Use of a visual analog scale for evaluation of bother from pelvic organ prolapse

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1 Ultrasound Obstet Gynecol 2014; 43: Published online in Wiley Online Library (wileyonlinelibrary.com). DOI: /uog Use of a visual analog scale for evaluation of bother from pelvic organ prolapse D. ULRICH*, R. GUZMAN ROJAS, H. P. DIETZ, K. MANN and G. TRUTNOVSKY *Monash University, Department of Obstetrics and Gynaecology, Melbourne, Australia; Medical University Graz, Department of Obstetrics and Gynaecology, Graz, Austria; Sydney Medical School Nepean, Nepean Hospital, Penrith, Australia KEYWORDS: 4-dimensional translabial ultrasound; bother; pelvic organ prolapse; urogynecology; visual analog scales ABSTRACT Objectives A specified anatomical degree of prolapse may cause no bother in one individual and a severe form of bother in another. The aim of this study was to determine the factors contributing to the degree of bother due to a given degree of prolapse, to help with the clinical evaluation of patients and planning of preventive intervention trials and surgical treatment. Methods Consecutive patient records of 654 women who had attended a urogynecology unit between August 2011 and December 2012 were reviewed. All patients underwent a standardized interview, clinical examination and four-dimensional translabial ultrasound scan. The degree of bother was evaluated using a visual analog scale. Results Six hundred and thirty-six women were included in the analysis, with ultrasound data available for cystocele, rectocele and enterocele descent and rectocele depth measurements and 442 for uterine descent. 313 women (49.2%) had subjective symptoms of female pelvic organ prolapse at a mean bother score of 6.0 ± 2.6. Average bother score for the complete dataset was 3.0 ± 3.5. Parity, vaginal delivery, levator avulsion, any significant clinical prolapse or prolapse seen on ultrasound were associated with prolapse bother and all clinical and ultrasound measures of pelvic organ descent remained significant or near significant on multivariate analysis. Conclusions Quantification of prolapse bother using a visual analog scale is valid and repeatable and may represent a simple tool for use in clinical practice. Copyright 2013 ISUOG. Published by John Wiley & Sons Ltd. INTRODUCTION Female pelvic organ prolapse (FPOP) is defined as the herniation of pelvic organs into the vagina and is a common condition in women, resulting in a lifetime risk of surgery ofupto1in5 1. FPOP can involve different compartments and is divided into anterior vaginal wall prolapse, caused by herniation of the bladder (cystocele); posterior vaginal wall prolapse, caused by rectal or bowel herniation (rectoor enterocele); and apical prolapse, caused by uterine or vaginal cuff prolapse. FPOP is frequently associated with symptoms of a vaginal bulge, lump or a dragging pelvic sensation. However, a given anatomical degree of prolapse may cause no bother in one individual and a severe form of bother in another 2. Better correlation between subjective symptoms and FPOP can be obtained when single compartment prolapse is analyzed 3, however there are probably multiple factors that can influence prolapse bother. Since the introduction of the pelvic organ prolapse quantification (POP-Q) system, women undergo a standardized evaluation of prolapse stage, but data on prolapse bother are not commonly obtained 4.Inthe POP-Q system, there are two reference points anteriorly (Aa, Ba), two posteriorly (Ap, Bp) and two apically (C, D). Points Aa and Ap are 3 cm proximal to or above the hymenal ring anteriorly and posteriorly, respectively. Points Ba and Bp are defined as the most distal position of the remaining upper anterior and posterior vaginal wall, respectively. Apically, point C represents the cervix or cuff and point D represents the posterior fornix (omitted in women after hysterectomy). Three other measurements are taken: the vaginal length at rest, the genital hiatus from the middle of the urethral meatus to the posterior midline hymen and the perineal body from the posterior aspect of the genital hiatus to the mid-anal opening. Pelvic floor imaging has been introduced recently to investigate women with pelvic floor dysfunction; it provides objective detailed measurements of the extent of POP and seems to correlate well with symptoms of prolapse 5 7. Validated questionnaires exist to assess health-related quality of life, symptom-specific details, sexual function and global impression of improvement 8. However they Correspondence to: Dr D. Ulrich, Medical University Graz, Department of Obstetrics and Gynaecology, Graz, Austria ( daniela.ulrich@medunigraz.at) Accepted: 26 September 2013 Copyright 2013 ISUOG. Published by John Wiley & Sons Ltd. ORIGINAL PAPER

2 694 Ulrich et al. require considerable time for completion, imposing an additional workload on patients and clinicians 9. The quality of life impact or subjective bother of any clinically relevant symptom can be determined using visual analog scales (VAS), which is a highly repeatable method 10. VAS were originally developed for pain management and have recently been incorporated into urogynecological symptom evaluation, facilitating quick assessment of the patient s subjective bother related to a certain symptom or symptom complex. The aims of this study were to determine how well the VAS score correlates with clinical and ultrasound findings of prolapse and to identify confounding factors such as body mass index (BMI), parity and mode of delivery. PATIENTS AND METHODS This observational study was designed to evaluate the routine use of VAS in the assessment of FPOP and was approved by the local human research ethics committee (NBMLHD 12 74). Consecutive patient records of 654 women who had attended a urogynecology unit between August 2011 and December 2012 were reviewed. A comprehensive history was obtained with the help of a nonvalidated, standardized in-house interview, and prolapse staging was performed according to the International Continence Society POP-Q staging system 4. Significant prolapse was defined as POP-Q Stage 2 or higher, with the most distal portion of the prolapse descending to 1 cm above the hymenal ring or below All women underwent four-dimensional (4D) translabial ultrasound using a GE Kretz Voluson 730 Expert or Voluson I system (GE Kretz Medizintechnik, Zipf, Austria) as described previously 14. Ultrasound volume data were obtained with the women supine at rest, on maximal Valsalva maneuver and on pelvic floor muscle contraction. Women were taught how to perform a pelvic floor muscle contraction and a Valsalva maneuver, i.e. prolonged forced expiration against a closed glottis and contracted diaphragm and abdominal wall. Significant prolapse on ultrasound was defined as previously established using receiver operating characteristics statistics (cystocele descent to 10 mm below the symphysis pubis, uterine prolapse to the symphysis pubis or beyond and rectal descent to 15 mm below the symphysis or worse) 7. Archived ultrasound volumes were analyzed retrospectively by two operators (D.U., G.T.), who were blinded to all clinical findings to obtain objective measures of prolapse. Measurements of organ descent were obtained on maximal Valsalva maneuver against the inferior margin of the symphysis pubis for each compartment, including cystocele, uterine, enterocele and rectocele descent and rectocele depth using the software 4D View v (GE Kretz Medizintechnik) as described previously (Figure 1) 15. A test retest series of all ultrasound parameters was conducted before the analysis and showed good interobserver agreement. The intraclass correlation coefficient (ICC; single measures, absolute agreement definition) were 0.88 (95% CI, ), Figure 1 Image obtained by four-dimensional translabial ultrasound on maximal Valsalva maneuver showing measurement of organ descent in a case of pelvic organ prolapse. Reference line at level of symphysis pubis. A, ampulla recti; B, bladder; R, rectum; S, symphysis pubis; U, uterus (95% CI, ) and 0.93 (95% CI, ) for cystocele, uterine and rectocele descent, respectively. Subjective bother of POP was assessed using a VAS, a measurement instrument that assesses the severity of a symptom on a scale from 0 to 10 cm in a continuous manner with high reproducibility 16. The physician explained how the VAS works and asked, How much do the symptoms of prolapse, that is the sensation of a lump or bulge in the vagina, bother you?. The patients were then asked to move a sliding indicator on the VAS instrument. The degree of bother was read off on the back of the instrument and rounded to the nearest mm. No bother was deemed to have a score of zero. In an unrelated study we previously tested the repeatability of VAS bother scores in 40 women by retesting at the end of the clinical examination, approximately 1 h after initial assessment, and found high repeatability (ICCs > 0.90) 17. This is consistent with data found in the literature, e.g. a psychometric evaluation study by Lukacz et al. 10 found similar repeatability for VAS scores. Statistical analysis was carried out with the software SAS v 9.3 (SAS Institute Inc., Cary, NC, USA). Demographic data are presented as mean ± SD or n (%). The bother score between groups was compared with the Mann Whitney U-test. Linear regression analysis was used to demonstrate the mean increase in VAS bother score of prolapse. For those variables that were statistically significant on univariate analysis, an additional adjusted analysis was performed controlling for age, BMI, parity, avulsion and operative vaginal delivery; P < 0.05 was considered statistically significant. No adjustments were made for multiple comparisons. RESULTS Six hundred and fifty-four women had been seen between August 2011 and December Ultrasound data were missing on 18 patients, leaving 636 women for inclusion in the analysis, with ultrasound data available for cystocele,

3 VAS for prolapse bother 695 Table 1 Demographic data of 636 women assessed for pelvic organ prolapse Parameter Value Age (years) 57 ± 13 Body mass index (kg/m 2 ) 29± 6 Parity 2.6 ± 1.3 Previous Cesarean section 82 (12.9) Previous operative vaginal delivery 181 (28.5) Previous hysterectomy 194 (30.5) Previous anti-incontinence or prolapse surgery 147 (23.1) Postmenopausal status 410 (64.5) Data are given as n (%) or mean ± SD. Table 2 Objective measurements of extent of prolapse by International Continence Society pelvic organ prolapse quantification (POP-Q) system and ultrasonographic measurement in 636 women assessed for pelvic organ prolapse Parameter n Mean ± SD POP-Q Ba (cm) ± 1.9 C (cm) ± 2.9 Bp (cm) ± 1.5 Ultrasound Bladder descent (mm) ± 17.1 Uterine descent (mm) ± 16.4 Rectal descent (mm) ± 13.6 Rectocele depth (mm) ± 9.5 Enterocele descent (mm) ± 11.7 Relative to hymen. Points Ba and Bp are the lowest points of the prolapse on the anterior and posterior vaginal walls. Point C represents the cervix. Relative to inferior symphyseal margin; negative values denote results below the symphysis pubis. rectocele and enterocele descent and rectocele depth measurements. Out of the 636 women 194 (30.5%) had had a previous hysterectomy, leaving 442 for the assessment of uterine prolapse. Demographic data are shown in Table 1. Three hundred and thirteen women (49.2%) had subjective symptoms of FPOP at a mean bother score of 6.0 ± 2.6. Average bother score for the complete dataset was 3.0 ± 3.5. Four hundred and sixty-eight women (73.6%) reported symptoms of stress urinary incontinence, 477 (75.0%) symptoms of urgency urinary incontinence, 202 (31.8%) symptoms of fecal incontinence and 298 (46.9%) symptoms of voiding dysfunction. The results of the clinical POP-Q staging and ultrasound measurements are presented in Table 2. One hundred and forty-seven women (23.1%) had an avulsion visible on tomographic ultrasound, and mean hiatal area on Valsalva maneuver was 29.5 (range, ) cm 2. Table 3 shows the bother scores according to significant prolapse seen on clinical examination and on ultrasound. Women with any isolated significant prolapse had a significantly higher bother score than women without any significant prolapse (P < except for rectocele on ultrasound). Similarly the bother score was significantly higher in cases of significant multicompartment prolapse than in cases without significant prolapse. Significant uterine and vault prolapse caused the highest bother, independently of the diagnostic method, although it was only statistically significantly different for clinical POP staging (uterine prolapse vs cystocele, rectocele or multicompartment prolapse; P < ). We tested a number of potential predictors of prolapse bother, as shown in Table 4. Parity, previous vaginal delivery, levator avulsion, any significant clinical prolapse or any prolapse seen on ultrasound were associated with prolapse bother (P < ). All clinical and ultrasound measures of pelvic organ descent remained significant or near significant in the adjusted analysis. Age and BMI had no independent effect on bother. On modeling the effect of single predictors on prolapse bother, adding a second or third compartment to the model virtually always improved its performance for the prediction of prolapse bother. Hence, the best model contained all three compartments, both for clinical examination (R 2 = 0.23) and for ultrasound assessment of prolapse (R 2 = 0.21). DISCUSSION To our knowledge this is the first paper to report the use of a VAS for the assessment of FPOP and to validate such a scale by correlating subjective bother of FPOP with clinical and 4D ultrasound prolapse assessment. In this large study we were able to show that a VAS bother score for prolapse symptoms is highly significantly associated with both clinical and sonographic measures of pelvic organ descent. The main predictors of a high bother score were POP seen on clinical examination and POP found on ultrasound. Risk factors for POP such as parity, operative vaginal delivery or levator avulsion found on ultrasound were associated with bother, but this association disappeared on multivariate analysis. Surprisingly, age, BMI and previous surgery were not significant predictors of bother, even on univariate analysis. Another finding was that the effect of clinically or sonographically determined prolapse on bother was cumulative, i.e. the presence of prolapse in other compartments increased bother for a given degree of prolapse in the index compartment, as shown in the highly significant effect of multicompartment prolapse and the modeling reported above. Women without significant prolapse have only a low bother score, suggesting that the VAS score is able to determine specifically the bother of prolapse caused in a patient. Interestingly uterine and apical prolapse are associated with the highest bother scores compared with other single-compartment prolapse conditions. This is consistent with the finding that, for a given station, uterine descent is much more likely to be associated with symptoms of prolapse 13. Patient-reported measures are important owing to the commonly observed discrepancy between objective findings on examination and actual symptoms related to those findings 18. VAS have been shown by others to be a reliable tool for the assessment of quality of life in urogenital research 2,10. Such findings are confirmed by this study. While a VAS may seem a simplistic instrument for

4 696 Ulrich et al. Table 3 Bother score in study population of women assessed for pelvic organ prolapse (n = 636 for prolapse in anterior and posterior compartments, n = 443 for uterine prolapse, n = 180 for vault prolapse), as measured by the pelvic organ prolapse quantification system (POP-Q) and by ultrasound, according to whether there was significant isolated or multicompartment prolapse vs no significant prolapse in any compartment Significant prolapse No significant prolapse Parameter n (%) Bother score n (%) Bother score P POP-Q Isolated cystocele (cm) 122/636 (19.2) 3.1 ± (16.5) 0.8± 2.1 < Isolated rectocele (cm) 115/636 (18.1) 2.6 ± (16.5) 0.8 ± 2.1 < Isolated uterine prolapse (cm) 20/443 (4.5) 6.5 ± (16.5) 0.8± 2.1 < Isolated vault prolapse (cm) 16/180 (8.9) 6.4 ± (16.5) 0.8 ± 2.1 < Clinical multicompartment prolapse (cm) 244/636 (38.4) 4.2 ± (16.5) 0.8 ± 2.1 < Ultrasound Isolated cystocele (mm) 100/636 (15.7) 3.8 ± (45.4) 1.9 ± 3.2 < Isolated rectocele (mm) 72/636 (11.3) 2.6 ± (45.4) 1.9± 3.2 NS Isolated uterine prolapse (mm) 10/443 (2.3) 5.4 ± (45.4) 1.9 ± 3.2 < Multicompartment prolapse (mm) 156/636 (24.5) 4.4 ± (45.4) 1.9 ± 3.2 < Bother score given as mean ± SD. Multicompartment prolapse defined as significant prolapse in at least two compartments. NS, not significant. Table 4 Linear regression analysis of factors predicting prolapse bother in 636 women assessed for pelvic organ prolapse Model β*(95% CI) P (univariate) P (adjusted) Age (per 1 year increase) 0.02 (0.00 to 0.04) 0.08 Body mass index (per 1 unit increase) 0.03 ( 0.08 to 0.02) 0.19 Parity (per 1 child increase) 0.5 (0.2 to 0.7) < Avulsion 1.8 (1.2 to 2.5) < < Previous operative vaginal delivery 1.3 (0.7 to 1.9) < Previous anti-incontinence or prolapse surgery 4.8 ( 1.8 to 11.4) 0.15 Previous hysterectomy 3.5 ( 2.5 to 9.5) 0.25 Multicompartment prolapse clinically 2.3 (1.7 to 3.0) < < Ba (per cm increase) 0.7 (0.6 to 0.9) < < C (per cm increase) 0.5 (0.4 to 0.6) < < Bp (per cm increase) 0.6 (0.4 to 0.8) < < Bladder decent on ultrasound (per mm increase) 0.7 (0.5 to 0.8) < < Uterine descent on ultrasound (per mm increase) 0.8 (0.6 to 1.0) < < Rectal descent on ultrasound (per mm increase) 0.3 (0.1 to 0.5) Rectocele depth on ultrasound (per mm increase) 0.7 (0.1 to 1.2) 0.01 NS Multicompartment prolapse on ultrasound 1.6 (1.0 to 2.2) < *β gives the mean increase in VAS bother score (in cm on a scale of 0 10), for every unit increase of explanatory variable, or for the people with the condition vs those without it. Adjusted for age, body mass index, parity, avulsion and operative vaginal delivery, unless one of these variables was the variable of interest. Note that parity, avulsion and operative vaginal delivery all remained independently predictive of bother (P = 0.002, 0.01 and 0.002, respectively), in this multivariate model. Subset analysis using only women with objective prolapse (n = 496) yielded very similar results. Points Ba and Bp are the lowest points of the prolapse on the anterior and posterior vaginal walls, respectively. Point C represents the cervix. NS, not significant. the assessment of quality-of-life impact, it has substantial advantages. A VAS instrument is much easier to use for both patient and physician and it requires very little time. While Abdel-Fattah et al. 9 showed that VAS may have limitations in women with stress urinary incontinence, we found good correlation between objective prolapse and VAS. A VAS is clearly not a replacement for a clinical examination, but it seems likely that it will be very useful in the evaluation of symptom severity, which is relevant for treatment planning. Surgical intervention for POP should be based on objective clinical findings, but in most cases the indication to perform surgery is based on the impact that the condition has on quality of life. We usually do not operate on women who are not bothered by their prolapse symptoms, except in cases of significant voiding dysfunction clearly due to the prolapse, or in women with posterior compartment prolapse causing symptoms of obstructed defecation. Thus, it appears that VAS, a quick measure of prolapse bother, will be a highly useful tool for assisting the planning of treatment. In addition, postoperative improvement can be easily measured by repeating the VAS test, although this aspect was not examined in this study. A recent study found a significant improvement in the VAS score postoperatively for incontinence and prolapse surgery 19. The large sample size in the present study allowed us to perform construct validation of the VAS measurements for bother, however we have not evaluated convergent validity, i.e. comparison with a validated questionnaire. It must be noted that it is impossible to

5 VAS for prolapse bother 697 determine convergent and discriminant validity in a single item instrument, but this does not preclude its investigation. The international consultation on incontinence questionnaire (ICIQ) is one of the validated prolapse questionnaires to assess the presence, severity and impact of vaginal symptoms and associated sexual symptoms on quality of life and the outcome of treatment, however it requires more time to be completed and does not assess the overall bother of the patient 20. There is in fact a validated single outcome measure tool, the patient global impression of improvement, however this only allows assessment of change of bother after intervention 21. There are several limitations to this study that must be acknowledged. It was performed at a tertiary urogynecological unit and most of our patients were Caucasian. This implies that our conclusions will be limited to similar populations. Even though the repeatability of this scale was found to be good in an unrelated study (ICCs of > 0.90) 17, and while it is clearly valid in the assessment or FPOP, prospective work demonstrating the sensitivity to change following surgical or conservative therapy seems to be urgently needed before widespread introduction of VAS instruments into clinical practice can be recommended. Further studies comparing the performance of standard prolapse questionnaires and VAS scores will also be of interest. In conclusion, a VAS for assessment of bother caused by symptoms of prolapse seems to be a valid tool for determining subjective severity of POP in women. REFERENCES 1. Smith F, Holman D, Moorin R, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010; 116: Swift SE, Tate SB, Nicholas J. Correlation of symptoms with degree of pelvic organ support in a general population of women: what is pelvic organ prolapse? 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