**2. Methodological description**

This was a randomized clinical trial research delevoped in the city of Belém, state of Pará, Brazil. the aim of this research was to study the effects of PFMT with EMG BF on bladder neck mobility, motor activity of PFM with EMG, PFM strength, levator ani muscle thickness and the quality of life of women with SUI, involving 50 women, 25 in each group, complaining of SUI was carried out. The relevant baseline characteristics are shown in Table 1.

The inclusion criteria were women aged from 30 and 55 years, with negative urine test and urodynamic diagnosis of SUI due to bladder neck hypermobility, pressure of stress-induced urine loss (PSIUL) higher than 90 cm of H2O. Patients with SUI due to intrinsic insufficiency with PSIUL of less than 60 cm, those who have undergone previous SUI surgery and those who presented vaginal prolapse of any degree in the physical examination were excluded. All the patients were referred by urologists or gynecologists, who requested and executed the urinary sediment and quantitative urine culture, urodynamic study and ultrasound test. The sample was randomized using sealed envelopes to choose the patients who would receive EMG BF and the ones who would be part of the control group. The control group was offered the same treatment given to Gbio after the end of the study. The Gbio underwent thirty-minute training sessions twice a week for eight weeks 14.

The ultrasound was conducted by the Toschiba-Nomio equipment (Tokyo, 2004) to measure urethral mobility (in centimeters) and the thickness of the levator ani muscle (in centimeters). Urethral mobility was measured by the transvaginal technique using a convex

In the literature, there are some questionnaires to assess quality of life of women with SUI, but the King's Health (KHQ) is the most commonly used in Brazil, which is validated in Portuguese and evaluates the presence of UI symptoms AND ITS relative impact, leading to

Many factors are involved in the SUI physiopathology, especially the rotational descent of the urethra, a functionally shorturethra, pudendal nerve lesions, fascia laceration, pelvic floor muscle (PFM) ruptures, intrinsic urethral mechanism deficiency and bladder neck

PFM functional detoriation, or weakness is an important factor causing SUI11. Physical therapy is considered a first line option for the rehabilitation of the pelvic floor muscles. Regarding to the conservative treatment, Kinesiotherapy is considered as level 1 evidence of its beneficial effects in SUI women (ICI 2009), but when we talk about operative interventions, Slings are the level 1 evidence. The most commonly used treatment modalities are pelvic floor muscle training (PFMT) to strengthen the PFM, vaginal electrostimulation, biofeedback (BF), vaginal cones and behavioral therapy, including

Electromyographic biofeedback (EMG BF) can be used to measure, assess and treat PFM dysfunctions and is one of the potential treatment modalities used for the rehabilitation of pelvic floor muscles10, once in its clinical use allows the patient to obtain informations about the physiological process of contraction, which used to be unknown in most of the cases. it facilitates the motor control of the pelvic floor muscles, favoring the re- education through a

This was a randomized clinical trial research delevoped in the city of Belém, state of Pará, Brazil. the aim of this research was to study the effects of PFMT with EMG BF on bladder neck mobility, motor activity of PFM with EMG, PFM strength, levator ani muscle thickness and the quality of life of women with SUI, involving 50 women, 25 in each group, complaining of SUI

The inclusion criteria were women aged from 30 and 55 years, with negative urine test and urodynamic diagnosis of SUI due to bladder neck hypermobility, pressure of stress-induced urine loss (PSIUL) higher than 90 cm of H2O. Patients with SUI due to intrinsic insufficiency with PSIUL of less than 60 cm, those who have undergone previous SUI surgery and those who presented vaginal prolapse of any degree in the physical examination were excluded. All the patients were referred by urologists or gynecologists, who requested and executed the urinary sediment and quantitative urine culture, urodynamic study and ultrasound test. The sample was randomized using sealed envelopes to choose the patients who would receive EMG BF and the ones who would be part of the control group. The control group was offered the same treatment given to Gbio after the end of the study. The Gbio

The ultrasound was conducted by the Toschiba-Nomio equipment (Tokyo, 2004) to measure urethral mobility (in centimeters) and the thickness of the levator ani muscle (in centimeters). Urethral mobility was measured by the transvaginal technique using a convex

more consistent results9.

information, education, awareness and advice12.

**2. Methodological description** 

visual or hearing feedback generated by electromyography 13.

was carried out. The relevant baseline characteristics are shown in Table 1.

underwent thirty-minute training sessions twice a week for eight weeks 14.

hypermobility10.

endocavitary probe with a frequency of 6.5 MHz and the thickness of the levator ani muscle was measured by the transabdominal technique using a 3.5 MHz transducer. This test was conducted while the bladder contained a maximum of 50 ml of urine15 and by the same specialist in diagnostic imaging.

After referral, the patients were assessed by the same specialized physical therapist before and after the study. PFM strength was done by digital vaginal palpation using the Ortiz16 scale to assess PF muscle strength. PFM EMG motor activity was measured with PHENIX equipment (Vivaltis, Paris, France), model USB-4 through a 5-cm long and 5.5-cm wide vaginal probe, dampened with KY Johnson gel. The probe was introduced 3 cm inside of the vagina's introitus. The PFM electric signal was registered in microvolts (µv) by two 1-cm rings located in the probe, captured and viewed by patients on the computer screen.

The electrical signal of the PFM was registered in microvolts (µv), with the use of an individual intravaginal probe with the patient lying in supine position, flexed legs and feet supported by a stretcher after instruction the patient was asked to perform 3 maximal PFM contractions. The highest registration of the contraction was selected as starting point for the treatment that was registered by and transmitted to the computer through a visual signal. The King´s Health Questionnaire (KHQ) was also applied.

The King´s Health Questionnaire (KHQ) assesses both the presence of urinary incontinence and its relative impact. It consists of 30 questions distributed across nine domains: general health, impact on life, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity (coping) measures17. There is also a scale of symptoms: increased urinary frequency, nocturia, urgency, bladder overactivity, SUI, nocturnal enuresis, incontinence during sexual intercourse, urinary infections and bladder pain. Each domain receives a individual score; therefore, there is not an overall score. Scores vary from zero to 100 and the higher the score, the worse the quality of life associated with that domain17.

Before they started treatment, Gbio patients received information on the function of pelvic floor muscles and were informed of the importance of continuing their exercises and functional training, so, adaptation into daily life activities. In addition to the EMG BFassisted exercises, patients were advised to do the same exercises at home to strengthen the PFM through slow and rapid contractions, being told to do three series of 10 contractions in the supine, sitting and orthostatic positions three times a day with a duration of 5-10 seconds, the contraction per subject was verified through an initial assessment of each individual18. They were also encouraged to undergo functional PFM training, i.e. to contract this muscle group during stress activities and increased intra-abdominal pressure.

The same EMG BF that was used to test the electromyographic activity of the PFM was also used to train the Gbio. The EMG BF was connected to a computer, equipped with specific software. Two pre-established programs with alternate contraction and relaxation periods were used: a twenty-minute program (85 rapid contractions and 34 slow contractions including) and a ten-minute program (including 54 rapid contractions and 24 slow contractions) 19. The women watched the contractions on the computer screen receiving visual feedback. Recent literature reviews show there is no a consensus regarding what kind of training program would be the most effective 20,21. This study's protocol was based on the review of Hay-Smith et. al, in which the maximum number of daily contractions requested from patients was estimated at between 36 and 200 21,22.

Effects of Pelvic Floor Muscle Training with

**Anatomo-functional characteristics** 

**Kings Health Questionnaire** 

\* Student's t test \*\* Mann-Whitney

Biofeedback in Women with Stress Urinary Incontinence 63

EMG-test (µV) 9.40 ±5.99 15.28 ±8.52 0.0068\* Muscular strength (me, min, max) 3 (1 - 4) 4 (2 - 4) 0.0009\*\* Thickness (mm) 11.66 ±1.65 13.27 ±2.12 0.0044\* Urethal mobility (mm) 17.67 ±4.53 9.26 ±3.01 <0.0001\*

General health 25 (0 - 75) 25 (0 - 50) 0.3933 Impact on life 50 (0 - 100) 33.3 (0 - 66.6) 0.0305\*\* Role limitations 33.3 (0 - 66.6) 0.0 (0 - 33.3) 0.0099\*\*

Physical limitations 33.3 (0 - 100) 0.0 (0 - 33.3) 0.0010\*\* Social limitations 0.0 (0 - 77) 0.0 (0 - 66.6) 0.3084 Personal relationships 0.0 (0 - 100) 0.0 (0 - 50) 0.0426\*\* Emotions 33.3 (0 - 100) 11.1 (0 - 44.4) 0.2444 Sleep and energy 16.6 (0 - 83.3) (16.6 (0 -66.6) 0.8311 Severity (coping) 26.7 (0 - 80) 6.6 (0 - 73) 0.0021\*\*

Figures below show transvaginal ultrasound from bladder neck during rest and effort phases, before and after treatment with EMG BF. Figures 1 and 2 : ultrasound before

Fig. 1. Rest Fig. 2. Effort Fig. 3. Rest Fig. 4. Effort HDUVJ: Horizontal Distance from Urethrovesical Junction; PUD: Pubo-Urethral Distance; UVJ:

The EMG test presented a statistically significant difference (p= 0.0068) between the groups; Gbio (15.28 ±8.52 µV) presented higher levels of PF motor activity than Gc (9.40 ±5.99 µV).

Urethrovesical Junction; VDUVJ: Vertical Distance from Urethrovesical Junction.

me: mean; min: minimum value; max: maximum value; EMG: Electromyographic.

Table 2. Gc (n=25) and Gbio (n=25) after the treatment.

treatment. Figures 3 and 4: ultrasuond post- treatment.

**4. To show the bladder neck mobility** 

**Gc Gbio Value-p** 

Descriptive statistics, with mean and standard deviation, were used to analyze the data. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity variance by the Levene test. The inter-group data were analyzed using Student's t test for independent samples, when there was heterocedasticity we applied the Mann-Whtiney U test. Categorical variables were tested by the chi-square test. The significance level alpha = 0.05 were considered to reject the null hypothesis. The data were put into an Excel database and analyzed with SPSS, version 14.023.

#### **3. Results**

Relevant baseline and KHQ characteristics before the treatment, presented in Table 1, showed that there were no present statistically significant differences between both groups.


Student's t test and Mann-Whitney's test

me: mean; min: minimum value; max: maximum value; EMG: Electromyographic.

Table 1. Relevant baseline characteristics and KHQ domains - data obtained before intervention, Gc (n=25) and Gbio (n=25).

Based on statistically significant differences in all the characteristics assessed (Table 2), comparison of anatomic and functional characteristics between the groups after intervention showed that treatment was associated with changes in the configuration of anatomic and functional structures of the PF.


\* Student's t test

62 Urinary Incontinence

Descriptive statistics, with mean and standard deviation, were used to analyze the data. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity variance by the Levene test. The inter-group data were analyzed using Student's t test for independent samples, when there was heterocedasticity we applied the Mann-Whtiney U test. Categorical variables were tested by the chi-square test. The significance level alpha = 0.05 were considered to reject the null hypothesis. The data were put into an Excel database

Relevant baseline and KHQ characteristics before the treatment, presented in Table 1, showed that there were no present statistically significant differences between both groups.

Age (years) 445.5 ±5.6 45.8 ±5.2 0.3957 Number of children 2 ±1 2 ±1 0.8757 Time of incontinence (years) 3.9 ±3.8 3.5 ±2.1 0.0776 EMG-test (µV) 9.36 ±5.66 7.76 ±5.06 0.2977 Muscular strength (me, min, max) 3 (1 - 4) 3 (1 - 4) 0.1519 Thickness (mm) 11.55 ±1.77 11.01 ±1.97 0.3139 Urethal mobility (mm) 16.97 ±4.40 16.10 ±7.04 0.3467

General health 25 (0 - 75) 25 (25 - 75) 0.1282 Impact on life 50 (0 - 100) 33.3 (0 - 66.6) 0.3781 Role limitations 33.3 (0 - 100) 0 (0 - 77) 0.3987 Physical limitations 0 (0 - 100) 33.3 (0 - 100) 0.2959 Social limitations 16.6 (0 - 83.3) 26.6 (0 - 80) 0.4231 Personal relationships 33. 3 (0 - 100) 0 (0 - 66.6) 0.6208 Emotions 16.6 (0 - 66.6) 0 (0 - 66.6) 0.6766 Sleep and energy 0 (0 - 100) 22.2 (0 - 100) 0.6139 Severity (coping) 16.6 (0 - 100) 26.6 (0 - 100) 0.4492

me: mean; min: minimum value; max: maximum value; EMG: Electromyographic.

Table 1. Relevant baseline characteristics and KHQ domains - data obtained before

Based on statistically significant differences in all the characteristics assessed (Table 2), comparison of anatomic and functional characteristics between the groups after intervention showed that treatment was associated with changes in the configuration of anatomic and

**Gc Gbio Value-p** 

and analyzed with SPSS, version 14.023.

**3. Results** 

**General characteristics** 

**Kings Health Questionnaire** 

Student's t test and Mann-Whitney's test

functional structures of the PF.

intervention, Gc (n=25) and Gbio (n=25).

\*\* Mann-Whitney

me: mean; min: minimum value; max: maximum value; EMG: Electromyographic.

Table 2. Gc (n=25) and Gbio (n=25) after the treatment.
