26 participants complied with the entire study protocol, were treated
twice, and assessed 5 times (before and after the first and second
session and two weeks after the second session) and ended the study.
Among the 16 (80%) participants of the study group who completed the
study, the oxford scale at enrollment was 2.6±1.2 and increased to
3.85±1.1 at the fifth evaluation (p<0.05), while in the 10
(50%) participants of the control group it was 3.4±1.1 vs. 3.9±1.0
(p<0.05). There was 42.5% improvement in Oxford scale for the
study group vs 14.7% for the control group. (figure 2,)
Although perineometry measurements were superior in the control group
prior to the study, as well as at the end of the study, there was an
improvement in the pelvic floor strength compared within each group
before and after the study. Perineometry measurements were improved in
the study group from enrollment to the fifth evaluation by 23%
(23.1±15.2 vs 28.6±16.1 cmH2O respectively
(p<0.05) while no difference was found between the first and
the fifth evaluation in the control group 30.0±12.7 vs 30.3±9.6
cmH2O respectively (p=n.s) (figure 3).
There were no differences in PI of the UA, UmbA, and MCA PI in both
groups.
There was no difference between the first and the fifth measurement of
CL (40.54±6.91 vs 39.88±8.91mm in the study group, and 42.23±6.87 vs
42.30±7.39mm in the control group, respectively, (p=n.s) (figure 4)
PFDI-20 showed significant improvement: in the study group it was
reduced from 27.8±12.5 to 19.3±10.8 (42% improvement) and in the
control group from 22.6±16.4 to 20.1±13.7 (12% improvement) p=0.001 for
both groups. (figure 5)
There were no cases of cervical shortening, decreased blood flow to
uterus or fetus, preterm birth or vaginal bleeding in the study or
control groups.
None of the patients had preterm birth vaginal bleeding or described any
adverse effects due to the intervention methods
Discussion
Principal findings : This is the first study to evaluate
the effect of manual fascial mobilization treatment in comparison to
pelvic floor muscle training for pregnant women. We found that the
technique used was safe. Both the study and the control group included
participants with mild to moderate pelvic floor dysfunction , both
groups were similar in their demographical characteristics, while,
perineometry measurements were superior in the control group prior to
the study, it was improved in the study group from enrollment to the
fifth evaluation by 23% while no difference was found in the control
group. We were able to show that the treatment group had better results
after one, as well as after two sessions, compared to the control group,
in both Oxford test, cervical length, and perineometry. There was better
compliance to end the study in the PFFM group compared to the controls,
and there was more than 40% improvement in both Oxford as well as
PFDI-20 in the longitudinal evaluation for 16 participants who lasted
the entire PFFM study group vs, 10-14% improvement in the control
group.
Results : The validity of our results can be shown in a
comparison to the study by Caroci et al8 who analyzed
220 gravidas. The average perineometry PFMS was 33.4±21.2
cmH2O. We found similar measurements in the control
group, (29.40±12.32) and lower in the study group (21.95±14.95
cmH2O). The median Oxford scale in our study was 3.0 in
the control group vs. 3.5 in the study group, similarly, Resende at
al44 found an average of 2.1 ±0.9 of Oxford scale
among 15 primiparous. Patricelli et al28 reported an
average of 2.53±0.57 among nulliparous.. Thus, the Oxford in the control
group was similar to that described elsewhere, while the study group had
weaker pelvic floor muscles.
We found positive correlation between Perinometer measurements and
Oxford grading scale before and after intervention in both study and
control groups (table 2), similarly, Da Roza et al45described a positive correlation between Oxford scale and Perineometry
in pregnant women as well as Batista et al7 and
Gameiro et al46.
We found PFDI-20 of 27.1±12.2 vs. 26.0±13.5 respectively in the study
vs. control group in second trimester women, prior to
intervention,(p=0.7) similar to the results by Martinez F. et
al47 in which women in the third trimester had a
PFDI-20 score of 32.77 and 20.83 in the first trimester.
The positive effect of PFMT was shown by Boyle et al11
12 In a Cochrane meta-analysis of 22 trials involving 8,485 women.
Continent women who had intensive antenatal pelvic floor muscle training
were less likely to report urinary incontinence post-partum. Davenport
et al48 published a metanalysis of 24 studies
including 15,982 women. PFMT decreased the odds of UI in pregnancy (15
randomized controlled trials (RCTs), n=2764 women; OR 0.50, 95% CI 0.37
to 0.68, I2=60%) and in the postpartum period (10 RCTs, n=1682 women;
OR 0.63, 95% CI 0.51, 0.79, I2=0%). Schreiner et
al49 published a metanalysis of 22 trials that
compared EPI-NO perineal dilator (Tecsana, Munich, Germany), pelvic
floor muscle training, and perineal massage with a significant reduction
in the duration of the second stage of labor (P<0.01), and
decreased incidence of urinary incontinence. Similarly, in our study
PFMT showed benefit on pelvic floor symptoms and strength. However, the
improvement measured after PFFM was superior. We have found 10-15%
improvement in Oxford scale, perineometry and PFDI-20 with PFMT vs more
than 40% improvement when PFFM was used. Moreover, even though women in
the study group had a weaker pelvic floor prior to study intervention,
the results of Oxford scale and Perineometer were similar after
intervention in both groups.
Pulsatility Indexes (PI) measurements of the uterine arteries are a
parameter for uterine blood supply50 51. Increased PI
of the Ut artery during the third trimester was found to be associated
with intra-uterine growth restriction of the fetus52.
In our study the PI of the UA UmbA MCA was unchanged when compared
before and after treatment in the study group as well as in the
controls.
Okido et al53 examined the PI’s of MCA, UA and UmbA in
96 women who were randomized to intervention (n=26) with daily PFMT
program vs no intervention (n=33). Results showed normal values of the
PI’s of both UA, MCA and UmbA, with no difference between groups.
Measurements performed at 28 and 32 weeks of gestation, showed no impact
of treatment on resistance to flow as measured by uterine artery PI.
Similarly, in our study performed between 24-32 weeks, the PI’s of the
UA as well the UmbA and MCA did not change before and after treatment.
Cervical Length elongated after the first treatment in the study group
(39.8±6.5 vs 43.4±10.2 mm respectively p<0.05). while no
difference was found in the controls (40.9±6.7 vs 40.0±8.6 before and
after exercise respectively p=n.s). In the longitudinal measurement we
found no effect of treatment for both groups.
Many etiologies have been postulated for the shortening of the cervical
length during pregnancy, including primary cervical insufficiency,
inflammation and infectious processes, genetic etiology, and others.
Aran et al54 recently presented that a short cervix
can be due to weak pelvic floor muscles, and thus elongation of cervical
length may be achieved by improving the pelvic floor muscular function
and strength through better gliding of the fascia.
Clinical implications Pelvic Floor Fascial Mobilization
(PFFM) is an innovative manual technique for treatment of pelvic floor
dysfunction by improving fascial gliding. The connective (Fascial)
tissues form a ubiquitous network throughout the whole body, which is
usually regarded as a passive contributor to biomechanical behavior of
muscles and organs. Treatment of fascia may improve muscle
function.22 Fascial scar release techniques by soft
tissue mobilization have shown improvements for treatment of abdominal
and pelvic adhesions related pain.23
PFFM is an intra vaginal and / or intra rectal manual therapy technique
developed (by S.N.) to treat pelvic fascial dysfunction, continuous to
the total outer body Fascial manipulation® technique
developed by Stecco29-31 33. PFFM was shown to rapidly
improve pelvic floor function in a male cyclist involved in an accident
after only two, 40 minutes intervention sessions36Treatment of fascia may improve muscle strength,22 and
by PFFM, the pelvic floor musculature could gain proper strength and a
balanced tone. PFFM was associated with an improvement of PFM strength
by more than 40% as well as reducing subjective symptoms by more than
40%. Such improvement was not found for pelvic floor exercise
PFFM can benefit cervical length as well. Anatomically, the cardinal and
the uterosacral ligaments provide extensive attachment of the cervix to
the lateral pelvic walls, the greater sciatic foramen, the piriformis,
and the lateral sacrum, as far as the sacroiliac joints. The uterosacral
ligaments are attached to the cervix postero-laterally, and posteriorly
to the fascia in front of the sacroiliac joints55 56.
The apex of the vagina and uterus are held in place by the uterosacral
and cardinal ligaments, anchoring the cervix over the levator plate.
This 3-dimensional fascial-ligamentous creates a cradle-like structure
holding the cervix in its proper position.
This may lead to better and equal support of the ligamentous structures,
and hence, change the tension applied on the cervix, and contribute to
its length and endurance. We found when an elongation of the CL measured
on 20 participants after treatment with PFFM with no effect of regular
pelvic exercise. Research implications : We present a
possible innovative and safe method for the treatment of pelvic floor
disorders in pregnant women is investigated. Further study is needed on
a larger sample size to evaluate the effect of PFFM on elongation of
cervical length during pregnancy and to evaluate the effect of PFFM on
prevention and treatment of urinary incontinence.