Tweetable abstract
Vaginal fascial mobilization can improve pelvic floor dysfunction and cervical length in pregnant women.
Abstract
Objective Pelvic Floor Fascial Mobilization (PFFM) is an innovative intervention to improve pelvic floor dysfunction. Design Pregnant women at 24-30 weeks gestation, complaining of pelvic pain, and or stress urinary incontinence, were prospectively randomized to PFFM (study group) vs. pelvic floor muscle training (PFMT). Strength and function of the pelvic floor muscles was compared before and after interventions. Setting- Outpatient pregnancy clinic at a tertiary medical center Sample- 40 women randomly allocated to PFFM or PFMT Methods Each patient was treated twice, one week apart and was assessed immediately before and after each intervention, and one week after the second treatment. Main Outcome Measures PFDI 20 questionnaire , Oxford grading scale, perineometry to measure pelvic floor symptoms function and strength, transvaginal ultrasound cervical length
Results
PFFM group Oxford scale improved from 2.65±1.18 to 3.45±1.28 after the first session (p<0.001) with no difference in the PFMT group 3.40±1.05 vs 3.40±1.05 (p=1). Cervical Length elongated in the PFFM group after one treatment (39.8±6.5 vs 43.4±10.2 mm, p<0.05, but not in the PFMT group 40.9±6.7 vs 40.0±8.6 respectively (p=n.s).
Among 26 participants who lasted the entire study – PFMT was associated with more than 40% improvement in both Oxford as well as PFDI-20 and Perineometry was improved by 23% (23.13±15.15 vs 28.58±16.07 cmH2O (p<0.05) while no such difference was found with PFMT; 30.03±12.73 vs 30.25±9.61 cmH2O respectively (p=n.s).
Conclusions
PFFM may improve pelvic floor function and strength, alleviate symptoms and elongate the cervix. Further bigger study is needed to better evaluate this method.
Funding (To include the name of the funding body and the grant identifier)
No funding was granted for this trial
Key Words : Pelvic floor, Manual Therapy, Pregnancy, Cervical Length
Introduction
Pregnancy and birth are considered as the main risk factors for damage to the pelvic floor structure and function. The damage may appear as stress incontinence, fecal incontinence, pelvic organ prolapses, pelvic and low back pain or urination and defecation difficulties. Each pregnancy may intensify the damage and the symptoms become more severe as gestation advances1-9.
The different modalities of treatment for pelvic floor dysfunction; includes physiotherapy for Pelvic Floor Muscle Training (PFMT), perineal massage or manual techniques10.
PFMT have shown promising results with improvement in urinary stress incontinence (UI), after an intensive intervention program that lasts an average of 8 to 24 weeks11 12, In a Cochrane database review of 31 trials, the authors concluded that PFMT could be part of a first line conservative management program for women with UI. PFMT can also be used as a preventive mode of treatment during pregnancy with moderate results. Recently, a Cochrane review of 46 trials, provided evidence that PFMT in early pregnancy for continent women may prevent the onset of UI in late pregnancy and postpartum13. However, prolonged and continuous exercise as well as compliance and perseverance are needed in order to achieve satisfactory results14.
Manual technique for the pelvic floor musculature is an optional treatment modality 15-20, Antenatal digital perineal massage was shown to reduce the likelihood of perineal trauma (mainly episiotomies), the reporting of ongoing perineal pain, and is generally well accepted by women21. Perineal trauma and levator muscle injury are one of the major causes of pelvic floor dysfunction after childbirth. However, neither the effectiveness of manual treatment for pelvic floor dysfunction nor the influence on possible adverse effects to the pregnancy, such as cervical shortening, preterm birth, or blood flow to the fetus, was well investigated by randomized controlled trials. In fact, the influence of manual therapy is unknown, and most of the literature is dedicated to PFMT, and mainly for postpartum rehabilitation.
Pelvic Floor Fascial Mobilization (PFFM) is an innovative intra vaginal and / or intra rectal manual therapy technique developed (by S.N.) to treat pelvic fascial dysfunction by improving fascial gliding. 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
This is a pioneer study comparing the influence of PFFM vs. conventional PFMT on the function and strength of the pelvic floor muscles, in 2nd and 3rd trimester pregnant women with pelvic floor dysfunction. The primary outcome was the pelvic floor strength before and after treatment in each group. Secondary outcomes included: Umbilical Artery (UmbA) blood flow, uterine artery (UA) blood flow, fetal Middle Cerebral Artery (MCA) flow, and cervical length (CL).
Materials and Methods
A prospective randomized unblinded controlled trial performed between January 2018 and July 2019, at an outpatient pregnancy clinic in a single tertiary medical center. We enrolled primiparous and multiparous pregnant women at 24-30 weeks gestation, with symptoms related to pelvic floor dysfunction.
Exclusion criteria included: First delivery, Gestational age >30 weeks gestation at enrollment, Premature contractions, Cervical shortening, Placenta previa, Placenta accreta, Multifetal pregnancy, Maternal connective tissue disease and neurological illness.
Sample size was calculated based on an α-error of 5%, with a power of 80%, based on the assumption that PFFM will improve pelvic floor strength and function by 30%, compared to control. Randomization was done with the ”Randomizer.org”24 based on two random sets of numbers from 1-20. The allocation of each number to study or control group was in an envelope by the
Research facilitator (I.H.) The patient received the ordinal number for participation upon signing the informed consent, from the main researcher (S.N) based on the chronological assignment to the study. The main researcher was blinded to the association between the chronological number and the study group allocation prior to the initialization of the intervention for each patient.
Each patient was treated twice during the study period, one to two weeks apart and was assessed five times: immediately before and after each intervention, and one week after the second treatment session.
During the first and fifth assessment women were evaluated for pelvic floor dysfunction using PFDI-20 questionnaire (pelvic floor disability index-20) validated in Hebrew. Pelvic muscle strength and function was assessed 5 times using Oxford Grading Scale, modified by Laycock25, that includes 6 levels (0-5) and by a Perineometer device7 (PeritrontmVaginal Perineometer ,Cardio-Design, Australia). Both Oxford scale and the Perineometer are considered efficient and well correlated with the use of surface electro myography (SEMG) that present the level of the muscle electrical activity26-28.
Uterine and fetal blood flow was assessed 5 times as well, before and after each intervention and one week after the second intervention. All measurements were performed by the operator who was blinded to study allocation. Abdominal ultrasound was used to measure: Uterine Artery (UA) blood flow pulsatility index (PI), umbilical artery (UmbA) blood flow PI and Middle cerebral artery (MCA) PI, uterine Cervical Length (CL) was measured by transvaginal ultrasound from the internal to external cervical os (Voluson P6, General Electric Inc. USA).
Pelvic Floor Facial Mobilization is a manual therapy based upon the sequences and movement planes of Stecco’s Fascial Manipulation® technique29-33 relying on similar main principles of treating fascial densifications along pre-defined routs. According to Stecco’s method, the body is divided to different segments, each includes Myofascial units (MFU) that belong to different movement planes. Embedded in each myofascial unit are centers of perception (CP), centers of coordination (CC), and centers of fusion (CF). Myofascial units in the same plane of movement creates a myofascial sequence.29-33
Centers of Fusion (CF) are the converging points of the vectors for every two adjacent MFUs and are responsible for coordinating the movements in intermediate directions between the two planes. CFs are principally located over the retinacula surrounding the joints29-31. Since the key fascial areas (CCs) are different than the areas where pain or symptoms are perceived (CPs), treatment is applied at a distance, away from the painful area which is advantageous in management of pain 34 35.
The centers of coordination (CC’s) and centers of fusions (CF’s) in the pelvic floor region are presented in figure 1, 36