Comparison between the significant of antenatal pelvic floor exercises and non-intervention in preventing urinary incontinence: A systematic Literature Review

Background: Epidemiology evidence reported that women who had a baby are at increased risk of developing urinary incontinence, particularly those who have had vaginal deliveries (27). Conservative intervention such as pelvic floor muscle training (PFMT) are superior in preventing and treating urinary incontinence (15). Purpose: To systematically review the literature and present the best available evidence for the efficacy and effectiveness of antenatal pelvic floor muscle training in preventing and treating the urinary incontinence rather than non-intervention. Data source: PubMed, Cochrane library, BMJ Group, BioMed Central, Wiley online library. Study selection: 9 randomized, control trials (RCTs) published in English from 2001-2014. Data extraction: Incontinence due to other causes other than childbirth. Data synthesis: The study focus on pelvic floor exercise versus non-intervention for the antenatal women, incontinence must be as a result of childbirth, and randomized control study. Limitation of the study: The reviewed study are limited to 9 randomized control trial. Conclusion: There is significant evidence that pelvic floor muscle training (PFMT) are superior in preventing and treating urinary incontinence as compared to non-intervention.


I. Introduction
Urinary incontinence as defined by the International Continence Society is the complain of any involuntary leakage of urine. (10). According to Boyle (3), 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 Affected women suffer social stigma and are withdrawn socially.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. (4) 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 (1). Data Synthesis: Forty articles were selected from electronic bibliographies and screened for retrieval (n=40). 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 fourteen randomized control trials full articles (n=14). Five articles were exempted for not meeting the inclusion criteria (n=5) such as incontinence due to other cause other than childbirth. The nine most appropriate articles were left (n=9) Figure 1  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. Comparison between the significant of antenatal pelvic floor exercises and non-intervention in .. General Comments: the study is high quality with interval validity, but the study is in doubt as it does not show the outcomes that were as a result of PFMT. There is treatment integrity and the study methods is valid with P-Value indicated. The result can be generalized to the pre-pot-natal population.

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Nine RCTs (n=9) 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 follow-up 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 sixth 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 eighth 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.

III. Discussion
This systematic review reports the evidence of PFMT intervention in the treatment and prevention of urinary incontinence in pre-post-natal women from full text studies published in English during the last 13 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 two studies. Variations in outcome measures rather than RCT quality, resulted in heterogeneity between studies.
Despite extensive efforts to standardize outcome assessment for urinary incontinence (1). 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 and condition-specific 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 (Dumoulin and Hay-Smith, 2010). 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 (Ismail, 2009). 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 (National Associated for Continence, 2016). 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 (Dumoulin and Hay-Smith, 2010; Reilly et al., 2002). 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 nontreatment.
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 (Dumoulin and Hay-Smith, 2010). 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 DOI: 10 . 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 (Dumoulin and Hay-Smith, 2010; Sahakian, 2012). Regardless, some of the studies hold that longterm 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.

IV. Conclusion
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. 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.
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. Are antenatal pelvic floor exercises significantly better than non-intervention in preventing urinary incontinence? 1.Quality of evidence: Nine studies have surveyed the significance of pelvic floor muscle training exercises in preventing and treating urinary incontinence both in late pregnancy and after delivery. All the studies were of good quality methodologically and have reduction in urinary incontinence or regaining of continence as the primary end point.

Applicability:
The evidence is fully applicable as it shows PFMT reduces existing urinary incontinence as well as significantly reducing its occurrence in pregnancy 3. External validity: It is reasonable to generalize the results of all the 9 studies in the target population and the general population as the integrity of the studies is safeguarded and a sizeable randomized sample of the population with similar characteristics used. 4 Consistency: There is a high degree of consistency in the available evidence. There is no study that demonstrated conflicting results. 5. Quantity of evidence: All the studies included had evidence that was statistically significant and with significant impact in reduction of urinary incontinence. 6. Clinical impact: Pelvic floor muscle training if implemented both correctly and consistently will have a great impact in urinary incontinence reduction during late pregnancy and early postpartum period as compared to normal antenatal and postnatal care. It also significantly reduces existing urinary incontinence in postnatal women. There are no indicated risks of the intervention in the evidence available. 7. Other factors: There were no other factors taken into consideration when assessing evidence base. 8.Evidence statement: In an expectant lady without urinary incontinence, starting them on pelvic floor muscle training exercise with good supervision at between gestation weeks 20 and 34 ,will significantly reduce episodes of urinary incontinence in late pregnancy and early postpartum. In a postpartum woman with urinary incontinence, pelvic floor muscle exercise will significantly reduce incontinence by 6 to 12 months. In the long run, there is no significant difference between control and PFMT.

Evidence level 1++ 1+
Comparison between the significant of antenatal pelvic floor exercises and non-intervention in ..  The study addresses an appropriate and clearly focused question Well covered 1.2

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The assignment of subjects to treatment groups is randomized Well covered 1. 3 An adequate concealment method is used Adequately covered 1.4 Subjects and investigators are kept 'blind' about treatment allocation Well covered 1.5 The treatment and control groups are similar at the start of the trial Well covered 1. 6 The only difference between groups is the treatment under investigation Well covered 1.7 All relevant outcomes are measured in a standard, valid and reliable way. Well covered 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
Not stated 1.9 All the subjects analyzed in the groups to which they were randomly allocated(often referred to as intention to treat analysis) Does this study help to answer the key question? Yes, PFMT group gives better outcome than non-intervention both in short and long terms. The study addresses an appropriate and clearly focused question Well covered 1.2 The assignment of subjects to treatment groups is randomized Well covered 1. 3 An adequate concealment method is used Adequately addressed 1.4 Subjects and investigators are kept 'blind' about treatment allocation Well covered 1. 5 The treatment and control groups are similar at the start of the trial Well covered 1. 6 The only difference between groups is the treatment under investigation Well covered 1.7 All relevant outcomes are measured in a standard, valid and reliable way. Well covered 1. 8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? None 1.9 All the subjects analyzed in the groups to which they were randomly Well covered Comparison between the significant of antenatal pelvic floor exercises and non-intervention in .. Does this study help to answer the key question? Yes-up to I year there is significant improvement in continence for PFMT group. In six years the improvement shrinks and the difference in effect between the intervention group and the control is minimal. The treatment and control groups are similar at the start of the trial Well covered 1. 6 The only difference between groups is the treatment under investigation Well covered 1.7

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All relevant outcomes are measured in a standard, valid and reliable way. Well covered 1. 8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? none 1.9 All the subjects analyzed in the groups to which they were randomly allocated(often referred to as intention to treat analysis) How was this study funded/ Not stated 3.9 Does this study help to answer the key question? Yes-PFMT has a better prognosis for postpartum urinary and faecal incontinence than non-intervention  The treatment and control groups are similar at the start of the trial Well covered 1. 6 The only difference between groups is the treatment under investigation Well covered 1.7 All relevant outcomes are measured in a standard, valid and reliable way. Well covered 1. 8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
Not addressed 1.9 All the subjects analyzed in the groups to which they were randomly allocated(often referred to as intention to treat analysis) What intervention (treatment, procedure) is being investigated in the study? Pelvic floor muscle exercise (PFMT) 3.4 What comparison are made in the study Pelvic floor muscle exercise v Nonintervention (Usual pre and postnatal care) 3.5 How long are patients followed up in the study? 20 weeks gestation to 3 months after delivery (8months) 3. 6 What outcome measure(s) are used in the study? Reduction in urinary incontinence ,pelvic floor strength and urinary bladder mobility 3.7 What size of the effect is identified in the study? 19.2% episodes of urinary incontinence in the PFMT compared with 32.7% in nonintervention group(RR =0.59, 0.37 -0.92) 3. 8 How was this study funded/ Not stated 3.9 Does this study help to answer the key question? Yes, women on PFMT show better response than the control group All the subjects analyzed in the groups to which they were randomly allocated(often referred to as intention to treat analysis) What outcome measure(s) are used in the study? Self-reported urinary and anal incontinence after the intervention period (at 32-36 weeks gestation).

3.7
What size of the effect is identified in the study? 11% of women in the intervention reported any weekly urinary incontinence compared to 19% of the nonintervention group (P= 0.004). 3% of women in the intervention reported faecal incontinence versus 5% in non-intervention. 3.8 How was this study funded/ Not stated 3.9 Does this study help to answer the key question? Yes, women on PFMT show better response than the control group Dr. Najwa Alfarra Comparison between the significant of antenatal pelvic floor exercises and non-intervention in preventing urinary incontinence: A systematic Literature Review." IOSR Journal of Nursing and Health Science (IOSR-JNHS) , vol. 6, no.6 , 2017, pp. 38-56.