- Email: [email protected]
Correlation of symptoms with degree of pelvic organ support in a general population of women: what is pelvic organ prolapse?
Correlation of symptoms with degree of pelvic organ support in a general population of women: What is pelvic organ prolapse? Steven E. Swift, MD,a Susan B. Tate, MD,a and Joyce Nicholas, PhDb Charleston, SC OBJECTIVE: The purpose of this study was to evaluate the correlation between the symptoms of pelvic organ prolapse and the stage of support as determined by the pelvic organ prolapse quantification system. STUDY DESIGN: Four hundred ninety-seven women who were seen for annual gynecologic examinations were recruited. Subjects underwent a pelvic examination and their degree of pelvic support was described according to the pelvic organ prolapse quantification system. They also completed a seven-question questionnaire regarding common symptoms of pelvic organ prolapse. Trend analysis was accomplished with linear regression. RESULTS: Only 477 subjects correctly responded to the questionnaire. They were aged 18 to 82 years (mean age, 44 years). Forty-seven percent were white, 52% were African American, and 1% were of another racial group. The number of subjects with the various pelvic organ prolapse quantification stages were stage 0 (18 subjects), stage I (214 subjects), stage II (231 subjects), and stage III (14 subjects). No subject had stage IV prolapse. The average number of positive responses per subject for the symptoms was 0.27 for stage 0, 0.55 for stage I, 0.77 for stage II, and 2.1 for stage III. This trend did not attain statistical significance. The correlation of symptoms with the leading edge of the prolapse revealed that the average number of symptoms that were reported per subject increased from <1 to >1 when the leading edge of the prolapse extended beyond the hymenal remnants. This trend was statistically significant. CONCLUSION: Women with pelvic organ prolapse with the leading edge of the prolapse beyond the hymenal remnants (some stage II and all stage III) have increased symptoms, which may help define symptomatic pelvic organ prolapse. (Am J Obstet Gynecol 2003;189:372-9.)
Key words: Pelvic organ prolapse
What is pelvic organ prolapse, and how do we define it? The answers to these questions may appear obvious but actually are very nebulous, and this represents a large deficit in the knowledge base of modern gynecology. The problem is highlighted by the American College of Obstetricians and Gynecologists technical bulletin on pelvic organ prolapse in which pelvic organ prolapse was defined as ‘‘. . .protrusions of the pelvic organs into or out of the vaginal canal.’’1 This definition is very vague and covers a wide range of subjects from those with any mobility of the vaginal walls to subjects with complete uterovaginal eversion. Arguably, this definition includes >95% of the adult female population and probably
From the Departments of aObstetrics and Gynecology and bBiometry and Epidemiology, Medical University of South Carolina, Charleston, SC, USA. Presented at the Sixty-Fifth Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, January 25-28, 2003, Hot Springs, Va. Reprint requests: Steven Swift, MD, Department of Obstetrics and Gynecology, Medical University of South Carolina, 96 Jonathon Lucas St, Suite 634, PO Box 250619, Charleston, SC 29425. E-mail: [email protected] Ó 2003, Mosby, Inc. All rights reserved. 0002-9378/2003 $30.00 + 0 doi:10.1067/S0002-9378(03)00698-7
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almost every women who has ever been delivered of a term fetus. Another issue in defining pelvic organ prolapse regards the patient’s symptoms. This is a condition that has its greatest impact on the patient’s quality of life and infrequently is associated with significant morbidity. Therefore, it should be defined, in part, according to the degree of symptoms that a patient has. Currently, we have some information on the distribution of pelvic organ support in various populations, but very little data exist that correlate symptoms with physical findings. It has been shown that approximately 3% to 6% of the population will have pelvic organ support defects so that the leading edge of the vagina is past the vaginal introitus.2-5 This represents pelvic organ prolapse that is generally recognized by clinicians as significant and intuitively is symptomatic. However, do women with lesser degrees of prolapse have significant symptoms? Do all those women with prolapse past the introitus have significant symptoms? It has yet to be established at what point or stage of support a patient with pelvic support defects become symptomatic. This study evaluated the correlation of symptoms of pelvic organ prolapse with the degree of pelvic organ support as defined by the pelvic organ prolapse
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quantification (POPQ) examination. This allowed for a determination of the stage or point at which patients begin to experience the symptoms of prolapse and allows for a better definition of symptomatic pelvic organ prolapse. Material and methods This was a study of 497 women aged $18 years who were seen at one of four centers for routine gynecologic health care. The detailed description of this population and the distribution of their pelvic organ support has been published previously.2 Subjects were eligible for inclusion if they were seeking annual gynecologic examinations or had any gynecologic complaints that required a pelvic examination and Papanicolaou test as part of their visit. Therefore, a portion of their visit was dedicated to routine gynecologic health care. Pregnant subjects or subjects who were within 6 weeks after delivery were excluded. Only subjects who were examined by obstetrics-gynecology residents or attending physicians who were familiar with the POPQ classification system were recruited to participate in the study. After informed consent was obtained, subjects underwent a POPQ examination in the dorsal lithotomy position.6 All points, except the total vaginal length, were recorded while the subject performed maximal Valsalva effort. If it was felt that the subject was not able to perform a Valsalva maneuver, the subject was first coached by the examiner in the performance of a Valsalva maneuver. If they still could not perform a Valsalva maneuver, the measurements were recorded with the subject forcefully coughing. Measurements were obtained and recorded according to the document describing the POPQ system.7 Subjects were then assigned a POPQ stage: stage 0, no prolapse; stage I, leading edge of the prolapse is >1 cm above the hymen; stage II, leading edge of the prolapse is #1 cm proximal or distal to the plane of the hymen; stage III, leading edge of the prolapse is >1 cm below the plane of the hymen but protrudes no further than 2 cm less than the total vaginal length; and stage IV, essentially complete eversion of the total lower genital tract. At this same visit, patients were asked to complete a seven-question questionnaire that consisted of questions that relate to symptoms that are associated commonly with pelvic organ prolapse. The seven questions involved the presence of the following symptoms: (1) a sense of something falling out of the vagina, (2) the ability to see or feel a vaginal bulge, (3) low back or groin pain after standing, (4) low back or groin pain worse at the end of the day, (5) urinary incontinence, (6) fecal or flatus incontinence, and (7) splinting to defecate. The possible responses were ‘‘yes,’’ ‘‘no,’’ or ‘‘sometimes.’’ If they answered ‘‘yes’’ or ‘‘sometimes’’ to any of these seven questions, there was a follow-up question that queried whether this symptom bothered them, to which the only
response was ‘‘yes’’ or ‘‘no.’’ Therefore, we had a question regarding the presence of the seven symptoms and a second level of questions regarding bothersomeness. Statistical analysis was completed using SPSS software (version 10.0.5; SPSS Inc, Chicago, Ill). Trend analyses for Tables I and II were completed with simple linear regression, which was weighted by sample size. Results This was an observational study of the relationship between the symptoms of pelvic organ prolapse and the degree of support that is present, as defined by the POPQ system. Between June 1997 and November 1998, a total of 497 women were examined at four centers. Most of the subjects (86%) were seen at the Medical University of South Carolina house staff general outpatient gynecology and obstetrics clinic. The other 14% of subjects were seen at three other outpatient gynecology clinics (Mountain Area Health Education Center, Asheville, NC; Greenville Hospital Systems, Greenville, SC; and the practice of Steven Lewis, MD, Gaffney, SC). Of the 497 women who participated, the 477 women who correctly completed the questionnaires form the basis of this report. All subjects signed an informed consent that was approved by the local Institutional Review Board before participating in this study. The mean age of the subjects was 44 years (range, 18-82 years). Forty-seven percent of the subjects were white; 52% of the subjects were African American, and 1% of the subjects were of another racial group. The POPQ stages for the subjects were 18 subjects with stage 0 prolapse, 214 subjects with stage I prolapse, 231 subjects with stage II prolapse, and 14 subjects with stage III prolapse. No subjects in this study had stage IV prolapse. The symptoms of low back and groin pain were very common among women with any degree of support or prolapse. Forty-eight percent of subjects responded positively to the symptom of low back or groin pain, with 33% of subjects reporting this as a bothersome symptom. The average number of positive responses to the two questions about low back or groin pain per subject by POPQ stage was 0.88 positive responses per subject with stage 0 prolapse, 1.15 positive responses per subject with stage I prolapse, 1.25 positive responses per subject with stage II prolapse, and 1.28 positive responses per subject with stage III prolapse. In addition, those five subjects with the most significant prolapse (subjects whose leading edge of their prolapse was >4 cm past the hymenal remnants) did not report any low back or groin pain. This symptom was present uniformly throughout our population and did not appear to aid in the definition of those subjects with worsening prolapse. Therefore, it was excluded from the final analysis because it was deemed too nonspecific to aid in the analysis. The remaining five questions regarding symptoms of pelvic organ prolapse were used for the final analysis.
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Table I. The correlation between the average number of symptoms and their bothersomeness per subject by stage of support
Stage of support (No. subjects) Stage Stage Stage Stage
No. of positive responses/subject to questions regarding symptoms of pelvic organ prolapse*
0 (26) I (206) II (231) III (14)
0.27 0.55 0.86 2.07
No. of positive responses/subject to questions regarding bothersomeness of symptomsy 0.19 0.35 0.56 1.36
*Not a statistically significant linear trend with stage (P ¼ .222). yNot a statistically significant linear trend with stage (P ¼ .227).
Table II. The correlation between the average number of symptoms and their bothersomeness per subject by the leading edge of their support as measured in centimeters above or past the hymen (per the POPQ)
Leading edge of support (No. subjects) 3 cm (26) 2 cm (206) 1 cm (158) 0 or at hymen (64) +1 cm (9) +2 and +3 cm +4 through +7 cm (5)
No. of positive No. of positive responses/subject responses/subject to to questions regarding questions regarding symptoms of pelvic bothersomeness of organ prolapse* symptomsy 0.27 0.55 0.87 0.75 1.40 2.0 2.2
0.19 0.35 0.57 0.47 1.11 1.56 1.8
*Statistically significant linear trend with leading edge (P ¼ .004). yStatistically significant linear trend with leading edge (P ¼ .005).
Table I shows the average number of positive responses/subject (yes or sometimes) to the five questions regarding symptoms of pelvic organ prolapse by stage. Those subjects with stage 0 to II prolapse had an average of <1 positive response per subject to the five questions. Those with stage III prolapse reported, on average, >2 positive responses/subject to the symptoms in the questionnaire. Table I also shows the average number of positive responses per subject about the bothersomeness of any symptom by stage. Again, those subjects with stage 0 to II prolapse had <1 bothersome positive response per subject; those subjects with stage III prolapse reported, on average, >1 bothersome symptom per subject. Linear regression analysis that was weighted for sample size demonstrated that the increases in symptoms and bothersome symptoms with stage (Table I) did not reach statistical significance (P ¼ .222 and .227, respectively). Table II shows the average number of positive responses per subject (yes or sometimes) to the five questions
regarding symptoms of pelvic organ prolapse by leading edge of vaginal prolapse. Note that the leading edge numbers begin at 3 cm. This is due to the way in which measures are taken and recorded with the POPQ system. Here it can be seen that subjects whose leading edge is at or above the hymenal remnants had on average <1 symptom per subject. Once the leading edge protrudes at least 1 cm past the hymenal remnant, the average number of positive responses per subject increases to >1. Table II also shows the average number of positive responses per subject to the bothersomeness of any symptom by the leading edge of vaginal prolapse. Again, the number of bothersome symptoms per subject increases to >1 as the leading edge descends beyond +1 cm past the hymenal remnants. Linear regression of the data revealed a statistically significant trend of increasing positive responses per subject to questions regarding symptoms of pelvic organ prolapse as the leading edge of their pelvic support advanced from 3 cm to +4 through +7 cm (P ¼ .004, Table II). Additionally, the number of positive responses per subject to questions regarding bothersomeness of symptoms increased with the advance of the leading edge of support, and this trend was also statistically significant (P ¼ .005). Comment Currently there is a lack of understanding regarding the cause, epidemiologic condition, and natural history of pelvic organ prolapse. Investigations into these areas are hampered by the lack of a good definition of the condition. Severe forms of pelvic organ prolapse can be recognized as abnormal by even the most novice health care provider, and good pelvic organ support can be discerned by those providers who are familiar with gynecology. However, defining the point at which a woman goes from normal support to pathologic pelvic organ prolapse is difficult. Currently, definitions of pelvic organ prolapse are varied with no consensus. The National Institutes of Health (NIH) recently convened a conference to standardize the terminology for research into pelvic floor disorders.8 In the document that was produced from the conference, it was stated that there is no current definition of pelvic organ prolapse that is acceptable. In addition, they stated that basing a definition on physical findings alone would be incomplete and any definition should include a subject’s symptoms. However, they proceeded to submit a definition and stated that normal pelvic organ support is the complete lack of any prolapse. They then defined pelvic organ prolapse as ‘‘Descent of the vagina . . . cervix, apex, anterior or posterior vaginal wall . . . to within 1 cm of the hymen or lower: stage I or worse by ICS (POPQ) staging.’’ According to the published research, this proposed definition would classify between 30% and 90% of the population as having abnormal pelvic organ support.2-5
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The NIH conference made no recommendations regarding how symptoms should be incorporated into a definition. So, although the participants of the NIH conference based their recommendations on the best available information at that time, again we are left with an incomplete definition of abnormal pelvic organ support or prolapse that is based solely on physical findings. This study looked at data that were collected during a study of the distribution of pelvic organ support in a population of women who came in contact with gynecologic health care providers for annual health care maintenance (subjects who needed an annual Papanicolaou smear).2 As part of this study, subjects were required to complete a short questionnaire of seven questions regarding what were, at that time, described as the classic symptoms that were associated with pelvic organ prolapse. This list of symptoms was devised from the American College of Obstetricians and Gynecologists technical bulletin on pelvic organ prolapse and the American Urogynecologic Society quarterly report on enterocele.1,9 The questionnaire used in this study was devised in 1996 before the development of good quality-of-life tools for the assessment of the symptoms of pelvic organ prolapse. The subjects were asked to respond ‘‘yes,’’ ‘‘no,’’ or ‘‘sometimes’’ to the seven questions. These questions queried subjects about (1) the sense of something coming out of the vagina, (2) the ability to feel or see something protruding from the vagina, (3) and (4) the presence of lower back or groin pain after prolonged standing or at the end of the day, (5) the presence of urinary incontinence, (6) the presence of fecal and flatus incontinence, and (7) the need to splint to defecate. If subjects responded ‘‘yes’’ or ‘‘sometimes’’ to any of these questions, they were queried further by a follow-up question. They were asked whether the symptom in question bothered, to which they could respond only ‘‘yes’’ or ‘‘no.’’ This was done to document the presence of symptoms of prolapse and to further determine whether that symptom bothered the subject. To assess the subject’s level of pelvic organ support, we used the POPQ system.7,10 The POPQ is a very reliable and specific technique that measures in centimeters the support of various aspects of the vaginal canal. All measures are taken in reference to the hymenal remnants. If the leading edge of the vaginal segment that is being measured remains above the hymenal remnant, it is given a negative designation; if it is at the level of the hymen, it is designated 0, and if it protrudes beyond the hymenal remnants, it has a positive designation. Two values are obtained for the anterior, apex, and posterior vaginal walls. By using this system, a complete and detailed diagram of the subject’s vaginal support is obtained. In addition, a less-specific ordinal stage of support is assigned as well. This allowed for the correlation of vaginal support, by both ordinal stage and leading edge in
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centimeters, with the number of symptoms that were reported and the bothersomeness of those symptoms in this population. The population that was studied in this report involved subjects with a variety of concerns who were seeking gynecologic health care and who required a pelvic examination and annual Papanicolaou test as part of their visit. This represents a typical gynecologic patient and therefore is not a population that was selected for either the presence or absence of pelvic organ prolapse. Accordingly, this lead to a small number of subjects with significant prolapse. However, this is probably a more accurate reflection of the population of subjects who are seen by a gynecologic health care provider; this study represents a less biased look at the correlation of symptoms with pelvic organ support than previous research that queried subjects who were being seen specifically for the evaluation of prolapse. One of the most interesting findings from the data, on reported symptoms, was the common report of low back or groin pain in our population. Almost one half of our subjects reported this symptom, and one third of the subjects reported it as bothersome. This made us question the inclusion of this data in our final analysis because the symptom appeared very nonspecific to the condition being evaluated. Recently, the association between pelvic organ prolapse and pelvic or low back pain was evaluated specifically.11 It was noted that pelvic and low back pain scores were similar, regardless of the degree of prolapse, and that scores for pain actually improved with increasing prolapse. In another report, regarding a quality-of-life tool that was designed specifically for pelvic organ prolapse, the symptom of low back and groin pain was discounted. A questionnaire was developed that included 17 questions regarding specific symptoms of pelvic organ prolapse. Of those 17 questions, only 1 question mentioned low back pain and then only in conjunction with vaginal pain.12 Therefore, it is not surprising that this symptom was unreliable in our population and that we thus left the 2 questions regarding low back and groin pain out of our final analysis. Five questions remained regarding symptoms of pelvic organ prolapse and the degree to which the symptoms bothered the subject. From Table I, it can be seen that the number of symptoms per subject and the number of positive bothersome responses per subject increase as subject’s stage of prolapse goes from 0 to III. The rise between stage 0 prolapse and II prolapse is gradual, with a more abrupt increase with stage III prolapse. The average number of reported symptoms per subject more then doubles as one goes from stage II prolapse to stage III prolapse. Table I also shows the relationship between the bothersomeness of the symptoms and the stage of support. Again, there are few reported bothersome symptoms per subject with stage 0 to II support, but
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subjects with stage III prolapse report >1 bothersome symptom per subject. These data were analyzed with linear regression, and a statistically significant trend was not demonstrated. This lack of statistical significance may have been due to the weighting done for sample size; there were only 14 subjects with stage III pelvic organ prolapse. Table II shows the relationship between the subjects’ reported symptoms and the leading edge of their support or prolapse as measured in centimeters. This is a more specific measure of the subjects’ prolapse than the ordinal stage; from the Table, it can be appreciated that there is a significant increase in the presence of the symptoms and their bothersomeness once the leading edge reaches +1 cm. This represents a portion of patients with POPQ stage II prolapse and all stage III prolapse. When the leading edge of the prolapse is above the hymenal remnants (leading edge is designated as #0) the number of positive responses per subject to the queries is <1, and the number of bothersome symptoms per subject is much <1. Once the leading edge of the prolapse protrudes beyond the hymenal remnants and the protection of the vaginal canal, the number of symptoms per subject increases abruptly. This is not surprising because it has been shown that one of the most common complaints of subjects with prolapse is the sense of a vaginal bulge that they can see or feel, and this symptom was queried in two of the five questions in the questionnaire.13 Additionally, it is at this same point that subjects become much more bothered by their symptoms. This trend appears obvious from the tables, and the trend of an increasing number of symptoms per subject and the bothersomeness of those symptoms with advancing pelvic organ prolapse was statistically significant. However, although the trend is statistically significant, it does not give us a point or cutoff beyond which subjects are statistically more likely to have symptoms. It seems intuitive that, once the prolapse protrudes out of the vaginal canal, subjects will become more symptomatic; this obviously represents pathologic pelvic organ prolapse. Furthermore, the low incidence of symptoms when the prolapse remains at or above the hymen suggests that this lesser degree of relaxation may not represent true disease, but again these data do not define that point at which a subject goes from normal to pathologic pelvic organ prolapse. The results of this study suggest that a reasonable general definition of abnormal or pathologic pelvic organ support or pelvic organ prolapse is a woman with prolapse that protrudes beyond the hymenal remnants. This does not mean, however, that women with lesser degrees of prolapse should have their symptoms ignored. Subjects with lesser degrees of prolapse should have other possible causes of their symptoms investigated and treated before these symptoms are attributed to pelvic organ prolapse. Alternatively, individuals who are asymptomatic but who have pelvic organ support defects that do not extend past
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the hymenal remnants could be considered normal or could be defined as having asymptomatic pelvic support defects. The real questions involve the treatment of those women with asymptomatic pelvic support defects. Should we intervene in the absence of symptoms, despite anatomic changes, or should we follow conservatively? When is the optimal timing for intervention, early on at the discovery of asymptomatic support defects or only after the patient has experienced more severe symptomatic pelvic organ prolapse? Finally, does early intervention provide for a better surgical result? These questions cannot be answered by the results of this study, but until we develop a meaningful definition of pelvic organ prolapse, its natural history and optimal treatment will remain elusive. This study represents a starting point in the development of a more specific definition of pelvic organ prolapse. With the use of disease-specific questionnaires and querying large numbers of patients who have a wide distribution of pelvic organ support will allow for statistical analysis of trends, which will provide greater insight into the definition of and eventually the understanding of the condition of pelvic organ prolapse.
REFERENCES 1. American College of Obstetricians, and Gynecologists. Pelvic organ prolapse. Washington (DC): The College; 1995. Technical bulletin No.: 214. 2. Swift SE. The distribution of pelvic organ support in a population of women presenting for routine gynecologic health care. Am J Obstet Gynecol 2000;183:277-85. 3. Samuelsson EU, Victor FTA, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol 1999;180: 299-305. 4. Versi E, Harvey M, Cardozo L, Brincat M, Studd J. Urogenital prolapse and atrophy at menopause: a prevalence study. Int Urogynecol J 2001;12:107-10. 5. Bland DR, Earle BB, Vitolins MZ, Burke G. Use of the pelvic organ prolapse staging system of the International Continence Society, American Urogynecologic Society, and the Society of Gynecologic Surgeons in perimenopausal women. Am J Obstet Gynecol 1999; 181:1324-8. 6. Swift SE, Herring MD. Comparison of pelvic organ prolapse in the dorsal lithotomy versus the standing position. Obstet Gynecol 1998;91:961-4. 7. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JOL, Klarskov P, et al. The standardization of terminology of female pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10-7. 8. Weber AM, Abrams P, Brubaker L, Cundiff G, Davis G, Domchowski RR, et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J 2001;12:178-86. 9. American Urogynecologic Society. Enterocele (AUGS Quarterly Report. vol 10, No. 4). Chicago: American Urogynecologic Society; 1992. 10. Hall AF, Theofrastous JP, Cundiff GC, Harris RL, Hamilton LF, Swift SE, et al. Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ prolapse classification system. Am J Obstet Gynecol 1996;175:1467-9. 11. Heit M, Culligan P, Rosenquist C, Shott S. Is pelvic organ prolapse a cause of pelvic or low back pain? Obstet Gynecol 2002;99: 23-8.
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12. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated quality of life questionnaire for the symptomatic assessment of women with uterovaginal prolapse [abstract]. Int Urogynecol J 2000;11(Suppl):S25. 13. Elkerman RM, Cundiff GW, Bent AE, Nihira MA, Melick C. Correlation of symptoms with location and severity of pelvic organ prolapse [abstract]. Int Urogynecol J 2000;11(Suppl):S26.
Discussion DR KATHIE HULLFISH, Charlottesville, Va. Dr Swift and colleagues continue to contribute to our muchneeded database of pelvic floor epidemiologic information. The question included in the title of this manuscript, ‘‘What is pelvic organ prolapse?’’ is often posed to me by medical students and residents alike, and I confess that the exact nature of a satisfactory answer continues to elude me. Webster’s dictionary defines a disease as ‘‘an illness or sickness often characterized by typical patient problems (symptoms) and physical findings (signs).’’1 Furthermore, symptoms are explained as ‘‘any subjective evidence of disease that can only be appreciated by the patient,’’ and signs are explained as ‘‘any objective evidence of disease.’’1 Unlike many disease processes, pelvic organ prolapse defies a precise definition, and our understanding of the pathophysiologic condition of prolapse is in its infancy. Pelvic organ prolapse is not contagious, to the best of our knowledge (so much for the model infectious disease). The ‘‘acquisition’’ of prolapse usually is not incurred at one single point in time, but more often, as the result of multifactorial events over time (with certain aspects of vaginal childbearing, age, obesity, and previous hysterectomy, for example, some commonly cited culprits). Alterations in connective tissue at the cellular level and possibly genomics may help us in the future, but as of now, prolapse is not predictable; we do not know whether there is a precursor disease state. To demonstrate the prevailing confusion about pelvic organ prolapse, one only has to review the evolution of staging definitions over time; pelvic organ prolapse has been subject to multiple years of debate and description, from grades to half-way stages to POPQs.2 The current descriptive study by Dr Swift and colleagues is as an extension of an earlier investigation.3 In that study, Dr Swift described the distribution of pelvic organ support using the POPQ system in 497 women who were being seen for routine outpatient gynecologic care. The POPQ stage distributions showed that most women had either stage I (43.3%) or stage II (47.7%) prolapse. Because disorders of the pelvic floor have a direct impact on a patient’s quality of life, the current investigation is the next logical step to evaluate patient symptoms together with that objective examination. A seven-item dichotomous questionnaire was completed by 477 of the original 497 patients at the time of their POPQ evaluation to query about the presence or absence of any symptoms of bulging or prolapse, low back or groin pain, urinary incontinence, fecal or flatal incontinence, and any need for manual assistance to defecation. A positive response was then further qualified
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as to the presence or absence of ‘‘bothersomeness’’ to the patient for that particular symptom. (Back pain was later disregarded from the study analysis because of its common reporting, which is further substantiated by a recent study by Heit et al.4) The main conclusion was that once prolapse was present more than 1 cm beyond the hymen (ie, stage III pelvic organ prolapse), patients reported $2 queried symptoms with at least one of those symptoms being bothersome. An increased number of symptoms were reported once the leading edge of the prolapse came outside the hymen. On the basis of this preliminary investigation therefore, Dr Swift suggests that pelvic organ prolapse might be considered to be abnormal or pathologic once the leading edge of the prolapse protrudes beyond the hymen. The diagnosis for patients with visible prolapse seems intuitively logical. (And certainly more easy to demonstrate to our students and residents.) However, the question of how to treat those patients who have disturbing quality-of-life symptoms with lesser degrees of prolapse remains puzzling to us all. Moreover, given the fact that this was a cross-sectional study, we do not know how pelvic organ prolapse symptoms might have changed over time in this patient population. Because this work is descriptive, I would like to ask the following questions: 1. The NIH consensus report on the standardized terminology for researchers in the field of female pelvic medicine emphasizes the importance of including patient symptoms in research database collections.5 However, the report does not endorse any one specific quality-of-life instrument. Your study distinguished quality of life from subjective symptoms by first asking for symptoms and then for quality-oflife decrements (‘‘bothersomeness’’) that were associated with those symptoms. a. Can you comment on the various methods that are currently in use for the assessment of quality of life and subjective symptoms and how your investigation might inform us on how best to assess quality of life or subjective symptoms? For instance, what roles do you see for conditionspecific quality-of-life measures (eg, the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire6)? What are the proper ‘‘domains’’ for quality of life measure, how should we decide on them, and how might studies best distinguish between symptoms and quality of life? b. How did you arrive at your seven-part questionnaire? What was the time reference for symptom reporting (eg, current, within the past week, month)? c. Did you consider incorporating questions that were related to sexual functioning? 2. The POPQ is site specific, not organ specific. Previous investigators have shown differing results with respect to compartmental symptoms and prolapse. For
Key words: Pelvic organ prolapse
What is pelvic organ prolapse, and how do we define it? The answers to these questions may appear obvious but actually are very nebulous, and this represents a large deficit in the knowledge base of modern gynecology. The problem is highlighted by the American College of Obstetricians and Gynecologists technical bulletin on pelvic organ prolapse in which pelvic organ prolapse was defined as ‘‘. . .protrusions of the pelvic organs into or out of the vaginal canal.’’1 This definition is very vague and covers a wide range of subjects from those with any mobility of the vaginal walls to subjects with complete uterovaginal eversion. Arguably, this definition includes >95% of the adult female population and probably
From the Departments of aObstetrics and Gynecology and bBiometry and Epidemiology, Medical University of South Carolina, Charleston, SC, USA. Presented at the Sixty-Fifth Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, January 25-28, 2003, Hot Springs, Va. Reprint requests: Steven Swift, MD, Department of Obstetrics and Gynecology, Medical University of South Carolina, 96 Jonathon Lucas St, Suite 634, PO Box 250619, Charleston, SC 29425. E-mail: [email protected] Ó 2003, Mosby, Inc. All rights reserved. 0002-9378/2003 $30.00 + 0 doi:10.1067/S0002-9378(03)00698-7
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almost every women who has ever been delivered of a term fetus. Another issue in defining pelvic organ prolapse regards the patient’s symptoms. This is a condition that has its greatest impact on the patient’s quality of life and infrequently is associated with significant morbidity. Therefore, it should be defined, in part, according to the degree of symptoms that a patient has. Currently, we have some information on the distribution of pelvic organ support in various populations, but very little data exist that correlate symptoms with physical findings. It has been shown that approximately 3% to 6% of the population will have pelvic organ support defects so that the leading edge of the vagina is past the vaginal introitus.2-5 This represents pelvic organ prolapse that is generally recognized by clinicians as significant and intuitively is symptomatic. However, do women with lesser degrees of prolapse have significant symptoms? Do all those women with prolapse past the introitus have significant symptoms? It has yet to be established at what point or stage of support a patient with pelvic support defects become symptomatic. This study evaluated the correlation of symptoms of pelvic organ prolapse with the degree of pelvic organ support as defined by the pelvic organ prolapse
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quantification (POPQ) examination. This allowed for a determination of the stage or point at which patients begin to experience the symptoms of prolapse and allows for a better definition of symptomatic pelvic organ prolapse. Material and methods This was a study of 497 women aged $18 years who were seen at one of four centers for routine gynecologic health care. The detailed description of this population and the distribution of their pelvic organ support has been published previously.2 Subjects were eligible for inclusion if they were seeking annual gynecologic examinations or had any gynecologic complaints that required a pelvic examination and Papanicolaou test as part of their visit. Therefore, a portion of their visit was dedicated to routine gynecologic health care. Pregnant subjects or subjects who were within 6 weeks after delivery were excluded. Only subjects who were examined by obstetrics-gynecology residents or attending physicians who were familiar with the POPQ classification system were recruited to participate in the study. After informed consent was obtained, subjects underwent a POPQ examination in the dorsal lithotomy position.6 All points, except the total vaginal length, were recorded while the subject performed maximal Valsalva effort. If it was felt that the subject was not able to perform a Valsalva maneuver, the subject was first coached by the examiner in the performance of a Valsalva maneuver. If they still could not perform a Valsalva maneuver, the measurements were recorded with the subject forcefully coughing. Measurements were obtained and recorded according to the document describing the POPQ system.7 Subjects were then assigned a POPQ stage: stage 0, no prolapse; stage I, leading edge of the prolapse is >1 cm above the hymen; stage II, leading edge of the prolapse is #1 cm proximal or distal to the plane of the hymen; stage III, leading edge of the prolapse is >1 cm below the plane of the hymen but protrudes no further than 2 cm less than the total vaginal length; and stage IV, essentially complete eversion of the total lower genital tract. At this same visit, patients were asked to complete a seven-question questionnaire that consisted of questions that relate to symptoms that are associated commonly with pelvic organ prolapse. The seven questions involved the presence of the following symptoms: (1) a sense of something falling out of the vagina, (2) the ability to see or feel a vaginal bulge, (3) low back or groin pain after standing, (4) low back or groin pain worse at the end of the day, (5) urinary incontinence, (6) fecal or flatus incontinence, and (7) splinting to defecate. The possible responses were ‘‘yes,’’ ‘‘no,’’ or ‘‘sometimes.’’ If they answered ‘‘yes’’ or ‘‘sometimes’’ to any of these seven questions, there was a follow-up question that queried whether this symptom bothered them, to which the only
response was ‘‘yes’’ or ‘‘no.’’ Therefore, we had a question regarding the presence of the seven symptoms and a second level of questions regarding bothersomeness. Statistical analysis was completed using SPSS software (version 10.0.5; SPSS Inc, Chicago, Ill). Trend analyses for Tables I and II were completed with simple linear regression, which was weighted by sample size. Results This was an observational study of the relationship between the symptoms of pelvic organ prolapse and the degree of support that is present, as defined by the POPQ system. Between June 1997 and November 1998, a total of 497 women were examined at four centers. Most of the subjects (86%) were seen at the Medical University of South Carolina house staff general outpatient gynecology and obstetrics clinic. The other 14% of subjects were seen at three other outpatient gynecology clinics (Mountain Area Health Education Center, Asheville, NC; Greenville Hospital Systems, Greenville, SC; and the practice of Steven Lewis, MD, Gaffney, SC). Of the 497 women who participated, the 477 women who correctly completed the questionnaires form the basis of this report. All subjects signed an informed consent that was approved by the local Institutional Review Board before participating in this study. The mean age of the subjects was 44 years (range, 18-82 years). Forty-seven percent of the subjects were white; 52% of the subjects were African American, and 1% of the subjects were of another racial group. The POPQ stages for the subjects were 18 subjects with stage 0 prolapse, 214 subjects with stage I prolapse, 231 subjects with stage II prolapse, and 14 subjects with stage III prolapse. No subjects in this study had stage IV prolapse. The symptoms of low back and groin pain were very common among women with any degree of support or prolapse. Forty-eight percent of subjects responded positively to the symptom of low back or groin pain, with 33% of subjects reporting this as a bothersome symptom. The average number of positive responses to the two questions about low back or groin pain per subject by POPQ stage was 0.88 positive responses per subject with stage 0 prolapse, 1.15 positive responses per subject with stage I prolapse, 1.25 positive responses per subject with stage II prolapse, and 1.28 positive responses per subject with stage III prolapse. In addition, those five subjects with the most significant prolapse (subjects whose leading edge of their prolapse was >4 cm past the hymenal remnants) did not report any low back or groin pain. This symptom was present uniformly throughout our population and did not appear to aid in the definition of those subjects with worsening prolapse. Therefore, it was excluded from the final analysis because it was deemed too nonspecific to aid in the analysis. The remaining five questions regarding symptoms of pelvic organ prolapse were used for the final analysis.
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Table I. The correlation between the average number of symptoms and their bothersomeness per subject by stage of support
Stage of support (No. subjects) Stage Stage Stage Stage
No. of positive responses/subject to questions regarding symptoms of pelvic organ prolapse*
0 (26) I (206) II (231) III (14)
0.27 0.55 0.86 2.07
No. of positive responses/subject to questions regarding bothersomeness of symptomsy 0.19 0.35 0.56 1.36
*Not a statistically significant linear trend with stage (P ¼ .222). yNot a statistically significant linear trend with stage (P ¼ .227).
Table II. The correlation between the average number of symptoms and their bothersomeness per subject by the leading edge of their support as measured in centimeters above or past the hymen (per the POPQ)
Leading edge of support (No. subjects) 3 cm (26) 2 cm (206) 1 cm (158) 0 or at hymen (64) +1 cm (9) +2 and +3 cm +4 through +7 cm (5)
No. of positive No. of positive responses/subject responses/subject to to questions regarding questions regarding symptoms of pelvic bothersomeness of organ prolapse* symptomsy 0.27 0.55 0.87 0.75 1.40 2.0 2.2
0.19 0.35 0.57 0.47 1.11 1.56 1.8
*Statistically significant linear trend with leading edge (P ¼ .004). yStatistically significant linear trend with leading edge (P ¼ .005).
Table I shows the average number of positive responses/subject (yes or sometimes) to the five questions regarding symptoms of pelvic organ prolapse by stage. Those subjects with stage 0 to II prolapse had an average of <1 positive response per subject to the five questions. Those with stage III prolapse reported, on average, >2 positive responses/subject to the symptoms in the questionnaire. Table I also shows the average number of positive responses per subject about the bothersomeness of any symptom by stage. Again, those subjects with stage 0 to II prolapse had <1 bothersome positive response per subject; those subjects with stage III prolapse reported, on average, >1 bothersome symptom per subject. Linear regression analysis that was weighted for sample size demonstrated that the increases in symptoms and bothersome symptoms with stage (Table I) did not reach statistical significance (P ¼ .222 and .227, respectively). Table II shows the average number of positive responses per subject (yes or sometimes) to the five questions
regarding symptoms of pelvic organ prolapse by leading edge of vaginal prolapse. Note that the leading edge numbers begin at 3 cm. This is due to the way in which measures are taken and recorded with the POPQ system. Here it can be seen that subjects whose leading edge is at or above the hymenal remnants had on average <1 symptom per subject. Once the leading edge protrudes at least 1 cm past the hymenal remnant, the average number of positive responses per subject increases to >1. Table II also shows the average number of positive responses per subject to the bothersomeness of any symptom by the leading edge of vaginal prolapse. Again, the number of bothersome symptoms per subject increases to >1 as the leading edge descends beyond +1 cm past the hymenal remnants. Linear regression of the data revealed a statistically significant trend of increasing positive responses per subject to questions regarding symptoms of pelvic organ prolapse as the leading edge of their pelvic support advanced from 3 cm to +4 through +7 cm (P ¼ .004, Table II). Additionally, the number of positive responses per subject to questions regarding bothersomeness of symptoms increased with the advance of the leading edge of support, and this trend was also statistically significant (P ¼ .005). Comment Currently there is a lack of understanding regarding the cause, epidemiologic condition, and natural history of pelvic organ prolapse. Investigations into these areas are hampered by the lack of a good definition of the condition. Severe forms of pelvic organ prolapse can be recognized as abnormal by even the most novice health care provider, and good pelvic organ support can be discerned by those providers who are familiar with gynecology. However, defining the point at which a woman goes from normal support to pathologic pelvic organ prolapse is difficult. Currently, definitions of pelvic organ prolapse are varied with no consensus. The National Institutes of Health (NIH) recently convened a conference to standardize the terminology for research into pelvic floor disorders.8 In the document that was produced from the conference, it was stated that there is no current definition of pelvic organ prolapse that is acceptable. In addition, they stated that basing a definition on physical findings alone would be incomplete and any definition should include a subject’s symptoms. However, they proceeded to submit a definition and stated that normal pelvic organ support is the complete lack of any prolapse. They then defined pelvic organ prolapse as ‘‘Descent of the vagina . . . cervix, apex, anterior or posterior vaginal wall . . . to within 1 cm of the hymen or lower: stage I or worse by ICS (POPQ) staging.’’ According to the published research, this proposed definition would classify between 30% and 90% of the population as having abnormal pelvic organ support.2-5
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The NIH conference made no recommendations regarding how symptoms should be incorporated into a definition. So, although the participants of the NIH conference based their recommendations on the best available information at that time, again we are left with an incomplete definition of abnormal pelvic organ support or prolapse that is based solely on physical findings. This study looked at data that were collected during a study of the distribution of pelvic organ support in a population of women who came in contact with gynecologic health care providers for annual health care maintenance (subjects who needed an annual Papanicolaou smear).2 As part of this study, subjects were required to complete a short questionnaire of seven questions regarding what were, at that time, described as the classic symptoms that were associated with pelvic organ prolapse. This list of symptoms was devised from the American College of Obstetricians and Gynecologists technical bulletin on pelvic organ prolapse and the American Urogynecologic Society quarterly report on enterocele.1,9 The questionnaire used in this study was devised in 1996 before the development of good quality-of-life tools for the assessment of the symptoms of pelvic organ prolapse. The subjects were asked to respond ‘‘yes,’’ ‘‘no,’’ or ‘‘sometimes’’ to the seven questions. These questions queried subjects about (1) the sense of something coming out of the vagina, (2) the ability to feel or see something protruding from the vagina, (3) and (4) the presence of lower back or groin pain after prolonged standing or at the end of the day, (5) the presence of urinary incontinence, (6) the presence of fecal and flatus incontinence, and (7) the need to splint to defecate. If subjects responded ‘‘yes’’ or ‘‘sometimes’’ to any of these questions, they were queried further by a follow-up question. They were asked whether the symptom in question bothered, to which they could respond only ‘‘yes’’ or ‘‘no.’’ This was done to document the presence of symptoms of prolapse and to further determine whether that symptom bothered the subject. To assess the subject’s level of pelvic organ support, we used the POPQ system.7,10 The POPQ is a very reliable and specific technique that measures in centimeters the support of various aspects of the vaginal canal. All measures are taken in reference to the hymenal remnants. If the leading edge of the vaginal segment that is being measured remains above the hymenal remnant, it is given a negative designation; if it is at the level of the hymen, it is designated 0, and if it protrudes beyond the hymenal remnants, it has a positive designation. Two values are obtained for the anterior, apex, and posterior vaginal walls. By using this system, a complete and detailed diagram of the subject’s vaginal support is obtained. In addition, a less-specific ordinal stage of support is assigned as well. This allowed for the correlation of vaginal support, by both ordinal stage and leading edge in
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centimeters, with the number of symptoms that were reported and the bothersomeness of those symptoms in this population. The population that was studied in this report involved subjects with a variety of concerns who were seeking gynecologic health care and who required a pelvic examination and annual Papanicolaou test as part of their visit. This represents a typical gynecologic patient and therefore is not a population that was selected for either the presence or absence of pelvic organ prolapse. Accordingly, this lead to a small number of subjects with significant prolapse. However, this is probably a more accurate reflection of the population of subjects who are seen by a gynecologic health care provider; this study represents a less biased look at the correlation of symptoms with pelvic organ support than previous research that queried subjects who were being seen specifically for the evaluation of prolapse. One of the most interesting findings from the data, on reported symptoms, was the common report of low back or groin pain in our population. Almost one half of our subjects reported this symptom, and one third of the subjects reported it as bothersome. This made us question the inclusion of this data in our final analysis because the symptom appeared very nonspecific to the condition being evaluated. Recently, the association between pelvic organ prolapse and pelvic or low back pain was evaluated specifically.11 It was noted that pelvic and low back pain scores were similar, regardless of the degree of prolapse, and that scores for pain actually improved with increasing prolapse. In another report, regarding a quality-of-life tool that was designed specifically for pelvic organ prolapse, the symptom of low back and groin pain was discounted. A questionnaire was developed that included 17 questions regarding specific symptoms of pelvic organ prolapse. Of those 17 questions, only 1 question mentioned low back pain and then only in conjunction with vaginal pain.12 Therefore, it is not surprising that this symptom was unreliable in our population and that we thus left the 2 questions regarding low back and groin pain out of our final analysis. Five questions remained regarding symptoms of pelvic organ prolapse and the degree to which the symptoms bothered the subject. From Table I, it can be seen that the number of symptoms per subject and the number of positive bothersome responses per subject increase as subject’s stage of prolapse goes from 0 to III. The rise between stage 0 prolapse and II prolapse is gradual, with a more abrupt increase with stage III prolapse. The average number of reported symptoms per subject more then doubles as one goes from stage II prolapse to stage III prolapse. Table I also shows the relationship between the bothersomeness of the symptoms and the stage of support. Again, there are few reported bothersome symptoms per subject with stage 0 to II support, but
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subjects with stage III prolapse report >1 bothersome symptom per subject. These data were analyzed with linear regression, and a statistically significant trend was not demonstrated. This lack of statistical significance may have been due to the weighting done for sample size; there were only 14 subjects with stage III pelvic organ prolapse. Table II shows the relationship between the subjects’ reported symptoms and the leading edge of their support or prolapse as measured in centimeters. This is a more specific measure of the subjects’ prolapse than the ordinal stage; from the Table, it can be appreciated that there is a significant increase in the presence of the symptoms and their bothersomeness once the leading edge reaches +1 cm. This represents a portion of patients with POPQ stage II prolapse and all stage III prolapse. When the leading edge of the prolapse is above the hymenal remnants (leading edge is designated as #0) the number of positive responses per subject to the queries is <1, and the number of bothersome symptoms per subject is much <1. Once the leading edge of the prolapse protrudes beyond the hymenal remnants and the protection of the vaginal canal, the number of symptoms per subject increases abruptly. This is not surprising because it has been shown that one of the most common complaints of subjects with prolapse is the sense of a vaginal bulge that they can see or feel, and this symptom was queried in two of the five questions in the questionnaire.13 Additionally, it is at this same point that subjects become much more bothered by their symptoms. This trend appears obvious from the tables, and the trend of an increasing number of symptoms per subject and the bothersomeness of those symptoms with advancing pelvic organ prolapse was statistically significant. However, although the trend is statistically significant, it does not give us a point or cutoff beyond which subjects are statistically more likely to have symptoms. It seems intuitive that, once the prolapse protrudes out of the vaginal canal, subjects will become more symptomatic; this obviously represents pathologic pelvic organ prolapse. Furthermore, the low incidence of symptoms when the prolapse remains at or above the hymen suggests that this lesser degree of relaxation may not represent true disease, but again these data do not define that point at which a subject goes from normal to pathologic pelvic organ prolapse. The results of this study suggest that a reasonable general definition of abnormal or pathologic pelvic organ support or pelvic organ prolapse is a woman with prolapse that protrudes beyond the hymenal remnants. This does not mean, however, that women with lesser degrees of prolapse should have their symptoms ignored. Subjects with lesser degrees of prolapse should have other possible causes of their symptoms investigated and treated before these symptoms are attributed to pelvic organ prolapse. Alternatively, individuals who are asymptomatic but who have pelvic organ support defects that do not extend past
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the hymenal remnants could be considered normal or could be defined as having asymptomatic pelvic support defects. The real questions involve the treatment of those women with asymptomatic pelvic support defects. Should we intervene in the absence of symptoms, despite anatomic changes, or should we follow conservatively? When is the optimal timing for intervention, early on at the discovery of asymptomatic support defects or only after the patient has experienced more severe symptomatic pelvic organ prolapse? Finally, does early intervention provide for a better surgical result? These questions cannot be answered by the results of this study, but until we develop a meaningful definition of pelvic organ prolapse, its natural history and optimal treatment will remain elusive. This study represents a starting point in the development of a more specific definition of pelvic organ prolapse. With the use of disease-specific questionnaires and querying large numbers of patients who have a wide distribution of pelvic organ support will allow for statistical analysis of trends, which will provide greater insight into the definition of and eventually the understanding of the condition of pelvic organ prolapse.
REFERENCES 1. American College of Obstetricians, and Gynecologists. Pelvic organ prolapse. Washington (DC): The College; 1995. Technical bulletin No.: 214. 2. Swift SE. The distribution of pelvic organ support in a population of women presenting for routine gynecologic health care. Am J Obstet Gynecol 2000;183:277-85. 3. Samuelsson EU, Victor FTA, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol 1999;180: 299-305. 4. Versi E, Harvey M, Cardozo L, Brincat M, Studd J. Urogenital prolapse and atrophy at menopause: a prevalence study. Int Urogynecol J 2001;12:107-10. 5. Bland DR, Earle BB, Vitolins MZ, Burke G. Use of the pelvic organ prolapse staging system of the International Continence Society, American Urogynecologic Society, and the Society of Gynecologic Surgeons in perimenopausal women. Am J Obstet Gynecol 1999; 181:1324-8. 6. Swift SE, Herring MD. Comparison of pelvic organ prolapse in the dorsal lithotomy versus the standing position. Obstet Gynecol 1998;91:961-4. 7. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JOL, Klarskov P, et al. The standardization of terminology of female pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10-7. 8. Weber AM, Abrams P, Brubaker L, Cundiff G, Davis G, Domchowski RR, et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J 2001;12:178-86. 9. American Urogynecologic Society. Enterocele (AUGS Quarterly Report. vol 10, No. 4). Chicago: American Urogynecologic Society; 1992. 10. Hall AF, Theofrastous JP, Cundiff GC, Harris RL, Hamilton LF, Swift SE, et al. Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society pelvic organ prolapse classification system. Am J Obstet Gynecol 1996;175:1467-9. 11. Heit M, Culligan P, Rosenquist C, Shott S. Is pelvic organ prolapse a cause of pelvic or low back pain? Obstet Gynecol 2002;99: 23-8.
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12. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated quality of life questionnaire for the symptomatic assessment of women with uterovaginal prolapse [abstract]. Int Urogynecol J 2000;11(Suppl):S25. 13. Elkerman RM, Cundiff GW, Bent AE, Nihira MA, Melick C. Correlation of symptoms with location and severity of pelvic organ prolapse [abstract]. Int Urogynecol J 2000;11(Suppl):S26.
Discussion DR KATHIE HULLFISH, Charlottesville, Va. Dr Swift and colleagues continue to contribute to our muchneeded database of pelvic floor epidemiologic information. The question included in the title of this manuscript, ‘‘What is pelvic organ prolapse?’’ is often posed to me by medical students and residents alike, and I confess that the exact nature of a satisfactory answer continues to elude me. Webster’s dictionary defines a disease as ‘‘an illness or sickness often characterized by typical patient problems (symptoms) and physical findings (signs).’’1 Furthermore, symptoms are explained as ‘‘any subjective evidence of disease that can only be appreciated by the patient,’’ and signs are explained as ‘‘any objective evidence of disease.’’1 Unlike many disease processes, pelvic organ prolapse defies a precise definition, and our understanding of the pathophysiologic condition of prolapse is in its infancy. Pelvic organ prolapse is not contagious, to the best of our knowledge (so much for the model infectious disease). The ‘‘acquisition’’ of prolapse usually is not incurred at one single point in time, but more often, as the result of multifactorial events over time (with certain aspects of vaginal childbearing, age, obesity, and previous hysterectomy, for example, some commonly cited culprits). Alterations in connective tissue at the cellular level and possibly genomics may help us in the future, but as of now, prolapse is not predictable; we do not know whether there is a precursor disease state. To demonstrate the prevailing confusion about pelvic organ prolapse, one only has to review the evolution of staging definitions over time; pelvic organ prolapse has been subject to multiple years of debate and description, from grades to half-way stages to POPQs.2 The current descriptive study by Dr Swift and colleagues is as an extension of an earlier investigation.3 In that study, Dr Swift described the distribution of pelvic organ support using the POPQ system in 497 women who were being seen for routine outpatient gynecologic care. The POPQ stage distributions showed that most women had either stage I (43.3%) or stage II (47.7%) prolapse. Because disorders of the pelvic floor have a direct impact on a patient’s quality of life, the current investigation is the next logical step to evaluate patient symptoms together with that objective examination. A seven-item dichotomous questionnaire was completed by 477 of the original 497 patients at the time of their POPQ evaluation to query about the presence or absence of any symptoms of bulging or prolapse, low back or groin pain, urinary incontinence, fecal or flatal incontinence, and any need for manual assistance to defecation. A positive response was then further qualified
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as to the presence or absence of ‘‘bothersomeness’’ to the patient for that particular symptom. (Back pain was later disregarded from the study analysis because of its common reporting, which is further substantiated by a recent study by Heit et al.4) The main conclusion was that once prolapse was present more than 1 cm beyond the hymen (ie, stage III pelvic organ prolapse), patients reported $2 queried symptoms with at least one of those symptoms being bothersome. An increased number of symptoms were reported once the leading edge of the prolapse came outside the hymen. On the basis of this preliminary investigation therefore, Dr Swift suggests that pelvic organ prolapse might be considered to be abnormal or pathologic once the leading edge of the prolapse protrudes beyond the hymen. The diagnosis for patients with visible prolapse seems intuitively logical. (And certainly more easy to demonstrate to our students and residents.) However, the question of how to treat those patients who have disturbing quality-of-life symptoms with lesser degrees of prolapse remains puzzling to us all. Moreover, given the fact that this was a cross-sectional study, we do not know how pelvic organ prolapse symptoms might have changed over time in this patient population. Because this work is descriptive, I would like to ask the following questions: 1. The NIH consensus report on the standardized terminology for researchers in the field of female pelvic medicine emphasizes the importance of including patient symptoms in research database collections.5 However, the report does not endorse any one specific quality-of-life instrument. Your study distinguished quality of life from subjective symptoms by first asking for symptoms and then for quality-oflife decrements (‘‘bothersomeness’’) that were associated with those symptoms. a. Can you comment on the various methods that are currently in use for the assessment of quality of life and subjective symptoms and how your investigation might inform us on how best to assess quality of life or subjective symptoms? For instance, what roles do you see for conditionspecific quality-of-life measures (eg, the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire6)? What are the proper ‘‘domains’’ for quality of life measure, how should we decide on them, and how might studies best distinguish between symptoms and quality of life? b. How did you arrive at your seven-part questionnaire? What was the time reference for symptom reporting (eg, current, within the past week, month)? c. Did you consider incorporating questions that were related to sexual functioning? 2. The POPQ is site specific, not organ specific. Previous investigators have shown differing results with respect to compartmental symptoms and prolapse. For