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Research Reports |
DF Borello-France, PT, PhD, is Assistant Professor, Department of Physical Therapy, 111 Health Sciences Bldg, Duquesne University, Pittsburgh, PA 15282 (USA)
VL Handa, MD, is Associate Professor, Gynecology and Obstetrics, Johns Hopkins University, Baltimore, Md
MB Brown, PhD, is Professor, Department of Biostatistics, University of Michigan, Ann Arbor, Mich
P Goode, MD, MSN, is Associate Director for Clinical Programs, Geriatric Research, Education, and Clinical Center, Birmingham Veterans Affairs Medical Center, and Professor of Medicine, University of Alabama at Birmingham, Birmingham, Ala
K Kreder, MD, is Professor and Vice Chair, Department of Urology, University of Iowa, Iowa City, Iowa
LL Scheufele, PT, BScPT, BCIA-PMDB, GCFP, is Pelvic Floor Physical Therapist, Johns Hopkins Bayview Medical Center, Baltimore, Md
AM Weber, MD, MS, is Project Scientist, Pelvic Floor Disorders Network, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md
Pelvic Floor Disorders Network (see listing of member sites and investigators in the Footnotes)
Address all correspondence to Dr Borello-France at: borellofrance{at}duq.edu
Submitted June 12, 2006;
Accepted December 21, 2006
 | Abstract |
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Subjects and Methods: Three hundred seventeen women without urinary stress incontinence who were enrolled in a multicenter surgical trial were examined to determine pelvic-floor muscle function (by Brink scale score). The subjects were 61.6±10.2 (
±SD) years of age. Thirteen percent of the subjects had stage II (to the hymen) pelvic organ prolapse, 68% had stage III (beyond the hymen) prolapse, and 19% had stage IV (complete vaginal eversion) prolapse. Subjects with lowest (3–6) and highest (10–12) Brink scale scores were compared on prolapse severity, pelvic symptoms and bother, quality of life, and sexual function.
Results: Subjects with the highest Brink scores (n=75) had less advanced prolapse, smaller genital hiatus measurements, and less urinary symptom burden compared with those with the lowest Brink scores (n=56). The results indicated that pelvic-floor muscle function was not associated with condition-specific quality of life or sexual function.
Discussion and Conclusion: Although modestly clinically significant, better pelvic-floor muscle function was associated with less severe prolapse and urinary symptoms.
| Introduction |
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 TopAbstract Introduction MethodResultsDiscussion and ConclusionsReferences |
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Normal support of the pelvic organs depends on the integrity of the pelvic-floor muscles, the supportive connective tissue of the vagina (the endopelvic fascia and the uterosacral and cardinal ligaments), and normal innervation.7 The pelvic-floor muscles include the pubococcygeus, puborectalis, and iliococcygeus (collectively known as the levator ani muscles).8 When functioning properly, tonic and voluntary activity of the levator ani muscles narrows the urogenital hiatus and draws the urethra, vagina, and rectum toward the pubic bone. In this situation, the supporting connective tissues experience minimal tension. Loss of levator ani muscle function has been proposed as a mechanism for prolapse.7 As muscular support is lost, the urogenital hiatus widens and connective tissue support, under tension, become stretched or torn, thus leading to prolapse.7
Loss of pelvic-floor muscle support is only one of the many risk factors for developing prolapse.9,10 Samuelsson et al11 investigated factors related to prolapse in 487 Swedish women who were receiving gynecologic care. Among multiple variables, age, parity, and pelvic-floor muscle strength (force-generating capacity, as estimated by vaginal palpation) were associated with prolapse. However, only 2% of the women in the study by Samuelsson et al had pelvic organ prolapse severe enough to reach the vaginal introitus.
In a study of 358 women after prolapse surgery, Vakili et al12 found that women with greater preoperative pelvic-floor muscle strength (as assessed by vaginal palpation) had less recurrent prolapse and were less likely to have repeat surgery. Because of the retrospective nature of this study, missing data led to the elimination of some cases, potentially introducing a selection bias. Given the limitations of both studies,11,12 further investigation toward understanding the relationship between pelvic-floor muscle function and pelvic organ prolapse and its effect on QOL and sexual function is needed.
Understanding the degree of risk that a given factor contributes to the etiology of prolapse is important in both prevention and intervention. A recent randomized controlled study including pelvic floor muscle exercise as an adjunct to surgery for pelvic organ prolapse or urinary incontinence demonstrated improvements in continence status, diurnal urinary frequency, pelvic floor muscle strength, and QOL.13 However, the effectiveness of pelvic floor muscle exercise alone as an intervention for pelvic organ prolapse had not been determined.14 Exploring the relationship of pelvic-floor muscle function and prolapse is a preliminary step toward answering this question. The aim of this prospective study was to determine whether prolapse severity; pelvic symptoms; condition-specific, health-related QOL; and sexual function differ based on pelvic-floor muscle strength in women who are planning to have surgery for prolapse. We hypothesized that women with better pelvic-floor muscles function would have less severe prolapse, fewer pelvic symptoms, and better QOL and sexual function.
| Method |
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TopAbstractIntroductionMethodResultsDiscussion and ConclusionsReferences |
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To be defined as stress continent for study eligibility, women were screened at the clinical sites by completing the Medical, Epidemiologic, and Social Aspects of Aging (MESA) questionnaire16 and answering "never" or "rarely" to the stress incontinence questions. However, at subsequent telephone interviewing, about 20% of the eligible subjects did experience some level of stress incontinence. In addition, women could experience urge incontinence and still be eligible for the study. The institutional review board at each PFDN clinical site and the data coordinating center at the University of Michigan approved the protocol, and all participants provided written informed consent.
Procedure
Prolapse stage and pelvic-floor muscle function data were obtained by the site research nurse or surgeon investigator according to standardized criteria documented in the study procedural manual. Staff from the central telephone interviewing facility at the University of Michigan administered baseline symptom, QOL, and sexual function questionnaires to participants.
Pelvic organ prolapse stage.
The International Continence Society, the American Urogynecologic Society, and the Society of Gynecologic Surgeons have agreed on a standardized system to describe pelvic support in women known as the Pelvic Organ Prolapse Quantification (POP-Q).17 For the POP-Q examination, women were in dorsal lithotomy position. Maximal extent of prolapse was measured (in centimeters) using defined vaginal points relative to the hymen. Points above (or inside) the hymen were negative numbers (eg, –3 cm), and points below (or outside) the hymen were positive numbers (eg, +3 cm); points at the hymen were 0 cm. All vaginal points were measured with maximal valsalva effort except for total vaginal length, which was measured at rest. Genital hiatus was measured at rest and with maximal valsalva effort.
The POP-Q measures (Fig. 1) included in the analyses, in addition to ordinal prolapse stage, were: (1) greatest descent of the anterior vagina (point "Ba") and posterior vagina (point "Bp"); (2) the cervix or the vaginal cuff in women without a uterus (point "C"); (3) for women with a uterus, the posterior fornix (point "D"); (4) total vaginal length (ie, the greatest depth of the vagina when point "C" or "D" was reduced to normal position); and (5) genital hiatus (ie, the distance from the middle of the external urethral meatus to the inferior hymenal ring).17 Intraobserver reliability coefficients (r) for the POP-Q measures have been reported to range from .522 (point "C") to .912 (genital hiatus). Interobserver reliability coefficients (r) ranged from .765 (point "C") to .934 (point "Ba").18
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Pelvic-floor muscle function.
Pelvic-floor muscle function is defined as the ability to perform a correct contraction, meaning a squeeze around pelvic openings and an inward, upward movement (lift) of the pelvic floor.19 Pelvic-floor muscle function was examined by vaginal palpation and quantified using the standardized Brink scale.20 The Brink scale considers 3 dimensions to evaluate the pelvic-floor muscle contraction: (1) squeeze pressure felt around the examiner's fingers, (2) duration, and (3) vertical displacement of the examiner's fingers. Each dimension or subscale is rated separately on a 4-point categorical scale, and the ratings then are summed for a composite score ranging from 3 to 12, with a higher score indicating better muscle function (Tab. 1.)
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Examiners followed standardized criteria for pelvic-floor muscle examination and Brink scale scoring specified in the study policy and procedure manual. The pelvic-floor muscle examinations were performed with women positioned supine with their hips flexed and slightly abducted and knees flexed. An examiner's gloved and lubricated index and middle fingers, oriented vertically, were inserted along the posterior vagina to the level of the examiner's proximal interphalangeal joints. Women were asked to contract their pelvic-floor muscles following the instruction: "Squeeze around my fingers as hard and as long as you can, as if you are trying to hold back the passage of gas or a bowel movement."
If a subject performed the contraction incorrectly (by straining or contracting her hip muscles instead of her pelvic-floor muscles), the examiner did not rate or record a Brink scale score for this contraction but provided feedback to the subject on how to contract her muscles correctly and then asked her to perform another pelvic-floor muscle contraction. If the contraction was performed correctly, the examiner rated the squeeze pressure and vertical displacement dimensions according to Brink scale criteria.20 Muscle contraction duration was determined and rated during a separate pelvic-floor muscle contraction. Examiners timed the contraction using a stopwatch. The stopwatch was stopped when the contraction weakened, or if the subject maintained the contraction beyond 8 seconds. Subjects were cautioned not to "bear down" or perform a Valsalva maneuver during all pelvic-floor muscle contractions. A brief rest period (20–30 seconds) was given between contractions.
Symptom burden, quality of life, and sexual function.
The Pelvic Floor Distress Inventory (PFDI)22 assesses pelvic-floor symptoms across 3 subscales: the Urinary Distress Inventory (UDI), the Pelvic Organ Prolapse Distress Inventory (POPDI), and the Colorectal-anal Distress Inventory (CRADI). In completing the PFDI, subjects are asked to indicate whether they have a particular symptom and, if so, to assess how much it bothers them on a 4-point scale ranging from 1 ("not at all") to 4 ("quite a bit"). Scores for the UDI and the POPDI range from 0 to 300, and scores for the CRADI range from 0 to 400. Higher scores indicate more symptoms and worse symptom bother.
The effect of pelvic symptoms on QOL was assessed using the Pelvic Floor Impact Questionnaire (PFIQ).22 The PFIQ also contains 3 subscales: the Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colo-Rectal-Anal Impact Questionnaire (CRAIQ). The degree to which pelvic symptoms affect QOL, in particular physical activity, social relationships, travel, and emotional health, is rated on a categorical scale, with scores ranging from 1 (activity/feeling affected "not at all") to 4 (activity/feeling affected "quite a bit"). Each subscale of the PFIQ is rated from 0 to 300, with higher scores indicating a worse effect on QOL. Both the PFDI and the PFIQ have been tested for internal consistency, reproducibility, and validity.22
To assess sexual function, subjects were asked to respond to the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12),23 which measures sexual function across 3 factors: behavioral/ emotive, physical, and partner-related. The PISQ-12 scores can be reported as scores for individual items or as a total score, ranging from 0 to 48, with higher scores indicating better sexual function. Test-retest reliability and validity of the PISQ-12 have been reported for sexually active women.23 A PISQ-12 score can be computed only for women who complete at least 11 of the 12 items.23
Data Analysis
We aimed, a priori, to compare women with the best and worst pelvic-floor muscle function with respect to prolapse severity and QOL. All hypotheses assumed that the greatest difference would be found between subjects with the highest and lowest Brink scale quartiles. Because we aimed to assess whether prolapse severity, POP-Q, and QOL outcomes differed as a function of Brink scale score, we chose to present the outcome scores according to Brink scale scoring categories. Therefore, Brink scale scores were categorized into low, medium, and high quartiles for analysis.
Treating Brink scale scores as categorical, we first grouped subjects based on approximate Brink scale quartiles, representing 25% of the study population with the lowest scores (3–6), 50% of subjects in the middle range (7–9), and the remaining 25% with the highest scores (10–12). If the distribution by scores had been perfectly even, the number of subjects in each quartile would be 80 (25% of 320); however, because the distribution was not perfect, the resultant groups contained 56, 186, and 75 subjects, respectively. The Fisher exact test was used to compare women in the highest and lowest Brink scale quartiles on menopausal status and POP-Q stage, and an age-adjusted analysis of variance (ANOVA) was used to compare POP-Q points. The 2-tailed Wilcoxon rank sum test was used for comparisons of PFDI, PFIQ, and PISQ scores due to their skewed distributions.
We also aimed to determine whether Brink scale scores differed by prolapse stage. For these analyses, Brink scale scores were treated as continuous. A 2-sample t test was used for comparisons of Brink subscale scores between women with stage IV versus stage II prolapse. The total Brink scale scores of women with stage IV versus stage II prolapse were compared by age-adjusted ANOVA.
With 56 and 75 subjects in the 2 Brink scale quartiles being compared, there was 80% power to identify an effect size of 0.5 (ie, a difference of 0.5 standard deviations). In addition, there was 80% power to identify a difference between proportions of 50% and 75%, or of similar magnitude.
| Results |
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TopAbstractIntroductionMethodResultsDiscussion and ConclusionsReferences |
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Age, self-reported menopausal status, POP-Q stage, and selected POP-Q points are presented in Table 2. Menopausal status and POP-Q stage did not differ between Brink scale quartiles. Age decreased from the lowest to the highest Brink scale quartile, but the difference was only marginally statistically significant (P=.05). Mean genital hiatus with maximal strain was 0.8 cm smaller in the women in the highest Brink scale quartile compared with those in the lowest Brink scale quartile (P=.01). Other POP-Q measures did not differ between Brink scale quartiles.
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| Discussion and Conclusions |
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TopAbstractIntroductionMethodResultsDiscussion and ConclusionsReferences |
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Another plausible explanation is that prolapse contributes to pelvic-floor muscle weakness. Advancing prolapse could cause passive stretch and impaired contractility of the pelvic-floor muscles.24 It is possible that pelvic-floor muscle dysfunction could both contribute to the development of prolapse and represent a consequence of prolapse. By the time women reach clinical care for prolapse, it is not possible to determine which came first. Longitudinal studies would help to determine the temporal relationship between pelvic-floor muscle weakness and prolapse.
It is noteworthy that, despite the differences observed, Brink scale quartiles did not distinguish between stages of prolapse. It may be that, once prolapse of a certain degree (eg, stage II) develops, pelvic-floor muscle function is not further impaired. That is, the reason that the Brink scale quartiles were similar across stages of prolapse may be that a certain level of pelvic-floor muscle dysfunction had been reached and, regardless of further advancement of the prolapse itself, the level of pelvic-floor muscle function (or dysfunction) remained stable.
We selected vaginal palpation to assess pelvic-floor muscle function because of its practicality in both research and clinical settings. The standardized Brink scale was desirable as an evaluation scale because of its demonstrated interrater reproducibility, test-retest reliability, and validity20 and because of its prior use in research related to pelvic-floor disorders.21 It is possible, however, that the Brink method of assessing pelvic-floor muscle function is not sufficiently precise to demonstrate a clear association with prolapse severity.
Physical therapists may be more familiar with other pelvic-floor muscle grading scales, such as the Oxford or Laycock scale,25 which evaluates strength of contraction on a 6-point scale ranging from 0 (no contraction) to 5 (strong contraction). In contrast, the Brink scale measures 3 different aspects of pelvic-floor muscle function: squeeze pressure, duration of contraction, and vertical displacement. In this study, we assigned categorization to the total Brink scale score, with the connotation of poor pelvic-floor muscle function for the low scores and good, or at least better, pelvic-floor muscle function to the high scores. This categorization is relatively arbitrary and has not been separately validated.
Studies are needed to compare various scales for evaluating pelvic-floor muscle function based on digital examination with each other and with other means of assessing pelvic-floor muscle function, such as pressure perineometry or force measurements. In addition, pelvic-floor muscle function tests and measures have not been adequately evaluated for construct validity, particularly with regard to identifying aspects of muscle physiology that are most critical to providing pelvic support. Thus, there is no consensus as to how to "best" assess pelvic-floor muscle function, and overcoming this current limitation should be a high priority for future research.
Although we found a statistically significant association between prolapse severity and Brink scale scores, we observed considerable overlap in Brink scale scores across prolapse stages (Fig. 2), and comparisons by Brink scale quartiles and prolapse stage were not statistically significant (Tab. 2). These findings are not surprising, given the multifactorial etiology of prolapse. However, they do limit the clinical interpretation of our findings, especially in the absence of comparison data from women without prolapse. Regardless, we suggest that it is prudent to consider all known risk factors when determining a physical therapist prognosis and plan of care for a woman with pelvic organ prolapse.
We also observed a statistically significant association between Brink scale quartile and UDI score, which reflects the number of urinary symptoms and their associated bother. Again, the magnitude of the difference between the lower and upper Brink scale quartiles was modest: a 17-point difference between the means, in a subscale with an upper limit of 300 points. Poor pelvic-floor muscle function has been correlated with urinary incontinence. Women with stress incontinence have weaker pelvic-floor muscles,26–28 and pelvic-floor muscle exercise is an effective intervention for stress and urge incontinence.29 In our study, women who reported stress incontinence on the MESA questionnaire were excluded by study design; yet, we still observed a small increase in UDI scores among women with poor pelvic-floor muscle function. This finding suggests that pelvic-floor muscle weakness may predispose women to other urinary symptoms besides stress incontinence; whether prolapse is a key feature of this association or not is unknown.
Other than urinary incontinence, Brink scale quartiles were not associated with other pelvic-floor symptoms. For example, we did not see an association between pelvic-floor muscle function and severity of prolapse symptoms (ie, POPDI and POPIQ scores), colorectal symptoms (ie, CRADI and CRAIQ scores), or sexual function (PISQ-12 scores). Pelvic symptoms have correlated poorly, if at all, with clinical measurements of prolapse severity.30–32 The findings of our study support the perception of prolapse symptoms and their associated bother as complex and incompletely understood at the current time. Other demographic, etiologic, and psychosocial variables may play a greater role in symptom bother and effect on QOL than pelvic-floor muscle function in women with prolapse.
A limitation of this study was that we included only women who had prolapse bothersome enough to seek treatment. In addition, only women who were eligible and who agreed to enroll in a randomized surgical trial for prolapse contributed data to this study, potentially limiting the generalizability of our findings. The cross-sectional nature of this study also precludes us from determining a causal or temporal relationship between pelvic-floor muscle function and prolapse.
This study's results cannot be used directly to support the potential preventative role of pelvic-floor muscle exercise for women with prolapse. Recent research has begun to examine whether pelvic-floor muscle exercise is effective as a primary or secondary prevention for pelvic organ prolapse.13 Certainly, pelvic-floor muscle exercise has a well-established role in the prevention and management of other pelvic-floor disorders, including urinary and fecal incontinence.29 Further research is needed to investigate the potential for physical therapy interventions in the prevention and rehabilitation of pelvic organ prolapse.
| Footnotes |
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Pelvic Floor Disorders Network Members: University of Alabama at Birmingham—Holly E Richter, PhD, MD (Principal Investigator), Kathryn L Burgio, PhD (Co-Principal Investigator), Patricia S Goode, MD (Co-Investigator), R Edward Varner, MD (Co-Investigator), Velria Willis, RN, BSN (Research Coordinator); Baylor College of Medicine—Paul M Fine, MD (Principal Investigator), Rodney A Appell, MD (Co-Principal Investigator), Peter K Thompson, MD (Co-Investigator), Peter M Lotze, MD (Co-Investigator), Naomi Frierson (Research Coordinator); University of Iowa—Ingrid Nygaard, MD (Principal Investigator), Debra Brandt, RN (Research Coordinator), Denise Haury, RN (Research Coordinator), Karl Kreder, MD (Co-Investigator), Catherine Bradley, MD (Co-Investigator), Satish Rao, MD (Co-Investigator); Johns Hopkins Medical Institutes—Geoffrey Cundiff, MD (Principal Investigator), Victoria Handa, MD (Co-Investigator), Robert Gutman, MD (Co-Investigator), Mary Elizabeth Sauter, NP (Research Coordinator), Jamie Wright, MD (Co-Investigator); Loyola University, Chicago—Linda Brubaker, MD (Principal Investigator), Mary Pat Fitzgerald, MD (Co-Principal Investigator), Kimberly Kenton, MD (Co-Investigator), Dorothea Koch, RN (Research Coordinator), Charity Ball, RN (Research Coordinator); University of North Carolina at Chapel Hill—Anthony G Visco, MD (Principal Investigator), AnnaMarie Connolly, MD (Co-Investigator), John Lavelle, MD (Co-Investigator), Mary J Loomis, RN (Research Coordinator), Anita K Murphy, NP (Research Coordinator), Ellen C Wells, MD (Co-Investigator), William E Whitehead, PhD (Co-Investigator); University of Pittsburgh/Magee–Womens Hospitals—Halina Zyczynski, MD (Principal Investigator), Diane Borello-France, PhD (Co-Investigator), Judy A Gruss, BS, MS (Research Coordinator), Wendy Leng, MD (Co-Investigator), Pamela A Moalli, MD, PhD (Co-Investigator), Elizabeth Sagan, MD (Co-Investigator), Arnold Wald, MD (Co-Investigator); Data Coordinating Center, University of Michigan—Morton B Brown, PhD (Principal Investigator), John T Wei, MD, MS (Co-Principal Investigator), Beverley Marchant, RN (Project Manager), John OL DeLancey, MD (Co-Investigator), Nancy K Janz, PhD (Co-Investigator), Dean G Smith, PhD (Co-Investigator), Patricia A Wren, PhD (Co-Investigator), Li Peng, MS (Statistician), James Imus, MS (Statistician), Yang Wang Casher, MS (Database Programmer); Steering Committee Chairman—Robert Park, MD; NIH Project Scientist—Anne M Weber, MD, MS.
A poster presentation of this research was given at the 2005 American Urogynecologic Society Meeting; September 15–17, 2005; Atlanta, Ga.
This article reflects work performed by the Pelvic Floor Disorders Network, supported by the National Institute of Child Health and Human Development (grants U01 HD41249, U10 HD41268, U10 HD41248, U10 HD41250, U10 HD41261, U10 HD41263, U10 HD41269, and U10 HD41267).
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