Group B-Control group (n=20)
Exercise session with personal guidance of PFMT provided for 40 min.
based on a protocol for physiotherapy training of the pelvic floor
adopted from Salvesen & MØrkved42. Women were
instructed to perform 2 sets of 8-12 near maximal pelvic floor muscle
contractions and hold the contraction for 6–8 seconds. At the end of
each contraction the women were asked to add three to four fast
contractions. The resting period was 12 seconds. training was performed
in lying and sitting positions. In addition, the women were instructed
to repeat the exercise at home twice a day.
All participants in both groups were assessed immediately post
intervention for Oxford scale measurement, Perineometry, Ultrasound
measurements of UA, UmbA and MCA PI’s and CL.
One week after the first session, reassessment of all the participants
prior to second intervention and repeat treatment and exercise were
performed. After two more weeks participants fifth evaluation and
completion of PFDI-20 for the second time were
performed.
Flow chart of study randomization, patient allocation and Data analysis
is described in Figure 6
Statistical analysis
Normality of the data was tested using the Shapiro–Wilk or Kolmogorov–
Smirnov tests. Categorical variables are described as frequency and
percentage. continuous variables are described using either mean and
standard deviation or median and interquartile range. Categorical
variables were compared using the Chi square test.
A Two-Way Repeated Measures analysis as well as ANOVA mixed design was
performed:
1) Before and after the manipulation at the first session,
2) Throughout the five measurements,
A Pair Sample t-Test was conducted for each group separately.
Significance accepted at p < 0.05. IBM Statistical Package for
the Social Sciences (IBM SPSS v.21; IBM Corporation Inc, Armonk, NY,
USA).
Results
40 women who complained of symptoms associated with pelvic floor
dysfunction were enrolled and randomized,43 20 in each
group. The median: age, gravidity, parity, BMI, and gestational age were
similar between groups (table 1). Study group had a weaker pelvic floor
muscles at enrollment. The average Oxford scale was 2.7±1.2 in the study
group vs.3.4±1.0 in the control (p<0.05). perineometry was
22.0±15.0 vs. 29.4±12.3 cmH2o respectively
(p<0.086)
However, prior to intervention, there was no difference in the severity
of symptoms as tested by PFDI-20: 27.1±12.2 vs. 26.0±13.5 points
respectively in the study vs control group (p=0.7).
After the first session, Oxford test in the study group improved from
2.7±1.2 to 3.5±1.3 (p<0.001) while no difference was shown in
the control group 3.4±1.0 vs 3.4±1.1 (p=1).
The perineometry measurements, were marginally improved in the study
group 22.0±14.4 vs 24.6±17.5 (p=0.075). With no difference in the
control group 29.4±12.3 vs 30.1±12.5 (p=n.s). We found positive
correlation between perineometry measurements and Oxford grading scale
before (r=0.73) and after intervention (r=0.69) in both study and
control groups P<0.001.
Uterine artery pulsatility Indexes (PI) measurement were decreased when
compared before and after the first treatment, in both groups. There was
no difference in Umbilical Artery flow.
Cervical Length elongated in the study group after the first treatment
(39.8±6.5 vs 43.4±10.2 mm respectively, p<0.05. while CL in
the control group was 40.9±6.7 vs 40.0±8.6 before and after exercise
respectively (p=n.s).