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The Journal of Maternal-Fetal & Neonatal Medicine

ISSN: 1476-7058 (Print) 1476-4954 (Online) Journal homepage: https://www.tandfonline.com/loi/ijmf20

Device-assisted pelvic floor muscle postpartum


exercise programme for the management of pelvic
floor dysfunction after delivery

Natalia Vladimirovna Artymuk & Svetlana Yurevna Khapacheva

To cite this article: Natalia Vladimirovna Artymuk & Svetlana Yurevna Khapacheva (2020):
Device-assisted pelvic floor muscle postpartum exercise programme for the management of
pelvic floor dysfunction after delivery, The Journal of Maternal-Fetal & Neonatal Medicine, DOI:
10.1080/14767058.2020.1723541

To link to this article: https://doi.org/10.1080/14767058.2020.1723541

Published online: 04 Feb 2020.

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THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE
https://doi.org/10.1080/14767058.2020.1723541

ORIGINAL ARTICLE

Device-assisted pelvic floor muscle postpartum exercise programme for the


management of pelvic floor dysfunction after delivery
Natalia Vladimirovna Artymuk and Svetlana Yurevna Khapacheva
G.A. Ushakova Obstetrics and Gynecology Department, Kemerovo State Medical University, Kemerovo, Russia

ABSTRACT ARTICLE HISTORY


Background: Pelvic floor dysfunction (PFD) is a multifactorial condition that clinically manifests Received 16 November 2019
as the pelvic prolapse, urinary and/or rectal incontinence, and sexual dysfunction. Revised 21 January 2020
Aim: We aimed to evaluate the efficacy of two pelvic floor trainers for the prevention of PFD in Accepted 27 January 2020
women during the postpartum period.
KEYWORDS
Materials and methods: This was a prospective, randomized, open-label study in 70 women in Pelvic floor dysfunction;
the postpartum period. Participants were randomized to complete a daily, 20-min set of pelvic pelvic floor muscle exercise;
floor muscle exercises using the EmbaGYN (UK; Group 1, n ¼ 40) or the Magic Kegel Master prolapse; rectal
device (China; Group 2, n ¼ 40) for 4 weeks. All participants anonymously completed the PFDI-20 incontinence; sexual
questionnaire and FSFI form at baseline and last visit. Pelvic floor muscle strength was measured dysfunction; urinary
using the XFT-0010 device. incontinence
Results: After the completion of the 4-week pelvic floor muscle exercise program, there was a
significant decrease in the rates of all PFD symptoms including pelvic organ prolapse and urin-
ary and/or fecal incontinence in both groups. The rates of sexual dysfunction after the exercise
program decreased significantly only in Group II (69.4 versus 25.0%; h ¼.001). After the program,
Group I showed a significant reduction in the number of women with symptoms of urgent urin-
ary incontinence versus baseline (35.3 versus 8.8% p ¼ .009). Similarly, the rates of urine loss
associated with coughing, sneezing or laughing in Group I decreased from 41.2% at baseline to
11.8% after the program (h ¼.006) and the rates of urine leakage independent of physical activ-
ity from 23.5 to 5.9% (p ¼ .040), respectively.
Conclusion: The 4-week postpartum pelvic floor muscle exercise program utilizing the
EmbaGYN or Magic Kegel Master device has significantly increased the pelvic floor muscle
strength and decreased the symptoms of pelvic organ prolapse, urinary and fecal incontinence.
The use of the Magic Kegel Master device significantly reduced the symptoms of sexual dysfunc-
tion. The use of the EmbaGYN device was effective in addressing the individual symptoms of
urinary incontinence.

Introduction 50–60-year-olds, reaching almost 80% [4]. Pregnancy


Pelvic floor dysfunction (PFD) is a multifactorial condi- and delivery are significant risk factors for PFD [4–6].
tion that clinically manifests as the pelvic prolapse, For instance, women with first- or second-degree peri-
urinary and/or rectal incontinence, and sexual dysfunc- neal tears or after episiotomy showed signs of abnor-
tion [1]. Symptoms of PFD have been reported in mal pelvic morphometry on 3 D rotational ultrasound
19.7–50.3% of women aged 20–39 years and in at 3 months after delivery [4]. Furthermore, elective
41–77.2% of women aged 50–79 years [1]. However, cesarean delivery may not fully protect against the
the true prevalence of this condition may be underes- postpartum stress urinary incontinence [5].
timated due to the diversity of symptoms leading to There is currently no consensus on the best
the referral of women with PFD to a broad range of approach to PFD management [7]. Pelvic floor muscle
specialists and, potentially, underdiagnosis [2]. exercises have been effective in reducing the symp-
Pelvic floor dysfunction usually starts to develop toms of PFD, but this intervention needs to com-
during the postpartum period and often remains mence before the clinical manifestations of the
asymptomatic for a long time [3,4]. The highest condition [8–10]. The efficacy of nonsurgical manage-
incidence of PFD has been reported among the ment may also be higher in women who adopt an

CONTACT Natalia Vladimirovna Artymuk artymuk@gmail.com G.A. Ushakova Obstetrics and Gynecology Department, Kemerovo State Medical
University, 22a Voroshilov street, Kemerovo 650056, Russia
ß 2020 Informa UK Limited, trading as Taylor & Francis Group
2 N. V. ARTYMUK AND S. Y. KHAPACHEVA

overall healthy lifestyle: quit smoking, maintain 4 weeks of the study, we contacted the patients by
healthy body weight, control blood sugar, and phone weekly to assess progress and provide motiv-
undergo treatment of respiratory and gastrointestinal ation and encouragement. The pelvic floor muscle
comorbidities [11–13]. A study by Celiker et al. (2014) assessment was repeated at the second visit.
showed that pelvic floor muscle exercises effectively Participants also completed the 20-item Pelvic Floor
reduced the symptoms of stress and mixed urinary Distress Inventory (PFDI-20) questionnaire and the
incontinence and increased the strength of pelvic floor five-item Female Sexual Function Index (FSFI) ques-
muscles [14]. In a multicentre randomized controlled tionnaire. The 20-item PFDI included three categories
study by Hagen et al. (2014), women who received an of questions covering the symptoms of pelvic organ
individualized pelvic floor muscle exercise programs prolapse (Pelvic Organ Prolapse Distress Inventory –
reported a decrease of prolapse symptoms after POPDI-6), colorectal anal symptoms (Colorectal Anal
12 months; this improvement significantly increased Distress Inventory – CRAD-8) and urinary incontinence
the quality of life [15]. symptoms (Urinary Distress Inventory – UDI-6). All
Dedicated devices for pelvic floor exercises, also symptoms could be scored from 0 (never experienced)
referred to as pelvic floor trainers, are being increas- to 4 (constantly experiencing). The total score for the
ingly used to assist with the reduction of PFD symp- PFDI-20 questionnaire was calculated as a sum of the
toms; however, studies in the postpartum period are scores for all questions multiplied by 25 and can range
lacking [16]. Our study aimed to evaluate the efficacy from 0 to 300 points [17]. The five-item (short) FSFI
of pelvic floor trainer use for the prevention of PFD in included questions on the level of sexual desire/inter-
postpartum women. est (libido), sexual arousal, discomfort or pain during
and/or after intercourse, natural vaginal lubrication,
and the frequency of orgasms; each parameter could
Materials and methods be scored from 0 to 5. The total score below 22.15
This was a prospective, randomized, open-label study points was interpreted as a marker of female sexual
in 70 women in the postpartum period. We included dysfunction [18].
women who had undergone delivery in the preceding Pelvic floor muscle strength (mmHg) was measured
12 weeks, aged 18–45 years, and with a negative using the Pneumatic Pelvic Muscle Trainer XFT-0010
pregnancy test. Women after assisted delivery (forceps device (China). The assessment was carried out using
or ventouse), cesarean delivery, third- and fourth- the “Testing the level of strength of the pelvic
degree perineal tears, urinary and/or gastrointestinal muscles” program.
infections or inflammatory diseases, severe comorbid- The study was conducted at the Kemerovo Region
ities, and cognitive and mental disorders were Clinical Perinatal Center (Kemerovo, Russia). All women
excluded from the study. had given informed consent to participate in the
Eligible women were randomized in a 1:1 ratio study. The study protocol was approved by the Ethics
using the sealed envelope method to complete a Committee of the Kemerovo State Medical University.
daily, 20-min set of pelvic floor muscle exercises using Statistical data analysis was performed using the
the EmbaGYNTM (UK; Group 1, n ¼ 40) or the Magic analysis Tools Pack and Statistica v10.0 software.
Kegel Master device (China; Group 2, n ¼ 40) Continuous variables are presented as a mean, vari-
for 4 weeks. ance, and 95% confidence interval (CI) and were com-
The EmbaGYN device emits weak electrical impulses pared using a paired t-test (Student’s test). Categorical
which stimulate the branches of the genitofemoral variables are presented as absolute numbers and pro-
nerve, resulting in the contraction of the pelvic floor portions and were compared using a v2-test. When
muscles depending in the program settings. The testing statistical hypotheses, the level of critical sig-
Magic Kegel Master device is a silicone, peanut-shaped nificance <0.05 was utilized.
vibrating device controlled via a smartphone
Bluetooth app. The app records the muscle pressure
Results
data from the highly-sensitive sensors in the vaginal
piece and provides instructions and feedback to the We initially enrolled 80 eligible women, of whom 36
user. All patients used the “postpartum” exer- in Group I and 36 women in Group II completed the
cise program. study. Six women in Group I and four women in
At baseline, all patients underwent the pelvic floor Group II were excluded from the analysis due to non-
muscle assessment and device training. Over the adherence to the exercise program. There were no
THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 3

Table 1. Baseline demographics.


Parameter Group I (n ¼ 34) Group II (n ¼ 36) p
Age (years), M ± m 30.3 ± 3.8 29.4 ± 4.2 .874
Primigravida, n (%) 19 (57.7) 16 (45.5) .339
Primiparous, n (%) 19 (57.7) 16 (45.5) .339
Secundiparous, n (%) 15 (42.3) 20 (54.5) .339
Current or history of somatic diseases, n (%) 23 (67.5) 20 (55.6) .299
Age of menarche, M ± m 12.7 ± 1.1 12.8 ± 1.4 .955
History of gynaecological diseases, n (%) 10 (29.4) 10 (27.8) .880

Table 2. Pelvic floor muscle strength and PFD symptoms.


Baseline After the 4-week pelvic floor muscle exercise program p (versus baseline)
Group I Group II Group I Group II
Parameter (n ¼ 34) (n ¼ 36) p (n ¼ 34) (n ¼ 36) p Group I Group II
Strength of the pelvic floor muscles, 59.5 ± 0.7 58.6 ± 0.5 .860 65.8 ± 0.7 66.3 ± 1.0 .944 <.001 <.001
mmHg, mean ± SD
Frequency of PFD symptoms, n (%) 26 (76.4) 30 (83.3) .474 14/41.2 12 (33.3) .498 .001 .005
Pelvic organ prolapse, n (%) 23 (67.6) 23 (63.9) .741 10/29.4 8 (22.2) .492 .002 <.001
Urinary incontinence, n (%) 26 (76.5) 30 (86.1) .300 14/41.2 12 (33.3) .498 .004 <.001
Fecal incontinence, n (%) 26 (76.5) 25 (72.2) .685 8/23.5 11 (30.6) .509 <.001 <.001
Sexual dysfunction, % 55.9 69.4 .241 44.1 25.0 .093 .332 <.001
Decreased libido, % 38.2 50/0 .322 14.7 13.9 .923 .028 .002
Decreased sexual arousal, % 20.5 38.9 .095 20.5 11.1 .277 1.000 .007
Discomfort or pain, % 11.8 13.9 .791 11.8 5.6 .354 1.000 .233
Decreased natural lubrication, % 29.4 25.0 .679 20.6 11.1 .277 .401 .126
Lack of orgasm, % 41.1 58.3 .152 29.4 11.2 .056 .311 <.001

significant differences in the demographic characteris- Group I (p ¼ .006) and from 22.2% at baseline to 2.8%
tics between the study groups (Table 1). in Group II (p ¼ .013). The rate of foreign body sensa-
At baseline, pelvic floor muscle strength and the tion in the vagina decreased from 23.5% at baseline
rates of PFD symptoms and sexual dysfunction did not to 5.9% in Group I (p ¼ .040) and from 19.4% at base-
differ significantly between the groups. After the com- line to 5.6% in Group II (p ¼ .075). The rate of frequent
pletion of the 4-week exercise program, a significant urination decreased from 44.1% at baseline to 11.8%
increase in the pelvic floor muscle strength versus the in Group I (p ¼ .003) and from 58.3 to 22.2% in Group
baseline was observed in both groups (Group I: II (p ¼ .002).
59.5 ± 3.9 versus 65.8 ± 4.2 mmHg, p ¼ .0001; Group II: After completing the pelvic floor exercise program,
58.6 ± 3.3 versus 66.3 ± 5.8 mmHg, p ¼ .0001). After the significantly fewer women in Group I reported symp-
exercise program, we recorded a significant decrease toms of urgent urinary incontinence versus baseline
in the frequency of all PFD symptoms including pelvic (8.8 versus 35.3%, p ¼ .009). Similar trends were
organ prolapse and urinary and/or fecal incontinence observed for the urine loss associated with coughing,
in both groups. The pelvic muscle strength and fre- sneezing or laughing (11.8 versus 42.1%, h ¼.006) and
quency of PFD symptoms after the completion of the the loss of small amounts of urine independent of
exercise program did not differ significantly between physical activity (5.9 versus 23.5%, p ¼ .040). The num-
the study groups (p > .05). ber of patients experiencing incomplete bladder emp-
Specifically, at 12 weeks postpartum, symptoms of tying decreased significantly after the exercise
pelvic prolapse were reported in 67.6 and 63.9% of program versus the baseline only in Group I (2.9 ver-
women in Group I and II, respectively, colorectal-anal sus 32.1%, p ¼ .002).
symptoms in 76.5 and 86.1%, urinary incontinence in Table 2 shows the pelvic floor muscle strength, fre-
76.5 and 72.2%, and symptoms of sexual dysfunction quency of PFD and sexual dysfunction symptoms in
in 55.9 and 69.4% (p > .05 for all). After the comple- the study before and after the pelvic floor exer-
tion of the pelvic floor exercise program, the number cise program.
of patients complaining of the lower abdomen pres- After the pelvic floor muscle exercise program, the
sure decreased significantly versus the baseline from overall frequency of symptoms of sexual dysfunction
41.2 to 14.7% in Group I (p ¼ .016) and from 44.4 to decreased significantly only in Group II (69.4 versus
11.1% in Group II (p ¼ .005). The rate of pelvic 25.0%, p ¼ .001). In Group I, symptoms of sexual dys-
“heaviness” reduced from 32.4% at baseline to 5.9% in function at baseline were recorded in 55.9% patients
4 N. V. ARTYMUK AND S. Y. KHAPACHEVA

compared with 44.1% after the program (p ¼ .332). In a study by Serov et al. (2011), electric stimulation
The number of patients with decreased libido after of the pelvic floor muscles in patients with decreased
the exercise program decreased significantly in Group pelvic floor muscle tone with/without mild to moder-
I (p ¼ .028). ate stress urinary incontinence resulted in an 50%
improvement of clinical markers of PFD in 87.5% of
patients with symptoms of stress urinary incontinence
Discussion
and in 100% of asymptomatic women. The improve-
Prevalence of pelvic prolapse symptoms and other ment occurred after 4–5 weeks of treatment [22]. Eder
signs of PFD has been reported to vary between 19.7 et al. (2014) found that electric stimulation of the pel-
and 77.2%, and to a large extent depends on the age vic floor muscles using the EmbaGYN device in
of the study population and the methodology used patients with stress urinary incontinence was highly
[2]. We have previously reported >50% prevalence of efficacious. At week 12, the average number of urinary
PFD symptoms and 80% prevalence of sexual dys- incontinence episodes per day decreased by 56.2%
function symptoms in a cohort of 1167 women of (p ¼ .152) [23]. The EmbaGYN’s mechanism of action
reproductive age in the Kemerovo region [19]. The includes indirect stimulation of the pelvic floor
association between the pelvic organ prolapse, colo- muscles through the branches of the genitofemoral
rectal-anal and urinary incontinence symptoms with nerve. Repeated contraction caused by the electrical
parity has been well-established [19]. impulses increases the muscle mass and strength.
Our current study showed a high prevalence of Muscle contractions may also improve blood circula-
PFD symptoms in young women postpartum. tion in the adjacent deep tissues [24]. Finally, Yang
Specifically, the symptoms of pelvic prolapse within et al. (2017) showed that Kegel’s exercises combined
12 weeks after delivery were found in 63.9–67.6% of with electrical stimulation significantly reduced the
women, symptoms of urinary incontinence in degree of urinary incontinence [25].
72.2–76.5% and symptoms of sexual dysfunction in In our study, we obtained data on the higher effi-
55.9–69.4%. These findings indicate the need for post- ciency of the EmbaGYN device compared with Magic
partum pelvic rehabilitation and early detection of Kegel Master for some symptoms of urinary incontin-
PFD for timely, nonsurgical interventions to prevent ence. These included urgent and stress urinary incon-
the disease progression, reduce the need for surgery, tinence, urine leakage independent of physical
and improve women’s quality of life. activity, and the incomplete bladder emptying sensa-
Pelvic floor muscle exercises are the first-line strat- tion. However, the frequency of symptoms of sexual
egy for nonsurgical management of pelvic prolapse, dysfunction after the exercise program decreased sig-
including the cases associated with urinary and fecal nificantly only in patients using the vibrating Magic
incontinence. The exercises are usually based on Kegel Master device.
Kegel’s exercises but may also utilize devices providing
user feedback or vaginal trainers. Four randomized Conclusion
clinical trials showed that this approach was effective
The postpartum 4-week pelvic floor muscle exercise
in reducing the degree of pelvic prolapse in 17% of
program using the EmbaGYN or Magic Kegel Master
patients [20]. A decrease in the severity of urinary and
device has significantly increased the pelvic floor
fecal incontinence was observed in 40–60% of
muscle strength and decreased the symptoms of pel-
patients, and the lack of pelvic prolapse progression
vic organ prolapse, urinary and fecal incontinence ver-
was seen in more than 94% of women [21].
sus the baseline. The use of the Magic Kegel Master
Our study showed that a 4-week pelvic floor
device significantly reduced the symptoms of sexual
muscles exercise program using dedicated electrosti-
dysfunction. The use of the EmbaGYN device was
mulating or vibrating devices in the first 12 weeks of
effective for addressing the individual symptoms of
the postpartum period reduced all symptoms of PFD
urinary incontinence. Further larger-scale studies are
including pelvic prolapse, urinary and fecal incontin- needed to confirm the potential benefits of various
ence. Specifically, the use of the vibrating Magic Kegel methods and pelvic floor stimulation modes.
Master device significantly improved all parameters of
sexual function and decreased the number of women
with reduced sexual desire and arousal, discomfort or Acknowledgements
pain during sexual intercourse, vaginal dryness and The EmbaGYN (United Kingdom), Magic Kegel Master
lack of orgasm. (China) and Pneumatic Pelvic Muscle Trainer XFT-0010
THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 5

(China) were provided by Pentcroft Pharma CJSC [12] Ulrich D, Edwards SL, Su K, et al. Influence of repro-
(Moscow, Russia). ductive status on tissue composition and biomechan-
ical properties of ovine vagina. Plos One. 2014;9(4):
e93172.
Disclosure statement [13] Van Delft KW, Thakar R, Sultan AH, et al. The natural
history of levator avulsion one year following child-
No potential conflict of interest was reported by
birth: a prospective study. BJOG. 2015;122(9):
the author(s).
1266–1273.
[14] Celiker Tosun O, Kaya Mutlu E, Ergenoglu A, et al.
ORCID Does pelvic floor muscle training abolish symptoms
of urinary incontinence? A randomized controlled
Natalia Vladimirovna Artymuk http://orcid.org/0000-0001- trial. Clin Rehabil. 2015;29(6):525–537.
7014-6492 [15] Hagen S, Stark D, Glazener C, et al. Individualised pel-
vic floor muscle training in women with pelvic organ
prolapse (POPPY): a multicentre randomised con-
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