PELVIC FLOOR

Literature review

Pelvic floor exercises

Pelvic floor exercises are used as a first line treatment option once someone presents with the symptoms of SI (NICE 2003). A systematic review was carried out by Hay-Smith et al. (2001) on PFM training and its effectiveness for stress or mixed UI in women. They found that pelvic floor muscle training (PFMT) is more effective than no treatment or placebo in women with stress or mixed UI. The thorough search strategy and the statistical combination of studies strengthen the results of this review. Although 43 randomised control trials (RCTs) were identified and included in the review, 15 of these were conference abstracts, which limited the reviewers' ability to assess the quality of the trials and may have led to an exaggerated treatment effect. A large variation in the methods of teaching PFME’s, methods of assessing pelvic muscle strength, and measurement of clinical outcomes were identified and this should be rectified in future research. Furthermore, most of the studies in this review were limited to young premenopausal women, so more research is needed to establish the effect in other sample groups. The validity of the questionnaires used can be questioned in some of the studies reviewed. In order to minimize recall and interpretation bias, the patients were asked (at 0, 5 and 10 years) simple and straightforward questions that referred to their ‘actual’ condition. Thus the degree of incontinence and the frequency of home practicing could be compared in a standard way throughout the follow-up.

A more recent systematic review by Haddow et al. (2005) looked at the effectiveness of a PFME program on UI following childbirth. The primary aim of this review was to determine, from the available evidence, the effectiveness of an antenatal and/or a post-natal program of PFME compared with usual care on preventing, reducing or resolving the incidence and severity of SI, urge incontinence or mixed stress and urge UI following childbirth. The literature gathered underwent an assessment of quality and if there were any disagreements by the two assessors reviewing the literature, a third reviewer on the panel was used.

Six RCT’s met the inclusion criteria and the results of this review indicated that antenatal PFME and post-natal PFME are effective in resolving or reducing UI following childbirth. There was insufficient evidence to conclude that PFME can prevent UI in post-partum women. In most of these studies women were selected randomly and therefore included women without UI and women with UI. Two RCT’s selected their sample on the criteria of existing post-partum UI. The mixed results of this review mean that no conclusions can be reached about the effectiveness of a PFME program, antenatal or post-natal, on improving PFM strength. A number of studies reported a high percentage of women lost to follow-up and the data collected in most of the studies relied on self-reports relating to UI and/or frequency of exercising. These factors may have affected the overall results of the review.

Neumann et al. (2006) carried out a systematic review on pelvic floor muscle training and adjunctive therapies for the treatment of stress urinary incontinence in women. Both RCTs and non-RCTs were included in this review, cohort studies, case series were considered for this review in order to source all the available evidence relevant to clinical practice. Twenty four studies, including 17 RCTs and seven non-RCTs, met the inclusion criteria. The methodological quality of the studies varied but lower quality scores did not necessarily indicate studies from lower levels of evidence. This review found consistent evidence from a number of high quality RCTs that PFMT alone and in combination with adjunctive therapies is effective treatment for women with SUI with rates of 'cure' and 'cure/improvement' up to 73% and 97% respectively.

The methodological quality of the studies was variable, with some RCTs being of lower quality than the lower level studies. This provides a dilemma for systematic reviewers, as restriction of study inclusion to RCTs is considered to ensure identification of high quality studies. However, the possibility of well-designed cohort studies providing less biased evidence than poorly designed RCTs has been documented.

One of the aims of this review was to investigate outcomes relevant to clinical practice. To this end, level III and IV studies, not previously reported in systematic reviews of the literature on SUI, were included. The inclusion of these studies with lower levels of evidence provided information about aspects of physical therapy not obtainable from the RCTs reviewed, for example, about the different response rate and the effectiveness of treatment in the primary care setting.

Preventative during pregnancy

As pregnancy is one of the main causes of UI many studies over the years have looked into practicing PFME’s during pregnancy. Kathryn et al. (2003) looked at UI in the 12 month post- partum period. This study found that postpartum incontinence was associated with several risk factors such as childbirth and type of delivery which can help target at risk women for early intervention. It was found that PFME during pregnancy or postpartum period did not reduce the occurrence of SI.

Five hundred twenty three women took part in the study, aged 14-42 years. This sample was limited to obstetric deliveries only and a convenience sample was used. Bias is potentially introduced when a study population consists of volunteers, who may be particularly motivated and compliant. Volunteers may be well motivated to succeed, particularly in studies requiring commitment to a daily exercise program over a lengthy period of time. Thus the outcomes of studies with a sample of volunteers may overestimate the true treatment effect. Women who were alone in their hospital rooms were approached to take part in the study post partum.  

Structured questionnaires were used to ensure that each interviewee was presented with exactly the same questions in the same order. This ensures that answers can be reliably aggregated and that comparisons can be made with confidence between sample subgroups or between different survey periods. A structured interview also standardises the order in which questions are asked of survey respondents, so the questions are always answered within the same context. This is important for minimising the impact of . Some of the questions used were personal and interviewees may have been uncomfortable answering the questions truthfully.

Follow-up interviews were carried out via a telephone interview at several periods throughout the year upto 12 months. Telephone interviews have been shown to be as reliable as face to face interviews, with the benefits of less cost and time. When using a telephone based interview there could be something distracting the participant and therefore you may not have the full attention of the participant and not everyone will have a telephone so this must be taken into consideration when choosing this type of method. It has also been shown that calling someone’s home is intrusive and the participants may find this uncomfortable.

As the study was a longitudinal one, the data involved correlation among the outcomes at 6 weeks, 3 months, 6 months and 12 months post-partum. This study identified that logistic regression could not be used to examine any associations between UI and predictor variables due to this correlation. Instead they generalised estimating equations to account for the correlation.

There were 523 women at the beginning of the study to 493 participants at 6 weeks to 385 participants at 12 months. Examination of the drop out rate suggests that the rise in the rate of incontinence at the 12 month interview was the result of selective attrition. This study had several identifiable flaws including the lack of randomisation and blinding and using a convenience sample. Therefore, it was not possible to determine the direction of this effect. A random sample is one where the researcher insures that each member of that population has an equal probability of being selected.

The effect of pelvic muscle exercises on transient incontinence during pregnancy and after birth was researched by Sampselle et al. (1998). The results showed that when controlling for baseline UI score, the analysis of covariance showed less UI in the training group at 35 weeks pregnant, 6 weeks postpartum and 6 months postpartum. At the end of the 12 month period, the difference had disappeared. The number of women with UI before and after the intervention was not reported and a high drop out rate meant that the results may not have been a true reflection. This study supports the findings of Kathryn et al. (2003) which showed there was no significant difference between the groups in PFM strength.

A similar study by Morkved et al. (2003) looked at PFM training during pregnancy to prevent UI in late pregnancy and after delivery. Contrary to the findings of Kathryn et al’s (2003), this study found that in nulliparous pregnant women, an intensive programme of PFM training reduced the risk of UI in late pregnancy and after delivery. This study was a randomised, single blinded (assessor) controlled trial. A large sample size (n= 301) was used, which provided the study with sufficient power. Out of 1533 women who were provided with the information and invitation to take part in the study only 342 accepted and only 301 took part in the study due to drop outs. This would suggest that there might have been some bias in those women who agreed to enter the study as they would be more compliant to the exercises.

A selection criteria of an age >18 years, uncomplicated, singleton pregnancy at 18 week gestation was used, and therefore the sample may not be widely representative. Out of the women taking part 34% of them were already performing PFME and this was not accounted for in the allocation of groups. This study had a sound randomisation of participants to the control and experimental group. They measured the participants at 20 and 36 weeks’ gestation which was similar to Sampselle et al. (1998) but neither of these studies mentioned why these timeframes were chosen. PFME’s were carried out during pregnancy but it not known during which part of the pregnancy the exercises began. A 3 month follow up was carried out, making this study limited as they only have information on the continence of participants 3 months after delivery. The exercise protocol used was similar to that of Bo et al. (1999) which is of proven effectiveness and is in accordance with the recommendation for general training to increase strength of skeletal muscle.

In the above study the women were shown how to contract the pelvic floor before randomisation. The contraction of the pelvic floor by vaginal palpation by skilled physiotherapists was also checked. Sampselle et al. (1998) did not use this method. It is important to check that the women are performing the correct exercises and are getting the correct contraction. The training group in the study by Morkved et al. (2003) had a specific programme, which was given in detail in the study. The women in the control group received the customary information which was given by their midwife or General Practitioner’s, however they were not discouraged from doing PFME on their own. This study did not go into detail about what the customary information was. The outcome measure used in this study was a self-repot on UI. To date, there is no agreement about what the most appropriate outcome measure for UI is. This study justified the use of self-report over any other outcome measure. The results of this study can be used to show that intensive PFME training during pregnancy can prevent UI upto 3 months post pregnancy. However, the effects of PFME during pregnancy are not known after 3 months postpartum. A longitudinal study would need to be carried out beyond 3 months postpartum.

The effectiveness of PFME teaching in women with UI was researched by Stark (2001) aiming to devise a standardised teaching method for PFME’s. Ethical approval was met but did not mention who it was approved by. A selective inclusion criteria meant that it was less representative. The methodology included a standardised position for doing the PFME’s. This position was based on what the members of the research group were currently practicing as physiotherapists. This study did not use evidence which had shown to be the most effective position. Although looking at a study by Wister (2006) it showed that position did not show any differences in PFM strength. However, this study only looked at two different positions of supine and upright. Another study by Sapford et al (1998) showed that a supported sitting posture was the most effective way of getting the best PFM contraction.

The limitations of Stark’s (2001) study include the physiotherapist’s role of both educator and assessor which could have caused bias as there was no blinding. The reason given for this was due to ethical aspects of having a second examiner, the restrictions imposed by many physiotherapists working on their own and the aim of having a study which could be incorporated into daily practice. The study concluded that 2 out of the 66 women were unable to contract their PFM’s after teaching. Well taught PFE’s give a high degree of improvement in knowledge for the patients. This study however was not randomised, nor was it blinded. Further well randomised trials would need to be carried out using this information to establish guidelines for the most effective way of teaching PFME’s.

The efficacy of PFME and bladder training in women with persistent incontinence 3 months after delivery was evaluated by Glazer et al. (2001). This study was a RCT however it was not blinded. A central computer was used to stratify the sample by parity, type of delivery and severity of incontinence. A stratified sample improves the accuracy of estimation and focuses on relevant subgroups, however, it requires accurate information about the population otherwise it can cause bias.  Seven hundred and forty seven women at three different centres in the UK and New Zealand who had reported UI 3 months after delivery were sent postal questionnaires. Three hundred and seventy one women responded.

During the follow-up there was a drop out rate of 25% of the intervention group and 35% in the control group. The control group received standard management but it did not state what this was. It was concluded that instruction and periodic reinforcement by a nurse in PFME reduced the prevalence of both UI and faecal incontinence at 12 months postpartum. It is not known whether or not the participants in the control group with incontinence sought for help from other practitioners. It would not have been ethical to standardise this so that the control group did not practice any PFME’s, as treatment cannot be denied. This unknown effect could have altered the benefit of the results seen in the treatment group. The results of this study reinforce the utility of nursing visits and PFE’s in the treatment of postpartum incontinence. This, however may not be cost effective to have nursing visits postpartum for every women who presents with UI on a regular basis.

More recently, Fine et al. (2007) looked at the teaching and practicing of PFME in primiparous women during pregnancy and the post-partum period. Despite the benefits of PFME only 64% of women in the study reported that they had learned about PFME during pregnancy or after delivery. A striking difference in the exposure to PFME instruction based on race and education was also found, with non-white and less educated women being less likely to report receiving instructions compared with white and college educated women. A limitation of this study was its reliance on self-report data, which meant that the racial and educational differences that were found were attributable to healthcare disparities or to the difference in recall or reporting. Questions about performing PFME during pregnancy were not included. It is therefore not known whether the responses indicate new PFME behaviour or continuation of previous PFM exercises known to the patient. This study was based in the USA and may not be representative of the UK so this must be taken into consideration if the results from this study are to be used.

A similar study by Whitford et al. (2007) carried out a cross sectional study of the knowledge and practice of pelvic floor exercises during pregnancy and associated symptoms of stress UI in North-East Scotland using structured interviews. A higher percentage younger women and women from more deprived backgrounds were used. They found that only ¾ of women had access to information about PFME’s and those from a more deprived background and younger women were least likely to report knowing about the exercises. Sample size? Compared to 64% by fine et al. (2007)

The outcome measure used in this study was a self report questionnaire to measure whether or not the exercises were carried out. Foley et al. (2005) suggested that a key advantage of the questionnaire method was feasibility. Questionnaires are relatively easy to administer, are low-cost, require limited personnel/ effort, and have the potential to reach a dispersed sample. In addition, privately answered questionnaires are superior to personal interviews in assessing sensitive self-report issues. The disadvantages include a lack of flexibility and the need for literacy on the part of the participant. Interview methods are attractive because of their flexibility (including open-ended and probe questions) and the interviewer’s ability to assess the quality of the response. However, this is a high cost method, requiring extensive interviewer training, and it is difficult to study a dispersed and/or large sample. In addition, social desirability and interviewer bias can call into question the validity of personal interviews. Factors that may influence the validity and reliability of self-reported data include respondent characteristics and cognitive processes, as well as the general format and wording of the questionnaire or interview

In spite of these limitations the findings of this study highlight the need to promote and practice PFME during pregnancy. Three-quarters of women (77.9%) reported they had access to information about PFME’s. In contrast lower figures have been reported by other studies with Mason et al. (2001) reported 55.3% and Logan (2001) reported 53%. The differences could be due to the different methodologies used, using postal questionnaires rather than interviews. The way the questions were asked could also have an effect. The studying by Logan (2001) had a poor response rate and details of the questions asked were not given. This present study was also carried out in the North-East of Scotland and therefore may not be representative of the general population in the UK and health strategies and promotion may vary from different parts of the country. Considerations must be taking into account when using the information from this study as face to face interviews were used.  This may have been more embarrassing than the anonymity of a questionnaire, especially among the chosen sample, as younger women may be more embarrassed in reporting SI than the older population.

Compliance

Although PFME’s have been shown to be effective in the prevention and management of SI, compliance is an ongoing concern to physiotherapists. Several studies have been carried out on compliance of PFME. Cousins et al. (2000) looked at the factors that affect compliance with PFME’s. This study focused mainly on the delivery of the information given to patients regarding PFME’s. They found no significant difference between compliance and the delivery of information. Encouragement and positive feedback was shown to have an effect on compliance. The sample used in this study was small (n = 14). A type ΙΙ error can be generated as the sample size may have been too small to detect a difference in its variables. There was also a poor response rate which made it difficult to show any major differences. This study however, cannot be generalised to a wider population as the sample was not representative. There was also a lack of consistency between the samples with regards to the varying degrees of incontinence as well as patients who had undergone surgery with a lack of standardization of the sample.

Will put a few more studies on compliance here

Conclusion

There is limited published RCT’s available relating to identified problems of stress incontinence in women. There is a growing body of evidence to suggest this is an area that deserves attention, considering that there is now little doubt childbirth is the most important single factor underlying stress incontinence. It is extremely important that when we consider the emphasis today’s society places on exercise, to prevent problems later in life, awareness about the importance of protecting the pelvic floor through pelvic floor exercises alongside general exercise and sporting activities should be raised. Currently, the first time that the majority of women hear of pelvic floor exercises is at antenatal classes.

Given the evidence of the benefits of PFME’s, it is not unreasonable to systematically offer these conservative interventions to women who are identified as being at risk and taught in a way in which they have a significant benefit. The successful promotion of continence could result in a better quality of life for women most at risk, a reduction in surgery and less cost on the NHS.

Upon analysis of the literature PFME’s seems to be the most effective and favorable treatment to reduce the symptoms of UI during pregnancy. There seems to be little consistency to when PFME’s should be started in pregnancy with very few studies reporting this. There seems to be contradictory evidence with regards to the effects of PFME’s during pregnancy and post pregnancy to prevent UI. However, there is strong evidence to suggest that practicing PFME during pregnancy can reduce the symptoms of UI post pregnancy. More research needs to be done with better methodologies to show the prevention of UI with PFME’s post pregnancy.

Proposal

Title: Pelvic floor muscle exercises in early pregnancy to prevent stress urinary incontinence post pregnancy.

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