1. INTRODUCTION:

Malaysia's population is predicted to begin to age in 2020, when the proportion of the population aged 65 and up hits 7.2 percent. Furthermore, according to a statistical estimate of Malaysia's ageing population from 2015 to 2035, the percentage of Malaysia's population over the age of 65 is expected to be 13.17 percent by 2035¹. Consider this statement: it is likely that the elderly would experience physiological changes that contribute to health issues such as urinary incontinence (UI). Urinary incontinence is a prevalent and distressing women's health concern which has an impact on a person's mental health and quality of life. Urinary incontinence (UI) is described by the International Continence Society (ICS) as "any involuntary urinary leakage." It affects 17 to 45 percent of women globally² and is a frequent health problem, especially among women and the elderly³. UI not only causes physical problems, and it may even cause depression in women worldwide, as it causes psychological, social, as well as economic problems, and also affecting the patients' quality of life⁴. Stress urinary incontinence (SUI), the most common urinary incontinence subtype in women with a prevalence of 24.8%⁵ is defined as involuntary loss of urine during effort or physical exertion (for example, during sporting activities) or upon sneezing or coughing⁶. Urine will leak as a result of weakened pelvic floor muscles (muscles that support the pelvic organs such as bladder) or a weakened urethral sphincter (a thick muscle that control the flow of urine out of bladder). Normally these muscles stay closed and hold urine as the bladder expands. Urine is leaked when there is pressure on the abdomen and bladder, forcing urine through the weakened muscles. Therefore, fast and strong PFM contractions result in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage⁷.

Various interventions are available for preventing and treating incontinence, including medication, medical devices and surgery^8,9. Some of the patients are not keen for surgical intervention and pelvic floor muscle training (PFMT) will be another treatment’s option for female urinary incontinence problem. Pelvic ﬂoor muscle training (PFMT) may be the easiest to implement since it needs no special equipment or other costly resources and it is commonly recommended for both prevention and treatment of incontinence¹⁰. As stated by Teng et al. (2015)¹¹ that PFMT have been the first-line treatment for urinary incontinence since Arnold Kegel introduced them half a century ago. Until now, PFMT remains the first-line treatment for female UI with high levels of evidence and grades of recommendation¹². Despite it, surgical therapy should be indicated only after conservative therapies (an exercise programme or topical oestrogens) have failed¹³. Pelvic floor muscle training (PFMT) is defined as a program of repeated voluntary PFM contractions taught and supervised by a health care professional and the most commonly used physiotherapy treatment for women with SUI, is effective with all types of female incontinence, and, therefore, is recommended as a first-line therapy^14,15. Pelvic floor muscle training (PFMT) includes the repetitive contraction of pelvic floor muscle, which establishes the intensity level and the personal support, and increases the muscle feeling¹⁶.

In order to guide patient to have a correct pelvic floor muscle contraction, other method can be used along the pelvic floor muscle training is by the combination of pressure biofeedback equipment. Learning how to contract the pelvic floor muscles appropriately is difficult, which makes this procedure ineffective. In clinical practise, assistive methods such as vaginal cones and biofeedback can be used in conjunction with exercises to achieve this goal, and numerous studies have shown that these methods are successful in the treatment of incontinence¹⁷. As stated by Knight et al. (1994)¹⁸ BF offers the patient the chance to manipulate electro-physical responses of his/her pelvic ﬂoor muscles according to visual and auditory signals. This method can motivate the patients to achieve a stronger muscle contraction and thus, stimulate high adherence and intensive training¹⁹. Furthermore, the addition of BF to PFMT can promote a better coordination and control of PFM when compared to PFMT without BF²⁰. Despite it, BF would also be of great importance in the beginning of treatment²¹ particularly to women that are not aware of how their pelvic muscles work²². Physiotherapy has significant roles and seems to be an important part of conservative treatment of UI. In the pelvic floor muscle rehabilitation, Kegel pointed out that systematic muscle activity causes muscles to lose 4 times less of their mass than compared with staying inactive, and hence is the optimal method for improving the anatomical and functional improvement of muscles²³. However, there are also many strategies that was used to increase the effectiveness of PFMT such as vaginal cone, biofeedback and electrical stimulation. These devices seem to provide a motivation to the patient. This study aims to assess the effect of pelvic floor muscle training with biofeedback in improving the SUI severity, strength of pelvic floor muscle and quality of life among females with stress urinary incontinence.

2. MATERIALS AND METHODS:

Study Design:

This is a single group experimental pilot study with a repeated measure design.

Study Respondent:

Women aged between 45 to 65 years old, diagnosed with stress urinary incontinence, able to understand English or Malay language and consented to be part in the study were included in the study. Our exclusion criteria were: pregnant, delivered a baby < 6 months, had urinary infection, neurological disorder, had recent surgery at abdomen/back/perineal region < 6 months, virgin, had cognitive impairment, bedridden patient as well as having a stage 3 and 4 prolapse. 10 subjects were randomly selected using Research Randomizer based on recommended number of subjects required for a pilot study²⁴.

Ethical considerations:

Prior to study, an ethical clearance was obtained from the UniSZA Human Research Ethics Committee, Universiti Sultan Zainal Abidin UniSZ/UHREC/2019/107 and National Medical Research Register (NMRR-18-3987-45541). All women gave their written informed consent before study entry.

Training protocol and data collection:

Patients referred by Urogynaecologist from Urogynaecology Clinic, Hospital Raja Perempuan Zainab II (HRPZ II) for women’s health physiotherapy management were recruited in this study for 12 weeks. Subjects who fulfilled the inclusion criteria were given an information sheet detailing the purpose and details of the study and informed consent was obtained before proceeding with a questionnaire.

Demographic characteristics such as age, height, weight, marital status, education, employment status, obstetrics and gynaecology history were collected. All procedures were performed following the standard operating procedures (SOP) in physiotherapy management of urinary incontinence.

Initially, subjects were verbally educated about the location and function of pelvic floor muscle using an anatomical model. Then, subjects were instructed how to contract their pelvic floor muscles correctly. In addition, for the familiarity of the pelvic floor muscle contraction among the subjects, transabdominal real time ultrasound (RTU) to imaging their muscle’s contraction was used.

Severity of stress urinary incontinence

Was measured using an Incontinence Severity Index (ISI) questionnaire The severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe). The severity index is a short, simple, valid, reliable, and sensitive measure of urinary incontinence in women²⁵. It can therefore be recommended for routine use.

Pelvic floor muscle strength

Perineometer was used in the study to assess the pelvic floor muscle strength. It is designed to measure a pressure change in the vagina in response to voluntary contraction of the pelvic floor muscles. In this study, we used an air-filled vaginal probe made in Canada of 28mm in diameter,108mm total length, and 55mm active length connected to a tubing catheter of 150mm long and peritron manometer (Peritron, Melbourne, Australia). This vaginal probe covered with condom and lubricate with vagina lubrication gel then was inserted 3 to 4cm into patient’s vagina. When contraction of pelvic floor muscles happens, the pressure in the vaginal probe will transfer the pressure and reading will appear at peritron’s monitor. Perineometer has reported to have a strong correlation between two examiners (ICC = 0.98)²⁶. Also supported by Pereira²⁷ (2014) that have done a study used the same equipment and demonstrated a strong correlation between the value of three valid voluntary contractions of PFM during the evaluation (ICC = 0.97). In addition, Braza’les et al²⁸ (2017) indicated a high inter-rater reliability of manometry (Lin´s Concordance Correlation Coefficient = 0.95).

Quality of life

Validated Malay version of Incontinence Impact Questionnaire- Short Form IIQ-7 was used to measure the quality of life and as a screening questionnaire for urinary incontinence. Result of the study done by Nusee Z²⁹(2016) showed that the internal consistency IIQ-7 Bahasa Malaysia questionnaires was 0.90. The scoring was calculated by the average score of items responded which ranges from 0 to 3, multiplied by 100/3 to put scores on a scale of 0 to 100.

Pelvic floor muscle training with biofeedback.

Pelvic floor muscle training with biofeedback, were conducted in crook lying position, then a vaginal pressure probe covered with condom and lubricated with vaginal lubrication gel was inserted into patient’s vagina 3 to 4 cm deep that was connected to Myo200 biofeedback device. First, mean of vaginal resting pressure was recorded, then patient was asked to squeeze as strong as she can, exercise target was recorded and became a patient’s training target and was measured by millimetres of mercury (mmHg). Treatment time was 20 minutes per session. A training protocol of pelvic floor muscle training 5sec contraction, 8sec rest for 3sets and followed by one set of 10 fast contraction were given as a home exercise programme. They were informed to perform this exercise at least twice daily and to fill up the exercise diary given. In addition, the pelvic floor muscle training was also taught in various positions (crook lying, sitting and standing). The progression based on changing position of the patient from supine to standing. It took 20 minutes for every treatment session. Patients were instructed to come for physiotherapy treatment twice a week for 8 weeks then after 12 weeks of follow up.

Data Analysis:

Data were collected and analysed using SPSS (Statistical Products and Service Solution) version 23.0. Descriptive statistics was formulated and tabulated as mean and SD. Repeated measures of ANOVA was used to analyse the time effect, treatment effect and the time versus treatment for all the variables analysed.

3. RESULTS:

Table 1: Demographic Data, N=10

	Mean (SD)
Age	51.8 (8.78)
Weight	67.2 (7.04)
Height	158.7 (5.03)
BMI	26.68 (2.36)

Table 1shows demographic data of the 10 subjects

Table 2: Comparison of SUI severity within PFMT with BF Based On Time

Comparison	PFMT with BF
Comparison	Mean difference (95% CI)	P value
4^th week – 8^th week	4.60 (0.33, 8.87)	0.039*
4^th week – 12^th week	5.20 (2.03, 8.37)	0.009*
8^th week – 12^th week	0.60 (-0.98, 2.18)	0.624

Repeated measure ANOVA within group analysis was applied followed by pairwise comparison with 95% confidence Interval adjustment by Bonferroni correction

* Statistically significant

Table 2 showed a comparison of SUI severity. There was a significant difference of mean SUI severity based on time (F=37.81, p=< 0.001).

Pairwise comparison with confidence interval adjustment was performed by Bonferroni correction. The results showed that there were significant differences in all comparisons in PFMT with BF. However, there were no significant differences in 8^th week vs 12^th week with the mean differences 0.60 (-0.98, 2.18), p=0.624 at PFMT with BF. In short, there was a significant difference of mean SUI severity based on time.

Table 3: Comparison of strength of PFMT with BF based on time

Comparison	PFMT with BF
Comparison	Mean difference (95% CI)	P value
Baseline – 4^th week	- 4.60 (-10.26, 1.06)	0.101
Baseline – 8^th week	- 12.20 (-22.98, -1.42)	0.032*
Baseline – 12^th week	- 20.60 (-45.32, 4.12)	0.093
4^th week – 8^th week	-7.60 (-13.85, -1.35)	0.025*
4^th week – 12^th week	-16.00 (-39.52, 7.52)	0.180
8^th week – 12^th week	- 8.40 (-33.68, 16.88)	> 0.950

Repeated measure ANOVA within group analysis was applied followed by pairwise comparison with 95% confidence Interval adjustment by Bonferroni correction

* Statistically significant

Table 3 indicated that there was a significant difference of mean strength based on time (F=15.44, p=0.002).

Pairwise comparison with confidence interval adjustment was performed by Bonferroni correction. The results showed that there were significant differences in baseline vs 8^th week and 4^th week vs 8^th week in PFMT with BF. However, there were no significant differences in baseline vs 4^th, baseline vs 12^th, 4^th vs 12^th week and 8^th vs 12^th week with the mean differences of - 4.60 (-10.26, 1.06) p= 0.101, - 20.60 (-45.32, 4.12) p=0.093, -16.00

(-9.52, 7.52) p=0.180, - 8.40 (-33.68, 16.88) p> 0.950 at PFMT with BF.

In short, there was a significant difference of mean strength based on time.

Table 4: Comparison of Quality of life within PFMT With BF and based on time

Comparison	BF and PFMT
Comparison	Mean difference (95% CI)	P value
4^th week – 8^th week	57.14 (26.13, 88.14)	0.006*
4^th week – 12^th week	67.61 (38.76, 96.46)	0.002*
8^th week – 12^th week	10.47 (-17.58, 38.71)	0.647

Repeated measure ANOVA within group analysis was applied followed by pairwise comparison with 95% confidence Interval adjustment by Bonferroni correction

* Statistically significant

Table 4: There was a significant difference of mean quality of life based on time (F=104.11, p=<0.001).

Pairwise comparison with confidence interval adjustment was performed by Bonferroni correction. The results showed that there were significant differences in all comparisons in PFMT with BF. However, there were no significant differences within two comparison groups in 8th week vs 12th week with the mean differences of at 10.47 (-17.58, 38.71) p=0.647 at PFMT with BF.

In short, there was a significant difference of mean quality of life based on time.

4. DISCUSSION:

In this pilot study on the effectiveness of pelvic floor muscle training with biofeedback on stress urinary incontinence of severity, strength and quality of life in females of Kelantan state, Malaysia, the researchers found that mean age of patients with SUI were 51.8 years. Our finding is in line with the finding of Minassian et al (2013)³⁰ reported that urinary incontinence severity persisted across each decade of life, from age 41 through 83 years. The average weight, height, and body mass index were 67.2kg, 158.7cm and 26.68. Six out of ten females were overweight. Weight has a direct dosage effect on incontinence, with each 5-unit increase in BMI increasing incontinence risk by 20 to 70%. Furthermore, when compared to people of normal weight, obese patients have around twice the probability of presenting with the stress urinary incontinence. Constant tension on tendons and nerves, as well as increased intra-abdominal pressure, might irritate or create pain. Excessive stretching causes pelvic floor disorders³¹. Similarly, Lamerton (2018)³² stated that obesity is conducive to the occurrence of urinary incontinence; however, it can also increase the severity of this condition.

The result was significantly difference in all comparisons based on time, which explained that the severity of the condition was improving by pelvic floor muscle training with biofeedback. We noticed that there was no reduction in the severity of SUI for the first 4 weeks, since the patients were elderly, reduction on severity may require more time compared to adults and the result is due to the incorrect pelvic floor muscle contraction done by patient at the beginning of intervention. According to Lasak (2018)³³, when treating this condition, a thorough understanding of the functional anatomy of the pelvic floor, the principles of exercise physiology as they apply to the PFMs, proper muscle contraction technique, and taking into account the muscles external to the pelvic floor that are both functionally and anatomically connected to the pelvis could be crucial to the success of conservative therapy. The use of assistive device such as biofeedback proved to be superior in reducing the quantity of urinary leakage³⁴. However, after at 4^th weeks to 8^th weeks of intervention there was a 57% reduction in severity followed by 87% at 4^th weeks to 12^th weeks.

In this study we assess the pelvic floor muscle strength using a perineometer. Initially at baseline to 8^th weeks there were 76% improvement of pelvic floor muscle strength, however from 4^th weeks to 8^th weeks of intervention, there was only 33% of muscle strength improvement seen. Angelo (2017)³⁵ stated that perineometer has been widely employed as an assessment method in numerous clinical research in recent years and it has proven to be an easy and quick technique for assessing PFM contraction. Even though, Barbosa 2009³⁶, suggested that perineometers of different brands generate different results but, in our study, the perineometer that we used has given a significant result as it was reported to have a strong correlation (ICC = 0.98)²⁶.

Quality of life was measured using Incontinence Impact Questionnaire short form IIQ7. Quality of life of the patients who have pelvic floor muscle training with biofeedback in our study has reported a significant improvement of 52% at 4^th to 8^th weeks of intervention. The result also showed that after 12 weeks of intervention, the quality of life improved to 84%. Similarly, Wong et al (2001)³⁷ had used IIQ-7 and UDI-6 in their study demonstrated that both questionnaires can be used as self-report tools to assess the quality of life associated with urinary incontinence in the Chinese population as well as the IIQ-7 scores were related to patient characteristics and physical status. In our study improvement of quality of life was maintain at 12 weeks follow up similar to a study by Sahin et al (2021)³⁸ has concluded biofeedback assisted PFME had curative effects on incontinence in patients with SUI and biofeedback resulted in considerable changes in the parameters studied, with positive outcomes lasting three months following treatment.

5. CONCLUSION:

In our pilot study, we conclude that pelvic floor muscle training with biofeedback has significant effectiveness in reducing the severity, improving pelvic floor muscle strength and quality of life in female patients with stress urinary incontinence. We also conclude a pelvic floor muscle training with biofeedback of four to eight weeks is ideal for noticeable improvement.

6. ETHICAL CONSIDERATION:

Ethical clearance was obtained from the UniSZA Human Research Ethics Committee, Universiti Sultan Zainal Abidin UniSZ/UHREC/2019/107 and National Medical Research Register (NMRR-18-3987-45541).

7. CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

8. ACKNOWLEDGMENTS:

The authors would like to thank administration of health clinics of Kelantan under Ministry of Health, Malaysia.

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Received on 29.01.2022 Modified on 24.02.2022

Research J. Pharm.and Tech 2022; 15(4):1831-1836.

DOI: 10.52711/0974-360X.2022.00308