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).