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Urogynaecology
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previously.
Method Participants were asked about the presence of SUI, impact
PFMT on SUI did not continue for a long term despite the
majority claiming to still perform PFMT. These findings are in
keeping with those of other studies and raise concerns about the
long-term efficacy of PFMT. Strategies to improve compliance
with PFMT are required.
Keywords Antenatal, muscle training, patient compliance, pelvic
Please cite this paper as: Agur W, Steggles P, Waterfield M, Freeman R. The long-term effectiveness of antenatal pelvic floor muscle training: eight-year follow up
of a randomised controlled trial. BJOG 2008;115:985990.
Introduction
Postnatal stress urinary incontinence (SUI) is a common
problem affecting up to 34% of women, 1 while 35%
have faecal incontinence.2 The risk is higher, and incontinence is likely to persist in the long term after onset
during pregnancy. 3,4 Evidence suggests that vaginal delivery can contribute to damage to the pelvic floor through
muscle and fascial injury as well as disrupting the nerve
supply.5,6
Antenatal pelvic floor muscle training (PFMT) has been
shown to reduce the incidence of postnatal SUI in the short
term.79 However, in their 6-year follow-up study of postnatal PFMT, Glazener et al.10 showed a lack of long-term
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
985
Agur et al.
Methods
Participants were recruited in 19981999 during their 20week visit to the antenatal clinic of an acute NHS Trust
Teaching Hospital. All were primigravidae with bladder neck
mobility12 on perineal ultrasound.13 Details of methodology,
intervention and the outcome at 3 months following delivery
have previously been described.9 Participants were randomised (by computer-generated pseudorandom numbers) to
either monthly PFMT with supervision by a physiotherapist
or a control group where they received only verbal advice
and/or a leaflet on PFMT from their midwives. No record
of the control groups performance of PFMT was made, for
example Oxford score or perineometry as in the study group.
Eight years later, the participants were contacted by letter
inviting them to take part in this follow-up study. Letters
were followed up by a telephone call to explain the study
objectives and to determine whether or not they wished to
take part. Following informed verbal consent, participants
were asked to give details of their childbirth(s) over the past
8 years, the frequency of performing PFMT and the presence
of SUI in the past 48 weeks. Duration of the phone call
(from P.S.) averaged 10 minutes during which the symptom
questionnaire used in the previous study9 and the Kings
Health Questionnaire were completed. Inclusion criteria
were participation in the initial study, being in good general
health as well as willingness to complete the questionnaire by
telephone.
The prevalence of SUI at 8 years was assessed using the
symptom questionnaire used in the original study.9 A severity
question was used to ascertain whether leakage occurred once
a week, twice or more per week or daily. Participants with no
leakage in the previous 4 weeks were regarded as continent.
The original trial sample size had been calculated as 128 test
subjects and 128 controls (based on the results of the previous
study12) to obtain a 5% two-sided significance level and an
80% power to detect the difference in postpartum urinary
incontinence among participants in the two groups, allowing
for a 25% attrition rate.9
Two members of the research team (P.S. and W.I.A.)
entered the 8-year follow-up data onto database software.
Statistical analysis studied the relationship between subsequent childbirth(s), PFMT performance and urinary symptoms comparing all with the results of the original study
(M.W.).
Nominal categorical data were tested using exact forms of
the chi-square test. For 22 tables with a control (layer) variable, the CochraneMantelHaenszel test was used. Mann
Whitney nonparametric tests were used to compare groups
for measurements on an ordered, categorical scale. P < 0.05
were considered significant. Logistic regression model was
used for multivariate analysis as SUI at 8 years was common
(greater than one-third), and adjusted relative risks (RR) and
986
Results
A total of 164 (71%) of the 230 participants with available
postnatal data from the original study responded 8 years later
(Figure 1). No obvious difference was found between participants who responded at the original study and those who
responded 8 years later regarding age (27.6 versus 28.1 years),
mode of index delivery (caesarean section rates: 14.5 versus
15.2%), body mass index (24.5 versus 24.5) or the presence of
urinary incontinence (25.7 versus 26.2%).
The number of nonresponders was higher from the original
treatment group compared with the original control group
(34.2 versus 22.7%, P = 0.004). Nonresponders were younger
than responders, but there were no other significant differences (Table 1).
The mean age at the time of the original study was 27.6 years
(range: 1647 years). Eight years later, 114 (69.5%) participants
had at least one further delivery, while parity was unchanged
(i.e. para 1) in the remaining 50 (30.5%). More women in the
control group went on to have further deliveries compared
with the treatment group (80.0 versus 58.2%, P = 0.004).
The significant improvements in postnatal urinary incontinence seen in the PFMT group compared with controls at
3 months in the original trial (19.2 versus 32.7%, P = 0.02)
were not evident 8 years later (35.4 versus 38.8%, P = 0.75).
The severity of urinary incontinence showed little difference
between the PFMT and the control groups (Table 2). There
was no difference between the groups on any of the eight
domains of the Kings Health Questionnaire.
There was a small number of spontaneous remissions in the
control group: 12 women who had SUI at 3 months were now
dry at 8 years (14.1%). The majority of those who were continent at 8 years were also dry at 3 months: in the control
group, 56 women were dry at 3 months and 40 of them were
dry at 8 years (71%) and in the study group, 65 were dry at
3 months and 47 of them (72%) were dry at 8 years.
The frequency of performing PFMT was recorded from
direct questioning and graded as frequent (26 per week)
or infrequent (1 per week). In the study group at 8 years,
68.4% reported that they still performed PFMT and 38.0% of
them claimed to be undertaking this twice or more per week.
Although participants were not asked about the nature of
their daily activities or using the pretimed contraction (the
knack15), there was no difference in incontinence rates
between those performing PFMT twice or more per week
and those performing PFMT less frequently.
Table 3 and Figure 2 show the relationship between subsequent deliveries and the presence of SUI in the two groups.
In the PFMT group, 46 women had further pregnancies compared with 68 women in the control group. Only one-third of
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
Nonresponders
P value
28.0 (5.6)
25.8 (5.8)
0.002
24.5 (4.2)
23.7 (4.0)
0.13
14.9
14.9
0.9
26.2
24.2
0.87
SUI severity
Mean age in
years (SD)
Mean body
mass index (SD)
Caesarean section
rate at index
delivery (%)
Postpartum SUI
at 3 months (%)
Absent
Mild (1 per week)
Moderate (26 per week)
Severe (7 per week)
Total
52 (61.2)
12 (14.1)
15 (17.6)
6 (7.1)
33 (38.8)
NS
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987
Agur et al.
50 (30.5)
24 (48)
NS
114 (69.5)
37 (32.5)
NS
Discussion
This is the first long-term follow-up study of the effectiveness
of antenatal PFMT in prevention of SUI; a good response rate
was achieved at 8 years (71% of those who completed the
original trial and 61% of those originally randomised). As
there were more nonresponders in the treatment group, this
has the potential to bias the results. It is also possible that some
nonresponders might have improved with PFMT, and there is
no evidence that they had undergone continence surgery.
While antenatal PFMT has been shown to reduce the incidence
of postnatal SUI in the short term,79 the data suggest that the
improvement was not maintained 8 years later. It should be
noted, however, that the attrition rate of the current study
(39% of those originally randomised) is higher than that used
to calculate the sample size of the original study (25%), which
inevitably reduces the power of this current 8-year follow-up
study. Nevertheless, the results are in keeping with those of
a postnatal PFMT study, which showed that three-quarters of
the women still had urinary incontinence 6 years following the
index delivery.10 It has also been shown that the initially
marked difference in urinary symptoms shown between
women groups 6 months after starting an intensive PFMT
programme is no longer maintained 15 years later.16 The previous evidence suggests that the difference in the number of
participants performing PFMT (at 1 year) had disappeared 6
years later10 and that only 28% of women still perform PFMT
in the long term.16 Our data support these findings.
Possible reasons for loss of benefit might be poor compliance
in the study group (only 38.0% claimed to be training twice or
Figure 2. Effect of subsequent deliveries on prevalence of SUI 8 years following participation in the antenatal PFMT trial.
988
2008 The Authors Journal compilation RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
Figure 3. Effect of mode of index delivery 8 years ago on current prevalence of SUI in participants.
more per week) and that women in the control group were doing
regular PFMT, which in some women might have been effective;
the so-called Hawthorne effect of an RCT (also described as
avis effect by B et al.17). It is possible that women in the control
group might have been given verbal advice on PFMT in a subsequent pregnancy, but this is unlikely to have been supervised
training with a physiotherapist or a specialist nurse. It is not
possible to confirm whether the study group who had been
individually taught PFMT 8 years earlier (or the control group)
were still performing PFMT correctly at 8 years. It seems reasonable to assume, however, that the study group should still be
aware of the correct technique compared with controls.
As there is no information on how many participants in the
control group received verbal advice and/or the relevant leaflet 8 years ago, we cannot make a firm conclusion that superTable 4. Adjusted RR for SUI 8 years in a multivariate analysis
Factor
Further deliveries
None
1
One or more
0.72 (0.511.01)
Mode of index delivery
Normal delivery
1
Assisted
0.65 (0.381.14)
Caesarean section
0.49 (0.231.06)
SUI at 3-month postpartum
Absent
1
Present
1.98 (1.392.82)
*Adjusted for all other variables in the model.
P value
0.058
0.131
0.069
,0.001
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989
Agur et al.
Conclusions
The initially beneficial treatment effect of supervised antenatal
PFMT on SUI did not continue long term. These findings are
in keeping with those of other authors and raise questions
about the long-term efficacy of PFMT in prevention of SUI.
Strategies to improve compliance with PFMT are required.
Funding
Local NHS Trust. j
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