G Model
ARTICLE IN PRESS
MAT 6363 1–6
Maturitas xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial夽
1
2
3
Q1
4 5 6 7
Fabíola K. Alves a , Cássio Riccetto a , Délcia B.V. Adami a,b , Joseane Marques a , Larissa C. Pereira a , Paulo Palma a , Simone Botelho a,c,∗ a
Medical Sciences’ College in the State University of Campinas (UNICAMP), SP, Brazil Pontifical Catholic University of Minas Gerais (PUC MINAS), MG, Brazil Q2 c Federal University of Alfenas (UNIFAL/MG), MG, Brazil b
8
9 24
a r t i c l e
i n f o
a b s t r a c t
10 11 12 13 14 15
Article history: Received 19 December 2014 Received in revised form 28 February 2015 Accepted 8 March 2015 Available online xxx
16
23
Keywords: Electromyography Pelvic organ prolapse Pelvic floor muscle training Postmenopausal women Urinary symptoms Vaginal symptoms
25
1. Introduction
17 18 19 20 21 22
26Q3 27 28
Objectives: The purpose of this study was to investigate if a specific pelvic floor muscle training (PFMT) program effectively increases pelvic floor muscle (PFM) contractility and decreases anterior pelvic organ prolapse (POP) as well as urogynecological symptoms, in postmenopausal women. The mean outcome measure of this study was the pelvic floor surface electromyography (sEMG) activity. Study design: A clinical, randomized, blinded-assessor and controlled study was conducted with 46 postmenopausal women. Thirty women completed this study (mean age of 65.93 years), divided into two groups: Treatment Group – TG (n = 18) and Control Group – CG (n = 12). The evaluation was carried out using digital palpation, sEMG, pelvic organ prolapse quantification (POP-Q) as well as validated questionnaires by the International Consultation on Incontinence Questionnaires to investigate urogynecological symptoms. The treatment protocol consisted of 12 group sessions, twice a week, with 30 min of duration each. These data were then submitted to statistical analyses by the Statistical Analysis System for Windows software, with a significance level of 5%. Results: The pelvic floor muscle contractility increased after PFMT, evaluated by sEMG (p = 0.003) and digital palpation (p = 0.001), accompanied by a decrease in urinary symptoms (p < 0.001 for ICIQ-OAB scores e 0.036 for ICIQ UI-SF) as well as anterior pelvic organ prolapse (p = 0.03). Conclusion: This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. © 2015 Published by Elsevier Ireland Ltd.
Aging has an important role in urogynecological dysfunctions, especially in the development of both urinary incontinence (UI) and pelvic organ prolapse (POP). The physiological effects of the
夽 A study conducted by the Division of Female Urology in the Surgery Department, The Medical Sciences’ College in the State University of Campinas (UNICAMP) – Campinas, São Paulo, Brazil. ∗ Corresponding author at: Physiotherapy Course, Nursing School, Federal University of Alfenas, UNIFAL/MG, Building A, Room 107-D, CEP 37130-000, Av. Jovino Fernandes Sales, 2600 Santa Clara, Alfenas, MG, Brazil. Tel.: +55 35 3292 2377; fax: +55 35 3299 1381. E-mail addresses: [email protected] (F.K. Alves), [email protected] (C. Riccetto), [email protected] (D.B.V. Adami), joseanefi[email protected] (J. Marques), [email protected] (L.C. Pereira), [email protected] (P. Palma), [email protected] (S. Botelho). URL: http://www.unifal-mg.edu.br (S. Botelho).
decrease in estrogen combined with the aging process increase the risk of presenting these dysfunctions in postmenopausal women [1–3]. Furthermore, with the advancing of age there is a decrease in both the diameter and quantity of the periurethral stried muscle fibers [4,5] and hence a change in muscle function [4,6]. Currently, pelvic floor muscle training (PFMT) has been indicated by the International Continence Society (ICS) as a first choice in the prevention and treatment of both stress and mixed UI. Arnold Kegel [7] is known as the first researcher to use PFMT in the treatment of urogynecological dysfunctions. Soon after his earlier studies, many training protocols have been proposed by other researchers [8,9]. As the studies treating urinary symptoms were being conducted, a concomitant improvement of the pelvic organ prolapse was also observed, which has been the subject of recent publications [10,11]. This training is based on two essential functions of the pelvic floor muscles (PFM) – supporting the pelvic organs and
http://dx.doi.org/10.1016/j.maturitas.2015.03.006 0378-5122/© 2015 Published by Elsevier Ireland Ltd.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
G Model MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
2 46 47 48 49 50 51 52 53 54 55
56
57
ARTICLE IN PRESS
contributing to the sphincter urethra closure’s mechanism [12]. A voluntary PFM contraction promotes a squeeze and an inward lift of the PFM, resulting in urethral closure, stabilization, and a resistance to downward movement [13]. However, little is known about the effects of such training on PFM’s electromyographic activity (evaluation) in postmenopausal women. Thus, the main aim of this study was to evaluate the effects of a specific PFMT program on PFM contractility in postmenopausal women with urogynecological symptoms. 2. Materials and methods 2.1. Design
centimeters into the vaginal introitus, performing an abduction movement, while the patients were asked to perform a maximum contraction of the muscles, lifting inward and squeezing around the fingers. Muscle contractility was graded according to the Modified Oxford Grading Scale (zero to five points) [15]. Thus, during the initial evaluation, the patients were also taught how to contract their PFM correctly (they were asked to breathe normally and then lift the perineum inwards and squeeze around the vagina without any movement of the pelvis or visible cocontraction of the gluteal or hip-adductor muscles), while the appropriate contractions were confirmed by digital palpation. PFM contractility was also registered using a sEMG equipment (EMG System do Brasil® ), which consisted of a signal conditioner with a band pass filter with cut-off frequencies at 20–500 Hz, an amplifier gain of 1000× and a common mode rejection ratio of >120 dB. All data were processed using specific software for acquisition and analysis (AqData® ). Moreover, a 12-bit A/D (analog to digital converter) signal converting plate was used to convert analog signals into digital ones with a 2.0 kHz anti-aliasing filter sampling frequency and an input range of 5 mV. Surface EMG was recorded using a vaginal probe (Physio-Med Services® ), which has two opposing metal sensors. The probe was inserted and manually positioned into the vagina, by the researcher, with the aid of hypoallergenic gel (KY – Johnson’s & Johnson’s® ), with its metallic sensors placed laterally [14]. The reference surface electrode was positioned on the right wrist (between the radius and the styloid process of the ulna). The sEMG evaluation protocol consisted of three maximal voluntary PFM contractions, recorded by the vaginal probe (channel 1). The PFM contraction has been previously taught to the volunteers, asking them to lift the probe in a cranial direction and observe its contraction graphs on the computer screen. Each requested contraction, was performed with a rest period of 3 min, in order to avoid muscle fatigue [14].
96
A clinical, randomized, assessor-blinded and controlled study was conducted from January to May 2013 at a Primary Physical Therapy Care Unit in Congonhal, Minas Gerais, Brazil. The women, who had attended in an Elderly Fitness Group at the same care unit, at least for six months, were invited to participate in this study. It was approved by the regional Ethics Review Board (protocol: CAEE06493812.4.0000.5404) and by the Brazilian Clinical Trial Register (RBR-23NF3S). All participants gave their informed and written consent according to the Helsinki Declaration. This study included 46 postmenopausal women during at least 5 years, who presented some urogynecological complaints: stress, urgency or mixed urinary incontinences detected by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ UI-SF) questionnaire; urgency either with or without urinary incontinence, urinary frequency higher than eight voids per day and noctury (which are overactive bladder symptoms) by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaire; vaginal symptoms like pain, dryness, heaviness and/or vaginal nodules evaluated by the International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS) questionnaire. The exclusion criteria were: women with vaginal or urinary infections; pelvic cancer; uncontrolled metabolic disorders (hypertension and diabetes); cognitive, psychiatric or neurological disorder; inability to contract the PFM; POP stage IV according to the Pelvic Organ Prolapse Quantification System (POP-Q) and severe heart disease, who were a total of four volunteers (n = 4). Specifically for the POP analyses all stage III women were excluded (n = 3). The 42 volunteers included in this study were randomized by draw into two groups: Treatment Group – TG (n = 21) and Control Group – CG (n = 21). For the randomization process, each participant blindly drew a sealed envelope from a box with 42 of them, each containing a preprinted card with either CG or TG written on it and was put in one of the two groups according to the drawn card. The study was performed by two investigators (FKA and DBVA). The treatment protocol was conducted by the main investigator (FKA) and PFM contractility evaluation was carried out by the second investigator (DBVA) who was unaware of the treatment protocol, in order to blind the analysis.
2.3.3. Satisfaction with the treatment Additionally, a visual analog scale ranging from 0 to 10 was used to evaluate the level of satisfaction with the treatment.
97
2.2. Primary outcomes
2.4. Pelvic floor muscle training program
2.2.1. Pelvic floor muscle assessment PFM contractility evaluation was performed through digital palpation as well as surface electromyography (sEMG), seven days before then after the PFMT program, putting the subjects in supine position, with their lower limbs flexed and their feet on the stretcher [14]. PFM contractility evaluation was conducted first by digital palpation where the index and middle fingers were introduced 2–3
All women performed a Fitness Program based on global muscle stretching, endurance and functional exercises for the elderly, which was supervised by a physical educator. Just before starting the Fitness Program sessions, the women from the TG were divided into groups of seven people and performed the PFMT protocol, which consisted of 12 sessions of 30 min each, twice a week, totalizing a six week treatment, supervised by the main researcher (physiotherapist FKA).
58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95
98 99 100 101 102 103 104 105
2.3. Secondary outcomes 2.3.1. Assessment of urogynecological symptoms Culturally adapted and validated versions of the questionnaires by the International Consultation on Incontinence modular questionnaire – ICIQ (http://www.iciq.net/) [16] were used to evaluate the presence of urinary and vaginal symptoms: International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) [17]; International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB) [18]; and International Consultation Questionnaire on Vaginal Symptoms (ICIQ-VS) [19]. 2.3.2. Pelvic organ prolapse assessment To investigate pelvic organ prolapse presence the POP-Q System was used [20].
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139
140
141 142 143 144 145 146 147 148 149
150 151 152
153 154 155
156
157 158 159 160 161 162 163 164
G Model MAT 6363 1–6
ARTICLE IN PRESS F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
3
Fig. 1. Population design. Participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome.
179
The first session consisted of a guiding class where each participant was taught the exercises to follow and familiarized with the Gym Ball, individually. During the treatment protocol, pelvic mobility, stretching, strengthening and relaxation exercises were performed in every session, in five different positions (supine, followed by sitting on the floor, then on the Gym Ball, squat and standing positions), along with the PFM contractions, which were carried out consisting of four series of ten fast contractions together with four series of ten sustained contractions, lasting for 8 s, followed by a sixteen second relaxation period, maintaining the same positions according to Marques’s Protocol [21]. Although the CG subjects were instructed about the PFM function and the correct way to contract it, they continued performing only physical fitness sessions for 60 min without PFMT and were reassessed after six weeks, together with the TG subjects.
180
2.5. Data analysis
165 166 167 168 169 170 171 172 173 174 175 176 177 178
181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196
For the sEMG data analysis, 5 s of each recorded contraction (microvolts – V) were selected. An average of three Root Mean Square (RMS) was calculated for each participant to proceed with comparisons. These data were then submitted to statistical analysis by the Statistical Analysis System for Windows. The Chi Square and Fisher’s Exact tests were both used to compare categorical variables between the two groups (marital status, education level, delivery mode and skin color). The Mann–Whitney test was used to compare the numeric variables (age, body mass index, delivery numbers, the results of PFM sEMG, digital palpation and pelvic organ prolapse as well as the questionnaires’ scores) in basal time between the groups due to the absence of a normal distribution. The Analysis of Variance (ANOVA), followed by Tukey’s Multiple Comparison and Contrast Profile tests were performed for the between groups comparisons along all treatment time. The
Wilcoxon Test was used for the POP analysis. The significance level for the statistical tests was 5%. Initially, a sample size of 21 women per group was indicated to electromyographic data in order to present a power analysis of more than 0.80, however due to a sample size loss (n = 12) this sample power analysis posteriorly decreased to 0.55.
3. Results From the 42 women, included in the study, three from the TG did not complete the treatment (due to health or family problems) and nine from the GC did not perform the final evaluation (refused to complete the study due physical exam), thus were excluded from the sample. Hence, only 30 women with a mean age of 65.93 (±8.76) years (age ranged from 52 to 80) completed the study, 18 from the TG and 12 from the CG (Fig. 1). No significant differences between the groups for all demographic and clinical variables were found, except for the POP which was bigger in the TG (Table 1). In this preliminary study, an increase in the PFM contractility was observed in the TG after PFMT, using both digital palpation (p = 0.001) and sEMG (p = 0.003), as shown in Table 2 (effect size: 0.17; 0.55, respectively). UI was detected in 83.33% of the women. The more common complaint was mixed UI (76.92%), followed by pure stress incontinence (15.38%) and urgency incontinence (7.69%). There was a decrease in the ICIQ-OAB score only in TG after the treatment (p < 0.001) with a significant difference between the groups compared before and after the treatment (p = 0.002; effect size: 0.47). There was a decrease in the ICIQ UI-SF score of the TG after the treatment (p = 0.036; effect size: 0.60) (Fig. 2A and B). There was a significant decrease of the anterior POP only in the TG (p = 0.03; effect size: 0.44) when compared with the CG (p = 0.7).
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
197 198 199 200 201 202
203
204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227
G Model
ARTICLE IN PRESS
MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
4 Table 1
4. Discussion
Q8 Demographic and clinical characteristics. CG (n = 12) Age (years) M (SD) BMI (kg/m2 ) M (SD) Number of deliveries M (SD) Skin color (%) White Black Other Marital status (%) Married Widow Education degree (%) Illiterate Elementary school High school
TG (n = 18)
65.67 (±9.21) 31.52 (±5.71) 3.92 (±2.11)
66.11 (±8.72) 29.43 (±3.91) 3.56 (±2.79)
41.67 0 25
61.11 22.22 16.65
41.67 58.33
66.67 33.33
0 91.67 8.33
11.11 77.78 11.11
Clinical characteristics Anterior pelvic organ prolapse (%) 0 Stage 0 Stage 1 83.33 Stage 2 16.67 Stage 3 0 Posterior pelvic organ prolapse (%) 0 Stage 0 83.33 Stage 1 Stage 2 16.67 0 Stage 3 Mode of delivery (%) 25 Vaginal 33.33 Vaginal with episiotomy Urgency cesarean section 0 Elective cesarean section 0 41.67 Both 2.25 Digital palpation (M)** EMG (V) M (SD) 25.38 (±13.76) Urinary Incontinence (%) 83.33 Presence No presence 8.33 Presence in pre-pregnancy 8.33
5.56 27.78 55.56 11.11 11.11 33.33 38.89 16.67 44.44 11.11 16.67 11.11 16.67 2.17 15.44 (±8.22) 83.33 16.66 0
p-Value* a
0.65 0.31a 0.44a
b
0.25
0.17c
0.77b
0.012b
0.045b
0.13b
0.791a 0.083a b
0.56
The table represents the comparison among the studied groups – Treated Group (TG) and Control Group (CG) during the initial evaluation. Digital palpation classified according to the Modified Oxford Grading Scale. M (SD): mean (standard deviation); Q9 BMI: body mass index; V: microvolts. * p Value obtained by a Mann–Whitney test, b Chi-square Test, c Fisher’s Exact Test.
228 229 230 231
No significant differences were found in the posterior POP (p = 0.31; effect size: 0.15) and the ICIQ-VS score (p = 0.08; effect size: 0.10). The satisfaction with the treatment was greater in the TG according to the Visual Analog Scale (p < 0.001).
PFMT is recommended by the ICS as a means of preventing and treating pelvic floor dysfunctions [22], for being minimally invasive and without complications. However, few studies have been conducted with postmenopausal women, especially using electromyography to assess PFM contractility, which is considered to be a reliable and reproducible method in clinical researches. We showed that PFMT provides an increase in PFM contractility (by both digital palpation and sEMG) and can be effective in the control of urinary symptoms in postmenopausal women. PFMT can improve the strength, endurance and coordination of these muscles. Like our study, other authors [23–26] demonstrated improvement in urinary symptoms in postmenopausal women after the PFMT programs, but the most of them have not used sEMG for PFM contractility evaluation and have included only women with stress urinary incontinence. Pereira et al. [23] verified an increase in PFM contractility evaluated by vaginal manometry, followed by improvements in urinary symptoms and life quality. Madill et al. [24] confirmed improvements in urinary symptoms and PFM strength using digital palpation, but unlike our study, they did not find any effects in the sEMG results. Other studies [25,26] have shown that PFMT, performed in group, reduced urine loss, even assessed through a stress test [25] or in symptom scores [26]. Dugan et al. [27] performed a PFMT program followed by some general pelvic care instructions for elderly women with OAB or UI symptoms and also found significant improvement in urinary incontinence symptoms. Besides the improvement in PFM contractility, a decrease in the degree of the anterior POP was observed as well, in postmenopausal women after training. The POP severity being bigger in any one of the groups during the initial evaluation could have negatively interfered in the results, however, fortunately, in our study it was bigger in the treated group, which did not let this to occur. Pelvic organs are mainly supported by the levator muscles and stabilized by the pelvic ligaments. The failure of the levator ani functions is an important factor that leads to POP [3]. Thus, adequate training of the PFM could provide better support to these organs. Some studies have suggested that supervised PFMT has both POP anatomical and symptom improvements [10,24]. Maddil et al. [24] found a reduction in both the anorectal angle and urethrovesical junction was higher at rest, during contraction and while straining (stress), by magnetic resonance image, showing improvement in pelvic organ support after PFMT in elderly women. In our study, we used the POP-Q system, a recommended investigation method by ICS, however we are aware that we could have associated to it
Fig. 2. Urinary symptoms assessment by both International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) and International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB). (A) Significant decrease of ICIQ-OAB score after pelvic floor muscle training was observed in TG (p < 0.001) with interaction and groups and times (p = 0.002); (B) Significant decrease of ICIQ-UI SF score after PFMT was observed in TG, with difference between the groups (p = 0.03); ICIQ-UI SF: International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form; ICIQ-OAB: International Consultation on Incontinence Overactive Bladder Questionnaire; *p value (p < 0.05) obtained by Analysis of Variance (ANOVA), followed by Tukey’s multiple comparison and Contrast Profile tests.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
232
233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276
G Model
ARTICLE IN PRESS
MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
5
Table 2
Q10 Pelvic floor muscle assessment by both digital palpation and surface electromyography. Evaluation
Digital palpation sEMG (V)
CG (n = 12) M (SD)
p-Value*
TG (n = 18) M (SD)
Initial
Final
Initial
Final
2.25 (±1.05) 25.38 (±13.76)
2.58 (±0.99) 27.80 (±13.96)
2.17 (±0.98) 15.44 (±8.22)
3.16 (±1.09) 28.12 (±16.80)
0.001 0.003
The table represents the comparison between the groups: Control Group (CG) and Treated Group (TG), during the initial and final evaluation. M (SD): mean (standard deviation); digital palpation classified according to the Modified Oxford Grading Scale; sEMG: surface electromyography; V: microvolts.
277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316
317
318 319 320 321
magnetic resonance image and ultrasound to have a more objective anatomical condition quantification. Our study corroborates with Brækken et al. [10] who demonstrated a significant POP downgrade and urinary symptom improvement, however, our study differs from theirs, since we have not found any significant improvement in vaginal symptoms and posterior POP degree, probably due to the difference in age within the samples (48.9 years in Brækken’s study [10] versus 65.93 years in our study) and the duration of the protocol (6 months in Braeken’s study versus 6 weeks in our study). Different treatment protocols have been proposed for the management of pelvic floor dysfunctions. There was not enough evidence to make recommendations about the best standard approach to PFMT, but it has been suggested that the women could receive a regular supervision [28]. Our protocol was inspired by the study accomplished by Marques and collaborators [21], which was effective having a significant improvement in PFM contractility in primiparous pregnant and postpartum women, accompanied with a concomitant decrease in urinary symptoms. According to these authors, this protocol does not only promote PFMT, but also causes benefits to the body posture and breathing dynamics [21]. Although Bo and Hebert [29] state that there is not enough evidence that other global training protocols are effective in stress urinary incontinence treatment, we verified that our protocol actually improved pelvic floor muscle contractility. Considering the biomechanical principles of the pelvic balance, we believe that kinesiotherapy should not be restricted only to the PFM but it should emphasize the interaction and harmony of all the components involved in the pelvic floor function. The treatment, performed in group, could offer additional benefits, like the increase in motivation and consequently the treatment adherence. Additionally, group treatments are attractive options for the public health system because they have lower costs [30]. The small sample size is a limitation of this study, especially in the control group, that presented an important sample loss. Furthermore, we consider it necessary to verify the effect of a long term PFMT. The applied PFMT program is an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. 5. Conclusion This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women.
322 Q4
Contributors
323 Q5
Fabíola Kenia Alves: protocol/project development, data collection, data analysis, manuscript writing and editing. Cássio Riccetto and Simone Botelho: protocol/project development, data analysis, manuscript writing and editing.
324 325 326
Délcia Barbosa Vasconcelos Adami: data collection and data analysis. Joseane Marques and Larissa Carvalho Pereira: data collection. Paulo Palma: data analysis, manuscript writing and editing. Competing interests The authors declare no conflict of interest. Funding The authors have received no funding for this study. Acknowledgements We are grateful to the city of Congonhal’s Health Public Service Q6 for permitting data collection. We are also grateful to CAPES (The Q7 Coordination of High Level Students’ Perfection) for the financial support. References [1] Milsom I, Altman D, Lapitan MC, Nelson R, Sillén U, Thomof D. Epidemiology of urinary and faecal incontinence and pelvic organ prolapse. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence – 4th international consultation on incontinence. 4th ed. Commitee 1; 2009. p. 35–112. [2] Lee J. The menopause: effects on the pelvic floor, symptoms and treatment options. Nurs Times 2009;105(48):22–4. [3] Tinelli A, Malvasi A, Rahimi S, et al. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause 2010;17(1):204–12. [4] Perucchini D, DeLancey JOL, Ashton-Miller JA, Peschers U, Kataria T. Age effects on urethral striated muscle. I. Changes in number and diameter of striated muscle fibers in the ventral urethra. Am J Obstet Gynecol 2002;186:351–5. [5] Clobes AM, Delancey JOL, Morgan DM. Urethral circular smooth muscle in young and old women. Am J Obstet Gynecol 2008;198(5):587e1–5e. [6] Ashton Miller J, Delancey JOL. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci 2007;1101:266–96. [7] Kegel AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol 1948;56:238–49. [8] Burns PA, Pranikoff K, Nochajski TH, Hadley EC, Levy KJ, Ory MG. A comparison of effectiveness of biofeedback and pelvic floor muscle exercise treatment of stress incontinence in older-community dwelling women. J Gerontol 1993;48(4):M167–74. [9] Bø K, Talseth T, Holme I. Single, blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones and no treatment in management of genuine stress incontinence in women. BMJ 1999;318:487–93. [10] Brækken IH, Majida M, Engh ME, Bø K. Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial. Am J Obstet Gynecol 2010;203(2):170. [11] Hagen S, Stark D, Glazener C, et al. Individualized pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomized controlled trial. Lancet 2014;383(9919):796–806. [12] Nishizawa O, Ishizuka O, Amura K, Gotoh M, Hasegawa T, Hirao Y. Guidelines for management of urinary incontinence. Int J Urol 2008;15:857–74. [13] Bø K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther 2005;85:269–82. [14] Botelho S, Riccetto C, Herrmann V, Pereira LC, Amorim C, Palma P. Impact of delivery mode on electromyographic activity of pelvic floor: comparative prospective study. Neurourol Urodyn 2010;29(7):1258–61. [15] Laycock J, Jerwood D. Pelvic floor muscle assessment: the perfect scheme. Physiotherapy 2001;87:631–42. [16] Abrams P, Avery K, Gardener N, Donovan J, ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: http://www.iciq.net/. J Urol 2006;175(3 Pt1):1063–6.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
327 328 329 330
331
332
333
334
335
336 337 338 339
340
341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383
G Model MAT 6363 1–6 6 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405
ARTICLE IN PRESS F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
[17] Tamanini JTN, Dambros M, D’Ancona CL, Palma P, Rodrigues Netto NJ. Validac¸ão para o português do “International Consultation on Incontinence Questionnaire—Short Form” (ICIQ-SF). Rev Saúde Pública 2004;38:438–44. [18] Pereira SB, Thiel RRC, Riccetto C, et al. Validac¸ão do International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) para a língua portuguesa. RBGO 2010;32:273–8. [19] Tamanini JT, Almeida FG, Girotti ME, Riccetto CL, Palma PC, Rios LA. The Portuguese validation of the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) for Brazilian women with pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2008;19(10):1385–91. [20] Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapsed and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175(1):10–7. [21] Marques J, Botelho S, Pereira LC, et al. Pelvic floor muscle training program increases muscular contractility during first pregnancy. Neurourol Urodyn 2013;32(7):998–1003. [22] Abrams P, Andersson KE, Birder L, et al. Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn 2010;29:213–40. [23] Pereira VS, de Melo MV, Correia GN, Driusso P. Long-term effects of pelvic floor muscle training with vaginal cone in post-menopausal women with urinary incontinence: a randomized controlled trial. Neurourol Urodyn 2013;32(1):48–52.
[24] Madill SJ, Pontbriand-Drolet S, Tang A, Dumoulin C. Effects of PFM rehabilitation on PFM function and morphology in older women. Neurourol Urodyn 2013;32(8):1086–95. [25] Sherburn M, Bird M, Carey M, Bø K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn 2011;30:317–24. [26] Kim H, Suzuki T, Yoshida Y, Yoshida H. Effectiveness of multidimensional exercises for the treatment of stress urinary incontinence in elderly community-dwelling Japanese women: a randomized, controlled, crossover trial. J Am Geriatr Soc 2007;55:1932–9. [27] Dugan SA, Lavender MD, Hebert-Beiner J, Brubaker L. A pelvic floor fitness program for older women with urinary symptoms. PMR 2013;5(8):672–6. [28] Hay-Smith EJC, Herderschee R, Dumoulin C, Herbison GP. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev 2013;(2). [29] Bø K, Herbert RD. There is not yet strong evidence that exercises regimens other than pelvic floor muscle training can reduce stress urinary incontinence in women: a systematic review. J Physiother 2013;59(3):159–68. [30] Camargo FO, Rodrigues AM, Arruda RM, Sartori MGF, Girão MJ, Castro RA. Pelvic floor muscle training in female stress urinary incontinence: comparison between group training and individual treatment using PERFECT assessment scheme. Int Urogynecol J 2009;20(12):1455–62.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427
ARTICLE IN PRESS
MAT 6363 1–6
Maturitas xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial夽
1
2
3
Q1
4 5 6 7
Fabíola K. Alves a , Cássio Riccetto a , Délcia B.V. Adami a,b , Joseane Marques a , Larissa C. Pereira a , Paulo Palma a , Simone Botelho a,c,∗ a
Medical Sciences’ College in the State University of Campinas (UNICAMP), SP, Brazil Pontifical Catholic University of Minas Gerais (PUC MINAS), MG, Brazil Q2 c Federal University of Alfenas (UNIFAL/MG), MG, Brazil b
8
9 24
a r t i c l e
i n f o
a b s t r a c t
10 11 12 13 14 15
Article history: Received 19 December 2014 Received in revised form 28 February 2015 Accepted 8 March 2015 Available online xxx
16
23
Keywords: Electromyography Pelvic organ prolapse Pelvic floor muscle training Postmenopausal women Urinary symptoms Vaginal symptoms
25
1. Introduction
17 18 19 20 21 22
26Q3 27 28
Objectives: The purpose of this study was to investigate if a specific pelvic floor muscle training (PFMT) program effectively increases pelvic floor muscle (PFM) contractility and decreases anterior pelvic organ prolapse (POP) as well as urogynecological symptoms, in postmenopausal women. The mean outcome measure of this study was the pelvic floor surface electromyography (sEMG) activity. Study design: A clinical, randomized, blinded-assessor and controlled study was conducted with 46 postmenopausal women. Thirty women completed this study (mean age of 65.93 years), divided into two groups: Treatment Group – TG (n = 18) and Control Group – CG (n = 12). The evaluation was carried out using digital palpation, sEMG, pelvic organ prolapse quantification (POP-Q) as well as validated questionnaires by the International Consultation on Incontinence Questionnaires to investigate urogynecological symptoms. The treatment protocol consisted of 12 group sessions, twice a week, with 30 min of duration each. These data were then submitted to statistical analyses by the Statistical Analysis System for Windows software, with a significance level of 5%. Results: The pelvic floor muscle contractility increased after PFMT, evaluated by sEMG (p = 0.003) and digital palpation (p = 0.001), accompanied by a decrease in urinary symptoms (p < 0.001 for ICIQ-OAB scores e 0.036 for ICIQ UI-SF) as well as anterior pelvic organ prolapse (p = 0.03). Conclusion: This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. © 2015 Published by Elsevier Ireland Ltd.
Aging has an important role in urogynecological dysfunctions, especially in the development of both urinary incontinence (UI) and pelvic organ prolapse (POP). The physiological effects of the
夽 A study conducted by the Division of Female Urology in the Surgery Department, The Medical Sciences’ College in the State University of Campinas (UNICAMP) – Campinas, São Paulo, Brazil. ∗ Corresponding author at: Physiotherapy Course, Nursing School, Federal University of Alfenas, UNIFAL/MG, Building A, Room 107-D, CEP 37130-000, Av. Jovino Fernandes Sales, 2600 Santa Clara, Alfenas, MG, Brazil. Tel.: +55 35 3292 2377; fax: +55 35 3299 1381. E-mail addresses: [email protected] (F.K. Alves), [email protected] (C. Riccetto), [email protected] (D.B.V. Adami), joseanefi[email protected] (J. Marques), [email protected] (L.C. Pereira), [email protected] (P. Palma), [email protected] (S. Botelho). URL: http://www.unifal-mg.edu.br (S. Botelho).
decrease in estrogen combined with the aging process increase the risk of presenting these dysfunctions in postmenopausal women [1–3]. Furthermore, with the advancing of age there is a decrease in both the diameter and quantity of the periurethral stried muscle fibers [4,5] and hence a change in muscle function [4,6]. Currently, pelvic floor muscle training (PFMT) has been indicated by the International Continence Society (ICS) as a first choice in the prevention and treatment of both stress and mixed UI. Arnold Kegel [7] is known as the first researcher to use PFMT in the treatment of urogynecological dysfunctions. Soon after his earlier studies, many training protocols have been proposed by other researchers [8,9]. As the studies treating urinary symptoms were being conducted, a concomitant improvement of the pelvic organ prolapse was also observed, which has been the subject of recent publications [10,11]. This training is based on two essential functions of the pelvic floor muscles (PFM) – supporting the pelvic organs and
http://dx.doi.org/10.1016/j.maturitas.2015.03.006 0378-5122/© 2015 Published by Elsevier Ireland Ltd.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
G Model MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
2 46 47 48 49 50 51 52 53 54 55
56
57
ARTICLE IN PRESS
contributing to the sphincter urethra closure’s mechanism [12]. A voluntary PFM contraction promotes a squeeze and an inward lift of the PFM, resulting in urethral closure, stabilization, and a resistance to downward movement [13]. However, little is known about the effects of such training on PFM’s electromyographic activity (evaluation) in postmenopausal women. Thus, the main aim of this study was to evaluate the effects of a specific PFMT program on PFM contractility in postmenopausal women with urogynecological symptoms. 2. Materials and methods 2.1. Design
centimeters into the vaginal introitus, performing an abduction movement, while the patients were asked to perform a maximum contraction of the muscles, lifting inward and squeezing around the fingers. Muscle contractility was graded according to the Modified Oxford Grading Scale (zero to five points) [15]. Thus, during the initial evaluation, the patients were also taught how to contract their PFM correctly (they were asked to breathe normally and then lift the perineum inwards and squeeze around the vagina without any movement of the pelvis or visible cocontraction of the gluteal or hip-adductor muscles), while the appropriate contractions were confirmed by digital palpation. PFM contractility was also registered using a sEMG equipment (EMG System do Brasil® ), which consisted of a signal conditioner with a band pass filter with cut-off frequencies at 20–500 Hz, an amplifier gain of 1000× and a common mode rejection ratio of >120 dB. All data were processed using specific software for acquisition and analysis (AqData® ). Moreover, a 12-bit A/D (analog to digital converter) signal converting plate was used to convert analog signals into digital ones with a 2.0 kHz anti-aliasing filter sampling frequency and an input range of 5 mV. Surface EMG was recorded using a vaginal probe (Physio-Med Services® ), which has two opposing metal sensors. The probe was inserted and manually positioned into the vagina, by the researcher, with the aid of hypoallergenic gel (KY – Johnson’s & Johnson’s® ), with its metallic sensors placed laterally [14]. The reference surface electrode was positioned on the right wrist (between the radius and the styloid process of the ulna). The sEMG evaluation protocol consisted of three maximal voluntary PFM contractions, recorded by the vaginal probe (channel 1). The PFM contraction has been previously taught to the volunteers, asking them to lift the probe in a cranial direction and observe its contraction graphs on the computer screen. Each requested contraction, was performed with a rest period of 3 min, in order to avoid muscle fatigue [14].
96
A clinical, randomized, assessor-blinded and controlled study was conducted from January to May 2013 at a Primary Physical Therapy Care Unit in Congonhal, Minas Gerais, Brazil. The women, who had attended in an Elderly Fitness Group at the same care unit, at least for six months, were invited to participate in this study. It was approved by the regional Ethics Review Board (protocol: CAEE06493812.4.0000.5404) and by the Brazilian Clinical Trial Register (RBR-23NF3S). All participants gave their informed and written consent according to the Helsinki Declaration. This study included 46 postmenopausal women during at least 5 years, who presented some urogynecological complaints: stress, urgency or mixed urinary incontinences detected by the International Consultation on Incontinence Questionnaire Short-Form (ICIQ UI-SF) questionnaire; urgency either with or without urinary incontinence, urinary frequency higher than eight voids per day and noctury (which are overactive bladder symptoms) by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaire; vaginal symptoms like pain, dryness, heaviness and/or vaginal nodules evaluated by the International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS) questionnaire. The exclusion criteria were: women with vaginal or urinary infections; pelvic cancer; uncontrolled metabolic disorders (hypertension and diabetes); cognitive, psychiatric or neurological disorder; inability to contract the PFM; POP stage IV according to the Pelvic Organ Prolapse Quantification System (POP-Q) and severe heart disease, who were a total of four volunteers (n = 4). Specifically for the POP analyses all stage III women were excluded (n = 3). The 42 volunteers included in this study were randomized by draw into two groups: Treatment Group – TG (n = 21) and Control Group – CG (n = 21). For the randomization process, each participant blindly drew a sealed envelope from a box with 42 of them, each containing a preprinted card with either CG or TG written on it and was put in one of the two groups according to the drawn card. The study was performed by two investigators (FKA and DBVA). The treatment protocol was conducted by the main investigator (FKA) and PFM contractility evaluation was carried out by the second investigator (DBVA) who was unaware of the treatment protocol, in order to blind the analysis.
2.3.3. Satisfaction with the treatment Additionally, a visual analog scale ranging from 0 to 10 was used to evaluate the level of satisfaction with the treatment.
97
2.2. Primary outcomes
2.4. Pelvic floor muscle training program
2.2.1. Pelvic floor muscle assessment PFM contractility evaluation was performed through digital palpation as well as surface electromyography (sEMG), seven days before then after the PFMT program, putting the subjects in supine position, with their lower limbs flexed and their feet on the stretcher [14]. PFM contractility evaluation was conducted first by digital palpation where the index and middle fingers were introduced 2–3
All women performed a Fitness Program based on global muscle stretching, endurance and functional exercises for the elderly, which was supervised by a physical educator. Just before starting the Fitness Program sessions, the women from the TG were divided into groups of seven people and performed the PFMT protocol, which consisted of 12 sessions of 30 min each, twice a week, totalizing a six week treatment, supervised by the main researcher (physiotherapist FKA).
58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95
98 99 100 101 102 103 104 105
2.3. Secondary outcomes 2.3.1. Assessment of urogynecological symptoms Culturally adapted and validated versions of the questionnaires by the International Consultation on Incontinence modular questionnaire – ICIQ (http://www.iciq.net/) [16] were used to evaluate the presence of urinary and vaginal symptoms: International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) [17]; International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB) [18]; and International Consultation Questionnaire on Vaginal Symptoms (ICIQ-VS) [19]. 2.3.2. Pelvic organ prolapse assessment To investigate pelvic organ prolapse presence the POP-Q System was used [20].
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139
140
141 142 143 144 145 146 147 148 149
150 151 152
153 154 155
156
157 158 159 160 161 162 163 164
G Model MAT 6363 1–6
ARTICLE IN PRESS F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
3
Fig. 1. Population design. Participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome.
179
The first session consisted of a guiding class where each participant was taught the exercises to follow and familiarized with the Gym Ball, individually. During the treatment protocol, pelvic mobility, stretching, strengthening and relaxation exercises were performed in every session, in five different positions (supine, followed by sitting on the floor, then on the Gym Ball, squat and standing positions), along with the PFM contractions, which were carried out consisting of four series of ten fast contractions together with four series of ten sustained contractions, lasting for 8 s, followed by a sixteen second relaxation period, maintaining the same positions according to Marques’s Protocol [21]. Although the CG subjects were instructed about the PFM function and the correct way to contract it, they continued performing only physical fitness sessions for 60 min without PFMT and were reassessed after six weeks, together with the TG subjects.
180
2.5. Data analysis
165 166 167 168 169 170 171 172 173 174 175 176 177 178
181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196
For the sEMG data analysis, 5 s of each recorded contraction (microvolts – V) were selected. An average of three Root Mean Square (RMS) was calculated for each participant to proceed with comparisons. These data were then submitted to statistical analysis by the Statistical Analysis System for Windows. The Chi Square and Fisher’s Exact tests were both used to compare categorical variables between the two groups (marital status, education level, delivery mode and skin color). The Mann–Whitney test was used to compare the numeric variables (age, body mass index, delivery numbers, the results of PFM sEMG, digital palpation and pelvic organ prolapse as well as the questionnaires’ scores) in basal time between the groups due to the absence of a normal distribution. The Analysis of Variance (ANOVA), followed by Tukey’s Multiple Comparison and Contrast Profile tests were performed for the between groups comparisons along all treatment time. The
Wilcoxon Test was used for the POP analysis. The significance level for the statistical tests was 5%. Initially, a sample size of 21 women per group was indicated to electromyographic data in order to present a power analysis of more than 0.80, however due to a sample size loss (n = 12) this sample power analysis posteriorly decreased to 0.55.
3. Results From the 42 women, included in the study, three from the TG did not complete the treatment (due to health or family problems) and nine from the GC did not perform the final evaluation (refused to complete the study due physical exam), thus were excluded from the sample. Hence, only 30 women with a mean age of 65.93 (±8.76) years (age ranged from 52 to 80) completed the study, 18 from the TG and 12 from the CG (Fig. 1). No significant differences between the groups for all demographic and clinical variables were found, except for the POP which was bigger in the TG (Table 1). In this preliminary study, an increase in the PFM contractility was observed in the TG after PFMT, using both digital palpation (p = 0.001) and sEMG (p = 0.003), as shown in Table 2 (effect size: 0.17; 0.55, respectively). UI was detected in 83.33% of the women. The more common complaint was mixed UI (76.92%), followed by pure stress incontinence (15.38%) and urgency incontinence (7.69%). There was a decrease in the ICIQ-OAB score only in TG after the treatment (p < 0.001) with a significant difference between the groups compared before and after the treatment (p = 0.002; effect size: 0.47). There was a decrease in the ICIQ UI-SF score of the TG after the treatment (p = 0.036; effect size: 0.60) (Fig. 2A and B). There was a significant decrease of the anterior POP only in the TG (p = 0.03; effect size: 0.44) when compared with the CG (p = 0.7).
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
197 198 199 200 201 202
203
204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227
G Model
ARTICLE IN PRESS
MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
4 Table 1
4. Discussion
Q8 Demographic and clinical characteristics. CG (n = 12) Age (years) M (SD) BMI (kg/m2 ) M (SD) Number of deliveries M (SD) Skin color (%) White Black Other Marital status (%) Married Widow Education degree (%) Illiterate Elementary school High school
TG (n = 18)
65.67 (±9.21) 31.52 (±5.71) 3.92 (±2.11)
66.11 (±8.72) 29.43 (±3.91) 3.56 (±2.79)
41.67 0 25
61.11 22.22 16.65
41.67 58.33
66.67 33.33
0 91.67 8.33
11.11 77.78 11.11
Clinical characteristics Anterior pelvic organ prolapse (%) 0 Stage 0 Stage 1 83.33 Stage 2 16.67 Stage 3 0 Posterior pelvic organ prolapse (%) 0 Stage 0 83.33 Stage 1 Stage 2 16.67 0 Stage 3 Mode of delivery (%) 25 Vaginal 33.33 Vaginal with episiotomy Urgency cesarean section 0 Elective cesarean section 0 41.67 Both 2.25 Digital palpation (M)** EMG (V) M (SD) 25.38 (±13.76) Urinary Incontinence (%) 83.33 Presence No presence 8.33 Presence in pre-pregnancy 8.33
5.56 27.78 55.56 11.11 11.11 33.33 38.89 16.67 44.44 11.11 16.67 11.11 16.67 2.17 15.44 (±8.22) 83.33 16.66 0
p-Value* a
0.65 0.31a 0.44a
b
0.25
0.17c
0.77b
0.012b
0.045b
0.13b
0.791a 0.083a b
0.56
The table represents the comparison among the studied groups – Treated Group (TG) and Control Group (CG) during the initial evaluation. Digital palpation classified according to the Modified Oxford Grading Scale. M (SD): mean (standard deviation); Q9 BMI: body mass index; V: microvolts. * p Value obtained by a Mann–Whitney test, b Chi-square Test, c Fisher’s Exact Test.
228 229 230 231
No significant differences were found in the posterior POP (p = 0.31; effect size: 0.15) and the ICIQ-VS score (p = 0.08; effect size: 0.10). The satisfaction with the treatment was greater in the TG according to the Visual Analog Scale (p < 0.001).
PFMT is recommended by the ICS as a means of preventing and treating pelvic floor dysfunctions [22], for being minimally invasive and without complications. However, few studies have been conducted with postmenopausal women, especially using electromyography to assess PFM contractility, which is considered to be a reliable and reproducible method in clinical researches. We showed that PFMT provides an increase in PFM contractility (by both digital palpation and sEMG) and can be effective in the control of urinary symptoms in postmenopausal women. PFMT can improve the strength, endurance and coordination of these muscles. Like our study, other authors [23–26] demonstrated improvement in urinary symptoms in postmenopausal women after the PFMT programs, but the most of them have not used sEMG for PFM contractility evaluation and have included only women with stress urinary incontinence. Pereira et al. [23] verified an increase in PFM contractility evaluated by vaginal manometry, followed by improvements in urinary symptoms and life quality. Madill et al. [24] confirmed improvements in urinary symptoms and PFM strength using digital palpation, but unlike our study, they did not find any effects in the sEMG results. Other studies [25,26] have shown that PFMT, performed in group, reduced urine loss, even assessed through a stress test [25] or in symptom scores [26]. Dugan et al. [27] performed a PFMT program followed by some general pelvic care instructions for elderly women with OAB or UI symptoms and also found significant improvement in urinary incontinence symptoms. Besides the improvement in PFM contractility, a decrease in the degree of the anterior POP was observed as well, in postmenopausal women after training. The POP severity being bigger in any one of the groups during the initial evaluation could have negatively interfered in the results, however, fortunately, in our study it was bigger in the treated group, which did not let this to occur. Pelvic organs are mainly supported by the levator muscles and stabilized by the pelvic ligaments. The failure of the levator ani functions is an important factor that leads to POP [3]. Thus, adequate training of the PFM could provide better support to these organs. Some studies have suggested that supervised PFMT has both POP anatomical and symptom improvements [10,24]. Maddil et al. [24] found a reduction in both the anorectal angle and urethrovesical junction was higher at rest, during contraction and while straining (stress), by magnetic resonance image, showing improvement in pelvic organ support after PFMT in elderly women. In our study, we used the POP-Q system, a recommended investigation method by ICS, however we are aware that we could have associated to it
Fig. 2. Urinary symptoms assessment by both International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) and International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB). (A) Significant decrease of ICIQ-OAB score after pelvic floor muscle training was observed in TG (p < 0.001) with interaction and groups and times (p = 0.002); (B) Significant decrease of ICIQ-UI SF score after PFMT was observed in TG, with difference between the groups (p = 0.03); ICIQ-UI SF: International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form; ICIQ-OAB: International Consultation on Incontinence Overactive Bladder Questionnaire; *p value (p < 0.05) obtained by Analysis of Variance (ANOVA), followed by Tukey’s multiple comparison and Contrast Profile tests.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
232
233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276
G Model
ARTICLE IN PRESS
MAT 6363 1–6
F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
5
Table 2
Q10 Pelvic floor muscle assessment by both digital palpation and surface electromyography. Evaluation
Digital palpation sEMG (V)
CG (n = 12) M (SD)
p-Value*
TG (n = 18) M (SD)
Initial
Final
Initial
Final
2.25 (±1.05) 25.38 (±13.76)
2.58 (±0.99) 27.80 (±13.96)
2.17 (±0.98) 15.44 (±8.22)
3.16 (±1.09) 28.12 (±16.80)
0.001 0.003
The table represents the comparison between the groups: Control Group (CG) and Treated Group (TG), during the initial and final evaluation. M (SD): mean (standard deviation); digital palpation classified according to the Modified Oxford Grading Scale; sEMG: surface electromyography; V: microvolts.
277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316
317
318 319 320 321
magnetic resonance image and ultrasound to have a more objective anatomical condition quantification. Our study corroborates with Brækken et al. [10] who demonstrated a significant POP downgrade and urinary symptom improvement, however, our study differs from theirs, since we have not found any significant improvement in vaginal symptoms and posterior POP degree, probably due to the difference in age within the samples (48.9 years in Brækken’s study [10] versus 65.93 years in our study) and the duration of the protocol (6 months in Braeken’s study versus 6 weeks in our study). Different treatment protocols have been proposed for the management of pelvic floor dysfunctions. There was not enough evidence to make recommendations about the best standard approach to PFMT, but it has been suggested that the women could receive a regular supervision [28]. Our protocol was inspired by the study accomplished by Marques and collaborators [21], which was effective having a significant improvement in PFM contractility in primiparous pregnant and postpartum women, accompanied with a concomitant decrease in urinary symptoms. According to these authors, this protocol does not only promote PFMT, but also causes benefits to the body posture and breathing dynamics [21]. Although Bo and Hebert [29] state that there is not enough evidence that other global training protocols are effective in stress urinary incontinence treatment, we verified that our protocol actually improved pelvic floor muscle contractility. Considering the biomechanical principles of the pelvic balance, we believe that kinesiotherapy should not be restricted only to the PFM but it should emphasize the interaction and harmony of all the components involved in the pelvic floor function. The treatment, performed in group, could offer additional benefits, like the increase in motivation and consequently the treatment adherence. Additionally, group treatments are attractive options for the public health system because they have lower costs [30]. The small sample size is a limitation of this study, especially in the control group, that presented an important sample loss. Furthermore, we consider it necessary to verify the effect of a long term PFMT. The applied PFMT program is an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. 5. Conclusion This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women.
322 Q4
Contributors
323 Q5
Fabíola Kenia Alves: protocol/project development, data collection, data analysis, manuscript writing and editing. Cássio Riccetto and Simone Botelho: protocol/project development, data analysis, manuscript writing and editing.
324 325 326
Délcia Barbosa Vasconcelos Adami: data collection and data analysis. Joseane Marques and Larissa Carvalho Pereira: data collection. Paulo Palma: data analysis, manuscript writing and editing. Competing interests The authors declare no conflict of interest. Funding The authors have received no funding for this study. Acknowledgements We are grateful to the city of Congonhal’s Health Public Service Q6 for permitting data collection. We are also grateful to CAPES (The Q7 Coordination of High Level Students’ Perfection) for the financial support. References [1] Milsom I, Altman D, Lapitan MC, Nelson R, Sillén U, Thomof D. Epidemiology of urinary and faecal incontinence and pelvic organ prolapse. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence – 4th international consultation on incontinence. 4th ed. Commitee 1; 2009. p. 35–112. [2] Lee J. The menopause: effects on the pelvic floor, symptoms and treatment options. Nurs Times 2009;105(48):22–4. [3] Tinelli A, Malvasi A, Rahimi S, et al. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause 2010;17(1):204–12. [4] Perucchini D, DeLancey JOL, Ashton-Miller JA, Peschers U, Kataria T. Age effects on urethral striated muscle. I. Changes in number and diameter of striated muscle fibers in the ventral urethra. Am J Obstet Gynecol 2002;186:351–5. [5] Clobes AM, Delancey JOL, Morgan DM. Urethral circular smooth muscle in young and old women. Am J Obstet Gynecol 2008;198(5):587e1–5e. [6] Ashton Miller J, Delancey JOL. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci 2007;1101:266–96. [7] Kegel AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol 1948;56:238–49. [8] Burns PA, Pranikoff K, Nochajski TH, Hadley EC, Levy KJ, Ory MG. A comparison of effectiveness of biofeedback and pelvic floor muscle exercise treatment of stress incontinence in older-community dwelling women. J Gerontol 1993;48(4):M167–74. [9] Bø K, Talseth T, Holme I. Single, blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones and no treatment in management of genuine stress incontinence in women. BMJ 1999;318:487–93. [10] Brækken IH, Majida M, Engh ME, Bø K. Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial. Am J Obstet Gynecol 2010;203(2):170. [11] Hagen S, Stark D, Glazener C, et al. Individualized pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomized controlled trial. Lancet 2014;383(9919):796–806. [12] Nishizawa O, Ishizuka O, Amura K, Gotoh M, Hasegawa T, Hirao Y. Guidelines for management of urinary incontinence. Int J Urol 2008;15:857–74. [13] Bø K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther 2005;85:269–82. [14] Botelho S, Riccetto C, Herrmann V, Pereira LC, Amorim C, Palma P. Impact of delivery mode on electromyographic activity of pelvic floor: comparative prospective study. Neurourol Urodyn 2010;29(7):1258–61. [15] Laycock J, Jerwood D. Pelvic floor muscle assessment: the perfect scheme. Physiotherapy 2001;87:631–42. [16] Abrams P, Avery K, Gardener N, Donovan J, ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: http://www.iciq.net/. J Urol 2006;175(3 Pt1):1063–6.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
327 328 329 330
331
332
333
334
335
336 337 338 339
340
341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383
G Model MAT 6363 1–6 6 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405
ARTICLE IN PRESS F.K. Alves et al. / Maturitas xxx (2015) xxx–xxx
[17] Tamanini JTN, Dambros M, D’Ancona CL, Palma P, Rodrigues Netto NJ. Validac¸ão para o português do “International Consultation on Incontinence Questionnaire—Short Form” (ICIQ-SF). Rev Saúde Pública 2004;38:438–44. [18] Pereira SB, Thiel RRC, Riccetto C, et al. Validac¸ão do International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) para a língua portuguesa. RBGO 2010;32:273–8. [19] Tamanini JT, Almeida FG, Girotti ME, Riccetto CL, Palma PC, Rios LA. The Portuguese validation of the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) for Brazilian women with pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2008;19(10):1385–91. [20] Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapsed and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175(1):10–7. [21] Marques J, Botelho S, Pereira LC, et al. Pelvic floor muscle training program increases muscular contractility during first pregnancy. Neurourol Urodyn 2013;32(7):998–1003. [22] Abrams P, Andersson KE, Birder L, et al. Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn 2010;29:213–40. [23] Pereira VS, de Melo MV, Correia GN, Driusso P. Long-term effects of pelvic floor muscle training with vaginal cone in post-menopausal women with urinary incontinence: a randomized controlled trial. Neurourol Urodyn 2013;32(1):48–52.
[24] Madill SJ, Pontbriand-Drolet S, Tang A, Dumoulin C. Effects of PFM rehabilitation on PFM function and morphology in older women. Neurourol Urodyn 2013;32(8):1086–95. [25] Sherburn M, Bird M, Carey M, Bø K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn 2011;30:317–24. [26] Kim H, Suzuki T, Yoshida Y, Yoshida H. Effectiveness of multidimensional exercises for the treatment of stress urinary incontinence in elderly community-dwelling Japanese women: a randomized, controlled, crossover trial. J Am Geriatr Soc 2007;55:1932–9. [27] Dugan SA, Lavender MD, Hebert-Beiner J, Brubaker L. A pelvic floor fitness program for older women with urinary symptoms. PMR 2013;5(8):672–6. [28] Hay-Smith EJC, Herderschee R, Dumoulin C, Herbison GP. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev 2013;(2). [29] Bø K, Herbert RD. There is not yet strong evidence that exercises regimens other than pelvic floor muscle training can reduce stress urinary incontinence in women: a systematic review. J Physiother 2013;59(3):159–68. [30] Camargo FO, Rodrigues AM, Arruda RM, Sartori MGF, Girão MJ, Castro RA. Pelvic floor muscle training in female stress urinary incontinence: comparison between group training and individual treatment using PERFECT assessment scheme. Int Urogynecol J 2009;20(12):1455–62.
Please cite this article in press as: Alves FK, et al. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.03.006
406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427
