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Postpartum pelvic floor muscle training and pelvic organ prolapse—a randomized trial of primiparous women
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GYNECOLOGY
Postpartum pelvic floor muscle training and pelvic organ prolapse—a randomized trial of primiparous women Kari Bø, MSc, PhD, PT; Gunvor Hilde, MSc, PT; Jette Stær-Jensen, MD; Franziska Siafarikas, MD; Merete Kolberg Tennfjord, MSc, PT; Marie Ellstrøm Engh, PhD OBJECTIVE: Pelvic organ prolapse (POP) is a common and distressing condition. The aim of the present study was to evaluate the effect of pelvic floor muscle training (PFMT) on prevention and treatment of symptoms and signs of POP in primiparous postpartum women. STUDY DESIGN: This was a parallel group assessor blind randomized
controlled trial. One hundred seventy-five primiparous postpartum women, mean age 29.8 years (standard deviation 4.1), stratified on major levator ani defects or no defect diagnosed by 3-/4-dimensional ultrasound, participated in a 4-month PFMT starting at 6-8 weeks’ postpartum or control. All participants had thorough individual instruction and assessment of ability to perform correct pelvic floor muscle contractions. The PFMT group followed a supervised, weekly group training program and performed 3 sets of 8-12 daily maximal contractions at home. Main outcome was POP stage II or greater assessed by POP quantification and bladder neck position assessed by
3-/4- dimensional transperineal ultrasonography. Secondary outcome was symptoms of vaginal bulge using International Consultation on Incontinence Vaginal Symptoms questionnaire. RESULTS: Ninety-six percent of the intervention group adhered to 80% of both group and home training sessions. At postintervention, there was no significant risk difference in POP (rational ratio, 1.62; 95% confidence interval, 0.55e4.75), bladder neck position or symptoms of vaginal bulging. CONCLUSION: No effect was found of postpartum PFMT on POP in
primiparous women. More randomized controlled trials are needed before strong conclusions can be drawn on the effect of PFMT on POP in the particular population. Key words: exercise, pelvic organ prolapse, pelvic floor muscle training, postpartum, prevention
Cite this article as: Bø K, Hilde G, Stær-Jensen J, et al. Postpartum pelvic floor muscle training and pelvic organ prolapse—a randomized trial of primiparous women. Am J Obset Gynecol 2014;211:x-ex-x-ex.
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elvic organ prolapse (POP), in which the anterior vaginal wall, posterior vaginal wall, uterus (cervix), or vaginal apex descends into or out of the vagina,1 is common. Prevalence of POP based on clinical examination has been found to exceed 30% in the general female population, although prevalence based on the symptom of a vaginal bulge, ranges between 5 and 10%.2 Symptomatic POP can cause substantial discomfort, reduce quality of life and limit
activities of daily living. An estimated lifetime cumulative risk of POP surgery of 7% to 11% has been reported and reoperation is common.2 Severe complications can occur following prolapse surgery, especially after mesh implants.3,4 Therefore early nonsurgical prevention and treatment are warranted. The occurrence rate of POP stage II 3 to 6 months’ postpartum is reported to be between 18-56%.5 Moreover, 1540% of primiparous women have a
From the Department of Obstetrics and Gynecology, Akershus University Hospital, Lørenskog (all authors), and Department of Sports Medicine, Norwegian School of Sport Sciences (Dr Bø, MsHilde, and MsTennfjord), and Faculty of Medicine, University of Oslo, and Akershus University Hospital (Drs Stær-Jensen, Siafarikas, and Engh), Oslo, Norway. Received April 6, 2014; revised May 16, 2014; accepted June 20, 2014. The authors report no conflict of interest. This study was supported by grants from The Research Council of Norway. Trial registration: ClinicalTrials.gov (NCT01069484). Presented at the 43rd Annual Scientific Meeting of the International Continence Society, Barcelona, Spain, Aug. 26-30, 2013. Corresponding author: Kari Bø, PhD. [email protected] 0002-9378/$36.00 ª 2014 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.06.049
major defect of the levator ani muscle.5 Dietz and Simpson6 define major defect of the medial anterior part of the levator ani muscle when an abnormal insertion of the muscle toward the pubic bone is present at the plane of minimal dimension and 2.5 mm and 5.0 mm cranially is using tomographic ultrasound imaging. They have found that postpartum women with levator ani defects detected by ultrasound were twice as likely to have POP stage II or higher than those with an intact levator ani muscle. Several randomized controlled (RCTs) have shown that pelvic floor muscle training (PFMT) is effective in reducing symptoms and/or stage of POP in middle-aged women, and a systematic review concluded that there is level 1, grade A evidence to recommend PFMT in treatment of POP.7 Furthermore, an assessor blind RCT found that PFMT significantly improved pelvic floor muscle (PFM) strength and thickness, lifted the bladder neck and rectal ampulla, narrowed the levator hiatus
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area, and reduce muscle length in women with POP.8 These morphologic changes following PFMT indicate that such strength training may also have a potential preventive effect on postpartum POP. Therefore, the aim of the present study was to assess the effect of a 4month postpartum PFMT program on stage of POP, bladder neck position, and POP symptoms in primiparous women following vaginal delivery.
M ATERIALS
AND
M ETHODS
This is a 2-armed parallel group RCT evaluating the effect of PFMT on stage of POP, bladder neck position, and POP symptoms in primiparous women, stratified on major levator ani muscle defects. The trial was conducted at Akershus University Hospital, Norway, from February 2010 to May 2012. The study was approved by the Regional Medical Ethics Committee (REK South East 2009/289a), Norwegian Social Science Data Services (2799004), and registered at ClinicalTrials.gov (NCT01069484). All subjects gave written informed consent before entering the study. A primary analysis in this participant population addressing the prevention and treatment of urinary incontinence (UI) has been published.9 The present study was a planned secondary analysis.
Participants Women were recruited from a cohort study on pelvic floor dysfunction following first time pregnant women from gestational week 22 until 1 year postpartum and from the maternity ward of Akershus University Hospital, Norway. Inclusion criteria were vaginal delivery to a singleton infant after more than 32 weeks of gestation and ability to understand Scandinavian languages. Instrumental vaginal deliveries were included; 20% (35 of 175) had an instrumental vaginal delivery (33 with vacuum and 2 with forceps). Exclusion criteria included delivery by caesarean section, third, and fourth degree perineal tears and serious illness to mother or child. Women with third and fourth degree tears in Norway are routinely referred to
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TABLE 1
Characteristics of the PFMT and the control group at baseline, 6 wks’ postpartum Description Age, y, at delivery 2
Body mass index, kg/m
PFMT (n [ 87)
Control (n [ 88)
29.5 (4.3)
30.1 (4.0)
26.0 (4.1)
25.3 (3.9)
Numbers with major levator ani defects
27 (31.0%)
28 (31.8%)
Numbers with college/university education
64 (73.6%)
79 (89.8%)
Numbers married/cohabitant
80 (92.0%)
86 (97.7%)
2 (2.4%)
4 (4.5%)
Numbers smoking
a
Numbers being physically active 3 times/wk
a
Numbers doing PFMT >3 times/wk
20 (23.5%)
29 (33%)
26 (30.6%)
37 (42.0%)
Means with standard deviations (SD) or frequencies with percentages (%). PFMT, pelvic floor muscle training; SD, standard deviation. a
Total n ¼173; missing data on 2 women, both from PFMT (valid percent reported).
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
FIGURE
Flowchart
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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ajog.org physical therapists for PFMT and could ethically not be allocated to a control group. Intrauterine fetal deaths/stillborns were excluded from the analysis. Power calculation was done for the primary analyses on UI and was based on the results of a former study.10 No specific power calculation was done for stage and symptoms of POP. However, based on former prevalence studies, one could assume approximately the same prevalence rates (30%) of POP and UI in the postpartum period.5 Kretz Voluson E8 system (GE Health Care AS, Oslo, Norway) with 48 MHz curved array 3-dimensional/4dimensional transperineal ultrasound The women were stratified on major defects of the levator ani muscle assessed with the GE transducer (RAB4-8l/ obstetric; GE Health Care AS). At pretest, 6 weeks’ postpartum major defects of the levator ani muscle were diagnosed using tomographic ultrasound imaging of the axial plane at maximal pelvic floor muscle contraction as described by Dietz.11,12 The method has shown good intra- and interrater reliability shortly after childbirth.13 The participants were randomized in blocks of 10 to either PFMT or control with usual care. The randomization sequence was computer generated and opaque sealed envelopes were used. Allocation of participants into the PFMT and control group was administered outside the assessment room by a project midwife who was not involved in the assessment or the teaching of PFMT to the participating women.
Outcome Primary outcomes were stage of POP and bladder neck position. Secondary outcome was symptoms of POP (sensation of bulging). Outcomes were measured at 6 weeks (pretest) and 6 months’ (posttest) postpartum.
strain with the woman in the 45-degree lithotomy position. We defined no POP as stages 0 and I and POP as stage II or greater. The POP-Q examination followed a rigorous protocol and a standardized procedure.
Bladder neck position Two gynecologists performed transperineal ultrasound using the GE Kretz Voluson E8 (GE Healthcare AS) with 4-8 MHz curved array volume (RAB4-81/ obstetric). The assessment was done according to Schaer et al15 in the sagittal plane. Bladder neck level on the Y-axis was used to evaluate position. Symptoms of POP Sensation of bulging was assessed by an electronic questionnaire using International Consultation on Incontinence Questionnaire-vag which has demonstrated good reliability, validity, and sensitivity to change.16 The women
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answered 2 questions on bulging; whether they perceived bulging inside or outside the vagina. The gynecologists and physiotherapists assessing POP-Q, bladder neck position, and PFM variables were blinded to symptoms of POP and group allocation.
Ability to contract and PFM strength Two trained physiotherapists taught and assessed the ability to contract the PFM by observation of the perineum and vaginal palpation.17 Pelvic floor muscle strength was measured using a high precision pressure transducer connected to a balloon catheter (Camtech AS, Sandvika, Norway). The method has demonstrated good reliability.18 The middle of the balloon was placed 3.5 cm from the vaginal introitus.19 Only contractions with simultaneous visible inward movement of the catheter /perineum were considered correct.17
TABLE 2
Number of primiparous women in POP-Q stage 0, I, and II at 6 wks and 6 mos’ postpartum Description
6 wks’ postpartum
POP-Q stage
0
I
II
21
56
10
P value
6 mos’ postpartum 0
I
II
26
53
8
Total study group (n ¼ 175) PFMT (n ¼ 87)
.66 C (n ¼ 88)
.58
24
51
13
24
59
5
PFMT (n ¼ 60)
17
36
7
20
36
4
C (n ¼ 60)
18
36
6
19
37
4
4
20
3
6
17
4
Stratum with no levator ani muscle defect (n ¼ 120) .95
.98
Stratum with major levator ani muscle defect (n ¼ 55) PFMT (n ¼ 27)
.26
POP stage Stage of POP was diagnosed by 1 of 2 gynecologists using the reliable and valid Pelvic Organ Prolapse-Quantification examination (POP-Q)14 in which the maximal point of vaginal descent is measured relative to the hymen during
P value
C (n ¼ 28)
6
15
7
.28 5
22
1
Stage 0 denotes no prolapse, stage I is when the most distal portion of the prolapse is more than 1 cm above the level of the hymen, stage II when the most distal portion of the prolapse is 1 cm or less proximal to or distal to the plane of the hymen, stage III when the most distal portion of the prolapse is more than 1 cm below the plane of the hymen and stage IV when a complete eversion of the total length of the lower genital tract is demonstrated. C, control; PFMT, pelvic floor muscle training; POP-Q, pelvic organ prolapse quantification. Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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Intervention All women had been recommended in written form at the delivery ward to perform PFMT. At pretest instruction in correct PFM contraction and assessment of PFM function was done before randomization and in the same way for all participants. The PFMT group attended a weekly PFMT class led by trained physiotherapists for 4 months starting at 6-8 weeks’ postpartum.10,20-22 In addition, the intervention group was asked to perform 3 sets of 8-12 close to maximum PFM contractions per day at home. Participants reported adherence to the home program in a training diary, and physiotherapists registered class participation. The control group had no further supervision or follow-up during the intervention period. However, because of ethical reasons they were not discouraged from performing PFMT on their own, but they were asked to follow the prescription for the group they were randomized to. Statistical analyses Data were analysed using SPSS, version 15 and Review Manager 5.1 (SPSS, Inc, Armonk, NY). Background variables are reported as numbers and percentages and means with standard deviations (SDs). Data are analysed as intention to treat. For categorical data the last observation was carried forward and for continuous data the baseline value plus the added change observed in the corresponding control group was used. An additional per protocol analysis was performed and based on women adhering to more than 80% of the prescribed training sessions (at home and during group training) who were not pregnant again at the postintervention test at 6 months. Between groups comparisons on nominal data are analysed by c2 or Fisher exact test and the MantelHaenszel risk ratio (relative risk). Student t test was used to compare differences between groups in change of muscle strength. P value was set to .05.
R ESULTS One hundred seventy-five primiparous women were randomized into the study.
ajog.org Mean age of the participants was 29.8 years (SD 4.1) and mean body mass index was 25.7 kg/m2 (SD 4.0). Characteristics of the PFMT and control group are presented in Table 1. There were no statistical significant differences between groups in gestational age, length of second stage, infant birthweight, head circumference, or numbers with instrumental vaginal deliveries. Two women never met for the group training. Twelve women were lost to follow-up in the PFMT group and 3 in the control group. All were included in the intention to treat analyses (Figure). Seven of 175 (4%) were not able to contract correctly 6 weeks’ postpartum. Three of these 7 had learned to contract at 6 months’ postpartum (2 from training and 1 from control). Of those participating in the trial 96% of the women in the intervention group adhered to 80% of both group and home training sessions. At 6 months’ postpartum 16.5% of the control group reported to have performed PFM
exercises 3 times per week. There was a statistically significant difference in change of PFM strength from 6 weeks to 6 months in favor of the PFMT group (mean difference 3.6 cm H2O; 95% confidence interval, 6.7 to 0.6; P ¼ .02). No significant differences were found for the primary outcome measures at baseline (Table 2: POP stage and Table 3: details of POP-Q points and bladder neck position). Table 2 shows number of women with POP-Q stage 0, I, or II at baseline 6 weeks’ postpartum and postintervention at 6 months’ postpartum in the PFMT group and the control group. None of the participants had POP stage III or IV. Analyses are reported for the whole group and in the subgroups of women with and without major levator ani muscle defects. There were no statistically significant differences between groups or change in stage of prolapse between groups (data not shown). There was no statistically significant difference between groups in individual POP-Q
TABLE 3
Point values (cm) for POP and transperineal ultrasound measurement of BN position Description
6 wks’ postpartum
6 mos’ postpartum
POP-Q Ap
PFMT: 2.78 (0.4) C: 2.78 (0.5)
PFMT: 2.71 (0.7) C: 2.74 (0.4)
POP-Q: Bp
PFMT: 2.78 (0.4) C: 2.76 (0.6)
PFMT: 2.79 (0.4) C: 2.75 (0.4)
POP-Q: Aa
PFMT: 2.21 (0.7) C: 2.12 (0.8)
PFMT: 2.23 (1.1) C: 2.37 (0.9)
POP-Q: Ba
PFMT: 2.28 (0.6) C: 2.23 (0.8)
PFMT: 2.36 (0.7) C: 2.40 (0.7)
POP-Q: C
PFMT: 6.52 (1.3) C: 6.14 (1.2)
PFMT: 6.53 (1.3) C: 6.59 (1.2)
POP-Q: ghD
PFMT: C:
3.73 (0.8) 3.81 (0.8)
PFMT: C:
3.33 (0.6) 3.40 (0.7)
POP-Q: pb
PFMT: C:
4.07 (0.7) 4.02 (0.7)
PFMT: C:
3.70 (0.7) 3.71 (0.7)
BN position at rest (Y-axis)
PFMT: C:
2.63 (0.3) 2.64 (0.3)
PFMT: C:
2.81 (0.3) 2.74 (0.4)
PFMT (n ¼ 87) and control group (n ¼ 88). Mean cm with standard deviations (SD). All P values comparing 6 month measures between groups were nonsignificant. Ap, posterior vaginal wall, range 3 to þ3 proximal to the hymen; BN, bladder neck; Bp, leading- most point of posterior vaginal wall prolapse, range 3 to þ tvl (posterior fornix to hymen); C, most distal edge of cervix or vaginal cuff; gh, genital hiatus: perpendicular distance from midurethral meatus to posterior hymen; POP-Q, pelvic organ prolapse quantification; PFMT, pelvic floor muscle training. Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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4/27 (14.8%) 1/28 (3.6%)
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
Difference between groups reported as RR with 95% CIs between POP-Q stage 0/I and II.
CI, confidence interval; PFMT, postpartum pelvic floor muscle training; POP-Q, pelvic organ prolapse quantification; RR, relative risk.
1.00 (0.26e3.81) > .99 4/60 (6.7%)
.201 .769 3/27 (11.1%) 7/28 (25.0%) 0.44 (0.13e1.54) 7/60 (11.7%) 6/60 (10.0%) 1.17 (0.42e3.27)
4/60 (6.7%) 1.62 (0.55e4.75) .381 5/88 (5.7%) 8/87 (9.2%) POP-Q stage II 6 mo after delivery
Description
POP-Q stage II 10/87 (11.5%) 13/88 (14.8%) 0.78 (0.36e1.68) .523 6 wk after delivery
Difference between groups, RR (95% CI) Control (n [ 28) PFMT (n [ 27) Difference between groups, P RR (95% CI) value Control (n [ 60) Difference between groups, P PFMT RR (95% CI) value (n [ 60) Control (n [ 88) PFMT (n [ 87)
Major levator ani muscle defects (n [ 55) No major levator ani muscle defects (n [ 120) Total study sample (n [ 175)
An intensive PFMT program did not improve POP, bladder neck support or vaginal bulge symptoms in this population of primiparous women following vaginal delivery, nor did outcomes improve in the subgroup of women with major levator ani defects. Although others have demonstrated an effect of PFMT on POP in middle-aged women, there is a lack of knowledge of this relationship in postpartum women.7,23 Typically the studies in middle-aged women with POP find an improvement of 1 stage of prolapse measured by POPQ and improvement of symptoms after PFMT.24 In addition, in the study of Brækken et al8 women in the PFMT group lifted both the bladder neck and the rectal ampulla significantly compared with the control group. Hence, a similar effect of PFMT was hypothesized in the present study, but was not found. Six weeks postpartum women may not yet have returned to their optimal physical activity level, and their participation in sport and fitness activities may increase from 6 weeks to 6 months. This may explain why some women experience symptoms and have anatomic POP at 6 months and not at 6 weeks in our study. However, we expected that supervised PFMT would counteract this, but were not able to show this in the present study. General physical activity level was the same for both groups
TABLE 4
C OMMENT
Effect of PFMT on POP-Q stage II for the total sample and in subgroups of women with and without major levator ani muscle defects
P value
points or bladder neck position at 6 months’ postpartum (Table 3). Per protocol analyses did not change any of the results. Table 4 shows no significant change between groups in relative risk of being diagnosed with POP-Q stage II between the PFMT and the control group. Number of women with symptoms of bulging inside the vagina was significantly higher in the control group compared with the PFMT group both at baseline and after the intervention. There were no statistically significant changes within or between groups in numbers reporting symptoms of bulging inside or outside the vagina (Table 5). No adverse effects were reported in the treatment arm.
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4.15 (0.49e34.78) .190
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TABLE 5
Numbers and percentages (%) of primiparous women with symptoms of pelvic organ prolapse Description
6 wks’ pp
6 mos’ pp
Bulging inside the vagina, n
PFMT: 7 (8.0) C: 21 (23.9)a
PFMT: 8 (9.2) C: 22 (25.0)a
Bulging outside the vagina, n
PFMT: 5 (5.7) C: 6 (6.8)
PFMT: 5 (6.9) C: 6 (5.7)
C, control; PFMT, pelvic floor muscle training; pp, postpartum. a
P < .01 between groups at 6 wks and 6 mo postpartum.
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
between week 6 and 6 months’ postpartum period in the present study, and can therefore not explain the noneffect in the PFMT group. To date, there is sparse knowledge on remission of POP in the postpartum period. Elenskaia et al25 found that prolapse stage and symptoms had worsened from pregnancy results at both 14 weeks and 1 year postpartum. Chen et al26 found that the process of anatomic return to normal after labor and delivery is not completed at 6 weeks postpartum and continues to occur in the pelvic floor to 1 year postpartum. There is a need for further cohort studies and RCTs on POP in the postpartum period following both primiand multiparous women. The strengths of the present study are the RCT design, blinding of assessors, use of supervised training following recommendations for strength training, high adherence, and use of reliable and valid outcome measures. Number of women with stage I and II POP and symptomatic prolapse fall within the range of results in published cohort studies in the postpartum period5 and thus appear to be representative of this population. Limitations are some loss to follow-up and a small sample size in some of the comparisons. Also the questionnaire on prolapse symptoms was not validated in a postpartum population. Exercise training programs may be ineffectual because of insufficient dosage or low adherence to training. In the present study the women attended a training program that followed general
recommendations for strength training and the same protocol was effective both in the postpartum period in reducing urinary incontinence10 and in middleaged women with POP.8,24 However, in contrast to the present program, that by Brækken et al24 included individual supervised training. We chose group training in the present study because the same group protocol was effective in prevention and treatment of UI both during pregnancy22 and the postpartum period.10 Individual training may be required to prevent and treat POP as compared with stress urinary incontinence. One may assume that participants volunteering to exercise trials may be motivated for training and have a wish to be randomized to the exercise group. Those allocated to the control group may therefore exercise more than prescribed. This may also have been the case for the participants in the present study. They were asked to stick to the prescription for the group they were randomized to, but 16.5% reported to train 3 times per week. This may have influenced our results. However, this training dosage is substantially less than what was performed in the PFMT group and the change in PFM strength between groups was in favor of the PFMT group. On the other hand, the difference in change in strength between groups was statistically significant, but only mean 3.6 cm H2O. This small difference may not be clinically relevant and be one explanation why there was no effect on signs or symptoms of POP. In the study of Brækken et al8 middleaged women with POP had a mean
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bladder neck elevation of 4.2 mm (95% confidence interval, 2.8e5.6) following PFMT group vs no change in the control group. In the present study, both groups demonstrated a smaller and nonsignificant change in bladder neck elevation of mean 2.0 mm. Hence, the present training program may have been less effective. On the other hand, hormonal status is different in the postpartum period and may negatively influence both the connective tissue and muscle function. Our results indicate that there may be minor effect of PFMT in this particular population, that the program was not efficient or a combination of these 2 factors. In contrast to the studies in middle-aged women, our study of postpartum women did not include any women with POP-Q stage III. Hence, the program may have been more effective in a group with more severe POP. More RCTs are needed before strong conclusions can be drawn on the effect of PFMT in prevention and treatment on POP in primiparous women. Given the disparity between our results and those in populations of middle-aged women, we suggest that in future trials PFMT should include supervised individual training rather than, or in addition to, group training. Given the high prevalence of POP in the general female population, early prevention and treatment should have high priority. ACKNOWLEDGMENTS We thank midwife Tone Breines Simonsen for recruiting participants and administering clinical appointments and electronic questionnaires; physiotherapist therapist Kristin Gjestland for clinical testing and data entering; physiotherapists Ingeborg Hoff Brækken, Vigdis Skøld, and Ingvild Sandholt for supervising the interventional group training sessions and professor, PhD Ingar Holme, Norwegian School of Sport Sciences, for statistical advice.
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11. Dietz HP, Shek KL. Tomographic ultrasound imaging of the pelvic floor: which levels matter most? Ultrasound Obstet Gynecol 2009: 698-703. 12. Dietz HP, Bernardo MJ, Kirby A, Shek KL. Minimal criteria for the diagnosis of avulsion of the puborectalis muscle by tomographic ultrasound. Int Urogynecol J 2011;22:699-704. 13. Staer-Jensen J, Richter F, Hilde G, Brækken IH, Bø K, Engh ME. Pelvic floor muscle injuries 6 weeks postpartum- an intra- and interrater study. Neurourol Urodyn 2013;32: 993-7. 14. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10-7. 15. Schaer GN, Koechli OR, Schuessler B, Haller U. Perineal ultrasound for evaluating the bladder neck in urinary stress incontinence. Obstet Gynecol 1995;85:220-4. 16. Price N, Jackson SR, Avery K, Brookes ST, Abrams P. Development and psychometric evaluation of the ICIQ Vaginal Symptoms Questionnaire; the ICIQ-VS. BJOG 2006;113: 700-12. 17. Bø K, Kvarstein B, Hagen R, Larsen S. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: II, validity of vaginal pressure measurements of pelvic floor muscle strength and the necessity of supplementary methods for control of correct contraction. Neurourol Urodyn 1990a;9:479-87. 18. Bø K, Kvarstein B, Hagen R, Oseid S, Larsen S. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence, I, reliability of vaginal pressure measurements of
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pelvic floor muscle strength. Neurourol Urodyn 1990b;9:471-7. 19. Bø K. Pressure measurements during pelvic floor muscle contractions: the effect of different positions of the vaginal measuring device. Neurourol Urodyn 1992;11:107-13. 20. Bø K, Hagen RH, Kvarstein B, et al. Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: III, effects of two different degrees of pelvic floor muscle exercise. Neurourol Urodyn 1990c;9:489-502. 21. Bø K, Talseth T, Holme I. Single blind, randomised 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. 22. Mørkved S, Bø K, Schei B, et al. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol 2003;101: 313-9. 23. Hagen S, Stark D, Glazener C, et al; POPPY Trial Collaborators. Indivdualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet 2014;383:796-806. 24. Brækken IH, Majida M, Engh ME, Bø K. Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? Am J Obstet Gynecol 2010b;203:170 1-7. 25. Elenskaia K, Thakar R, Sultan AH, Sheer I, Onwuda J. Effect of childbirth on pelvic organ support and quality of life: a longitudinal study. Int Urogynecol J 2013;24:927-37. 26. Chen Y, LI F-Y, Chen J, Guess MK. The recovery of pelvic organ support during the first year postpartum. BJOG 2013;120:1430-7.
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Postpartum pelvic floor muscle training and pelvic organ prolapse—a randomized trial of primiparous women Kari Bø, MSc, PhD, PT; Gunvor Hilde, MSc, PT; Jette Stær-Jensen, MD; Franziska Siafarikas, MD; Merete Kolberg Tennfjord, MSc, PT; Marie Ellstrøm Engh, PhD OBJECTIVE: Pelvic organ prolapse (POP) is a common and distressing condition. The aim of the present study was to evaluate the effect of pelvic floor muscle training (PFMT) on prevention and treatment of symptoms and signs of POP in primiparous postpartum women. STUDY DESIGN: This was a parallel group assessor blind randomized
controlled trial. One hundred seventy-five primiparous postpartum women, mean age 29.8 years (standard deviation 4.1), stratified on major levator ani defects or no defect diagnosed by 3-/4-dimensional ultrasound, participated in a 4-month PFMT starting at 6-8 weeks’ postpartum or control. All participants had thorough individual instruction and assessment of ability to perform correct pelvic floor muscle contractions. The PFMT group followed a supervised, weekly group training program and performed 3 sets of 8-12 daily maximal contractions at home. Main outcome was POP stage II or greater assessed by POP quantification and bladder neck position assessed by
3-/4- dimensional transperineal ultrasonography. Secondary outcome was symptoms of vaginal bulge using International Consultation on Incontinence Vaginal Symptoms questionnaire. RESULTS: Ninety-six percent of the intervention group adhered to 80% of both group and home training sessions. At postintervention, there was no significant risk difference in POP (rational ratio, 1.62; 95% confidence interval, 0.55e4.75), bladder neck position or symptoms of vaginal bulging. CONCLUSION: No effect was found of postpartum PFMT on POP in
primiparous women. More randomized controlled trials are needed before strong conclusions can be drawn on the effect of PFMT on POP in the particular population. Key words: exercise, pelvic organ prolapse, pelvic floor muscle training, postpartum, prevention
Cite this article as: Bø K, Hilde G, Stær-Jensen J, et al. Postpartum pelvic floor muscle training and pelvic organ prolapse—a randomized trial of primiparous women. Am J Obset Gynecol 2014;211:x-ex-x-ex.
P
elvic organ prolapse (POP), in which the anterior vaginal wall, posterior vaginal wall, uterus (cervix), or vaginal apex descends into or out of the vagina,1 is common. Prevalence of POP based on clinical examination has been found to exceed 30% in the general female population, although prevalence based on the symptom of a vaginal bulge, ranges between 5 and 10%.2 Symptomatic POP can cause substantial discomfort, reduce quality of life and limit
activities of daily living. An estimated lifetime cumulative risk of POP surgery of 7% to 11% has been reported and reoperation is common.2 Severe complications can occur following prolapse surgery, especially after mesh implants.3,4 Therefore early nonsurgical prevention and treatment are warranted. The occurrence rate of POP stage II 3 to 6 months’ postpartum is reported to be between 18-56%.5 Moreover, 1540% of primiparous women have a
From the Department of Obstetrics and Gynecology, Akershus University Hospital, Lørenskog (all authors), and Department of Sports Medicine, Norwegian School of Sport Sciences (Dr Bø, MsHilde, and MsTennfjord), and Faculty of Medicine, University of Oslo, and Akershus University Hospital (Drs Stær-Jensen, Siafarikas, and Engh), Oslo, Norway. Received April 6, 2014; revised May 16, 2014; accepted June 20, 2014. The authors report no conflict of interest. This study was supported by grants from The Research Council of Norway. Trial registration: ClinicalTrials.gov (NCT01069484). Presented at the 43rd Annual Scientific Meeting of the International Continence Society, Barcelona, Spain, Aug. 26-30, 2013. Corresponding author: Kari Bø, PhD. [email protected] 0002-9378/$36.00 ª 2014 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.06.049
major defect of the levator ani muscle.5 Dietz and Simpson6 define major defect of the medial anterior part of the levator ani muscle when an abnormal insertion of the muscle toward the pubic bone is present at the plane of minimal dimension and 2.5 mm and 5.0 mm cranially is using tomographic ultrasound imaging. They have found that postpartum women with levator ani defects detected by ultrasound were twice as likely to have POP stage II or higher than those with an intact levator ani muscle. Several randomized controlled (RCTs) have shown that pelvic floor muscle training (PFMT) is effective in reducing symptoms and/or stage of POP in middle-aged women, and a systematic review concluded that there is level 1, grade A evidence to recommend PFMT in treatment of POP.7 Furthermore, an assessor blind RCT found that PFMT significantly improved pelvic floor muscle (PFM) strength and thickness, lifted the bladder neck and rectal ampulla, narrowed the levator hiatus
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area, and reduce muscle length in women with POP.8 These morphologic changes following PFMT indicate that such strength training may also have a potential preventive effect on postpartum POP. Therefore, the aim of the present study was to assess the effect of a 4month postpartum PFMT program on stage of POP, bladder neck position, and POP symptoms in primiparous women following vaginal delivery.
M ATERIALS
AND
M ETHODS
This is a 2-armed parallel group RCT evaluating the effect of PFMT on stage of POP, bladder neck position, and POP symptoms in primiparous women, stratified on major levator ani muscle defects. The trial was conducted at Akershus University Hospital, Norway, from February 2010 to May 2012. The study was approved by the Regional Medical Ethics Committee (REK South East 2009/289a), Norwegian Social Science Data Services (2799004), and registered at ClinicalTrials.gov (NCT01069484). All subjects gave written informed consent before entering the study. A primary analysis in this participant population addressing the prevention and treatment of urinary incontinence (UI) has been published.9 The present study was a planned secondary analysis.
Participants Women were recruited from a cohort study on pelvic floor dysfunction following first time pregnant women from gestational week 22 until 1 year postpartum and from the maternity ward of Akershus University Hospital, Norway. Inclusion criteria were vaginal delivery to a singleton infant after more than 32 weeks of gestation and ability to understand Scandinavian languages. Instrumental vaginal deliveries were included; 20% (35 of 175) had an instrumental vaginal delivery (33 with vacuum and 2 with forceps). Exclusion criteria included delivery by caesarean section, third, and fourth degree perineal tears and serious illness to mother or child. Women with third and fourth degree tears in Norway are routinely referred to
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TABLE 1
Characteristics of the PFMT and the control group at baseline, 6 wks’ postpartum Description Age, y, at delivery 2
Body mass index, kg/m
PFMT (n [ 87)
Control (n [ 88)
29.5 (4.3)
30.1 (4.0)
26.0 (4.1)
25.3 (3.9)
Numbers with major levator ani defects
27 (31.0%)
28 (31.8%)
Numbers with college/university education
64 (73.6%)
79 (89.8%)
Numbers married/cohabitant
80 (92.0%)
86 (97.7%)
2 (2.4%)
4 (4.5%)
Numbers smoking
a
Numbers being physically active 3 times/wk
a
Numbers doing PFMT >3 times/wk
20 (23.5%)
29 (33%)
26 (30.6%)
37 (42.0%)
Means with standard deviations (SD) or frequencies with percentages (%). PFMT, pelvic floor muscle training; SD, standard deviation. a
Total n ¼173; missing data on 2 women, both from PFMT (valid percent reported).
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
FIGURE
Flowchart
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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ajog.org physical therapists for PFMT and could ethically not be allocated to a control group. Intrauterine fetal deaths/stillborns were excluded from the analysis. Power calculation was done for the primary analyses on UI and was based on the results of a former study.10 No specific power calculation was done for stage and symptoms of POP. However, based on former prevalence studies, one could assume approximately the same prevalence rates (30%) of POP and UI in the postpartum period.5 Kretz Voluson E8 system (GE Health Care AS, Oslo, Norway) with 48 MHz curved array 3-dimensional/4dimensional transperineal ultrasound The women were stratified on major defects of the levator ani muscle assessed with the GE transducer (RAB4-8l/ obstetric; GE Health Care AS). At pretest, 6 weeks’ postpartum major defects of the levator ani muscle were diagnosed using tomographic ultrasound imaging of the axial plane at maximal pelvic floor muscle contraction as described by Dietz.11,12 The method has shown good intra- and interrater reliability shortly after childbirth.13 The participants were randomized in blocks of 10 to either PFMT or control with usual care. The randomization sequence was computer generated and opaque sealed envelopes were used. Allocation of participants into the PFMT and control group was administered outside the assessment room by a project midwife who was not involved in the assessment or the teaching of PFMT to the participating women.
Outcome Primary outcomes were stage of POP and bladder neck position. Secondary outcome was symptoms of POP (sensation of bulging). Outcomes were measured at 6 weeks (pretest) and 6 months’ (posttest) postpartum.
strain with the woman in the 45-degree lithotomy position. We defined no POP as stages 0 and I and POP as stage II or greater. The POP-Q examination followed a rigorous protocol and a standardized procedure.
Bladder neck position Two gynecologists performed transperineal ultrasound using the GE Kretz Voluson E8 (GE Healthcare AS) with 4-8 MHz curved array volume (RAB4-81/ obstetric). The assessment was done according to Schaer et al15 in the sagittal plane. Bladder neck level on the Y-axis was used to evaluate position. Symptoms of POP Sensation of bulging was assessed by an electronic questionnaire using International Consultation on Incontinence Questionnaire-vag which has demonstrated good reliability, validity, and sensitivity to change.16 The women
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answered 2 questions on bulging; whether they perceived bulging inside or outside the vagina. The gynecologists and physiotherapists assessing POP-Q, bladder neck position, and PFM variables were blinded to symptoms of POP and group allocation.
Ability to contract and PFM strength Two trained physiotherapists taught and assessed the ability to contract the PFM by observation of the perineum and vaginal palpation.17 Pelvic floor muscle strength was measured using a high precision pressure transducer connected to a balloon catheter (Camtech AS, Sandvika, Norway). The method has demonstrated good reliability.18 The middle of the balloon was placed 3.5 cm from the vaginal introitus.19 Only contractions with simultaneous visible inward movement of the catheter /perineum were considered correct.17
TABLE 2
Number of primiparous women in POP-Q stage 0, I, and II at 6 wks and 6 mos’ postpartum Description
6 wks’ postpartum
POP-Q stage
0
I
II
21
56
10
P value
6 mos’ postpartum 0
I
II
26
53
8
Total study group (n ¼ 175) PFMT (n ¼ 87)
.66 C (n ¼ 88)
.58
24
51
13
24
59
5
PFMT (n ¼ 60)
17
36
7
20
36
4
C (n ¼ 60)
18
36
6
19
37
4
4
20
3
6
17
4
Stratum with no levator ani muscle defect (n ¼ 120) .95
.98
Stratum with major levator ani muscle defect (n ¼ 55) PFMT (n ¼ 27)
.26
POP stage Stage of POP was diagnosed by 1 of 2 gynecologists using the reliable and valid Pelvic Organ Prolapse-Quantification examination (POP-Q)14 in which the maximal point of vaginal descent is measured relative to the hymen during
P value
C (n ¼ 28)
6
15
7
.28 5
22
1
Stage 0 denotes no prolapse, stage I is when the most distal portion of the prolapse is more than 1 cm above the level of the hymen, stage II when the most distal portion of the prolapse is 1 cm or less proximal to or distal to the plane of the hymen, stage III when the most distal portion of the prolapse is more than 1 cm below the plane of the hymen and stage IV when a complete eversion of the total length of the lower genital tract is demonstrated. C, control; PFMT, pelvic floor muscle training; POP-Q, pelvic organ prolapse quantification. Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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Intervention All women had been recommended in written form at the delivery ward to perform PFMT. At pretest instruction in correct PFM contraction and assessment of PFM function was done before randomization and in the same way for all participants. The PFMT group attended a weekly PFMT class led by trained physiotherapists for 4 months starting at 6-8 weeks’ postpartum.10,20-22 In addition, the intervention group was asked to perform 3 sets of 8-12 close to maximum PFM contractions per day at home. Participants reported adherence to the home program in a training diary, and physiotherapists registered class participation. The control group had no further supervision or follow-up during the intervention period. However, because of ethical reasons they were not discouraged from performing PFMT on their own, but they were asked to follow the prescription for the group they were randomized to. Statistical analyses Data were analysed using SPSS, version 15 and Review Manager 5.1 (SPSS, Inc, Armonk, NY). Background variables are reported as numbers and percentages and means with standard deviations (SDs). Data are analysed as intention to treat. For categorical data the last observation was carried forward and for continuous data the baseline value plus the added change observed in the corresponding control group was used. An additional per protocol analysis was performed and based on women adhering to more than 80% of the prescribed training sessions (at home and during group training) who were not pregnant again at the postintervention test at 6 months. Between groups comparisons on nominal data are analysed by c2 or Fisher exact test and the MantelHaenszel risk ratio (relative risk). Student t test was used to compare differences between groups in change of muscle strength. P value was set to .05.
R ESULTS One hundred seventy-five primiparous women were randomized into the study.
ajog.org Mean age of the participants was 29.8 years (SD 4.1) and mean body mass index was 25.7 kg/m2 (SD 4.0). Characteristics of the PFMT and control group are presented in Table 1. There were no statistical significant differences between groups in gestational age, length of second stage, infant birthweight, head circumference, or numbers with instrumental vaginal deliveries. Two women never met for the group training. Twelve women were lost to follow-up in the PFMT group and 3 in the control group. All were included in the intention to treat analyses (Figure). Seven of 175 (4%) were not able to contract correctly 6 weeks’ postpartum. Three of these 7 had learned to contract at 6 months’ postpartum (2 from training and 1 from control). Of those participating in the trial 96% of the women in the intervention group adhered to 80% of both group and home training sessions. At 6 months’ postpartum 16.5% of the control group reported to have performed PFM
exercises 3 times per week. There was a statistically significant difference in change of PFM strength from 6 weeks to 6 months in favor of the PFMT group (mean difference 3.6 cm H2O; 95% confidence interval, 6.7 to 0.6; P ¼ .02). No significant differences were found for the primary outcome measures at baseline (Table 2: POP stage and Table 3: details of POP-Q points and bladder neck position). Table 2 shows number of women with POP-Q stage 0, I, or II at baseline 6 weeks’ postpartum and postintervention at 6 months’ postpartum in the PFMT group and the control group. None of the participants had POP stage III or IV. Analyses are reported for the whole group and in the subgroups of women with and without major levator ani muscle defects. There were no statistically significant differences between groups or change in stage of prolapse between groups (data not shown). There was no statistically significant difference between groups in individual POP-Q
TABLE 3
Point values (cm) for POP and transperineal ultrasound measurement of BN position Description
6 wks’ postpartum
6 mos’ postpartum
POP-Q Ap
PFMT: 2.78 (0.4) C: 2.78 (0.5)
PFMT: 2.71 (0.7) C: 2.74 (0.4)
POP-Q: Bp
PFMT: 2.78 (0.4) C: 2.76 (0.6)
PFMT: 2.79 (0.4) C: 2.75 (0.4)
POP-Q: Aa
PFMT: 2.21 (0.7) C: 2.12 (0.8)
PFMT: 2.23 (1.1) C: 2.37 (0.9)
POP-Q: Ba
PFMT: 2.28 (0.6) C: 2.23 (0.8)
PFMT: 2.36 (0.7) C: 2.40 (0.7)
POP-Q: C
PFMT: 6.52 (1.3) C: 6.14 (1.2)
PFMT: 6.53 (1.3) C: 6.59 (1.2)
POP-Q: ghD
PFMT: C:
3.73 (0.8) 3.81 (0.8)
PFMT: C:
3.33 (0.6) 3.40 (0.7)
POP-Q: pb
PFMT: C:
4.07 (0.7) 4.02 (0.7)
PFMT: C:
3.70 (0.7) 3.71 (0.7)
BN position at rest (Y-axis)
PFMT: C:
2.63 (0.3) 2.64 (0.3)
PFMT: C:
2.81 (0.3) 2.74 (0.4)
PFMT (n ¼ 87) and control group (n ¼ 88). Mean cm with standard deviations (SD). All P values comparing 6 month measures between groups were nonsignificant. Ap, posterior vaginal wall, range 3 to þ3 proximal to the hymen; BN, bladder neck; Bp, leading- most point of posterior vaginal wall prolapse, range 3 to þ tvl (posterior fornix to hymen); C, most distal edge of cervix or vaginal cuff; gh, genital hiatus: perpendicular distance from midurethral meatus to posterior hymen; POP-Q, pelvic organ prolapse quantification; PFMT, pelvic floor muscle training. Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
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4/27 (14.8%) 1/28 (3.6%)
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
Difference between groups reported as RR with 95% CIs between POP-Q stage 0/I and II.
CI, confidence interval; PFMT, postpartum pelvic floor muscle training; POP-Q, pelvic organ prolapse quantification; RR, relative risk.
1.00 (0.26e3.81) > .99 4/60 (6.7%)
.201 .769 3/27 (11.1%) 7/28 (25.0%) 0.44 (0.13e1.54) 7/60 (11.7%) 6/60 (10.0%) 1.17 (0.42e3.27)
4/60 (6.7%) 1.62 (0.55e4.75) .381 5/88 (5.7%) 8/87 (9.2%) POP-Q stage II 6 mo after delivery
Description
POP-Q stage II 10/87 (11.5%) 13/88 (14.8%) 0.78 (0.36e1.68) .523 6 wk after delivery
Difference between groups, RR (95% CI) Control (n [ 28) PFMT (n [ 27) Difference between groups, P RR (95% CI) value Control (n [ 60) Difference between groups, P PFMT RR (95% CI) value (n [ 60) Control (n [ 88) PFMT (n [ 87)
Major levator ani muscle defects (n [ 55) No major levator ani muscle defects (n [ 120) Total study sample (n [ 175)
An intensive PFMT program did not improve POP, bladder neck support or vaginal bulge symptoms in this population of primiparous women following vaginal delivery, nor did outcomes improve in the subgroup of women with major levator ani defects. Although others have demonstrated an effect of PFMT on POP in middle-aged women, there is a lack of knowledge of this relationship in postpartum women.7,23 Typically the studies in middle-aged women with POP find an improvement of 1 stage of prolapse measured by POPQ and improvement of symptoms after PFMT.24 In addition, in the study of Brækken et al8 women in the PFMT group lifted both the bladder neck and the rectal ampulla significantly compared with the control group. Hence, a similar effect of PFMT was hypothesized in the present study, but was not found. Six weeks postpartum women may not yet have returned to their optimal physical activity level, and their participation in sport and fitness activities may increase from 6 weeks to 6 months. This may explain why some women experience symptoms and have anatomic POP at 6 months and not at 6 weeks in our study. However, we expected that supervised PFMT would counteract this, but were not able to show this in the present study. General physical activity level was the same for both groups
TABLE 4
C OMMENT
Effect of PFMT on POP-Q stage II for the total sample and in subgroups of women with and without major levator ani muscle defects
P value
points or bladder neck position at 6 months’ postpartum (Table 3). Per protocol analyses did not change any of the results. Table 4 shows no significant change between groups in relative risk of being diagnosed with POP-Q stage II between the PFMT and the control group. Number of women with symptoms of bulging inside the vagina was significantly higher in the control group compared with the PFMT group both at baseline and after the intervention. There were no statistically significant changes within or between groups in numbers reporting symptoms of bulging inside or outside the vagina (Table 5). No adverse effects were reported in the treatment arm.
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4.15 (0.49e34.78) .190
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TABLE 5
Numbers and percentages (%) of primiparous women with symptoms of pelvic organ prolapse Description
6 wks’ pp
6 mos’ pp
Bulging inside the vagina, n
PFMT: 7 (8.0) C: 21 (23.9)a
PFMT: 8 (9.2) C: 22 (25.0)a
Bulging outside the vagina, n
PFMT: 5 (5.7) C: 6 (6.8)
PFMT: 5 (6.9) C: 6 (5.7)
C, control; PFMT, pelvic floor muscle training; pp, postpartum. a
P < .01 between groups at 6 wks and 6 mo postpartum.
Bø. Pelvic floor muscle training for POP. Am J Obstet Gynecol 2014.
between week 6 and 6 months’ postpartum period in the present study, and can therefore not explain the noneffect in the PFMT group. To date, there is sparse knowledge on remission of POP in the postpartum period. Elenskaia et al25 found that prolapse stage and symptoms had worsened from pregnancy results at both 14 weeks and 1 year postpartum. Chen et al26 found that the process of anatomic return to normal after labor and delivery is not completed at 6 weeks postpartum and continues to occur in the pelvic floor to 1 year postpartum. There is a need for further cohort studies and RCTs on POP in the postpartum period following both primiand multiparous women. The strengths of the present study are the RCT design, blinding of assessors, use of supervised training following recommendations for strength training, high adherence, and use of reliable and valid outcome measures. Number of women with stage I and II POP and symptomatic prolapse fall within the range of results in published cohort studies in the postpartum period5 and thus appear to be representative of this population. Limitations are some loss to follow-up and a small sample size in some of the comparisons. Also the questionnaire on prolapse symptoms was not validated in a postpartum population. Exercise training programs may be ineffectual because of insufficient dosage or low adherence to training. In the present study the women attended a training program that followed general
recommendations for strength training and the same protocol was effective both in the postpartum period in reducing urinary incontinence10 and in middleaged women with POP.8,24 However, in contrast to the present program, that by Brækken et al24 included individual supervised training. We chose group training in the present study because the same group protocol was effective in prevention and treatment of UI both during pregnancy22 and the postpartum period.10 Individual training may be required to prevent and treat POP as compared with stress urinary incontinence. One may assume that participants volunteering to exercise trials may be motivated for training and have a wish to be randomized to the exercise group. Those allocated to the control group may therefore exercise more than prescribed. This may also have been the case for the participants in the present study. They were asked to stick to the prescription for the group they were randomized to, but 16.5% reported to train 3 times per week. This may have influenced our results. However, this training dosage is substantially less than what was performed in the PFMT group and the change in PFM strength between groups was in favor of the PFMT group. On the other hand, the difference in change in strength between groups was statistically significant, but only mean 3.6 cm H2O. This small difference may not be clinically relevant and be one explanation why there was no effect on signs or symptoms of POP. In the study of Brækken et al8 middleaged women with POP had a mean
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bladder neck elevation of 4.2 mm (95% confidence interval, 2.8e5.6) following PFMT group vs no change in the control group. In the present study, both groups demonstrated a smaller and nonsignificant change in bladder neck elevation of mean 2.0 mm. Hence, the present training program may have been less effective. On the other hand, hormonal status is different in the postpartum period and may negatively influence both the connective tissue and muscle function. Our results indicate that there may be minor effect of PFMT in this particular population, that the program was not efficient or a combination of these 2 factors. In contrast to the studies in middle-aged women, our study of postpartum women did not include any women with POP-Q stage III. Hence, the program may have been more effective in a group with more severe POP. More RCTs are needed before strong conclusions can be drawn on the effect of PFMT in prevention and treatment on POP in primiparous women. Given the disparity between our results and those in populations of middle-aged women, we suggest that in future trials PFMT should include supervised individual training rather than, or in addition to, group training. Given the high prevalence of POP in the general female population, early prevention and treatment should have high priority. ACKNOWLEDGMENTS We thank midwife Tone Breines Simonsen for recruiting participants and administering clinical appointments and electronic questionnaires; physiotherapist therapist Kristin Gjestland for clinical testing and data entering; physiotherapists Ingeborg Hoff Brækken, Vigdis Skøld, and Ingvild Sandholt for supervising the interventional group training sessions and professor, PhD Ingar Holme, Norwegian School of Sport Sciences, for statistical advice.
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