the PFM. Correct bioelectrical activity of the PFM is extremely important in the activity of these muscles. Reduced resting potential of the PFM affects the stress UI presence. A weakened myofascial and fascial-ligamentous system leads to developing SUI symptoms. Physiotherapeutic methods contributing to increasing the bioelectrical activity of muscles, such as sonofeedback, will therefore have a direct effect on reducing the severity of SUI symptoms, which is why it is so important to find such methods and apply them in everyday clinical practice.

Future studies with a larger number of patients would be recommended, as it is likely that too few participants may have been the reason for the lack of statistically significant changes in the parameters assessed. In addition, it is also advisable to conduct studies on patients with other medical conditions, especially those in which electrostimulation is contraindicated. Oncological patients with increased muscle tone can be such a group. There are no scientific reports that would evaluate the efficacy of sonofeedback in this patient group, and using this method seems reasonable, as it is completely noninvasive and safe.

Both sonofeedback and transvaginal electrostimulation of the PFM did not increase the bioelectrical activity of these muscles. Nevertheless, there was an upward trend observed.
Based on the results obtained, it can be concluded that the sonofeedback method is comparably effective in stimulating the bioelectrical activity of the pelvic floor muscles as the standard electrostimulation method with biofeedback training.
It is necessary to conduct further studies to assess the effectiveness of the sonofeedback method, especially in clinical application.

Author Contributions: Conceptualization, Gabriela Kołodyńska; Data curation, Maciej Zalewski and Anna Mucha; Formal analysis, Maciej Zalewski, Anna Mucha, Krystyna Rożek-Piechura and Waldemar Andrzejewski; Funding acquisition, Maciej Zalewski; Investigation, Anna Mucha; Methodology, Waldemar Andrzejewski; Project administration and Supervision, Gabriela Kołodyńska; Writing – original draft, Gabriela Kołodyńska; Writing – review & editing, Waldemar Andrzejewski, Krystyna Rozek-Piechura

Funding: None.

Institutional Review Board Statement: The study was approved by the Bioethics Committee of the Medical University of Wrocław number KB - 806/2018.

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.

Data Availability Statement: The datasets used and/or analyzed during the current study areavailable from the corresponding author on reasonable request.

Conflicts of Interest: None.

Acknowledgments: None.

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No competing interests reported.

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Assessment of the Possibility of Using Ultrasound Imaging in the Treatment of Stress Urinary Incontinence in Women

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