Effectiveness of antenatal pelvic floor muscle exercise in stress … Yik Kei.pdf · 2015. 10. 23. · i Abstract of dissertation entitled “Effectiveness of antenatal pelvic floor

i

Abstract of dissertation entitled

“Effectiveness of antenatal pelvic floor muscle exercise in stress

urinary incontinence during pregnancy and after delivery”

Submitted by

Wong Yik Kei

For the degree of Master of Nursing

at The University of Hong Kong

August 2015

Stress urinary incontinence is a common health problem in antenatal and postnatal

women. Although pelvic floor muscle exercise is regarded as a first-line conservative

method for prevention and treatment of this urological problem, it is not

comprehensively included in antenatal services in Hong Kong.

This thesis introduces evidenced-based guidelines for antenatal pelvic floor muscle

exercise to improve incontinence during pregnancy and after delivery. Based on

available evidence, the guidelines aim to decrease the rate of stress urinary

incontinence. The transferability and feasibility of application of the guidelines

clinically will be assessed. The implementation plan and evaluation plan will be

discussed.

ii

“Effectiveness of antenatal pelvic floor muscle exercise in stress

urinary incontinence during pregnancy and after delivery”

By

Wong Yik Kei

A thesis submitted in partial fulfillment of the requirements for

The Degree of Master of Nursing

At The University of Hong Kong.

August 2015

iii

Declaration

I declare that this thesis represents my own work, except where due acknowledgement

is mode, and it has not been previously included in a thesis, dissertation or report

submitted to the University or to any other institution or a degree, diploma or other

qualification.

Signed _________________________

Wong Yik Kei

iv

Acknowledgements

I would like to express my greatest gratitude to Dr. Marie Tarrant, my dissertation

supervisor, for her continuous support and guidance throughout my master studies. Dr.

Tarrant definitely helped and guided me to overcome a lot of challenges.

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Table of Contents

Abstract………………………………………………………………………………...i

Declaration……………………………………………………………………………iii

Acknowledgement…………………………………………………………………….iv

Table of contents………………………………………………………………………v

Chapter 1: Introduction…………………………………………………………..……1

1.1 Background……………………………………………………………………..1

1.2 Affirming the need……………………………………………………………...2

1.3 Objectives and significance……………………………………………………..4

Chapter 2: Critical Appraisal…………………………………………………………..6

2.1 Search and appraisal strategies…………………….……………………………6

2.2 Results………………………………………………………………….……….8

2.3 Summary and synthesis……………..…………………………………………14

Chapter 3: Translation and Application………………………………………………22

3.1 Introduction……………………………………………………………………22

3.2 Target audience/setting………………………………………………………...22

3.3 Assessing implementation potential…………………………………………...23

Chapter 4: Development Evidence-based Practice Guidelines………………………31

4.1 Guideline title…………………………………………………….……………31

4.2 Aims and objectives……………………………………...……………………31

4.3 Target group…………………………………….………………………….…..31

4.4 Recommendations…………………………………………………….……….32

Chapter 5: Implementation Plan……………………….….................………………36

5.1 Introduction....…………………………………………………………………36

5.2 Communication plan……………………………………………….………….36

5.3 Pilot testing.....…………………………………………………………………40

Chapter 6: Evaluation Plan………… ……………………………………………..…42

6.1 Intervention outcomes and outcome measurement……………………………42

6.2 Nature and number of clients involved………………………………………..44

6.3 Data analysis…………………….…………………………………………….45

6.4 Criteria for effectiveness………………………………………………………45

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Conclusion…………………………………………………..………………………..46

Reference………………………………..……………………………………………47

Appendices…………………………………………………….……………………..53

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Chapter 1: Introduction

1.1 Background

The International Continence Society defines stress urinary incontinence (SUI) as

‘the involuntary leakage of urine on effort or exertion, or on sneezing or coughing'

(Abrams et al., 2002). It is a distressing and common health complaint during

pregnancy and postpartum. Pregnancy and childbirth are risk factors for developing

SUI since they may weaken and cause damage to the pelvic floor muscles and

ligaments controlling the bladder neck and the urethra (Morkved, Bø, Schei &

Salvesen, 2003). The prevalence of SUI during pregnancy and after childbirth in

Chinese women varies from 18.6%to 37.8% and 6.9% to 25.9% respectively in

studies (Chan, Cheung, Yiu, Lee & Chung, 2012; Zhu et al., 2012; Yang et al., 2010).

SUI adversely affects quality of life by interfering with women's social, physical,

occupational and leisure activities. However, this health condition is not considered a

problem by health care professionals, and pregnant and postpartum women often

perceive it as normal, which inhibit seeking help (Cardozo & Cutner, 1997). Among

current interventions, pelvic floor muscle exercise (PFME) is regarded as a first-line

conservative method for prevention and treatment of SUI, as it helps strengthen the

periurethral muscles and improves the efficiency of sphincter function (Berghmans et

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al., 1998). Antenatal PFME is therefore recommended for all women during

pregnancy to reduce the incidence of SUI during pregnancy and in the postpartum

period (National Institute of Clinical Excellence, 2006).

1.2 Affirming the Need

In Hong Kong, the Maternal and Child Health Centers (MCHC) of the Department

of Health (DH) are the major service providers offering maternal services for women.

At a MCHC, pregnant women have shared antenatal care with Hospital Authority

(HA) hospitals, and postnatal follow-up is done mainly in MCHCs. Although urinary

incontinence (UI) is a distressing problem during pregnancy and after delivery and

affects the quality of life of women (Tozun, Ayranci, & Unsal, 2009), information on

its prevention and treatment is not comprehensively included in antenatal service.

Antenatal classes are given for pregnant women and their partners to help them better

prepare for labor and birth. These workshops only focused on breastfeeding, child

care and parenthood. It is known that PFME is effective in dealing with SUI, however,

there are no structured antenatal programs teaching women the correct way to perform

these exercises. The problem of UI is neglected by nurses as they perceive it as an

inevitable condition result of pregnancy and delivery (Kocaoz, Eroğlu, & Sivaslıoğlu,

2013). The significance of PFME is usually underestimated in the primary health care

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setting of the MCHC.

There is no evidence-based protocol in the MCHC for the management of antenatal

and postnatal SUI. Leaflets on PFME are distributed routinely at the first antenatal

visit and postnatal checkup. Verbal advice is given only if a client complains of

incontinence. However, the practice of instructing PFME is inconsistent among staff

as there are no guidelines or protocol for internal reference. Clients are only taught

verbally about PFME with a brief introduction in related pamphlets and are not

offered practical training sessions. Since the effectiveness of PFME highly depends

on the correctness and continuity of muscle contraction, it is vital that clients be

instructed in the technique of relaxation and contraction of pelvic floor muscles

(Mason, Glenn, Walton & Hughes, 2001). Frequent monitoring is recommended to

ensure the accuracy of and compliance with the exercise (Franchi, Ciolli, Greco,

Piserà, & Russo, 1999). An evidence-based protocol for an antenatal PFME program

is necessary to replace the current inconsistent practice.

In one study, the majority of women interviewed about their personal experience

with antenatal PFME agreed that these programs helped improve UI during pregnancy

and after delivery (Chiarelli, Murphy & Cockburn, 2003). A well-structured training

program on PFME was more effective than verbal advice from health care providers

in managing antenatal and postnatal incontinence condition ((Mason, Glenn, Walton

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& Hughes, 2001; Miquelutti, Cecatti, & Makuch 2013). However, since not many

systematic reviews have been done on this subject, it is necessary to conduct a review

in order to formulate a protocol and implement it into clinical settings.

1.3 Objectives and Significance

The study question is: Is antenatal PFME effective in reducing the incidence of

stress urinary incontinence during pregnancy and after delivery? The objectives of

this study are: 1) to determine the role of antenatal PFME in reducing the incidence of

SUI during pregnancy and after delivery; 2) to compare the different antenatal PFME

programs in reducing the incidence of SUI during pregnancy and after delivery; 3) to

construct an evidence-based protocol and evaluate the feasibility of the

implementation. It is hypothesized that following instructions on PFME via a

structured training program during the antenatal period, the incidence of SUI during

pregnancy and after delivery would decrease.

This study will benefit pregnant women and women who have given birth by

reducing the incidence, severity and frequency of SUI through a well-structured

antenatal PFME program. It will also help nurses in the MCHC instruct pregnant

women about PFME in a systematic and consistent way following the evidence-based

protocol. By reviewing and comparing relevant studies, weaknesses in training

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program may be discovered. This is significant since the findings of the study are the

basis for formulating evidence-based practice with ongoing evaluation and

modification to strengthen the program.

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Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies

Search Strategies

A search for relevant studies was done through the electronic database including

PubMed (from 1992 to 2014), the British Nursing Index (from 1999 to 2014),

CINAHL (from 1982 to 2014), Cochrane Library and ProQuest. Reference lists of

relevant articles were also searched for suitable trials. The keywords 'pelvic floor

muscle exercise', 'pelvic floor exercises', 'pelvic floor training', 'antenatal', ‘pregnant

women’, 'pregnancy', 'postnatal', 'postpartum’, 'urinary incontinence', 'stress urinary

incontinence', 'clinical trial', 'controlled trial' and randomized controlled trial' were

used to search the above databases.

Inclusion criteria

Types of studies

Randomized controlled trials (RCTs) and quasi-experimental controlled studies were

included.

Types of participants

Studies that recruited primigravidae or nulliparous antenatal women, with or

without UI symptoms, were included. Studies of women with and without a risk of

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bladder neck mobility were included.

Types of intervention

Trials in which PFME programs were used to improve UI symptoms, to prevent UI,

or both, were included in the review. PFME was defined as a repetition of voluntary

contraction and relaxation of pelvic floor muscles taught and supervised by health

care providers such as nurses and physiotherapists. PFME programs were included

regardless of the number and length of follow-up sessions, the number of participants

in the class, the number and length of contractions, and the purpose of the training

program.

Types of outcome measures

Outcome measures included self-reported SUI, and the quantification of symptoms

such as frequency and severity. Studies with other outcomes including quality of life,

pelvic floor muscle strength and socioeconomics were also considered.

Exclusion criteria

Trials with interventions such as drug therapy combined with pelvic floor muscle

training (PFMT) were excluded. Restrictions on language of publication and

publication status were not imposed.

Data extraction

Relevant information and data from each study were extracted and recorded in a

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'Table of Evidence' with columns including bibliographic citation, study type, level of

evidence, subject characteristics, intervention, comparison, length of follow up,

outcome measures, effect size, source of funding and quality rating.

Appraisal strategies

The Scottish Intercollegiate Guidelines Network (SIGN) framework was used as a

tool for appraisal of the quality of the included studies. SIGN guidelines are based on

a systemic review of evidence undertaken by a guideline development group to

critically assess the quality of studies with different study designs.

2.2 Results

The period of the search was from April 1, 2014 to July 20, 2015. The detailed

search process is shown in Appendix I. The search yielded nine eligible studies

(Kocaoz et al., 2013; Reilly et al., 2002; Stafne, Salvesen, Romundstad, Torjusen &

Mørkved, 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez, Gonzalez-Cerron,

Montejo & Barakat, 2014; Sangsawang & Serisathien, 2011; Dinc, Beji & Yalcin,

2009; Sampselle et al., 1998). Tables of evidence of the relevant studies are attached

in Appendix II. The results are highlighted in the following section.

Study Characteristics

Two of the nine studies were conducted in Turkey (Kocaoz et al., 2013; Dinc et al.,

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2009), two in Norway (Stafine et al., 2012; Morkved et al., 2003), one in the United

Kingdom (Reilly et al., 2002), one in Taiwan (Ko et al., 2010), one in Spain (Pelaez et

al., 2014), one in Thailand (Sangsawang & Serisathien, 2011) and one in the United

States (Sampselle et al., 1998). Seven studies were RCTs (Reilly et al., 2002; Stafne et

al., 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014; Dinc et al., 2009;

Sampselle et al., 1998). Two were quasi-experimental studies (Kocaoz et al., 2013;

Sangsawang & Serisathien, 2011).

Sample characteristics such as gestational age, age and body mass index (BMI)

were collected in all studies. Three studies only included subjects without UI (Kocaoz

et al., 2013; Reilly et al., 2002; Pelaez et al., 2014), while two studies included

subjects with UI (Sangsawang & Serisathien, 2011; Dinc et al., 2009). The other four

trials included subjects with or without UI (Stafne et al., 2012; Ko et al., 2010;

Morkved et al., 2003; Sampselle et al., 1998).

All studies included antenatal PFME training as their interventions. Six studies

offered regular training sessions in a given period (Reilly et al., 2002; Stafne et al.,

2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014; Sangsawang &

Serisathien 2011). One study offered a one-off training session (Kocaoz et al., 2013).

The remaining two did not mention the number of training sessions (Dinc et al., 2009;

Sampselle et al., 1998).

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Eight studies used the rate of SUI as an outcome measure and Sampselle et al.(1998)

used the severity of SUI. In addition, five studies also reported the frequency of SUI

(Kocaoz et al., 2002; Stafne et al., 2012; Pelaez et al., 2014; Sangsawang &

Serisathien, 2011; Dinc et al., 2009). Three studies assessed the outcome in the

antenatal period only (Stafne et al., 2012; Pelaez et al., 2014; Sangsawang &

Serisathien, 2011 ) while one included only the postpartum period (Reilly et al., 2002).

The other five included both periods (Kocaoz et al., 2013; Ko et al., 2010; Morkved et

al., 2003; Dinc et al., 2009; Sampselle et al., 1998).

Level of Evidence

With reference to the SIGN (2011) guidelines, two studies were ranked as RCTs

with a very low risk of bias (Reilly et al., 2002; Morkved et al., 2003). Three studies

were ranked as RCTs with a low risk bias (Stafne et al., 2012; Ko et al., 2010;

Sampselle et al., 1998). Two studies were RCTs with a high risk of bias (Pelaez et al.,

2014; Dinc et al., 2009). The other two studies were high quality control studies with

a very low risk of bias and a high probability that the relationship was causal (Kocaoz

et al., 2013; Sangsawang & Serisathien, 2011).

Quality Assessment

The methodological quality of each study was assessed using the methodology

checklists for randomized controlled trials (SIGN). Tables 1 and 2 summarize the

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internal validity assessment and the overall quality assessment of the selected studies.

Checklists of the assessment are shown in Appendix III.

Table 1: Internal Validity Assessment of Selected Studies

Clearly

Focused

Question

Random

Allocation

Adequate

Concealment

Double

Blind

Treatment

Allocation

Groups

Comparable

Only

Difference

is

Treatment

Valid

Measurement

of Outcomes

Drop-out

Rate

Intention

-to-Treat

analysis

Comparable

Results From

all Sites

Kocaoz et al.,

2013 + NA NA NA + + +

23% IG

26% CG – NA

Reilly et al.,

2002 + + + – + + +

13.7% IG

14.7% CG + NA

Stafne et al.,

2012 + + + – + + +

7.7% IG

14.3% CG + NR

Ko et al., 2010 + NR + NR + + + 4.8% + NA

Morkved et

al., 2003 + + + – + + +

1.7% IG

2.3% CG + NA

Pelaez et al.,

2014 + + – NR + + +

13.7% IG

7.3% CG – NA

Sangsawang &

Serisathien,

2011

+ NA NA NA + + + 11.4% IG

0% CG – NA

Dinc et al.,

2009 + NR + NR + + +

10.9% IG

15.2% CG – NA

Sampselle et

al., 1998 + + + – + + + 36.1% + NA

Covered (+); Not Covered (–); Not Reported (NR); Not Applicable (NA) Intervention Group (IG);

Control Group (CG)

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High Quality Studies

Four of the nine trials achieved a high quality rating (Reilly et al., 2002; Stafne et

al., 2012; Morkved et al., 2003; Sampselle et al., 1998). Although the research

questions were not mentioned in the four studies, the aims and objectives were stated

clearly with 'PICO' components. Three studies used computer generated allocation for

randomization (Reilly et al., 2002; Stafne et al., 2012; Sampselle et al., 1998) while

Morkved et al. (2003) performed block randomization. Allocation concealment was

Table 2: Overall Quality Assessment of the Selected Studies

Bias

Minimized

Direction of Bias Effect due to

Intervention

Results

Applicable to

Target Group

Overall quality

Rating

Kocaoz et al., 2013 + No randomization used. Yes Yes Fair (+)

Reilly et al., 2002 ++ Chance of selection bias. Only included

women with existing bladder neck mobility.

Yes Yes High (++)

Stafne et al., 2012

++ Subjects and investigators were not blinded to

treatment allocation. Significant difference in

severe SUI between groups, more frequent in

control group, which may have led to

overestimation of effect.

Yes Yes High (++)

Ko et al., 2010 + Randomization of assignment of subjects was not reported.

Yes Yes Fair (+)

Morkved et al.,

2003

++ Low drop-out rate and intention-to-treat

analysis minimized bias.

Yes Yes High (++)

Pelaez et al., 2014 + Inadequate concealment method used. Yes Yes Fair (+)

Sangsawang &

Serisathien, 2011

+ No randomization adopted. Short duration of

intervention and small sample size may have

led to overestimation of measured effects.

Yes Yes Fair (+)

Dinc et al., 2009 + If intention-to-treat analysis was applied, the

effect size would be overestimated.

Yes Yes Fair (+)

Sampselle et al.,

1998

++ High drop-out rate due to long study period

which affected effect size.

Yes Yes High (++)

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done by centralized allocation or using opaque sealed envelopes. Single-blinding

where investigators or assessors were blinded was used in three studies. The study of

Stafne et al. (2012) did not use blinding. Bias could be expected as result of

overestimation of the effect size.

The characteristics of subjects in both the intervention and control groups were

similar at the beginning of the trial in four studies (Reilly et al., 2002; Stafne et al.,

2012; Morkved et al., 2003; Sampselle et al., 1998). It was clearly stated that the only

difference between groups was the intervention. The overall drop-out rates were

acceptable, ranging from 1.7% to 14.7%. However, Sampselle et al. (1998) had a high

rate of 36.1% which may have been due to the long follow-up period. All studies

performed intention-to-treat analysis to analyze all subjects as randomized regardless

of the drop-out rate.

Moderate Quality Studies

The quality of the five remaining studies was rated as moderate. (Kocaoz et al.,

2013; Ko et al., 2010; 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011;

Dinc et al., 2009). The aims and objectives of the studies were addressed clearly in all

trials. As Kocaoz et al. (2002) and Sangsawang & Serisathien (2011) were

quasi-experimental studies, randomization was not applicable. The randomization

method was only reported by Pelaez et al. (2014) who used a computer generated

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program. Two studies (Ko et al., 2010; Dinc et al., 2009) didn't mention the method of

randomization but reported they used sealed envelopes for concealment. Blinding was

not mentioned in any of the studies.

All studies reported subject characteristics to ensure there were no significant

differences between the intervention and control groups. All studies ensured that the

only difference between groups was the intervention under investigation. The

drop-out rates were between 0% and 26%. Intention-to-treat analysis was only

addressed in one study (Ko et al., 2010), which contributed to a lower quality rating.

The overall effects in the nine studies were attributed to the study interventions, and

all of them were directly applicable to the targeted patient group.

2.3 Summary and Synthesis

Characteristics of the Interventions

All studies used different combinations of antenatal PFMT instructions as their

interventions. All of the interventions were well-structured and taught by nurses or

physiotherapists. The correct methods of contraction of pelvic floor muscles were

taught while the duration and frequency of exercising were indicated following a

strength-training protocol. Home exercises were included as part of the training

program. Three of the studies (Morkved et al., 2003; Pelaez et al., 2014; Stafne et al.,

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2012) included PFME in an antenatal exercise program comprising general aerobic

exercises. All interventions were delivered face-to-face. The majority of them were

done on a group basis (2-15 participants) (Stafne et al., 2012; Ko et al., 2010;

Morkved et al., 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011); one was

conducted on a one-to-one basis (Reilly et al., 2002); the other three studies (Kocaoz

et al., 2013; Dinc et al., 2009; Sampselle et al., 1998) did not report this. The

intervention periods ranged from 6 weeks to 22 weeks, with the mode 12 weeks. Most

of the interventions were comprised of weekly follow-up sessions, the frequency

ranging from three times a week to once a month; only Kocaoz et al. (2013)

conducted a one -off intervention. The duration of each training session ranged from

45 to 60 minutes in the five studies which reported it (Stafne et al., 2012; Ko et al.,

2010; Morkved et al., 2003; Pelaez et al., 2014; Sangsawang & Serisathien, 2011).

Effectiveness of the Interventions

All reviewed studies concluded that antenatal PFMT is effective in preventing or

treating SUI during pregnancy or after delivery. Except for Reilly et al (2002) who

assessed SUI after delivery, all studies showed that the incidence of SUI in the

antenatal period was significantly lower in the intervention groups than in the control

groups. Pelaez et al. (2014) and Sangsawang & Serisathien (2011) showed more

significant results compared with the others. Pelaez et al. (2014) reported a 4.8 %

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incidence of SUI in the 36th

gestational week in the intervention group compared with

39.3% in the control group (p=0.0001). Sangsawang & Serisathien (2011) reported an

incidence of 38.7% in the 26th

to 36th

gestational week in the intervention group and

100% in the control group (p=0.001). Five studies reported a statistically significant

difference in the frequency of SUI between the two groups (Kocaoz et al., 2013;

Stafne et al., 2012; Pelaez et al., 2014; Sangsawang & Serisathien, 2011; Dinc et al.,

2009). However, Kocaoz et al. (2013) reported insignificant results for the frequency

of SUI 'once a week or less' in the 28th

and 32nd

gestational weeks ( 3.85% in the

intervention group (IG) vs 2% in the CG and 7.69% in the IG vs 6% in the CG

respectively, with no P-value reported).

All six studies with postnatal evaluations reported significant differences between

the IG and CG in terms of the incidence, frequency and severity of SUI (Kocaoz et al.,

2013; Reilly et al., 2002; Ko et al., 2010; Morkved et al., 2003; Dinc et al., 2009;

Sampselle et al., 1998). However, Ko et al. (2010) reported insignificant results in the

incidence of SUI 3 days and 6 weeks postpartum (30% in the IG vs 41% in the CG

and 25% in the IG vs 35% in the CG, respectively). Sampselle et al (1998) evaluated

the severity of SUI 6 weeks, 6 months and 12 months postpartum. The difference

between groups at 12 months was insignificant with no P-value reported (+0.006

[mean; score assessing severity] in the IG vs +0.025 [mean; score assessing severity]

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in the CG).

Summary of the Evidence

From the reviewed studies, Pelaez et al. (2014) showed more statistically

significant differences between groups in the incidence of SUI in the antenatal period

(4.8 % in the IG vs 39.3% in the CG [p=0.001]). This might be because that study had

an intensive follow- up program with the longest intervention period among all

studies. Participants attended exercise sessions three times a week for 22 weeks. This

intensive training program provided continuous monitoring and supervision of the

correctness and continuum of pelvic floor exercises resulting in better effects. The

study of Sangsawang & Serisathien (2011) also showed a significant reduction in the

rate of SUI in the antenatal period. The study included subjects with UI at the

beginning of the trial. Only 38.7% of participants in the IG reported SUI compared

with 100% in the CG (p=0.001). Training sessions with smaller groups of 2-5

participants were adopted. This could ensure that every participant in the group was

supervised closely which increased the effectiveness of the intervention. A supervised

pelvic floor exercise intervention on a one-to one basis was used in the study of Reilly

et al. (2002). This might have been more effective than group instruction and

therefore there was a significant difference between the IG and CG (19.2% in the IG

vs 32.7% in the CG [p=0.023; 95% CI 0.37-0.92]).

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Kocaoz et al. (2013) reported insignificant results in the frequency of SUI in the

28th

and 32nd

gestational weeks (3.85% in the IG vs 2% in the CG and 7.69% in the

IG vs 6% in the CG, respectively, with no P-value reported). This might be attributed

to the short intervention in which a one-off training session was given without further

follow up. The high chance of discontinuity and inaccuracy of pelvic muscle exercise

might have led to the small effect size. In addition, the high dropout rate (23% in the

IG and 26% in the CG) might have contributed to the larger effect size as intention-

to- treat analysis was not adopted. Ko et al. (2010) demonstrated insignificant results

in the early postpartum ( 3 days postpartum: 30% in the IG vs 41% in the CG

[p=0.07]; 6 weeks postpartum: 25% in the IG vs 35% in the CG [p=0.06]). Vaginal

delivery might damage the pelvic floor muscles, which need time to heal in the early

postpartum period. Therefore, the outcome was insignificant in the early postpartum.

Sampselle et al. (1998) reported that the difference in the severity of SUI between

groups was not significant at 12 months postpartum. Despite the high dropout rate in

the study (36%) which reduced the power of the results as only a small sample was

included, bias was reduced by appropriate randomization and adherence to

intention-to-treat analysis. Since the other eight reviews only evaluated the outcomes

in a relatively short period (from the antenatal period until 6 months postpartum),

the benefits of PFME in SUI could not be well interpreted beyond this time period.

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Sampselle et al. (1998) provided evidence for the effect of PFME in SUI in a long

term follow- up after delivery in a reliable way, which could be taken into account in

the establishment of the evidence- based protocol.

Implications for Practice

To develop evidence-based guidelines, recommendations were made according to

the above information.

Most of the reviewed studies included pregnant women in the second trimester

(14th

to 24th

week), either with or without UI, depending on whether the studies aimed

at prevention, treatment or both. It is recommended that pregnant women in their

early second trimester be targeted. Basic characteristics such as parity, mode of

delivery, urinary symptoms, age and BMI will be assessed as these impose a direct

effect on the outcome measures. It will be difficult to recruit only pregnant women

with UI as it may be unfair to others without UI, as the MCHCs are supposed to

provide equal services to the public. To make the recruitment process easier, women

will be considered regardless of whether they have UI or not.

Studies suggest that a well-structured PFME program supervised by health care

professionals is more effective than verbal advice with written materials (Miquelutti

et al., 2013; Mason et al., 2001). The PFME intervention should include skills in

contraction and relaxation of pelvic floor muscles and guidelines on home exercises

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supervised and taught by trained nurses with optional supplementation with printed

material. Three studies had weekly interventions, for 12 weeks (Stafne et al., 2012;

Ko et al., 2010; Morkved et al., 2003). Each training session should be 45 to 60

minutes (Stafne et al., 2012; Ko et al., 2010; Morkved et al., 2003; Pelaez et al., 2014;

Sangsawang & Serisathien, 2011). A small group with approximately 8-12

participants should be considered (Morkved et al., 2003; Pelaez et al., 2014).

Although a one-to-one basis was used by Reilly et al. (2002), it may not be cost

effective in the MCHCs.

All studies evaluated the incidence of SUI in late pregnancy and/or postpartum.

The frequency of SUI was assessed in five studies (Kocaoz et al., 2013; Stafne et al.,

2012; Pelaez et al., 2014; Sangsawang & Serisathien, 2011; Dinc et al., 2009). These

two outcomes may be considered in the protocol. Evaluations in the 36th

gestational

week and 6 months postpartum are preferable.

Some concerns will be considered in the development of guidelines.

Misconceptions about UI among pregnant women should be clarified in the program.

Most pregnant women perceive UI as normal during pregnancy and after delivery

(Cardozo & Cutner, 1997). This may keep women in the intervention group from

performing PFME according to instructions. Information about the nature and adverse

effects of UI as well as preventive measures and treatment methods should be

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highlighted in the program (Mason et al., 2001). In addition, as pelvic floor training

involves home exercises, increasing motivation and monitoring should be carried out

in order to encourage and ensure the participants comply well with the program

(Franchi et al., 1999).

- 22 -

Chapter 3: Translation and Application

3.1 Introduction

SUI in the antenatal and postnatal periods is common in Hong Kong women, and

adversely affects various aspects of their quality of life. Healthcare professionals often

underestimate the problem as few of them have insight into this urological issue.

Neglecting early prevention and treatment and improper instruction of PFME may

lead to poor progress in incontinence in women. The literature on this health issue

shows that antenatal PFMT is essential to improve SUI during pregnancy and after

delivery. The implementation potential will be assessed in three areas, the

transferability of the findings, the feasibility and the cost-benefit ratio of the

innovation, before translating the literature guidelines into the targeted setting.

3.2 Target audience/setting

The innovation will be implemented in a MCHC. In the local setting, about 150

pregnant women register for their first antenatal checkup each month. It is known that

SUI is a common problem in pregnant women in Hong Kong, and it usually persists

in the postpartum period. Nonofficial observational data in 2010 in the local setting

reported a rate of urinary incontinence of about 20% among pregnant and postnatal

women. During antenatal checkups, many pregnant women express concerns about

- 23 -

their urological condition and especially UI. This shows the need to establish

well-structured PFMT for the target audience.

3.3 Assessing implementation potential

Transferability of findings

As shown by the Table of Evidence in Appendix II, PFMT will be launched in

antenatal clinics or antenatal wards for primigravida or nulliparous pregnant women

with or without a history of UI in their first or second trimester of pregnancy. The

local MCHCs provides antenatal checkup services for pregnant women, regardless of

UI status or parity. The similarity of characteristics of the target audience and setting

in the reviewed studies and those in the MCHC suggests that the proposed innovation

can be implemented in the local setting.

PFME improves the quality of life and physical well-being of women, as it is

effective in preventing and treating UI (Berghmans et al., 1998). The mission of the

DH is to 'safeguard the health of the people of Hong Kong through promotive,

preventive, curative and rehabilitative services' (Department of Health, 2013a). The

vision of the Family Health Service is to 'promote the health and well-being of ......

women and families', and its mission is 'to empower individuals, families and

communities to improve their health' (Department of Health, 2013b). As MCHCs are

- 24 -

under the Family Health Service of the Department of Health, the philosophy

concerning decreasing the rate and frequency of UI is consistent with the philosophy

of care in the proposed setting.

PFME training is recommended for all pregnant women. In 2013, 1854 pregnant

women registered for routine antenatal checkups at the targeted MCHC. The number

of clients in the practice setting who can benefit from the innovation is sufficient.

The training programs in all of the reviewed studies in Appendix II were conducted

in the first and second trimesters of pregnancy. Two reviewed studies had 45-minute

training sessions. (Ko et al., 2010; Sangsawang & Serisathien, 2011). One study had

one- off sessions (Kocaoz et al., 2013) while another suggested three sessions

(Sangsawang & Serisathien, 2011). It is proposed that the training be launched in two

45-minute sessions in the early second trimester. The proposed outcome, the rate and

frequency of SUI will be evaluated in the 36th

gestational week and 6 months

postpartum, as suggested in the literature (Stafne et al., 2012; Ko et al., 2010;


Feasibility

Organizational norms in relation to willingness to change affect the implementation

of innovations (Durlak & DuPre, 2008). In the local setting, nurses are free to carry

out innovations and are encouraged to bring up new ideas in clinical practice.

- 25 -

Schemes to reward staff for constructive and creative innovations encourage

implementation of new programs in the Department of Health. Termination of

undesirable innovations depends on the considerations of frontline staff. In the local

setting, a two-year program of monthly breastfeeding support groups was terminated

at the center level because of poor attendance rates and negative feedback from staff

and clients. These examples show that nurses are free to carry out and terminate

innovations. This shared decision-making practice, which refers to the extent to which

relevant parties collaborate in determining what will be implemented and how, makes

an implementation proceed more smoothly (Gottfredson & Gottfredson, 2002).

The new program will be implemented more effectively if it fits with the

organization’s current mission, priorities, and existing practices (Richard et al., 2004).

The organizational climate is conducive to evidence-based practice. There is a

bimonthly journal club in the local setting for staff to share the latest research.

Health care professionals are encouraged to bring up new ideas during the discussion.

Current services and interventions provided in the clinic setting, such as breastfeeding

support and postnatal counseling services, are mainly based on evidence from studies.

Some obstacles such as duty arrangement and staff training can be foreseen at the

administrative level. Physiotherapists and nursing specialists in urology in the DH

will be invited to train the staff in the proper methods of pelvic muscle training.

- 26 -

Coordination with other parties can bring different perspectives, skills, and resources

to bear on program implementation (Hahn, Noland, Rayens & Christie, 2002). The

new project will gain support from these parties as the department is planning

innovations to provide better health education for women.. The department will

support the innovation once administrative personnel approve. Measures to overcome

predicted obstacles will be discussed in later chapters.

Currently, antenatal PFMT is taught with videos. In each antenatal session, PFMT

videos are shown to clients having routine antenatal checkups. One nurse is

responsible for answering questions and responding to queries in this 30-45 minute

health education session. Verbal feedback from clients during routine interviews

shows that more interaction between nurses and clients is preferred. In the innovation,

the same manpower and the same period of time will be used to conduct PFMT in a

small group. Minimal interference with manpower is expected. However, the

workload of the staff will increase slightly because more nursing staff will be needed

for face-to-face training than for showing videos. Evaluation of the innovation will be

done using pre-test and post-test questionnaires on the outcome measures, the rate and

frequency of SUI. Additional statistical processing is needed for evaluation, which

could increase the staff workload. Resistance may be encountered in carrying out the

innovation.

- 27 -

Nurses in the local setting are well equipped with basic knowledge of urological

problems in pregnant and postpartum women continuing education and training on

related health issues are provided by the department. Most nurses are experienced in

educating clients about PFME, as they currently provide this service antenatally. It is

still recommended that all staff attend training sessions on conducting the innovation

to consolidate knowledge with practical experience. Collaboration with

physiotherapists and nursing specialists in urology is recommended for skills

assistance and instruction. The success of the implementation depends on the skill

proficiency of the providers. Service providers with better requisite skills are more

willing to implement an innovation at higher levels of dosage or fidelity (Ringwalt et

al., 2003). As the training courses increase nursing staff proficiency, the department

will be willing to support the innovation by releasing staff for training during office

hours.

No special equipment is needed for the innovation. Materials such as posters and

leaflets will be supplied directly by the department. The outcomes of the innovation

are the rate and frequency of SUI, which can be obtained using a questionnaire with a

self- reported severity index, a measuring tool created by Sandvik et al. (1993). It

comprises two questions assessing the frequency of urinary incontinence and the

amount of leakage. After multiplying the scores of the two questions, the resulting

- 28 -

value is categorized into slight, moderate and severe (Appendix IV). Published

evidence suggests the severity index is a valid measure of UI in women and it is

recommended for routine use (Hanley, Capewell & Hagen, 2001; Sandvik et al., 1993;

Sandvik, Seim, Vanvik & Hunskaar, 2000). Since pregnant women first come to the

MCHC around the 12th

gestational week, PFMT will be launched in two sessions in

the second trimester at the antenatal clients. Outcomes will be measured in the 36th

gestational week and 6 months postpartum.

Cost-benefit ratio of the innovation

In a previous review, evaluation of PFME for stress incontinence was done by

examining costs and quality-adjusted life years The study showed that appropriate

pelvic floor training in a patient with incontinence lowers National Health Service

costs and improves the benefits of treatment and quality of life (Costantini et al.,

2014).

The cost-benefit ratio of the implementation will be assessed. The innovation

benefits clients in different ways. PFME prevents and treats SUI by improving the

efficiency of sphincter function (Berghmans et al., 1998). With ta decrease in the

incidence of SUI in the antenatal and postnatal periods, quality of life improves as

clients are able to resume normal social, physical, occupational and leisure activities.

Other benefits are expected from implementing the program. Staff can better equip

- 29 -

themselves in professional knowledge of health promotion skills and related

gynecological health issues through participation in staff training sessions. Through

active contribution and discussion in the construction phase of the program, staff can

gain job satisfaction in decision making. It is expected that the program will be

effective in the prevention and treatment of SUI in the targeted women. Staff will feel

satisfied with the positive feedback from clients and favorable outcomes, which may

increase staff morale.

The innovation is recommended as there are risks in maintaining current practice.

Currently, pelvic floor muscle exercise is taught by a video. This passive method of

delivering health messages does not ensure that clients understand and perform the

exercises correctly (Sandvik et al., 1993). Since there are no follow-up sessions

afterwards, clients have no way to ask questions and clarify misconceptions, which

increases the risk of performing PFME incorrectly (De Oliveira, Lopes, Carla Longo e

Pereira & Zugaib, 2007). The overall decrease in the rate of SUI in current practice is

lower than that expected with the innovation. In addition, as the current method is not

very effective in treating and preventing SUI, negative feedback from clients may

lower staff morale and negatively affect the image of the department.

The costs of implementing the innovation have to be taken into account to

calculate the cost-benefit ratio. Material costs include staff training and posters placed

- 30 -

in the clinic. In addition to these set-up costs, operational costs are important in

determining the cost-effectiveness of the new practice. Operational costs include

written information for clients, the cost of conducting PFME training sessions and the

cost of evaluation. Total material costs per year will be $76,307. Details of the

calculations can be seen in Appendix V.

Non-material costs may arise from the innovation. Instead of waiting for queries

from the audience, as is done in current practice, nurses are active in PFMT. This may

increase the workload of staff as they need to have better preparation before launching

the health education sessions. Staff morale may be negatively affected and sick leave

may increase due to intentional absenteeism. Moreover, the staff turnover rate in the

clinic may increase if the increased workload causes resignations (Michie & Williams,

2003).

To conclude, the innovation is transferable, feasible and cost- effective and can be

implemented in the proposed local setting.

- 31 -

Chapter 4: Developing Evidence-based Practice Guidelines

4.1 Guideline title

Pelvic floor muscle exercise training for antenatal clients

4.2 Aims and objectives

The aim of this protocol is to decrease the rate and frequency of SUI by providing

structured PFME training.

The objectives are: 1) to provide a rational guideline based on scientific evidence

for the staff in providing antenatal PFME education; 2) to improve the quality of care

by reducing variations in practice by acting as a quality control; and 3) to promote

efficient use of resources in providing antenatal education in MCHCs.

4.3 Target group

Target users

Nurses of all levels in MCHCs providing PFME in antenatal clients.

Target patient population covered

Women attending MCHCs for antenatal checkups, in the second trimester of

pregnancy, without contraindications for performing PFME (e.g. high-risk of preterm

labor, pregnancy complications, twin pregnancies, pain during pelvic floor

- 32 -

contraction).

Target setting

Maternal and Child Health Centres of the Department of Health.

4.4 Recommendations

The protocol provides practical instructions for PFME training. Recommendations

on assessment, intervention and evaluation are made with the support of evidence and

are relevant to clinical practice. The levels of evidence and grades of

recommendations are appraised using SIGN (2011) guidelines (Appendix VI).

Assessment

1.1 Assess client’s health condition and pregnancy risk before recruitment.

Evidence:

Prior to recruitment, nurses must screen patients to exclude women with

contraindications to performing PFME during pregnancy, such as twin

pregnancies, a high risk of preterm delivery and pain during contraction when

doing PFME, which will affect the treatment effect. (Martin et al., 2006;

Sampselle et al., 1998) (1+; 1+)

Grade of Recommendation: A

1.2 Assess urinary incontinence before training using self-reported

questionnaires.

Evidence:

The status of SUI in early pregnancy will affect the outcome of PFME in the

antenatal period, since this will affect whether PFME is a preventive measure or

used for treatment purposes. (Boyle, Hay-Smith, Cody, & Mørkved, 2012;

- 33 -

Cooper & Cook, 2011) (1++; 1++)

A pretest self-report questionnaire will be used to evaluate outcomes. (De

Oliveira et al., 2007) (2+)


Intervention

2.1 Pelvic floor muscle training should be done in groups of 12.

Evidence:

It would be less time-consuming, more cost-effective and possibly more

motivating if pelvic floor exercise can be taught in a group setting compared

with individual training. (Bø & Haakstad, 2011) (1+)

Grade of Recommendation: B

2.2 The training should be conducted

a) early in the second trimester;

b) in two sessions: and

c) for 45 minutes.

Evidence:

PFMT during the second half of pregnancy reduced the prevalence of UI in late

pregnancy. (Mørkved et al., 2003; Reilly et al., 2002; Sampselle et al., 1998;

Stafne et al., 2012) (1++; 1++; 1+; 1+)

b) It is estimated that 30% of women are unable to contract the pelvic floor

muscles on a first attempt. Follow-up is important to increase the success rate.

(Bump, Hurt, Fantl & Wyman, 1991) (2-)

b) Monitoring of adherence to the training program in the follow up session is

more important than the total number of sessions. (Ko et al., 2011) (1+)

c) Training for PFME can be done within 45 minutes. (Ko et al., 2011;

Sangsawang & Serisathien, 2011) (1+; 2++)


2.3 The exercise regimen should comprise three repetitions of eight contractions,

each held for 6 seconds, with 2 minutes rest between repetitions. These should be

repeated twice daily at home.

- 34 -

Evidence:

This is a common regimen suggested by National Institute for Health and

Clinical Excellence guidelines for the management of UI in women, and it

significantly improves SUI in women. (Bø, 1995; Ko et al., 2011; Kocaoz, et al.,

2013; National Institute for Health and Clinical Excellence, 2006; Reilly et al.,

2002) (1+; 1+; 2++; 4; 1++)


2.4 Educational handbooks containing simple, clear instructions should be

distributed to participants.

Evidence:

Nurses should provide information about UI and PFME for pregnant women

verbally combined with handbooks for review at home. (Kocaoz et al., 2013;

Sangsawang & Serisathien., 2011) (2++; 2++)

Educational brochures on UI and PFME increase women’s awareness of the

subject, and stimulate interest and attract the attention of pregnant women.

Women will be able to understand the causes and treatment of SUI during

pregnancy and enhance their understanding of the benefits of PFME to minimize

the severity of SUI. (Kocaoz, et al., 2013; Sangsawang & Serisathien., 2011)

(2++; 2++)

Grade of Recommendation: B

Evaluation

3.1 Evaluations should be done in the 36th


postpartum.

Evidence:

Both the prevalence and severity of SUI increase throughout pregnancy and

PFME leads to less self-reported incontinence in late pregnancy. (Sampselle et

al., 1998; Sun, Chen, Chang & Chen, 2005; Thorp et al., 1999) (1+; 3; 2+)

Vaginal delivery might contribute to pelvic floor damage through muscular,

fascial, and nerve injuries. Tissue damage takes time to heal in the early

postpartum period. It is possible that an episiotomy will interfere with PFME in

the immediate postpartum period. Therefore, evaluation in the early postpartum

period is not suggested. (Ko et al., 2011) (1+)

- 35 -

The benefits of performing PFME in pregnancy are only evident up to six

months postpartum. This may be because of a lack of compliance with exercises

postpartum, or a result of birth trauma damaging the muscle and surrounding

structures. (Boyle et al., 2012; Cooper & Cook, 2011; Sampselle et al., 1998)

(1++; 1++; 1+)


3.2 Mode of delivery should be considered in evaluating outcomes.

Evidence:

Vaginal delivery is associated with a significantly higher postpartum UI rate than

cesarean delivery. (Ko et al., 2011) (1+)

Participants who had a cesarean birth were omitted from comparisons of pelvic

muscle strength because pelvic muscle damage would not be expected to occur.

(Sampselle et al., 1998) (1+)


3.3 Self-report outcomes are measured.

Evidence:

Speculum measures are not preferred compared with survey questions on

incontinence as there are contraindications to vaginal examination, such as

vaginitis and equipment malfunction. Pad tests can induce urinary tract infection

in pregnant women and women complain of discomfort when undergoing

urodynamic assessment. (Martin et al., 2006; Mørkved et al., 2003; Sampselle et

al., 1998) (1+; 1++; 1+)

Self-reports to evaluate the treatment effect cause minimal discomfort and

embarrassment for participants. (Mørkved et al., 2003) (1++)

The severity index is a simple, valid, reliable, and sensitive measure of UI in

women and therefore is recommended for routine use. (Hanley et al., 2001;

Sandvik et al., 1993; Sandvik et al., 2000) (1-; 1+; 1+)


- 36 -

Chapter 5: Implementation Plan

5.1 Introduction

PFME is suggested to be cost-effective and beneficial in the treatment of UI, since

this is a common health issue in the antenatal and postnatal periods. The

transferability of the research findings, feasibility and cost benefit ratio of the

innovation using PFMT in pregnant women had been assessed in previous chapters.

The communication and pilot testing plans were identified to facilitate the

implementation of the evidence-based protocol.

5.2 Communication plan

Potential stakeholders

Stakeholders are people who are affected by a proposed innovation because of the

expected results of the changes (Polit & Beck, 2012). Administrators such as nursing

officers, senior nursing officers and senior medical officers in the head offices are

potential stakeholders in the implementation of the innovation as they have decision

-making responsibilities for distribution of finances and resources and arrangement of

manpower. The frontline staff including nurse specialists in urology, doctors and

nurses will be affected by the changes in protocol. They may support or oppose the

innovation since their workloads and of work routines will be changed.

- 37 -

Communication process and methods

A team of health care professionals will be recruited to implement the new protocol.

Under the DH, four nursing officers are in charge of the targeted MCHC.

Recommendations for changes in guidelines and protocols in the workplace must first

be approved by the nursing officer in-charge. Senior nursing officers in the region will

be informed through the nursing officer for further approval. The implementation

team members will include two registered nurses, one nursing officer, one senior

nursing officer and one nurse specialist in urology. The team will participate in the

whole process of implementation and will function as resource and support persons,

auditors and trainers. Making sure the correct people are involved in the project

ensures individuals with appropriate skill sets and experts in the content of the

innovation are included (Dogherty, Harrison, Baker & Graham, 2012).

The implementation team will approach the administrators and convince them to

support the innovation. A one -hour presentation will be used to report evidence from

the studies. The prevalence and severity of UI in pregnant and postpartum women and

its effects on their quality of life will be highlighted in the presentation. The current

practice of showing a PFME program on video will be compared with the structured

training program in the innovation and the pros and cons will be discussed. The

administrators will be shown evidence from the literature supporting that antenatal

- 38 -

PFMT is significant in reducing the rate of SUI in the late antenatal and postnatal

periods. The feasibility and cost-benefit ratio, which have been discussed in the

previous chapter, will be addressed in the meeting. A detailed transparent explanation

of the process of implementation will be provided (Harrison et al., 2013).

With the approval and support of the administrators, nurses in the targeted center

involved in carrying out the innovation will be informed about the changes in the

protocol. A presentation will be given by the implementation team members to

explain the need for change and the significance of the new guideline. The timeline of

the implementation, workload, and benefits for staff and patients will be explained

to gain support from frontline staff. Misconceptions will be clarified. Counseling and

interviews will be offered for those with serious concerns about the changing protocol

and those who oppose or resist the new program. Studies emphasize the importance of

being organized and prepared for meetings so that group members’ time is not seen as

wasted and the work is not delayed (Graham & Harrison, 2005).

Training workshops will be held by the implementation team. Nurses in charge of

antenatal and postnatal services in the center will be trained to teach the PFME

program first. After that, these trained nurses will hold training workshops in small

groups to familiarize all nurses in the center with the information and flow of the new

protocol. Trainer nurses will be role models who allow other nurses to sit in on the

- 39 -

pelvic floor exercise program. Trainer nurses will also act as troubleshooters to

address concerns from other staff about mastering the new skills and the extra

workload.

Additional support will be provided through an updated resource kit and pocket

guide. The resource kit will be available in the clinic for staff reference. The pocket

guide, consisting of a summary of the new protocol and practical tips for launching

the new pelvic floor training program, will be given to all nurses.

Sustaining the change process

According to Harrison et al. (2013), guideline adaptation should not be considered

an episodic activity but part of a continuum in the evidence-informed practice journey.

Various measures are suggested to sustain the change process to ensure its

effectiveness and efficiency. The implementation team will evaluate the adequacy of

facilitation of the new practice guidelines (Dogherty, Harrison, Graham &

Keeping-Burke, 2014). Extra time will be allowed for staff to equip themselves with

the new skills and information. Additional training workshops will be provided if

necessary. This will ensure that all nurses are very familiar with the new protocol.

Compliance with the new guideline will be assessed by an audit system (Dogherty et

al., 2014). The ability of nurses to perform the new protocol will be audited by the

trainer nurses. Feedback will be given to the nurses after auditing.

- 40 -

Patient outcomes in terms of the rate of SUI and feedback from clients will be

monitored to modify the protocol. Success stories and nurses’ experiences s will be

shared in clinic meetings. Regular close contact will be maintained to ensure the right

individuals are informed and receive appropriate materials for a more complex

awareness of the updated issues (Dogherty et al., 2012). Revisions according to

updates l from the literature will be done frequently and guidelines will be modified

according to the latest review of evidence.

5.3 Pilot testing

A pilot study will be carried out after the communication process and staff training.

The aim of pilot testing is to determine the feasibility of the proposed change in the

PFME program in MCHCs to avoid unexpected difficulties and challenges before full

implementation (Polit & Beck, 2012; Van Teijlingen, Rennie, Hundley & Graham,

2001).

The new evidence-based practice guideline for the PFME program for pregnant

women will be applied in the target setting – the MCHC. Pilot testing will last two

weeks; two well trained nurses will run the program. One hour training will be given

to the nurses before the implementation. Posters will be placed in the waiting room

and leaflets will be distributed for each client to take home. The pilot test consists of

- 41 -

two 45 minutes sessions. The first session will introduce pelvic floor exercise and the

second will be a follow-up session. Twelve clients will be recruited and they will be

required to attend both sessions.

The process and outcome of the pilot test will be evaluated and the new guideline

will be modified accordingly. Modifications and additions to the process and support,

e.g. a heightened focus with more information and guidance on implementation, will

be provided (Fervers et al., 2011).

For the process outcome, interviews will be conducted with nurses to review the

logistics and difficulties in implementation. Nurses' compliance with the innovation

will be evaluated. For the outcome evaluation, client and healthcare provider

outcomes will be reviewed using the client satisfaction questionnaire and healthcare

provider questionnaire (Appendix VIII & IX).

The timeline of the communication plan is shown in Appendix VII.

- 42 -

Chapter 6: Evaluation Plan

The aim of the evaluation plan is to assess e the effectiveness of the new protocol

for the PFME training program in improving SUI in pregnant and postpartum women

in the local setting. Intervention outcomes will be measured and data will be analyzed

to assess the effectiveness.

6.1 Intervention outcomes and outcome measurement

The innovation will be assessed in terms of patient outcomes and healthcare

provider outcomes. Based on the identified evaluated studies in chapter 2, the

anticipated time of the intervention to take effect will be the measurement point for

the identified outcomes.

Patient outcome

The primary outcomes are the rate and frequency of SUI in late pregnancy and

postpartum. The secondary outcome is the satisfaction level of the participants. These

proposed outcomes will be evaluated in the 36th


postpartum, which is suggested in the literature (Stafne et al., 2012; Ko et al., 2010;


The primary outcomes will be determined by self-report. The measuring tool, the

severity index, will be adopted to assess the outcome. It comprises two questions

- 43 -

assessing the frequency of UI and the amount of leakage. After multiplying the scores

of the two questions, the resulting value is categorized into slight, moderate and

severe (Appendix IV). Published evidence suggests the severity index is a valid

measure of urinary incontinence in women and it is recommended it for routine use

(Hanley et al, 2001; Sandvik et al., 1993; Sandvik et al., 2000). Data will be collected

in the 36th

gestational week by self-reported questionnaires distributed during

antenatal checkups in the MCHC, and 6 months postpartum by telephone follow up

by nurses.

A self-reported questionnaire with a 5-point Likert Scale will be used to assess the

secondary outcome, the satisfaction level of the participants (Appendix VIII). Data

will be collected at the end of the follow- up session of the PFMT program.

Healthcare provider outcomes

Evaluation of the satisfaction level, skills and knowledge of the healthcare

providers will continue to ensure compliance and acceptance by the staff. The

satisfaction level will be evaluated every two months. A simple questionnaire

(Appendix IX) with a 5-level Likert Scale will be used for evaluation (Likert, 1932).

Nurses’ knowledge and skills in performing the new protocol will be audited by the

trainer nurses every half year and feedback will be given to the nurses after auditing.

- 44 -

6.2 Nature and number of clients involved

Eligibility criteria

All primigravida and nulliparous women attending the MCHC for antenatal

checkups in the early second trimester of pregnancy, with or without UI symptoms

without contraindications to performing PFME (e.g. high risk of preterm labor,

pregnancy complications, twin pregnancies, pain during pelvic floor contraction) will

be recruited.

Sample size calculation

Convenience sampling will be adopted to collect data from clients. The primary

outcome of the innovation is the rate of SUI. According to local estimates, the rate of

SUI is about 15% in pregnant women and 20% in postpartum women. From the

literature review in Chapter 2, a significant decrease in the rate of SUI after a PFMT

program ranges from around 10% to 20%. A decrease of 10% in the rate of SUI in

the 36th

gestational week and 6 months postpartum suggests that the new protocol is

effective.

The research question is a hypothesis test to determine the rate of SUI after

implementation of the innovation. Russ Lenth's power and sample size calculation

software will be used. The two-tailed Z-test for one proportion will be performed

(Lenth, 2010).

- 45 -

The settings will be as follows: null value = 0.2; actual value = 0.1; alpha = .05 and

power = .80. The sample size needed is 108. In the literature review, the dropout rate

from PFMT programs ranged from 1.7% to 36%. It is assumed that the dropout rate in

the local setting will be 10% for various reasons, mainly loss to follow-up. Therefore

120 clients must be recruited. It will take 8 weeks to recruit enough participants to

evaluate the effectiveness (Table 3).

Table 3: Estimation of time to recruit participants

New cases per week 36

Not fitting eligibility criteria 2

Total eligible cases per week 34

If 50% of antenatal clients agree to join the program, 17 women will participate.

Time to recruit 120 women

(12 clients per group)

120/17 = 7.1

= 8 weeks

6.3 Data analysis

SPSS version 23 for Windows was used for data analysis. In order to assess the

effectiveness of the program, the rate and frequency of SUI in participants will be

compared with existing statistics. The two-tailed z-test for one proportion will be used

to compare the rate of SUI in current and new practice.

6.4 Criteria for effectiveness

Based on the identified outcomes, criteria will be set to determine the effectiveness

- 46 -

of the innovation in the local setting. For patient outcomes, the literature review

shows that the average significant decrease in the rate of SUI after PFME training is

around 10-20%. Therefore, a decrease of 10% in the rate of SUI in in the 36th

gestational week and 6 months postpartum will reflect effectiveness of the innovation.

For the satisfaction level of clients and healthcare providers, the target is that more

than 70% will respond ‘Strongly agree’ or ‘Agree’ to corresponding questions in the

questionnaires. The new evidence -based practice protocol will be considered

effective for implementation if all the above criteria are met.

Conclusion

Well-structured antenatal PFMT is effective in reducing the incidence of SUI

during pregnancy and postpartum. The innovation for the pelvic floor training

program based on available evidence is considered to be transferrable, feasible and

cost-effective for implementation in the local setting. An evidence-based guideline

has been recommended for implementation, and an evaluation plan has been

discussed. Continuous review of updated research is suggested for modification of the

protocol.

- 47 -

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Appendix I

Search Strategy and Results for Selecting Studies in the Review

Database selection: PubMed, British Nursing Index, CINAHL, Cochrane Library, ProQuest

Keyword selection:

‘Urinary incontinence’ OR’ stress urinary incontinence’ AND ‘Pelvic floor muscle exercise’ OR ‘pelvic floor exercise’ OR ‘pelvic floor training’ AND

‘antenatal’ OR ‘pregnant women’ OR ‘pregnancy’ OR ‘postnatal’ OR ‘postpartum’

Limit: clinical trials, randomized controlled trials

No. of articles identified through database search:

PubMed: 32 BMI: 14 CINAHL: 208

Cochrane Library: 210 ProQuest: 201

No. of articles after duplicates removed:



No. of articles after screened by title:



No. of articles after screened by abstract:



No. of articles after screened by full text:



Total articles for review: 9

422 studies excluded after duplicates removed

203 articles excluded by title

20 articles excluded by abstract

11 articles excluded by full text

54

Appendix II

Table of Evidence

Bibiographic

Citation /

Study Type/

Country of

Study

E-

Level

Subject

Characteristic

Intervention Comparison Length

of

Follow

Up

Outcome Measures Effect Size Source of

Funding

Qua

-lity

Rati

-ng

Kocaoz et al.,

2013

Quasi

-experimental

Study

Turkey

2++ Pregnant women in

14th-20th gestational

weeks without UI; age

(mean + SD):

26.01+4.6; age range:

20-34

One-off AN

PFME training

session + home

exercises

(n=52)

AN routine

care + verbal

advice on

PFME

(n=50)

38wks (1) SUI at:

(a) AN 28th week (%)

(b) AN 32nd week (%)

(c) PN 12th week (%)

(2) Frequency of SUI at:

(a) AN 28th week:

(i) once a week or less (%)

(ii) several times a week or more (%)

(b) AN 32nd week:



(c) PN 12th week:



(1) SUI at:

(a) 5.8% in IG VS 30% in CG (P=0.002)

(b) 17.3% in IG VS 48% in CG (P=0.002)

(c) 1.9% in IG VS 18% in CG (P=0.007)

(2)(a) (i) 3.85% in IG VS 2% in CG **

(ii) 1.92% in IG VS 28% in CG *

(b) (i) 7.69% in IG VS 6% in CG **

(ii) 9.62% in IG VS 42% in CG*

(c) (i) 1.92% in IG VS 4% in CG*

(ii) 0% in IG VS 14% in CG*

* Sig. result, No P value reported

** Insig. Result, No P-value reported

NIL +

55

Reilly et al.,

2002

RCT

UK

1++ Primigravidae

pregnant women in

20th gestational

weeks, with high risk

of bladder neck

mobility without UI;

age (mean): 28; age

range: 16-47: BMI

(km/m2) (mean +

SD): 24.5 + 4.25

Monthly one to

one basis AN

PFME training

session from

20th week until

delivery + home

exercises

(n=139)

AN routine

care with

information

and verbal

advice on

PFME

(n=129)

32weeks SUI at PN 3 months (%)

19.2% in IG VS 32.7% in CG (P=0.023;

95% CI 0.37-0.92)

Funded by a

grant from

Wellbeing

++

56

Stafne et al.,

2002

RCT

Norway

1+ Pregnant women in

18th-22nd gestational

week, age (mean +

SD): 30.45+4.35;

BMI (km/m2) (mean

+ SD): 24.85 + 3.2;

nulliparous (%): 57

*Sig. difference in

severe SUI, more

frequent in CG (5% in

IG VS 10% in CG)

12- week, 60

minutes weekly

AN exercise

program

including

aerobics, PFME

and balance

exercise in

group basis

(8-15) + home

exercises

(n=429)

AN routine

care with

information

and advice on

PFME

(n=426)

16weeks (1) SUI at AN 32nd -36th week (%)

(2) Frequency of SUI at AN 32nd -36th

week: > once a week (%)

(1) 28% in IG VS 37% in CG (P=0.02; 95%

CI 0.5, 0.9)

(2) 7% in IG VS 13% in CG (P=0.03; 95%

CI 0.3, 0.9)

Funded by the

Norwegain

Fund for

Postgraduate

Training in

Physiotherapy;

the Liaison

Committee for

central Norway

Regional Health

Authority;

Norweigan

University of

Science and

Technology

++

Ko et al.,

2010

RCT

Taiwan

1+ Nulliparous pregnant

women in 16th-24th

gestational week, age

(mean + SD): 31.48 +

3.6; BMI (km/m2)

(mean + SD): 21.98 +

3.74

12-week,

45minutes

weekly AN

PFME training

session in group

basis + home

exercises

(n=150)

AN routine

care

(n=150)

48weeks SUI at:

(1) AN 36th week (%)

(2) PN 3 days (%)

(3) PN 6 weeks (%)

(4) PN 6 months (%)

(1) 34% in IG VS 51% in CG (P<0.01))

(2) 30% in IG VS 41% in CG (P=0.07)

(3) 25% in IG VS 35% in CG (P=0.06)

(4) 16% in IG VS27% in CG (P=0.04)

Supported by

Medical

Research

Project, Chang

Gung Memorial

Hospital

+

57

Morkved et

al., 2003

RCT

Norway

1++ Nulliparous

pregnant women in

18th gestational

weeks, age (mean +

SD): 27.45 + 4.45;

BMI (km/m2) (mean

+ SD): 23.25+3.25)

12-week, 60

minutes weekly

AN exercise

program

including PFME

and general

exercises in

group basis

(10-15)

+ home

exercises

(n=148)

AN routine

care with

information

on PFME

(n=153)

32weeks SUI at:

(1) AN 36th week (%)

(2) PN 3 months (%)

(1) 32% in IG VS 48% in CG (P=0.007;

95% CI 0.5, 0.89)

(2) 20% in IG VS 32% in CG (P=0.018;

95% CI 0.4, 0.9)

Funded by the

Norwegain

Fund for

Postgraduate

Training in

Physiotherapy

and the

Norwegian

Women’s Public

Health

Association

++

Pelaez et al.,

2014

RCT

Spain

1- Primigarous pregnant

women with 10th –

14th gestational week

without UI, age (mean

+ SD): 29.5+ 3.9;

BMI (km/m2) (mean

+ SD): 23.15+4.05)

22-week, three

times a week,

55-60 minutes

AN ex. program

including PFME

and aerobics in

group basis

(8-12)

(n=63)

AN routine

care with

information

on PFME

(n=89)

29weeks (1) SUI at AN 36th week (%)

(2) Frequency of SUI at AN 36th week:

(a) once a week (%)

(b) 2-3 times a week (%)

(c) once a day (%)

(d) several times a day (%)

(1) 4.8% in IG VS 39.3% in CG (P=0.0001)

(2) (a) 4.8% in IG VS 20.2% in CG

(P=0.0001)

(b) 0% in IG VS 10.1% in CG (P=0.0001)

(c) 0% in IG VS 7.9% in CG (P=0.0001)

(d) 0% in IG VS 1.1% in CG (P=0.0001)

Technical

assistance of

Gynecology and

Obstetrics

Service of

Fuenlabrada

University

Hosiptal

+

58

Sangsawang

et al., 2011

Quasi

-experimental

Study

Thailand

2++ Pregnant women with

20th -30th gestational

week with UI, age

(mean): 29.85; age

range: 18-43; BMI

(km/m2) (mean): 22.1

6-week, once

every 2 weeks,

45 minutes AN

PFME training

session in group

basis (2-5) +

home exercise

(n=31)

AN routine

care with

information

on PFME

(n=35)

6weeks (1) SUI at AN 26th -36th week (%)

(2) Frequency of SUI at AN 26th -36th week

(times/week):

(a) Range

(b) Mean+ SD

(1) 38.7% in IG VS 100% in CG (P=0.001)

(2) (a) 0-20 in IG VS 1.0-35.0 in CG

(P<0.001)

(b) 2.45 + 3.8 in IG VS 14.7 + 9.4 in CG

(P<0.001)

Funded by

Nursing Council

of Thailand

+

Dine et al.,

2009

RCT

Turkey

1- Pregnant women with

20th -34th gestational

week with UI, age

(mean + SD): 26.88 +

6.0

AN PFME

training session

+ home exercise

(n=46)

AN routine

care with

information

on PFME

(n=46)

28weeks (1) SUI at:

(a) AN 36th -38th week (%)

(b) PN 6-8 weeks (%)

(2) Frequency of SUI (no. of episodes in a

day):

(a) AN 36th -38th week (mean + SD)

(b) PN 6-8 weeks (mean + SD)

(1) (a) 43.2% in IG VS 71.4% in CG

(P<0.05)

(b) 17.1% in IG VS 38.4% in CG (P<0.05)

(2) (a)1.62+0.79 in IG VS 2.14+0.85in CG*

(b) 1.22+0.55 in IG VS 1.79+0.89 in CG *

*Sig. result, No P-value reported)

Funded by

University of

Istanbul

+

Sampselle et

al., 1998

RCT

US

1+ Primigarous pregnant

women with 20th

gestational week, age

(mean): 27.2+5.5

AN PFME

training session

+ home exercise

(n=34)

AN routine

care (n=38)

68weeks Severity of SUI (questionnaire assessing

symptoms) at:

(1) AN 35th week (mean)

(2) PN 6 weeks (mean)

(3) PN 6 months (mean)

(4) PN 12 months (mean)

(1) -0.025 in IG VS +0.188 in CG(p=0.043)

(2) -0.05 in IG VS +0.225 in CG (P=0.032)

(3) -0.063 in IG VS +0.038 in CG(P=0.044)

(4) +0.006 in IG VS +0.025 in CG

(Insig. result, No P-value reported)

Funded by

National

Institutes of

Health grants

++

59

Appendix III

Methodology Checklist

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Kocaoz, S., Eroğlu, K. & Sivaslıoğlu, A. A. Role of pelvic floor muscle exercises in the prevention of stress urinary incontinence during pregnancy

and the postpartum period. Gynecology and Obstetrics Investment, 75, 34-40.

Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 1 Reviewer: Y.K.Wong

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question. Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

N.A

1.3 An adequate concealment method is used.

Yes

Can’t say

No

N.A

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.i Yes

Can’t say

No

N.A

1.5 The treatment and control groups are similar at the start of the trial. Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the

study dropped out before the study was completed?

IG: 23%

CG: 26%

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows: High quality (++) Acceptable (+)Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the

methodology used, and the statistical power of the study, are you

certain that the overall effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the patient group

targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it

answers your question and mention any areas of uncertainty raised above.

PFME are effective for prevention of SUI in AN and PN period. Only one-off session was provided without continuous supervision on the

correctness and compliance of performing exercise at home.

60

S I G N



Reilly, E. T. C., Freeman, R. M., Waterfield, M. R., Waterfield, A. E., Steggles, P. & Pedlar, F. (2002). Prevention of postpartum stressincontinence

in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises. International Journal of

Obstetrics and Gynaecology, 109(1), 68–76.




1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.1 Yes

Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study

dropped out before the study was completed?

IG: 13.7%

CG: 14.7%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not

apply



Code as follows:

High quality (++) Acceptable (+) Unacceptable – reject 0




Yes



Yes



AN PFME are effective in reducing the risk of PN SUI in primigravidae with bladder neck mobility. The study only included women with

exiting bladder neck mobility.

61

S I G N



Stafne, S. N., Salvesen, K. A., Romundstad, P. R., Torjusen, I. H. & Mørkved, S. (2012). Does regular exercise including pelvic floor muscle training

prevent urinary and anal incontinence during pregnancy? A randomised controlled trial. International Journal of Obstetrics and Gynaecology, 119,

1270-1280.





Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No



IG: 7.7%

CG: 14.3%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not apply



Code as follows:





Yes



Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers

your question and mention any areas of uncertainty raised above.

Thorough instructed PFME is important to prevent and treat SUI in late pregnancy.

62

S I G N



Ko, P. O., Liang, C. C., Chang, S. D., Lee, J. T., Chao, A. S. & Cheng, P. J. (2011). A randomized controlled trial of antenatal pelvic floor

exercises to prevent and treat urinary incontinence. International Urogynecology Journal, 22, 17–22.





Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No



4.8%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not

apply



Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0




Yes



Yes



The positive effect of AN PFME may persist to PN period.

63

S I G N



Mørkved, S., Bø, K., Schei, B. & Salvesen, K. Å . (2003). Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a

single-bind randomized controlled trial. Obstetrics and Gynecology, 101(2), 313-319.





Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No



IG: 1.7%

CG: 2.3%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not

apply



Code as follows:

High quality (++)

Acceptable (+)





Yes



Yes



Intensive PFMT during AN prevents UI during AN and PN period.

64

S I G N



Pelaez, M., Gonzalez-Cerron, S., Montejo, R. & Barakat, R. (2014). Pelvic floor muscle training included in a pregnancy exercise program is

effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourology and Urodynamics 33, 67–71.





Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No



IG: 13.7%

CG: 7.3%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not apply



Code as follows:





Yes



Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers

your question and mention any areas of uncertainty raised above.

PFMT in general ex. class with former assessment of ability to perform the correct extraction was effective in primary of UI in primiporius

pregnant women.

65

S I G N



Sangsawang, B. & Serisathien., Y. (2011). Effect of pelvic floor muscle exercise programme on stress urinary incontinence among pregnant

women. Journal of Advanced Nursing 68(9), 1997–2007.





Yes

Can’t say

No


Yes

Can’t say

No

N.A


Yes

Can’t say

No

N.A


Can’t say

No

N.A


Can’t say □

No


Can’t say

No


Can’t say

No



IG: 11.4%

CG: 0%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not apply



Code as follows:

High quality (++)

Acceptable (+)


2.2 Taking into account clinical considerations, your evaluation of

the methodology used, and the statistical power of the study,

are you certain that the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable to the patient

group targeted by this guideline?

Yes



6 wks PFME decreases the severity of symptoms in pregnant women with UI

66

S I G N



Dinc, A., Beji, N. K. & Yalcin, O. (2009). Effect of pelvic floor muscle exercises in the treatment of urinary incontinence during pregnancy and the

postpartum period. International Urogynecology Journal, 20, 1223-1231.




1.1 The study addresses an appropriate and clearly focused question. Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No



IG: 10.87%

CG: 15.2%



Yes

Can’t say

No

Does not apply


Yes

Can’t say

No

Does not

apply



Code as follows:

High quality (++)

Acceptable (+)



methodology used, and the statistical power of the study, are you certain that

the overall effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted

by this guideline?

Yes



PFME are effective in PFM strength and treatment of UI

67

S I G N



Sampselle, C. M., Miller, J. M., Mims, B. L., Delancey, J. O. L., Ashton-miller, J. A. & Antonakos, C. L. (1998). Effect of pelvic muscle exercise on

transient incontinence during pregnancy and after birth. Obstetrics & Gynecology, 91(3), 406-412.

Guideline topic: Antenatal pelvic floor muscle exercise Key Question No: 9 Reviewer:

Y.K.Wong




Yes

Can’t say

No


Yes

Can’t say

No


Yes

Can’t say

No


Can’t say

No


Can’t say □

No


Can’t say

No


Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped

out before the study was completed?

36.1%

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as

intention to treat analysis).

Yes

Can’t say

No

Does not

apply


Yes

Can’t say

No

Does not

apply



Code as follows:

High quality (++)

Acceptable (+)



methodology used, and the statistical power of the study, are you certain

that the overall effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the patient group targeted

by this guideline?

Yes



High drop out rate possibly due to long study period. Only severity of UI, and not the prevalence of UI at baseline and after

intervention was recorded.

68

Appendix IV

Severity Index of urinary incontinence

Questions used to assess the degree or urinary incontinence in women:

(1) How often do you experience urinary leakage?

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

(2) How much urine do you lose each time?

1 Drops or little

2 More

The severity index is created by multiplying the results of

Questions (1) and (2):

1-2=slight

3-4=moderate

6-8=severe

Source:

Sandvik, H., Hunskaar, S., Seim, A., Hermstad, R., Vanvik, A. & Bratt, H. (1993).

Validation of a severity index in female urinary incontinence and its implementation

in an epidemiological survey. Journal of Epidemiology and Community Health, 47,

497-499.

69

Appendix V

Material costs of implementing new innovation

1. Set up cost

Training cost

(1 hour staff training session consists of lecture and Q & A session. A total of 3 training sessions will be launched to train all 21

staff in the clinic)

Cost of training venue Nil. Training will be conducted in health education room in clinic.

Cost of trainer (Nurse Specialists in

Urology of DH)

$322 (hourly pay) x 3 training sessions = $966

Cost of participants Average monthly salary of nurse in setting is $32562

Average hourly pay is: $32562/44 hours/4weeks = $185

Cost of participants is: $185 x 21 = $3885

Information poster(will be posted in clinic hall and health education room for promotion)

Cost of poster Nil. All posters will be directly supplied by headquarter of Department of Health.

Total set up cost (per year) is: $966 + $3885 = $4851

2. Operational cost

Written information for clients

Cost of booklets Nil. All booklets will be directly supplied by headquarter of Department of Health.

Cost of conducting PFME training session (Consists of two 45 minutes sessions)

Average manpower cost Average monthly salary of nurse in setting is $32562

Average manpower cost for 1 group of 45 minutes session is: $32562/44 hours/4weeks x

45minutes = $138.8

In 2013, there are 1854 new antenatal clients in unit. Assuming all clients consent to

attend, arranging in groups of 12,

No. of PFME sessions per year is: 1854/12 x 2 = 309 sessions

Average manpower cost per year is: $185 x 309 = $57165

Cost of evaluation

(Evaluation consists of two parts. Questionnaires will be given at AN 36 week visit, and one telephone follow up will be

conducted at PN 6 months.)

Average manpower cost (at first

evaluation)

Nil. No additional manpower is used.

Average manpower cost (telephone

follow up at PN 6 month)

30 minutes for asking the participants about their SUI condition.

Average manpower cost for 1 session is: $32562/44 hours/4weeks x 0.5hour = $92.5

Average manpower cost per year is:$92.5 x 155 sessions = $14291

Total operational costs (per year) is: $57165 + $14291 = $71456

Total material costs (per year) is: $4851 + $71456 = $76307

70

Appendix VI

Levels of evidence (SIGN, 2011)

Scottish Intercollegiate Guidelines Network

Key to evidence statements and grades of recommendations

SIGN GRADING SYSTEM 1999-2012

LEVEL OF EVIDENCE

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the

relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the

relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not

causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

GRADES OF RECOMMENDATIONS

At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and

demonstrating overall consistency of results

A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating

overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall

consistency of results; or

Extrapolated evidence from studies rated as 2++

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

71

Appendix VII

Timeline for the implementation plan

progress Weeks

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Prepare guideline

and protocol

Recruit implantation

team member

Communicate with

administrator

Communicate with

frontline staff

Staff training

Pilot testing

Pilot test evaluation

Implementation of

innovation

Sustain change of

process

72

Appendix VIII

Client Satisfaction Questionnaire

Please tick as appropriate:

Strongly

Agree

Agree Neutral Disagree Strongly

Disagree

1. The training is useful in

managing urinary

incontinence condition.

2. The content of the training is

understandable.

3. The healthcare professionals

are supportive and

knowledge.

4. The environment of the

training room is satisfactory.

73

Appendix IX

Healthcare Provider Satisfaction Questionnaire

Please tick as appropriate:

Strongly

Agree

Agree Neutral Disagree Strongly

Disagree

1. The protocol improves

satisfaction of work.

2. The protocol is easy to use

and understand.

3. The training session

provides sufficient

knowledge and skills for

implementing the protocol.

4. It builds confidence in

implementing the protocol

after the training session.

Documents

Effectiveness of antenatal pelvic floor muscle exercise in stress … Yik Kei.pdf · 2015. 10. 23. · i Abstract of dissertation entitled “Effectiveness of antenatal pelvic floor