Journal of Novel Physiotherapies
Open Access

Urinary incontinence as defined by the International Continence Society is the complain of any involuntary leakage of urine [1-3]. The world Health Organization (WHO) has classified UI as one of the ten major health problems of present times among women [4]. Causes of UI can be divided into: dysfunction of the bladder or urethra, and neurological or gynecological causes. Gynecological components include: the weakening of pelvic floor muscles, gynecological and obstetrical operations and pelvic organ prolapse [5]. Existing evidence indicates that both natural delivery, as well as the pregnancy itself [6] has a prominent impact on the functioning of pelvic floor muscles and the occurrence of urinary incontinence. SUI occurs when intra-vesical pressure exceeds urethral closure pressure in the absence of a detrusor contraction. SUI may be due to bladder neck hyper-mobility or poor urethral closure pressure [7]. The pelvic floor muscles (PFM) function to elevate the bladder, preventing descent of the bladder neck during rises in intra-abdominal pressure and to occlude the urethra. The theoretical basis for physical therapy to treat SUI is to improve PFM function by increasing strength, coordination, speed and endurance [5] in order to maintain an elevated position of bladder neck during raised intra-abdominal pressure with adequate urethral closure force [8]. Since 1992, conservative management of SUI has been promoted by the US Department of Health and Human Services (AHCPER) as first –line treatment for SUI for its efficacy, low cost and low risk [9].

According to Boyle [10], up to a third of women have urinary incontinence while about a 10th of them have stool incontinence after delivery. Urinary incontinence is a major clinical problem with profound effects on the quality of life and day-to-day activities of the affected women. It’s physically debilitating and socially incapacitating, with loss of self-confidence, helplessness, depression and anxiety all related to its occurrence. Affected women suffer social stigma and are withdrawn socially. As a result their productivity is significantly reduced and may lose interest in life.

Chiarelli P [11] indicates that the prevalence of urinary incontinence among women increases during young adult life: a study with over 40000 women estimated a prevalence of 12.8% in women aged 18-22 years, 36.1% in women aged 40-49, and 35% in women aged 70-74 years.

The severity of urinary incontinence varies in severity ranging from mild, moderate to severe forms. These levels of incontinence require different approaches in management in terms of duration and intensity. Epidemiological studies have shown an association between more severe forms of urinary incontinence and assisted vaginal deliveries or birth of high birth weight neonates which suggest the potential for an intervention promoting continence that is targeted at women who have just given birth [4].

According to the National Association for Continence (NAFC), pelvic floor exercises (PFEs) or pelvic floor muscle training (PFMT), also called Kegel exercises, are essential parts of behavioral treatment techniques that help increase bladder control and decrease bladder leakage. Though the technique requires conscious effort, consistent discipline, and a lifetime commitment, PFEs have been shown to improve mild to moderate urge and stress incontinence. When performed regularly and correctly, they strengthen bladder support, and build control and endurance to help improve, regain and maintain bladder and bowel control.

As such, health workers usually recommend pelvic floor exercise both during pregnancy and after childbirth. This aims at both preventing and treating fecal and urinary incontinence. Physiotherapists train expectant women who are expected to undertake the exercise several times a day in order to strengthen her pelvic floor muscles. This review will summarize the recent published data on the use of pelvic floor muscle training in preventing and treating urinary incontinence in prepost- natal women.

Data source

The studies identified from PubMed, Cochrane library, BMJ Group, Biomed Central, Wiley online library, and manual search of reference lists from systematic reviews and the proceedings of the International Continence Society (available at www.annals.org).

Study selection

One investigator independently decided on study eligibility according to recommendations from the Scottish intercollegiate Guideline developer handbook for systematic reviews of interventions to include original publications of randomized controlled trials (RCTs) that were published in English form from 2001- March 2016. Full texts of the RCTs that examined the effects of pelvic floor muscle training on urinary incontinence in pre-post-natal.

The study excluded secondary data analysis, case reports, case series, and RCTs that did not report patient outcomes.

Assessment of methodological quality

The quality of study was analyzed by using the following criteria: participant selection, length and loss of follow-up, use of intentionto- treat principle, masking of the treatment status, randomization scheme, adequacy of randomization and allocation concealment, and justification of sample size. Several strategies were used to reduce bias, including a comprehensive literature search for published evidence in several databases, a search of reference lists of systematic reviews and proceeding of the International Continence Society. The quality of the selected studies was assessed using a standard grading system, as Scottish Intercollegiate guideline network (SIGN, 2012). Evidence table can be found at Appendix 1 &2.

Since the methodological quality was dependent the trial reports contained in the selected studies, this assessment might have been influenced by the quality of the corresponding reports. In some cases, it was disappointing that some studies did not sufficiently describe the randomization process. Thus, it was difficult to ascertain whether there was sufficient concealment. Regardless, it was encouraging that more than two-thirds of the selected studies used blinded outcomes inspectors, given the trouble of blinding treatment providers and participants to PFMT. Overall, the share of withdrawals and dropout was between 0% and 20%, which provides for a desirable methodological quality. Sample sizes for most of the studies were small to moderate. This means that the selected studies used methodologies that are relatively easy to apply. Also, as expected of small sample studies, they provided a significantly accurate representation of the larger population [12]. This aspect of the selected studies ensured a high methodological quality for this study.

Methodological quality was also affected by the age of the selected studies. The more recent studies, for instance, considering the trial reports, tended to be less likely to be biased as compared to the older ones. Of all the selected studies, those that were found to be more likely to be biased recorded the largest treatment effect as compared to the studies which were found to be less likely to be biased. This affected the methodological quality since it represents a possible overestimation of treatment effect. It is also important to note that this trend was particularly observed in the selected studies with insufficient concealment of random allocation.

Also, the methodological quality would be higher if the testers who carried out the outcomes of incontinence study would have carefully chosen a primary outcome measure that was relevant to women, selected secondary methods to include a range of domains, and chose standardized tools with recognized responsiveness, reliability, and validity.

Data synthesis

Forty one articles were selected from electronic bibliographies and screened for retrieval (n=41). Thirty sex articles were excluded for not meeting the selection criteria (n=36) such as ineligible target population or case report or secondary data analysis, or no full texts available. The resultant was fifteen randomized control trials full articles (n=15). Five articles were exempted for not meeting the inclusion criteria (n=5) such as incontinence due to other cause other than childbirth. The ten most appropriate articles were left (n=10) (Figure 1).

Figure 1: Results of search.

Summaries of the studies included in the review are provided in Table 1. Studies are presented the information about the level of evidence; population, interventions investigated, outcome measures and information of determine the generalizability of the study findings.

Table 1: Best evidence. Evidence table (Mackway, et al. nd.)

Ten RCTs (n=10) were included. All studies reported adequacy of randomization, discussed participant selection, length and loss of follow up, use of intention-to-treat principle, and masking of the treatment status for both subjects and investigators. Seven RCTs reported adequate allocation concealment. There are marked heterogeneity in the type and intensity of interventions in both groups. All the studies used validated measurement tools.

One RCT (n=170) reported significant improvement in postnatal urinary incontinence, who participated in the PFMT compared with control group (19.2% versus 32.7% P=0.02), but no statistically significant effect at 3 months and they found significant difference between the groups at 8 years 35.8% versus 38.8% (P=0.7).

Second RCT (n=8485) reported a statistically significant reduction in sever incontinence in the intervention group at 12 months after delivery (response rate, RR 0.60, 95% confidence interval, CI: 0.35 to 1.03). The third RCT (n=747) found a statistically significant improvement in urinary incontinence in the intervention group 60%versus 69% control group at one year follow –up, and fecal incontinence 4% versus 11% control group. With significant ongoing difference over 6 years followup 76%versus 79% (95% CI: 10.2% to 4.1% for urinary incontinence, 12% versus 13%- 6.4% to 5.1%for fecal incontinence).

The fourth RCT reported statistically significant reduction in urinary incontinence by 59.9%in the intervention group versus 69% control group (95% CI: 1% to 1.7% P=0.037). Fecal incontinence in the intervention group improved by 19.7% versus 31.8% control group (4.7% to 19.6% P=0.002). The fifth RCT (n=6181), which reported a statistically significant reduction in incontinence in the intervention group at 34 weeks of pregnancy (RR0.44, 95%, CI: 0.52 to 0.97), and 20% less up to 12 months postnatal (RR 0.79, 95% CI: 0.70 to 0.90).

The fifth RCT (n=60) reported a decrease in UDI-6 and OAB-q scores in intervention group versus the control group during postpartum weeks 6-8 (P<0.05). Voiding functions were decreased during weeks 36-38 of pregnancy and improving during the postpartum period. And the pelvic floor muscle strength improved in the training group versus the control group.

The seventh RCT (n=300) reported a decrease in UDI-6 and IIQ- 7 scores in intervention group versus the control group. The seventh RCT (n=301) reported 32% of training group had urinary incontinence compared to 48% control group at 36 weeks of pregnancy (P=0.007) and 20% versus 32% at 3 months after delivery (P=0.018).

The ninth RCT (n=268) reported 19.2% of women in the supervised pelvic floor exercise had post-natal stress incontinence compared to 32.7% in the non-intervention group (RR0.59 “0.37-0.92”). The ninth RCT (n=855) reported that 11% of the women in the intervention group had urinary incontinence versus 19% of control group (P=0.004), and 3% had fecal incontinence in the intervention group versus to 5% in the control group.

This systematic review reports the evidence of PFMT intervention in the treatment and prevention of urinary incontinence in pre-postnatal women from full text studies published in English during the last 15 years. The quality of most of the RCTs was good; participants were not excluded from the analysis of outcomes, and randomized was adequate. However, allocation concealment was not addressed in three studies. Variations in outcome measures rather than RCT quality resulted in heterogeneity between studies.

Despite extensive efforts to standardize outcome assessment for urinary incontinence [4]. The included RCTs measured a variety of outcomes, including adherence to PFMT, self-reported symptoms, signs, and improvement; severity of urinary/ fecal incontinence as assessed by pad number/day, voiding functions were measured, and conditionspecific quality of life. The measurement of outcomes was inconsistent across the studies. Another factor which may influence outcome is the degree to which subjects actually comply with the treatment program prescribed and adhered to the PFMT. Subject compliance or adherence was infrequently and generally poorly reported with no standardized, validated or reliable approach to its assessment.

The following is a summary of the discussion regarding the overall completeness and applicability of evidence in the selected studies.

Outcomes measures and reporting

Some of the studies did not provide data in ways that could apply to meta-analysis or did not provide data for any of the pre-indicated outcomes of interests. Some challenges include reporting a measure of central tendency and leaving out a measure of dispersion, and inaccurate values for P without additional supporting information [5]. In the end, there was an overall lack of consistency in the most of the outcomes measures applied and reported in the selected studies. In other words, there were no particular outcomes that were shared among the trials, while at the same time, similar outcomes were measured and recorded in various ways [2]. Also, there was no validity and reliability testing conducted for some of the continence outcomes. As a result, it was difficult to carry out adequate comparisons between studies.

Most of the selected studies reported adverse effects of other approaches and only a few gave such a report for PFMT. In fact, the only adverse effect associated with PFMT was discomfort with training, which can be reversed by simply stopping the training programme [13-16]. Even though randomized trials are not the most suitable means of addressing safety, none of the selected studies suggest that PFMT is likely to be harmful.

Implications for practice

The findings of the selected studies suggest that PFMT brings about better outcomes as compared to non-treatment and other inactive treatment for treating urinary incontinence. In the cases where PFMT was used, the women were more likely to experience improvement or get cured entirely [5,16]. These women also reported fewer leakage episodes per day, better quality of life, and have less urine leakage on short pad tests as compared to non-treatment.

Most of the selected studies imply that treatment, especially in self-reported cases, has a greater impact for women with urinary incontinence taking part in a closely monitored PFMT programme for no less than three months [5]. Additionally, age does not matter can, therefore, not reduce the effect of treatment in urinary incontinent women in trials; the outcomes for older women were similar to those of younger women.

The selected studies imply suggest that the treatment effect is magnified if the PFMT programme is focused on valid psychological principles. For a successful programme, the right contraction has to be confirmed and recorded before the training, and the participants are monitored and supported to continue with the programme [7,13]. There is an overall widespread endorsement among the selected studies that PFMT should be integrated into the first line conservative management programmes for women with urinary incontinence.

However, most of the selected studies lack follow up past the completion of the treatment programme. Therefore, it would be difficult to establish the long-term results from the application of PFMT [5,17-20]. Regardless, some of the studies hold that long-term outcomes of PFMT are significantly greater when the participants are supervised for no less than three months. If the participant continues with the programme for an extended period, the treatment effect is likely to be enhanced accordingly or at least remain constant.

From the conclusions of the selected studies, there are a few considerations for future research on this topic. First, studies would need to consider the choice and reporting of secondary outcome measures [5]. Second, they would need to consider the choice of primary outcomes that matter to women, subsequent assessment of sample size, and the size of least clinically important effect.

Overall, there is evidence for the widespread recommendation for use of pelvic floor muscle training in preventing and treating urinary incontinence for pre-post-natal women as compared to nonintervention in Table 2. The limited nature of follow-up beyond the end of treatment in the majority of the published studies means that the long-term effects may be greater in women participating in supervised PFMT for at least three months. Continued adherence to training may be associated with maintained or increased treatment effect, but this hypothesis needs further testing. There is a need for at least one large, well conducted, and explicitly reported randomized trial, comparing PFMT with a control to investigate the longer-term clinical effectiveness of PFMT.

Table 2: Comparative summary of best evidence.

Given that most of the selected studies do not report any follow up beyond the completion of the treatment programme, it is difficult to determine the lasting outcomes from the application of PFMT.

In conclusion, pelvic floor exercises are beneficial and have no significant adverse effects. Substantially and durable improvements in continence can be achieved, when the patient is appropriately selected and the exercises are adequately performed.