|Year : 2020 | Volume
| Issue : 1 | Page : 12-19
Mulabandha yoga therapy and its utility in cases of urinary incontinence in females: A randomized clinical trial
Km Sweta1, Amrit Godbole2, HH Awasthi3, Uma Pandey4
1 Department of Rachana Sharira, AIMS, Mirzapur, Uttar Pradesh, India
2 Department of Kayachikitsa, Faculty of Ayurveda, IMS BHU, Varanasi, Uttar Pradesh, India
3 Department of Rachana Sharira, Faculty of Ayurveda, IMS BHU, Varanasi, Uttar Pradesh, India
4 Department of Obstetrics and Gynaecology, IMS-BHU, Varanasi, Uttar Pradesh, India
|Date of Submission||23-Feb-2020|
|Date of Acceptance||31-Mar-2020|
|Date of Web Publication||11-Jun-2020|
Department of Rachana Sharira, AIMS, Chunar, Mirzapur, Uttar Pradesh
Background: Urinary incontinence (UI) is a common condition in women, with prevalence ranging from 8.5% to 38% depending on age, parity, and definition. This problem is more common in Asian countries, where women usually do not seek treatment for their reproductive health problems and do not vocalize their symptoms. Mulabandha yoga therapy (MYT) is said to be effective for the management of UI. Hence, it was tried to see the effects of this method in females.
Aims and Objective: The aim and objective was to study the effect of yoga therapy in female patients for 3 months suffering from UI.
Methods: An intervention of Mulabandha yoga therapy (Contraction of pelvic group muscles) for the period of three months has been done by interventional group.
Design: Participants were allocated into two groups by generating random allocation sequence.
Participants: Fifty female participants were divided into two groups, i.e., interventional and noninterventional (control) groups. The interventional group (n = 25) received an intensive supervised MYT protocol along with medication and the control group (n = 25) received only oral medicines.
Outcome Measures: Improvement in UI symptoms was assessed using the Questionnaire for Urinary Incontinence Diagnosis (QUID). Both groups were evaluated at the beginning of the study and after 12 weeks.
Results: At the completion of study, data received from all the fifty women were included in the analysis. Percentage improvement in the QUID mean change was 58.72 in the intervention group and 21.54 in the control group. Intergroup comparison (Mann–Whitney test) was found to be statistically significant in the intervention group (p < 0.00), whereas it was nonsignificant in the control group (p = 0.14).
Conclusion: MYT plays a significant role in the improvement of UI symptoms.
Keywords: Mulabandha, perineal lock, urinary incontinence, urinary incontinence diagnosis
|How to cite this article:|
Sweta K, Godbole A, Awasthi H H, Pandey U. Mulabandha yoga therapy and its utility in cases of urinary incontinence in females: A randomized clinical trial. Yoga Mimamsa 2020;52:12-9
|How to cite this URL:|
Sweta K, Godbole A, Awasthi H H, Pandey U. Mulabandha yoga therapy and its utility in cases of urinary incontinence in females: A randomized clinical trial. Yoga Mimamsa [serial online] 2020 [cited 2020 Jul 9];52:12-9. Available from: http://www.ym-kdham.in/text.asp?2020/52/1/12/286552
| Introduction|| |
There is a high prevalence of urinary incontinence (UI) symptoms, and it also has significant impact on health-related quality of life (Saarni et al., 2006), which marks its association with enormous personal (Subak et al., 2008) and societal (Ganz et al., 2010; Irwin, Mungapen, Milsom, Kopp, Reeves & Kelleher, 2009) expenditure. This is a common condition in women, with prevalence ranging from 8.5% to 38% depending on age, parity, and definition (Herzog, Diokno, Brown, Normolle, & Brock, 1990; Thomas, Plymat, Blannin, & Meade, 1980). UI, as defined by The International Continence Society, is the complaint of any involuntary leakage of urine (Haylen, et al., 2009). The classification of UI may depend upon variety of conditions. The most common types of UI in women are incontinence due to stress and urge. Urinary stress incontinence is the complaint of involuntary leakage of urine on effort or exertion, such as sneezing or coughing. Urge incontinence is described as the involuntary leakage of urine, accompanied by or immediately preceded by a strong desire to pass urine (Price, Dawood, & Jackson, 2010). Often, there is association of urge incontinence with true cystitis or urinary infection (Padubidri, 2011). Both kinds of incontinence are primarily because of inadequate urethrae sphincter muscles that develop deficient urethral closure pressure to stop urine leakage (De Lancey, 1994). Usually, this is treated using conservative therapy or, if that fails, then surgery. Treatment selection based on understanding how the pelvic floor muscle (PFM) relationship provides bladder neck support can help guide treatment selection and effect. In the study it was said, women suffers partial tear of pelvic floor muscles during her delivery where marked effectiveness of pelvic muscle exercises had been seen (Kari, Bary, Siv, & Marijke, 2015). Mulabandha yoga therapy (MYT) is the most important part of the Hatha yoga tradition (Sarasawati, Sarasawati, & Svatmarama, 2012). It is known as the “perineal lock,' which is contraction of the muscles around the perineal body in males and the cervix in females. The underlying cause of UI is PFM weakness. In yoga, Mulabandha is one of the fundamentals of core body strength. The practice of Mulabandha yoga stimulates sensory-motor and autonomic nervous system in the pelvic region. The physical contraction of perineum has the beneficial effects of stimulating and regulating the nerves that innervate the lower pelvic region, thereby regulating internal pelvic organ functions. Therefore, MYT tones and strengthens the muscles of the pelvic region (Buddhananda, 1996). Pregnancy and mainly vaginal delivery are associated with a decrease in PFM strength, which results in weakening of ligaments, pelvic fascia tear, and abnormal disclosure of urethral sphincters (Fonti, Giordano, Cacciatore, Romano, & La Rosa, 2009). Several methods have been used to assess improvement in UI symptoms.
The most commonly used tool in physical therapy seems to be digital palpation (modified Oxford Grading Scale) (Ferreira, Barbosa, Souza, Antonio, Franco, & Bo, 2011). A valid questionnaire, the Questionnaire for Urinary Incontinence Diagnosis (QUID) (Bradley, et al., 2005), has been used to assess symptomatic improvements. However, currently, the authors are unaware of any published research on the effect of MYT on PFM strength in cases of UI.
The objective of this clinical trial was to obtain preliminary data to evaluate the effects of 12-week yoga intervention on the PFM of females with UI. This article reports on the outcomes of MYT over UI symptoms.
| Methods|| |
This was a single-blinded, randomized clinical trial with concealed allocation. Women who met the eligibility criteria and consented to participate were randomized to MYT or the control condition. This manuscript presents the results for the outcome measures of improvement in UI symptoms. Outcome measurements were performed at baseline and on completion of intervention. Group allocation was done by using a computer-generated random number system on a 1:1 allocation ratio to the intervention or control group.
Ethical clearance and informed consent
The protocol number ECR/526/Inst/UP/2014 was approved by the Institutional Human Research Ethics Committee of Banaras Hindu University, IMS, Varanasi, on March 20, 2015. Patients were enrolled from a Department of Gynaecology and Obstetrics, Sir Sunder Lal Hospital, IMS-BHU, Varanasi, India. Each participant received detailed information about the study and was provided written informed consent before the trial commenced.
Sample size calculation
Sample size was calculated based on the estimate of mean QUID score of a previously published study (Bradley, et al., 2010). Assuming 20% change in the mean value after intervention and taking the alpha as 5% and power as 80%, the sample size was calculated as 30. It was further assumed that 10% cases might lose during follow-up score. Therefore, on the whole, 66 participants were enrolled for the study.
Blinding and masking
It is a single-blind study. The answer sheets of the questionnaires were coded and analyzed only after the study was completed.
A random allocation sequence was generated online. The concealment of random allocation sequence was followed. The researcher enrolled the patients and assigned them to the intervention and control groups as per concealed random allocation sequence.
Participants were females, independent of their PFM strength and continence status, who were of age between 20 and 60 years, and had not been using any systemic hormonal therapy for the last 3 months. To be eligible, they also had to be able to contract their PFM and have not performed PFM training (PFMT) beforehand.
Exclusion criteria were those with diabetes mellitus, genital prolapse, rectal prolapse, thyroid disease, and discomfort with PFM strength.
Before evaluation of the ability to contract the PFM, all the participants received information about the procedures, an explanation of the basic anatomy of the PFM, and instructions on how to correctly contract their PFMs (Henderson, Wang, Egger, Masters, & Nygaard, 2013).
Evaluation of the ability to perform a correct PFM contraction was conducted with women in the supine position with knees and hips in a flexed and abducted position, and with their feet on a bench. The first evaluation was performed by the researcher using digital palpation. Only women with Grade 1 on the modified Oxford Grading Scale were included (Laycock, 1994). The study was conducted in accordance with the Indian Council of Medical Research's ethical guidelines for biomedical researches adopted from the World Medical Association – Declaration of Helsinki on human participants. The patients attending outpatient department of the institute were recruited for the study. Recruitment and data collection were performed at the Department of Obstetrics and Gynaecology, Sir Sunder Lal Hospital, IMS-BHU, Varanasi, India.
Participants randomized to the control group were requested to maintain their usual self-care throughout the trial period. They received only conservative medications and no other manipulative therapy was advised.
The intervention involved supervised MYT (Sarasawati, et al., 2012) sessions in groups of a maximum of five participants. A trained researcher supervised the yoga sessions twice a week for 12 weeks. Participants in the intervention group were also instructed to perform daily Mulabandha training at home except on the days of supervised training, were advised to follow written instructions, and were asked to record the frequency of training every week in a personal logbook. Participants' adherence to the supervised Mulabandha yoga sessions was monitored by the researcher. In the supervised sessions, the participants were encouraged to continue home Mulabandha yoga with appropriate intensity, frequency, and duration. All women were re-evaluated after every 4 weeks for a total of 12 weeks. A probable mechanism of Mulabandha yoga is described in [Figure 1].
Procedure of Mulabandha yoga
- (Saraswati, 2009) involves contraction of the muscles of the perineum (Gheranda Samhita, Hindi Commentary by Acharya Sriniwasa Sharma) and specially the muscles of pelvic floor. This contraction is important and characteristic
- Sit in Siddhasana (Svami, 2013) or Siddha yoni asana so that pressure is applied to the perineal/vaginal region. For men, this is located in the perineum, between the anus and the sexual organ
- For women, the trigger point is located behind the cervix where the uterus and vagina meet
- Close the eyes and relax the body and mind
- Inhale deeply, retain the breath inside, and contract the perineal/vaginal muscles as tightly as possible, without strain
- Patients are advised to hold the final position for as long as possible
- Slowly release the Mulabandha, by raising the head to the upright position, and exhale gradually
- Repeat the practice ten times with maximum contraction and total relaxation
- At first, practice short contractions and as control improves, then gradually increase the duration of the contraction.
The assessment was performed on the basis of mean changes and median values in the QUID score before and after treatment. The QUID [Appendix 1] identifies the presence and frequency of stress and urge UI symptoms. Three items focused on stress incontinence and three on urge incontinence symptoms. Each item includes six frequency-based response options, ranging from “none of the time” to “all of the time,” which are scored from 0 to 5 points. Scores are calculated in an additive manner, resulting in separate Stress and Urge scores, each ranging from 0 to 15 points. Its value as an outcome measure for treatment studies of UI has been evaluated. The improvement in the patients was assessed on the basis of relief in the symptoms and signs of the disease.
The obtained results were analyzed statistically.
Data analysis was done using SPSS software 20.0 (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY, USA). Baseline information for demographic and medical characteristics between groups was compared. Total number of cases of each of these parameters was calculated in percentage for each group. Chi-square test was performed, and no statistical significance was found at the baseline (p < 0.05). All the data were expressed till two decimal places. Statistical analyses of outcome measures at baseline and changes between groups at weeks 12 were performed. Significance of difference within each group was calculated by Wilcoxon signed-rank test, and intergroup comparison was done by Mann–Whitney test. We compared the difference in the mean change of questionnaire scores (QUID score) from baseline to follow-up between groups, and the median values were also calculated.
| Results|| |
Participant flowchart is presented in [Figure 2]. From 66 potential participants who expressed an interest in the study, 50 consented and underwent baseline testing, with 25 randomized to the MYT intervention with medications, and 25 in the control were put on only medications. Overall, intragroup comparison of prepost data or both groups showed statistical significance (p < 0.001), while in intergroup comparison, significant changes were observed at the baseline which became nonsignificant in the control group (p = 0.14) after treatment.
Compliance with the intervention
After recruitment, out of 66 participants, 16 withdrawn (n = 10 did not meet criteria and n = 6 declined to participate) after being diagnosed with UI. A total of fifty participants completed the study [Figure 1].
Characteristics of the group
A total of fifty participants satisfying the inclusion and exclusion criteria participated in the study. Baseline characteristics of the patients are shown in [Table 1].
On comparing the background characteristics of the intervention and control groups, it was found that the value of significance (p value) was not <0.05 in any case. Hence, the difference in both group baseline values was found to be nonsignificant.
Questionnaire for Urinary Incontinence Diagnosis
The study's objective was to evaluate QUID responsive scores when used as a clinical trial outcome measure. Participants enrolled for UI completed baseline and 3-month follow-ups. Data from both the groups were collected. Responses to change in the mean score along with the median score were assessed at baseline and follow-up score with 3-month outcomes. Baseline QUID Stress and Urge scores of the intervention group (both scaled 0–15, larger values indicating worse UI) were 11.12 ± 1.3 and 5.16 ± 1.34, respectively. After 3 months, QUID Stress and Urge scores in the intervention group improved (4.44 ± 1.35 and 2.28 ± 1.33, respectively, both p < 0.0001).
The median provides a helpful measure of the center of a dataset. By comparing the median to the mean, we get an idea of the distribution of a dataset. In [Table 2], it can be seen that the mean and median values are approximately same, hence, the dataset is evenly distributed from the lowest to the highest values.
|Table 2: Changes in mean (standard deviation) questionnaire scores and median scores from baseline to follow-up|
Click here to view
Intragroup comparison (Wilcoxon signed-rank test) was found to be statistically significant (p ≤ 0.5) in both intervention and control groups, but the improvement was found more significant in the intervention group [Table 2].
Intergroup comparison (Mann–Whitney test) was found to be significant in the intervention group (p = 0.00) but not significant in the control group (p = 0.14). This finding depicts that MYT helps patients to recover in their incontinence symptoms readily [Table 3].
|Table 3: z and p values for intergroup comparison (Mann-Whitney test) from baseline to follow-up|
Click here to view
| Discussion|| |
The major finding was that QUID score was reduced following the 12-week yoga intervention. This proves the efficacy of MYT, which can be implemented to restore PFM functions in females. The data support the use of the QUID as a tool for screening the improvements in UI symptom. Significant improvements in each of the QUID scales were demonstrated after 3-month follow-up of MYT. Earlier studies showed results indicating that PFMT (muscle-clenching exercises) helps women with all types of incontinence although most benefitted women were women with stress incontinence who exercise for 3 months or more (Dumoulin, & Hay-Smith, 2010). Mc auley in his study showed significant result of pelvic muscle exercises on UI and also reported some significant increase of self esteem of elderly females (McAuley, Elavsky, Motl, Konopack, Hu, & Marquez, 2005).
The present study showed significant changes in QUID Stress and Urge scores after MYT. These changes might have resulted due to gentle massaging of internal organs and improved metabolism due to yoga therapy (Kuvalayananda, 1993). This recovery was very helpful for the females to resume to their routine works early; also, the physiological and psychological impact of the intervention was more pronounced due to this recovery in comparison to the control group (Gadham, Sajja, & Rooha, 2015; Shantakumari, Sequeira, & El Deeb, 2013). This is because the Mulabandha could have helped in smooth and early healing of PFMs, which, in turn, causes subsidence of the pain and discomfort quite early in the intervention group when compared to the control group. In fact, it is evident from the past studies that PFMT significantly improved PFM strength and thickness (Radzimińska, Strączyńska, Weber-Rajek, Styczyńska, Strojek, & Piekorz, 2018). These results support the outcome of the present study. Thus, the MYT has been found to be more effective in restoring the PFM functions in females, thus showing significant relief in UI symptoms. However, additional research is warranted to validate the findings of this study on a larger sample size with randomized controlled trial for a longer duration.
The impact of MYT in public health domain in terms of disease prevention and treatment depends on exposure to the therapy and its frequency of self-practices. Regular practice of MYT may increase flexibility and pelvic muscle strength and tone. Generally, MYT interventions may be considered safe with rare adverse events however, to avoid the adverse events, MYT must be delivered by trained instructors.
Indian government is actively emphasizing in the integration of yoga therapies with modern medicines into the public health domain. We need to establish multiple trainees in yoga. There is a need to educate the public especially women about the beneficial effects of MYT on pelvic organ ailments. Integration of MYT with modern medicine also makes some important concept for developing standard measurements, which requires a large-scale study to prove the efficacy of these types of therapies.
Limitations of the study
- This is the first randomized controlled trial to explore the effects of MYT on UI compared with control group among females
- Patients from the outpatient department of the institute were only registered. Hence, generalizability of the study findings may be limited.
Small sample size was calculated because it was a time-bound study and assessment on a large sample size was not possible by a single research scholar within that time frameMaximum efforts were done to minimize the potential biasness, but due to lack of extra workforce, a single assessor has to perform all the assessmentsLack of prior research studies on the topicScope of further discussionsTime constraints.
| Conclusion|| |
MYT is a type of complementary health system. Today, integration of complementary system of medicine has been appreciated worldwide. From this study, it can be concluded that MYT shows significant improvements in UI symptoms. The improvements observed in this study may possibly be attributed to the focus of the MYT on PFMs with its internal organ. Longer duration and larger sample size are needed to explore the benefits of MYT over the UI symptoms. Larger sample size could have generated more accurate results.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]