Objective
The aim of this study was to investigate the effectiveness of pelvic floor muscle training in reversing pelvic organ prolapse and alleviating symptoms.
Study Design
This assessor-blinded, parallel group, randomized, controlled trial conducted at a university hospital and a physical therapy clinic randomly assigned 109 women with prolapse stages I, II, and III to pelvic floor muscle training (n = 59) or control (n = 50). Both groups received lifestyle advices and learned “the Knack.” In addition, pelvic floor muscle training comprised individual physical therapy sessions and home exercise. Student t test, Mann-Whitney U test, odds ratio, and effect size were used to compare groups.
Results
Eleven (19%) women in the pelvic floor muscle training group improved 1 Pelvic Organ Prolapse Quantification System stage vs 4 (8%) controls ( P = .035). Compared with controls, the pelvic floor muscle training group elevated the bladder (difference: 3.0 mm; 95% confidence interval, 1.5–4.4; P < .001) and rectum (5.5 mm; 95% confidence interval, 1.4–7.3; P = .022) and reduced frequency and bother of symptoms compared with controls.
Conclusion
Pelvic floor muscle training is without adverse effects and can be used as treatment for prolapse.
It has been estimated that approximately 50% of women lose some of the supportive mechanisms of the pelvic floor caused by childbirth, leading to different degrees of pelvic organ prolapse (POP). The prevalence of symptomatic POP is reported to be 3–28%, with prolapse symptoms such as vaginal bulging and heaviness being the most specific symptoms. These symptoms can greatly impair a woman’s quality of life and are the main indication for surgery. POP accounts for 20% of women on waiting lists for major gynecologic surgery. However, prolapse recurs in up to 58% of women after surgery, and about one-third of women who are operated on undergo at least 1 more surgery for prolapse. This highlights the need for prevention measures that could reduce the impact of POP.
Activity in the pelvic floor muscles (PFM) plays a critical role in supporting the pelvic organs. Women with POP have reduced PFM strength, and the severity of POP seems to increase with increasing PFM dysfunction. Pelvic floor muscle training (PFMT) is without adverse effects, and anatomic understanding of PFM function provides a theoretical basis for strength training of the PFM to be effective in prevention and treatment of POP.
A survey revealed that 92% of women’s health physical therapists (PTs) assessed or treated women with POP, despite a poor evidence base and lack of clinical referral guidelines. To date, only 3 randomized controlled trials (RCTs) have investigated the effect of PFMT on POP. One trial scored low on methodologic quality, 1 is a small pilot study, and 1 small trial, published in French, assessed symptoms only. A recent Cochrane review concluded that available evidence is insufficient to understand the role PFMT may play in reducing POP and recommends RCTs with high methodologic quality. The aim of the current study was to evaluate whether PFMT can (1) reverse and prevent further development of POP and (2) reduce symptoms related to POP.
Materials and Methods
Design
This explanatory study is an assessor-blinded, randomized, controlled, parallel group trial with stratification on severity of POP. Participants were women with POP stages I, II, and III as determined by the Pelvic Organ Prolapse Quantification System (POP-Q). Women with POP, regardless of symptoms, were enrolled by community gynecologists and advertisements in newspapers. The study was approved by the Regional Medical Ethics Committee (S-05146), Norwegian Social Science Data Services (200501371 SMRH), and registered at ClinicalTrials.gov (NCT00271297). All subjects gave written informed consent.
Participants were at least 1 year postpartum. Exclusion criteria included POP stage 0 or IV, inability to contract the PFM, breastfeeding, previous POP surgery, radiating back pain, pelvic cancer, neurologic disorders, psychiatric disorders, untreated urinary tract infection, planning to become pregnant during the next 6 months, or to be away for more than 4 weeks of the intervention period.
As preliminary data on effect size of PFMT to treat POP were not available at the start of the study, we used an effect size of 0.6 to calculate the sample size. This was found in a multicenter RCT evaluating the effect of PFMT for stress urinary incontinence (SUI). With a 2-sided alpha of .05 and a power of 80%, a sample size of 45 per group was required. Because of the possible drop-outs, we chose to include at least 50 women in each group.
Intervention
Women in both the PFMT and the control group were advised to avoid straining and taught how to contract their PFM before and during increases in abdominal pressure (“the Knack”). The controls were asked not to change frequency of, or to start, PFMT during the intervention period. Women in the PFMT group were advised to do 3 sets of 8–12 close to maximum PFM contractions per day and to record home training adherence in an exercise diary. Each woman was individually supervised by a PT once a week during the first 3 months and every second week during the last 3 months. All women in the PFMT group also received a booklet and a DVD showing the exercise program. This program has been successfully used in several RCTs on women with SUI.
Primary outcome measures
Stage of POP
The internationally recommended classification system POP-Q was used to test severity of POP.
Position of bladder and rectum
The participants emptied their bladder, and a bladder volume of <50 mL was confirmed by ultrasound. The women stood with legs slightly apart during the ultrasound examination. A GE Voluson 730 expert and an E8 ultrasound system (GE Healthcare, Oslo, Norway) were used, with a 4–8 MHz curved array 3-dimensional/4-dimensional (3D/4D) ultrasound transducer (RAB 4–8 l/obstetric) placed on the perineum in the sagittal plane. The women were told to relax their PFM, while recording 3D volumes. Position of the bladder and rectum was quantified by locating the urethrovesical junction (bladder neck) and rectal ampulla, respectively. The height of the organs was defined as the vertical distance perpendicular from the central axis of the symphysis pubis on a rectangular coordinate system in the midsagittal plane, as described by Schaer et al and found to be reliable.
Frequency and bother of prolapse symptoms
Participants completed a validated questionnaire to describe frequency (daily, weekly, monthly, or less than once per month) and bother (4-point scale) of prolapse symptoms (feeling of vaginal bulging and/or heaviness). Women were considered symptomatic if they had monthly symptoms or more often. Improvement was present if the women reported less frequent symptoms or less bother on the 4-point scale at 6 months posttest compared with baseline answers.
Secondary outcome measures
Frequency and bother of bladder and bowel symptoms
The same validated questionnaire was used to describe frequency and bother of bladder symptoms (SUI, urge urinary incontinence) and bowel symptoms (flatus, loose, and solid fecal incontinence, problems with emptying bowel). In addition, the International Consultation on Incontinence Urinary Incontinence Short Form questionnaire (ICIQ-UI SF) was used to assess urinary incontinence and its impact on quality of life.
Independent variable
PFM function was evaluated by a vaginal balloon catheter (ballon size 6.7 × 1.7 cm) connected to a high-precision pressure transducer (Camtech AS, Sandvika, Norway). Muscle strength was calculated as the mean of 3 maximal voluntary contractions. This method has been found to be reliable and valid if used with simultaneous observation of inward movement of the catheter and perineum during PFM contraction. Vaginal resting pressure was measured as the difference between atmospheric pressure and the vaginal high-pressure zone at rest, without any voluntary PFM activity. PFM endurance was defined as a sustained maximal contraction and was quantified during the first 10 seconds as the area under the curve (cmH 2 O sec).
Procedure, randomization, and blinding
The participants answered the postal questionnaires before baseline assessment. A PT (I.H.B.) examined the ability to contract the PFM and measured PFM function. Assessment was performed in a physical therapy clinic. All POP-Q and ultrasound examinations were performed by a gynecologist (M.M.) at a university hospital. Thereafter, women were stratified into 2 groups by severity of prolapse: (1) maximal vaginal descent at or above the hymen, and (2) maximal vaginal descent below the hymen. Within each strata, a computer-generated random number system with concealed envelopes, generated by a statistician, randomly assigned the women to either PFMT or control. The participants opened an opaque, sealed envelope with their group assignment. The gynecologist (M.M.) performing all the POP-Q and ultrasound examinations was blinded to group allocation, clinical, and background data. Before the 6-month posttest, all participants of both groups completed the postal questionnaire and were retested with the same outcome measures as baseline. The PT (I.H.B.) was blinded for all outcome measures but not the independent variable (PFM function). The ultrasound images were stored by deidentified code numbers and analyzed offline (4D View v 5.0 and 6.3; GE Healthcare) by 1 investigator (I.H.B.) blinded to group allocation, clinical, and background data.
Statistical analysis
Statistical analyses were carried out in SPSS version 15 (SPSS, Inc, Chicago, IL). The results are given as frequencies and percentages for categorical data and means, with 95% confidence intervals (CIs) for continuous data. Continuous data were checked for normality by Kolmogorov-Smirnov and Shapiro-Wilk tests. Between and within groups comparisons were tested with Student t test (normally distributed data), Wilcoxon signed rank test, and Mann-Whitney U test (not normally distributed data). Differences between groups in baseline categorical data were analyzed by χ 2 . To determine treatment effect, differences between groups with 95% CI and odds ratios (ORs) with 95% CI were calculated for categorical data, whereas effect sizes were calculated for continuous data using the formula: (mean of PFMT group – mean of control group)/SD. The 1 variable that significantly differed between groups at baseline (prolapse symptoms) was additionally analyzed with ordinal logistic regression analyses, using the final values as the dependent and baseline as the independent variable, together with the group as the exposure variable. The relationship between increase in PFM strength and changes in position of bladder and rectum, improvement in POP-Q, and subjective improvements were analyzed with Pearson product-moment correlation ( r ) for normally distributed data and Spearman rho (rho) for not normally distributed data. Interim analyses were not performed, and because of the low dropout, we did not perform per protocol analyses. Intention-to-treat analyses were used and baseline values were carried forward for the 1 woman who dropped out in each group. P values < .05 were considered statistically significant.
Results
One hundred forty-five women with POP were recruited to the trial from November 2005–April 2008. The flowchart ( Figure ) presents the numbers and reasons for exclusion. Of the 109 participants, 59 were randomly allocated to intensive PFMT and 50 to the control group. One woman in each group dropped out because of motivation problems (PFMT group) and urinary incontinence surgery offered at another hospital (control group).
Baseline
The mean age of the 109 participants was 48.9 years (SD ± 11.8) and 19 were classified as POP stage I, 65 as stage II, and 24 as stage III. One was not classified, as she was not able to perform a Valsalva maneuver during POP-Q. However, her POP-Q values at rest and the ultrasound imaging confirmed that she had POP stage I or greater. Table 1 presents background variables. There were no statistical differences between groups regarding age, parity, stage of POP, proportion of women with positive values for any POP-Q measure, or outcome measures at baseline, except that 43 of 59 women in the PFMT group compared with 26 of 50 women in the control group had prolapse symptoms ( P = .024). Twelve of the 44 postmenopausal women received hormone/estrogen replacement therapy.
| Detail | PFMT, n = 59 | Control, n = 50 |
|---|---|---|
| Background variables | ||
| Age, y | 49.4 (12.2) | 48.3 (11.4) |
| Postmenopausal, n (%) | 26 (44.1) | 18 (36.0) |
| Body mass index, kg/m 2 | 25.8 (3.8) | 26.18 (5.3) |
| Parity | 2.4 (0.8) | 2.4 (0.7) |
| With anterior wall POP, n (%) | 54 (93.1) | 49 (98.0) |
| With posterior wall POP, n (%) | 46 (79.3) | 42 (84.0) |
| With apical POP, n (%) | 47 (81.0) | 41 (82.0) |
| Stage of POP (POP-Q) | ||
| With stage I, n (%) | 8 (13.8) | 11 (22.0) |
| With stage II, n (%) | 36 (63.8) | 29 (58.0) |
| With stage III, n (%) | 14 (22.4) | 10 (20.0) |
| With positive POP-Q value, n (%) | 25 (41.3) | 15 (30.0) |
| Ultrasound measurements, vertical resting position of | ||
| Bladder neck, mm | 16.7 (9.2) | 19.3 (7.2) |
| Rectal ampulla, mm | 10.2 (11.1) | 10.9 (12.5) |
| Symptoms | ||
| With prolapse symptoms, n (%) | 43 (72.9) | 26 (52.0) |
| With bladder symptoms, n (%) | 51 (86.4) | 36 (72.0) |
| ICIQ-UI-SF | 7.4 (5.9) | 5.4 (4.7) |
| With bowel symptoms, n (%) | 38 (64.4) | 27 (54.0) |
| PFM function | ||
| PFM strength, cmH 2 O | 29.8 (18.6) | 30.8 (20.2) |
| PFM endurance, cmH 2 O sec | 212 (151) | 209 (152) |
| Vaginal resting pressure, cmH 2 O | 27.0 (7.5) | 30.3 (12.1) |
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