- Email: [email protected]
The Relationships Among Measures of Incontinence Severity in Women Undergoing Surgery for Stress Urinary Incontinence
Voiding Dysfunction The Relationships Among Measures of Incontinence Severity in Women Undergoing Surgery for Stress Urinary Incontinence Michael Albo,*,† Lisa Wruck, Jan Baker, Linda Brubaker, Toby Chai,† Kimberly J. Dandreo, Ananias Diokno, Patricia Goode,‡ Stephen Kraus,§ John W. Kusek, Gary Lemack,储 Jerry Lowder and William Steers¶ for the Urinary Incontinence Treatment Network From the Division of Urology, University of California, San Diego, California (MA), New England Research Institutes, Boston, Massachusetts (LW, KJD), Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah (JB), Departments of Obstetrics & Gynecology and Urology, Loyola University Chicago, Maywood, Illinois (LB), Division of Urology, University of Maryland, Baltimore (TC), National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (JWK), Maryland, Department of Urology, William Beaumont Hospital, Royal Oak, Michigan (AD), Birmingham/Atlanta Veterans Affairs Geriatric Research, Education and Clinical Center and Division of Gerontology and Geriatric Medicine, University of Alabama at Birmingham, Alabama (PG), Department of Urology, University of Texas, San Antonio (SK), and University of Texas Southwestern Medical Center, Dallas (GL), Texas, Division of Urogynecology and Pelvic Reconstructive Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (JL), and Department of Urology, University of Virginia, Charlottesville, Virginia (WS)
Purpose: We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques (Burch colposuspension vs pubovaginal sling) for stress urinary incontinence. Materials and Methods: A total of 655 women underwent a standardized preoperative assessment that included the Medical, Epidemiological and Social Aspects of Aging questionnaire, Urogenital Distress Inventory, Incontinence Impact Questionnaire, 3-day voiding diary, 24-hour pad test, a supine empty bladder stress test and Valsalva leak point pressure measurements. Correlations were estimated using Spearman correlation coefficients and 95% confidence intervals. T tests at ␣ ⫽ 0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test. Results: Baseline mean scores on Medical, Epidemiological and Social Aspects of Aging, Urogenital Distress Inventory and Incontinence Impact Questionnaire were 25.8, 151 and 171, respectively. Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm, respectively. Supine empty bladder stress test was positive in 218 patients, and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H2O. Weak to moderate correlations were observed between Medical, Epidemiological and Social Aspects of Aging, incontinence episode frequency, pad weight, Incontinence Impact Questionnaire and Urogenital Distress Inventory. On the other hand, Valsalva leak point pressure correlated poorly with all variables measured. The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49% and 60%, respectively. Conclusions: Urinary incontinence severity measures correlate moderately with each other at best. While Medical, Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life, Valsalva leak point pressure did not. Supine empty bladder stress test did not demonstrate a clinically significant association among severity measures. Key Words: urinary bladder; female; quality of life; urinary incontinence, stress; urodynamics
rinary incontinence, a highly prevalent condition in women, is defined by symptoms, its pathophysiology and/or its impact on QOL. Assessment of disease severity may be used to gain insight into the pathophysiology or to predict responses to therapy. Al-
U
though a wide range of methods have been proposed to measure the severity of urinary incontinence, including use of urinary symptom and impact questionnaires,1 voiding diary,2 pad testing3 and various urodynamic test parameters,4,5 none has emerged as the gold standard. The
Submitted for publication September 25, 2006. Supported by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases, U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and 60401. Supported by the National Institute of Child Health and Human Development and Office of Research in Women’s Health, National Institutes of Health. * Correspondence: Division of Urology, University of California San Diego Medical Center, 200 W. Arbor Drive, San Diego, California
92103-8897 (telephone: 858-657-8435; FAX: 858-657-8650; e-mail: [email protected]). † Financial interest and/or other relationship with Pfizer. ‡ Financial interest and/or other relationship with Ortho McNeil. § Financial interest and/or other relationship with Pfizer, Novartis, Astellas, Ortho McNeil and NIDDK. 储 Financial interest and/or other relationship with Pfizer, Astellas and Allergan. ¶ Financial interest and/or other relationship with Sanofi Aventis, Lilly, Novartis, Astellas, Pfizer and Allergan.
0022-5347/07/1775-1810/0 THE JOURNAL OF UROLOGY® Copyright © 2007 by AMERICAN UROLOGICAL ASSOCIATION
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Vol. 177, 1810-1814, May 2007 Printed in U.S.A. DOI:10.1016/j.juro.2007.01.032
MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN lack of a universally accepted severity measure creates difficulty in designing or comparing results in clinical and epidemiological studies. A multicenter, randomized clinical trial of the Burch colposuspension compared to the pubovaginal sling for the treatment of SUI provided an opportunity to examine the relationship between generally accepted severity measures including symptom and QOL questionnaires, pad test, voiding diary, supine empty bladder stress test, and urodynamic measurements in women before undergoing surgery. In addition, we hypothesized that the severity measures would correlate differently in patients with urodynamic evidence of ISD compared to those with no ISD, and in patients with mixed incontinence compared to those with pure stress incontinence. MATERIALS AND METHODS Study Design The UITN SISTEr protocol was designed to comply with the provisions of the Declaration of Helsinki and was approved by the National Institutes of Health and the respective institutional review boards from the 9 clinical sites in the UITN.6 All patients gave written informed consent before enrollment. Women were eligible for the trial if they reported predominant symptoms of SUI determined from the MESA questionnaire,7 displayed urethral hypermobility determined by a Q-tip test and had a positive standardized volume stress test. Measurements Before randomization patients underwent a standardized preoperative evaluation which included collection of several measures of severity, that is MESA symptom questionnaire, UDI, IIQ, 3-day voiding diary, 24-hour pad test, a standardized volume stress test, SEBST and VLPP obtained during standardized urodynamics testing. The MESA total score ranges from 0 to 45 and is a sum of its 2 components, the stress score and the urge score. The stress component consists of 9 questions regarding the frequency of stress related urine loss. Scores range from 0 to 27 and increase as the frequency of urine loss increases. Similarly the urge index consists of 6 questions regarding the frequency of urge related urine loss and scores range from 0 to 18.7 For the purposes of this analysis, participants were classified as having symptoms of pure stress incontinence if the MESA urge score was zero and classified as having mixed incontinence if the MESA urge score was greater than zero. The UDI consists of 3 subscales (obstructive symptoms, irritative symptoms and stress symptoms). The total UDI score has a range of 0 to 300 when all questions are answered. Each subscale score is computed as the mean of the items contributing to that subscore, and scaled to have a range from 0 to 100. Scores increase with worsening QOL.8 The IIQ consists of 4 subscales (activity, travel, social and emotional). The total IIQ score has a range of 0 to 400. Subscale scores are scaled to have a range of 0 to 100 and scores increase with worsening QOL.8 PW is calculated as the difference between total pad weights before and after the test during a 24-hour period.3 IEF is calculated as the mean number of involuntary epi-
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sodes of urine loss per day recorded on the 3-day voiding diary. VLPP is reported as the mean vesical pressure at leakage during a Valsalva maneuver minus mean vesical pressure at baseline of cystometrogram using atmospheric pressure as the reference. VLPP was obtained during standardized filling cystometry with the first measurement at a volume of 200 ml and repeated at 100 ml increments until SUI was observed on at least 2 of 3 Valsalva maneuvers at a given volume or until maximum cystometric capacity was reached. Urodynamic ISD was defined as VLPP 60 cm or less. The urodynamic testing procedures and quality control measures have been described by Nager et al.9 The supine empty bladder stress test was performed in the supine position with cough and straining maneuvers.10 A positive test was recorded if urethral leakage was observed during any of the maneuvers. Patients with PVR greater than 100 cc were excluded from this analysis. We examined the relationship between measures of severity in the entire study population as well as in 2 subgroups of patients, those with urodynamic ISD compared to patients with no ISD, and among patients with symptoms of mixed incontinence compared to those with symptoms of pure stress incontinence. Statistical Analysis Statistical analysis was performed using SAS® 9.1. Correlations were estimated using Spearman correlation coefficients and 95% CI. To evaluate the association between SEBST and each of the continuous severity measures, t tests at ␣ ⫽ 0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative SEBST. The sensitivity and specificity of SEBST for ISD was calculated along with 95% CI. RESULTS A total of 655 women were randomized between February 2002 and June 2004. Mean age was 52 years (SD 10) with a range of 28 to 81 years. Mean BMI was 30 kg/m2 (SD 6). The mean values and ranges for the severity measures evaluated are shown in table 1. There were 44 women (7%) with pure stress incontinence, 127 (30%) with ISD and 226 (37%) with a positive SEBST. The small number of patients with pure stress incontinence precluded subgroup analysis by type of incontinence symptoms. VLPP measurements were obtained in 428 patients (65%), and
TABLE 1. Descriptive statistics for severity measures and subgroups
MESA stress score MESA urge score MESA total score UDI obstructive symptoms UDI irritative symptoms UDI stress symptoms UDI total score Total IIQ PW (gm) IEF (leaks/day) VLPP (cm H2O)
No. Pts
Mean (SD)
Range
655 655 655 652 652 651 651 652 645 654 428
19 (5) 6 (4) 26 (7) 25 (22) 48 (25) 78 (22) 151 (49) 171 (101) 43.5 (79.4) 3.2 (3.0) 80 (36)
4–27 0–17 4–43 0–97 0–100 0–100 0–291 0–400 0.1–1,022.6 0.0–26.0 3–202
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MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN TABLE 2. Spearman correlation coefficients (CI)
MESA UDI IIQ PW IEF
UDI
IIQ
PW
IEF
VLPP
0.46 (0.40, 0.52) —
0.47 (0.41, 0.53) 0.58 (0.52, 0.63) —
0.33 (0.26, 0.40) 0.17 (0.09, 0.24) 0.34 (0.27, 0.41) —
0.37 (0.30, 0.43) 0.23 (0.16, 0.30) 0.34 (0.27, 0.41) 0.61 (0.56, 0.66) —
⫺0.14 (⫺0.23, ⫺0.05) ⫺0.01 (⫺0.11, 0.08) ⫺0.09 (⫺0.18, 0.01) ⫺0.11 (⫺0.20, ⫺0.01) ⫺0.10 (⫺0.19, ⫺0.01)
reasons for missing VLPP data included test artifact (85), leaked only with prolapse reduction (19), leaked only with cough (70) and no urodynamic study SUI demonstrated (53). There were weak to moderate positive and negative correlations between the continuous severity measures (table 2), ranging from a low of 0.01 (CI ⫺0.11 to 0.08) between VLPP and UDI to a high of 0.61 (CI 0.56 to 0.66) between IEF and PW. The correlations between the patient questionnaires (UDI, IIQ and MESA) were uniformly moderate. The correlation of PW and IEF with the QOL questionnaires was weak for UDI (0.17 and 0.23, respectively) and moderate with IIQ (0.34 and 0.34, respectively). VLPP was weakly negatively correlated or not at all correlated with the other severity measures. In the subgroup analysis of patients with ISD, correlation coefficients between VLPP and the other measures ranged from – 0.15 to 0.05, demonstrating little to no difference from the group as a whole. The associations between the SEBST and each of the continuous variables are presented in table 3. Mean MESA, UDI, IIQ and PW did not differ by SEBST result. IEF was statistically significantly higher in patients with a positive SEBST, with means of 3.7 episodes (SD 3.3) vs 2.9 episodes per day (SD 2.6) (p ⫽ 0.001). In addition, VLPP was significantly lower, statistically but not clinically, for patients with a positive SEBST vs a negative SEBST, with means of 75 (SD 36) vs 85 cm (SD 36), respectively (p ⫽ 0.011). Of the 118 patients with ISD, 58 had a positive SEBST for a sensitivity of 49% (CI 40%, 58%). Of 284 patients with no ISD 113 had a positive SEBST for a specificity of 60% (CI 54%, 66%). DISCUSSION We studied a number of urinary incontinence severity measures among a large cohort of United States women scheduled to undergo surgery for SUI. Only a modest correlation was observed between patient symptom self-assessment (MESA) and 2 objective measures of urine loss, voiding diary (IEF) and pad test (PW). While a stronger correlation was found between PW and IEF, only modest correlations existed between MESA and the QOL measures (UDI and IIQ).
TABLE 3. Continuous severity measures by SEBST
MESA UDI IIQ PW (gm) IEF (leaks/day) VLPP (cm H2O)
Mean (SD) Pos SEBST (218)
Mean (SD) Neg SEBST (377)
p Value
26 (7) 147 (50) 180 (102) 47.4 (78.6) 3.7 (3.3) 75 (36)
25 (8) 152 (49) 168 (102) 40.3 (789.3) 2.9 (2.6) 85 (36)
0.170 0.216 0.165 0.294 0.001 0.011
No correlation was demonstrated between VLPP and the other continuous severity measures, suggesting that while VLPP may be a measure of urethral sphincter dysfunction, it is not associated with patient symptom severity, quantity of urine loss, or the effect the condition has on patient QOL. A subgroup analysis in patients with VLPP above and below the traditional cutoff for ISD (60 cm H2O) failed to demonstrate an improvement in the correlation between VLPP and the other measures. The moderate correlations between MESA and the measures IEF and PW agree with prior studies comparing validated patient self-assessment tools with more objective measures of incontinence frequency and quantity of urine loss.3,11,12 Elser et al demonstrated moderate to strong correlations between patient recall of the number of pads used and prospectively recorded events on a 7-day diary and a pad test.11 Stach-Lempinen et al found that severity measured by a visual analog score correlated positively with PW and IEF and negatively with MUCP.13 They also found the QOL measure correlated weakly with PW and IEF, and weakly negative with MUCP. Two other studies have demonstrated as we have that IEF and PW correlate better with each other than with patient selfassessment of severity.3,12 VLPP was first described as a measure of urethral sphincter function.5 Subsequently a number of studies reported significant correlation between VLPP and measures of incontinence severity including Stamey grade,5,14 SEAPI grade,15 IEF and number of pads.16 Comparisons among these studies and with the data reported here are difficult due to the varying definitions of severity used. Other investigators have reported minimal or absent correlation between VLPP and severity measures.14,17 Nager et al performed correlation analysis on women enrolled in a multicenter trial for a urethral bulking agent.14 They used the Stamey grading system as a subjective measure of severity, the SEAPI-QMM for a QOL measure, a 7-day voiding diary to assess IEF, and VLPP and MUCP as measures of urethral function. While VLPP correlated negatively (– 0.36) with incontinence grade as noted in the preceding paragraph, it did not correlate with PW or QOL. Theofrastous et al performed correlation analysis on several severity measures from 75 women with pure SUI and found weak negative correlations (⫺0.2) between urethral function measurements (VLPP, MUCP), and IEF and PW. They demonstrated no correlation between VLPP and either of the QOL measures (UDI and IIQ).17 The observation that some patients with low MUCP values leaked with Valsalva despite having just voided, led to the development of the SEBST as a potential method to screen patients for ISD without having to perform urodynamics.18 Lobel and Sand defined ISD by MUCP criterion
MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN and reported a sensitivity of 65% to 70%, and a specificity of 67% to 76% for SEBST to diagnose ISD.18 McLennan and Bent defined ISD by VLPP criterion and reported a sensitivity of 79% and a specificity of 62.5%.10 Walter et al subsequently demonstrated that the PVR volume had minimal impact on the usefulness of the SEBST.19 Ultimately the test is thought to have a high negative predictive value for a VLPP less than 60 cm but lacks the sensitivity to make the diagnosis of ISD.10,18,19 Our data demonstrate a statistically significant association between SEBST and VLPP and IEF. However, the subtle differences in VLPP (75 vs 84 cm H2O) and IEF (3.7 vs 2.9) between those with positive and negative SEBST, respectively, are not likely clinically meaningful. There are a number of potential reasons why incontinence severity measures do not correlate strongly. They may measure different domains of urinary incontinence, as has been noted in prior publications of the SISTEr cohort. Richter et al observed that IEF was positively associated with BMI (p ⫽ 0.003),20 whereas Lemack et al performed a multivariate analysis on the factors associated with VLPP and found that VLPP was positively associated with BMI (p ⫽ 0.0129).21 These data suggest that for increasing BMI, severity measured by IEF worsens while severity measured by VLPP improves. In addition, there may be variability inherent to the measures. Patient self-assessment, especially by recall, has well documented limitations.22 Voiding diaries and pad tests potentially suffer from poor patient compliance, the effect the test may have on the patient normal voiding habits, the variation of the condition depending on activity, fluid intake, and proximity to a bathroom. Lastly, VLPP, while perhaps an accurate indicator of outlet resistance, does not necessarily reflect the bother associated with incontinence (patient reported severity) and it does not consider how variations in patient lifestyles may affect their incontinence. For instance, an active woman with VLPP of 100 cm H2O may experience more frequent incontinence or heavier pad use than a woman with a lower VLPP of 60 cm H2O who has a more sedentary lifestyle. The strengths of this study are the large sample size from geographically and ethnically diverse sites across the United States as well as the standardized methods of preoperative assessment and data collection. The primary limitation is that it is not representative of the entire population of women with SUI. Due to the inclusion criteria, the study population does not include 2 subgroups traditionally considered to have more severe incontinence, those with severe urge and those with immobile urethras, nor does it include those women whose symptoms are not severe enough for them to seek surgery. Therefore, patients at both ends of the severity spectrum potentially were excluded from this analysis. These data support the recent recommendations by a number of guidelines panels on the importance of using multiple measures to assess incontinence.23 A number of groups have attempted to combine severity measures into an incontinence score in an effort to more comprehensively assess the entire condition. Tools such as the Sandvik severity index24 and the International Consultation on Incontinence Questionnaire25 have demonstrated correlation with the voiding diary and pad test.3,25 Whether these indexes are more accurate than individual measures requires fur-
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ther investigation. Ultimately, for these scores to be clinically useful, it will be important to link severity measures to quality of life, expectations and satisfaction data.
CONCLUSIONS This analysis of baseline severity measures from a large population of women with predominant SUI suggests that no 2 severity measures are the same. Rather, they appear to measure different aspects of the incontinence condition and, thus, are not interchangeable when characterizing a patient population or assessing outcomes. This has practical implications for clinicians and investigators who are evaluating the results of new therapies. Before comparing results we must confirm that similar measures were used to define the patient population and to assess the outcomes. To facilitate such comparisons standardized measurement tools should be agreed upon and used by all investigators. As there is no gold standard for severity against which these measures can be compared, no conclusions can be drawn about the usefulness of a given measure. In addition, these data do not address the potential value of these measures as predictors of treatment outcomes or to assist in choosing appropriate therapy. Further investigation is recommended to evaluate the relationship between these severity measures and the efficacy and morbidity associated with surgical treatment. APPENDIX Steering Committee Dr. William Steers, University of Virginia, Charlottesville, Virginia; Dr. Ananias C. Diokno and Veronica Mallett, William Beaumont Hospital, Royal Oak and Oakwood Hospital, Dearborn, Michigan; Drs. Linda Brubaker and MaryPat FitzGerald, Loyola University Medical Center, Maywood, Illinois; Drs. Holly E. Richter and L. Keith Lloyd, University of Alabama, Birmingham, Alabama; Drs. Michael Albo and Charles Nager, University of California, San Diego, California; Drs. Toby Chai and Harry W. Johnson, University of Maryland, Baltimore, Maryland; Drs. Halina M. Zyczynski, Michael Chancellor and Wendy Leng, University of Pittsburgh, Pittsburgh, Pennsylvania; Drs. Philippe Zimmern and Gary Lemack, University of Texas Southwestern, Dallas, and Stephen Kraus and R. Duane Cespedes, University of Texas Health Sciences Center, San Antonio, Texas; Drs. Peggy Norton and Lindsey Kerr, University of Utah, Salt Lake City, Utah; Sharon Tennstedt and Anne Stoddard, New England Research Institutes, Watertown, Massachusetts; John W. Kusek and Dr. Leroy M. Nyberg, National Institute of Diabetes and Digestive and Kidney Diseases; and Dr. Anne M. Weber, National Institute of Child Health and Human Development.
Co-Investigators Jan Baker, Diane Borello-France, Kathryn L. Burgio, and Drs. Rowell S. Ashford, II, Seine Chiang, Ash Dabbous, Patricia S. Goode, Lee N. Hammontree, Kimberly Kenton, Salil Khandwala, David Lesser, Karl Luber, Emily Lukacz, Alayne Markland, Shawn Menefee, Pamela Moalli, Mikio Nihira, Kenneth Peters, Curt Powell, Elizabeth Sagan, Joseph Schaffer, Amanda Simsiman, Larry Sirls, Robert Starr and R. Edward Varner.
Study Coordinators Rosemary Bradt, Karen Debes, Rosanna Dinh, Judy Gruss, Lynn Hall, Alice Howell, Kathy Jesse, D. Lynn Kalinoski, Kathryn Koches, Barbara Leemon, Karen Mislanovich, Judith Murray, Shelly O’Meara, Norma Pope, Caren Prather, Sylvia Sluder, Mary Tulke and Gisselle Zazueta-Damian.
Biostatistical Coordinating Center Kimberly J. Dandreo, Liane Tinsley, Leslie Kalish, Susan McDermott, Beth Mohr, Anne Stoddard, co-principal investigator and Sharon Tennstedt, principal investigator.
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MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN 11.
Abbreviations and Acronyms BMI IEF IIQ ISD MESA
⫽ ⫽ ⫽ ⫽ ⫽
MUCP PVR PW QOL SEBST SISTEr
⫽ ⫽ ⫽ ⫽ ⫽ ⫽
SUI ⫽ UDI ⫽ UITN ⫽ VLPP ⫽
body mass index incontinence episode frequency Incontinence Impact Questionnaire intrinsic sphincter dysfunction Medical, Epidemiological and Social Aspects of Aging maximum urethral closure pressure post-void residual pad weight quality of life supine empty bladder stress test Stress Incontinence Surgical Treatment Efficacy Trial stress urinary incontinence Urogenital Distress Inventory Urinary Incontinence Treatment Network Valsalva leak point pressure
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Purpose: We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques (Burch colposuspension vs pubovaginal sling) for stress urinary incontinence. Materials and Methods: A total of 655 women underwent a standardized preoperative assessment that included the Medical, Epidemiological and Social Aspects of Aging questionnaire, Urogenital Distress Inventory, Incontinence Impact Questionnaire, 3-day voiding diary, 24-hour pad test, a supine empty bladder stress test and Valsalva leak point pressure measurements. Correlations were estimated using Spearman correlation coefficients and 95% confidence intervals. T tests at ␣ ⫽ 0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test. Results: Baseline mean scores on Medical, Epidemiological and Social Aspects of Aging, Urogenital Distress Inventory and Incontinence Impact Questionnaire were 25.8, 151 and 171, respectively. Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm, respectively. Supine empty bladder stress test was positive in 218 patients, and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H2O. Weak to moderate correlations were observed between Medical, Epidemiological and Social Aspects of Aging, incontinence episode frequency, pad weight, Incontinence Impact Questionnaire and Urogenital Distress Inventory. On the other hand, Valsalva leak point pressure correlated poorly with all variables measured. The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49% and 60%, respectively. Conclusions: Urinary incontinence severity measures correlate moderately with each other at best. While Medical, Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life, Valsalva leak point pressure did not. Supine empty bladder stress test did not demonstrate a clinically significant association among severity measures. Key Words: urinary bladder; female; quality of life; urinary incontinence, stress; urodynamics
rinary incontinence, a highly prevalent condition in women, is defined by symptoms, its pathophysiology and/or its impact on QOL. Assessment of disease severity may be used to gain insight into the pathophysiology or to predict responses to therapy. Al-
U
though a wide range of methods have been proposed to measure the severity of urinary incontinence, including use of urinary symptom and impact questionnaires,1 voiding diary,2 pad testing3 and various urodynamic test parameters,4,5 none has emerged as the gold standard. The
Submitted for publication September 25, 2006. Supported by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases, U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and 60401. Supported by the National Institute of Child Health and Human Development and Office of Research in Women’s Health, National Institutes of Health. * Correspondence: Division of Urology, University of California San Diego Medical Center, 200 W. Arbor Drive, San Diego, California
92103-8897 (telephone: 858-657-8435; FAX: 858-657-8650; e-mail: [email protected]). † Financial interest and/or other relationship with Pfizer. ‡ Financial interest and/or other relationship with Ortho McNeil. § Financial interest and/or other relationship with Pfizer, Novartis, Astellas, Ortho McNeil and NIDDK. 储 Financial interest and/or other relationship with Pfizer, Astellas and Allergan. ¶ Financial interest and/or other relationship with Sanofi Aventis, Lilly, Novartis, Astellas, Pfizer and Allergan.
0022-5347/07/1775-1810/0 THE JOURNAL OF UROLOGY® Copyright © 2007 by AMERICAN UROLOGICAL ASSOCIATION
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Vol. 177, 1810-1814, May 2007 Printed in U.S.A. DOI:10.1016/j.juro.2007.01.032
MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN lack of a universally accepted severity measure creates difficulty in designing or comparing results in clinical and epidemiological studies. A multicenter, randomized clinical trial of the Burch colposuspension compared to the pubovaginal sling for the treatment of SUI provided an opportunity to examine the relationship between generally accepted severity measures including symptom and QOL questionnaires, pad test, voiding diary, supine empty bladder stress test, and urodynamic measurements in women before undergoing surgery. In addition, we hypothesized that the severity measures would correlate differently in patients with urodynamic evidence of ISD compared to those with no ISD, and in patients with mixed incontinence compared to those with pure stress incontinence. MATERIALS AND METHODS Study Design The UITN SISTEr protocol was designed to comply with the provisions of the Declaration of Helsinki and was approved by the National Institutes of Health and the respective institutional review boards from the 9 clinical sites in the UITN.6 All patients gave written informed consent before enrollment. Women were eligible for the trial if they reported predominant symptoms of SUI determined from the MESA questionnaire,7 displayed urethral hypermobility determined by a Q-tip test and had a positive standardized volume stress test. Measurements Before randomization patients underwent a standardized preoperative evaluation which included collection of several measures of severity, that is MESA symptom questionnaire, UDI, IIQ, 3-day voiding diary, 24-hour pad test, a standardized volume stress test, SEBST and VLPP obtained during standardized urodynamics testing. The MESA total score ranges from 0 to 45 and is a sum of its 2 components, the stress score and the urge score. The stress component consists of 9 questions regarding the frequency of stress related urine loss. Scores range from 0 to 27 and increase as the frequency of urine loss increases. Similarly the urge index consists of 6 questions regarding the frequency of urge related urine loss and scores range from 0 to 18.7 For the purposes of this analysis, participants were classified as having symptoms of pure stress incontinence if the MESA urge score was zero and classified as having mixed incontinence if the MESA urge score was greater than zero. The UDI consists of 3 subscales (obstructive symptoms, irritative symptoms and stress symptoms). The total UDI score has a range of 0 to 300 when all questions are answered. Each subscale score is computed as the mean of the items contributing to that subscore, and scaled to have a range from 0 to 100. Scores increase with worsening QOL.8 The IIQ consists of 4 subscales (activity, travel, social and emotional). The total IIQ score has a range of 0 to 400. Subscale scores are scaled to have a range of 0 to 100 and scores increase with worsening QOL.8 PW is calculated as the difference between total pad weights before and after the test during a 24-hour period.3 IEF is calculated as the mean number of involuntary epi-
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sodes of urine loss per day recorded on the 3-day voiding diary. VLPP is reported as the mean vesical pressure at leakage during a Valsalva maneuver minus mean vesical pressure at baseline of cystometrogram using atmospheric pressure as the reference. VLPP was obtained during standardized filling cystometry with the first measurement at a volume of 200 ml and repeated at 100 ml increments until SUI was observed on at least 2 of 3 Valsalva maneuvers at a given volume or until maximum cystometric capacity was reached. Urodynamic ISD was defined as VLPP 60 cm or less. The urodynamic testing procedures and quality control measures have been described by Nager et al.9 The supine empty bladder stress test was performed in the supine position with cough and straining maneuvers.10 A positive test was recorded if urethral leakage was observed during any of the maneuvers. Patients with PVR greater than 100 cc were excluded from this analysis. We examined the relationship between measures of severity in the entire study population as well as in 2 subgroups of patients, those with urodynamic ISD compared to patients with no ISD, and among patients with symptoms of mixed incontinence compared to those with symptoms of pure stress incontinence. Statistical Analysis Statistical analysis was performed using SAS® 9.1. Correlations were estimated using Spearman correlation coefficients and 95% CI. To evaluate the association between SEBST and each of the continuous severity measures, t tests at ␣ ⫽ 0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative SEBST. The sensitivity and specificity of SEBST for ISD was calculated along with 95% CI. RESULTS A total of 655 women were randomized between February 2002 and June 2004. Mean age was 52 years (SD 10) with a range of 28 to 81 years. Mean BMI was 30 kg/m2 (SD 6). The mean values and ranges for the severity measures evaluated are shown in table 1. There were 44 women (7%) with pure stress incontinence, 127 (30%) with ISD and 226 (37%) with a positive SEBST. The small number of patients with pure stress incontinence precluded subgroup analysis by type of incontinence symptoms. VLPP measurements were obtained in 428 patients (65%), and
TABLE 1. Descriptive statistics for severity measures and subgroups
MESA stress score MESA urge score MESA total score UDI obstructive symptoms UDI irritative symptoms UDI stress symptoms UDI total score Total IIQ PW (gm) IEF (leaks/day) VLPP (cm H2O)
No. Pts
Mean (SD)
Range
655 655 655 652 652 651 651 652 645 654 428
19 (5) 6 (4) 26 (7) 25 (22) 48 (25) 78 (22) 151 (49) 171 (101) 43.5 (79.4) 3.2 (3.0) 80 (36)
4–27 0–17 4–43 0–97 0–100 0–100 0–291 0–400 0.1–1,022.6 0.0–26.0 3–202
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MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN TABLE 2. Spearman correlation coefficients (CI)
MESA UDI IIQ PW IEF
UDI
IIQ
PW
IEF
VLPP
0.46 (0.40, 0.52) —
0.47 (0.41, 0.53) 0.58 (0.52, 0.63) —
0.33 (0.26, 0.40) 0.17 (0.09, 0.24) 0.34 (0.27, 0.41) —
0.37 (0.30, 0.43) 0.23 (0.16, 0.30) 0.34 (0.27, 0.41) 0.61 (0.56, 0.66) —
⫺0.14 (⫺0.23, ⫺0.05) ⫺0.01 (⫺0.11, 0.08) ⫺0.09 (⫺0.18, 0.01) ⫺0.11 (⫺0.20, ⫺0.01) ⫺0.10 (⫺0.19, ⫺0.01)
reasons for missing VLPP data included test artifact (85), leaked only with prolapse reduction (19), leaked only with cough (70) and no urodynamic study SUI demonstrated (53). There were weak to moderate positive and negative correlations between the continuous severity measures (table 2), ranging from a low of 0.01 (CI ⫺0.11 to 0.08) between VLPP and UDI to a high of 0.61 (CI 0.56 to 0.66) between IEF and PW. The correlations between the patient questionnaires (UDI, IIQ and MESA) were uniformly moderate. The correlation of PW and IEF with the QOL questionnaires was weak for UDI (0.17 and 0.23, respectively) and moderate with IIQ (0.34 and 0.34, respectively). VLPP was weakly negatively correlated or not at all correlated with the other severity measures. In the subgroup analysis of patients with ISD, correlation coefficients between VLPP and the other measures ranged from – 0.15 to 0.05, demonstrating little to no difference from the group as a whole. The associations between the SEBST and each of the continuous variables are presented in table 3. Mean MESA, UDI, IIQ and PW did not differ by SEBST result. IEF was statistically significantly higher in patients with a positive SEBST, with means of 3.7 episodes (SD 3.3) vs 2.9 episodes per day (SD 2.6) (p ⫽ 0.001). In addition, VLPP was significantly lower, statistically but not clinically, for patients with a positive SEBST vs a negative SEBST, with means of 75 (SD 36) vs 85 cm (SD 36), respectively (p ⫽ 0.011). Of the 118 patients with ISD, 58 had a positive SEBST for a sensitivity of 49% (CI 40%, 58%). Of 284 patients with no ISD 113 had a positive SEBST for a specificity of 60% (CI 54%, 66%). DISCUSSION We studied a number of urinary incontinence severity measures among a large cohort of United States women scheduled to undergo surgery for SUI. Only a modest correlation was observed between patient symptom self-assessment (MESA) and 2 objective measures of urine loss, voiding diary (IEF) and pad test (PW). While a stronger correlation was found between PW and IEF, only modest correlations existed between MESA and the QOL measures (UDI and IIQ).
TABLE 3. Continuous severity measures by SEBST
MESA UDI IIQ PW (gm) IEF (leaks/day) VLPP (cm H2O)
Mean (SD) Pos SEBST (218)
Mean (SD) Neg SEBST (377)
p Value
26 (7) 147 (50) 180 (102) 47.4 (78.6) 3.7 (3.3) 75 (36)
25 (8) 152 (49) 168 (102) 40.3 (789.3) 2.9 (2.6) 85 (36)
0.170 0.216 0.165 0.294 0.001 0.011
No correlation was demonstrated between VLPP and the other continuous severity measures, suggesting that while VLPP may be a measure of urethral sphincter dysfunction, it is not associated with patient symptom severity, quantity of urine loss, or the effect the condition has on patient QOL. A subgroup analysis in patients with VLPP above and below the traditional cutoff for ISD (60 cm H2O) failed to demonstrate an improvement in the correlation between VLPP and the other measures. The moderate correlations between MESA and the measures IEF and PW agree with prior studies comparing validated patient self-assessment tools with more objective measures of incontinence frequency and quantity of urine loss.3,11,12 Elser et al demonstrated moderate to strong correlations between patient recall of the number of pads used and prospectively recorded events on a 7-day diary and a pad test.11 Stach-Lempinen et al found that severity measured by a visual analog score correlated positively with PW and IEF and negatively with MUCP.13 They also found the QOL measure correlated weakly with PW and IEF, and weakly negative with MUCP. Two other studies have demonstrated as we have that IEF and PW correlate better with each other than with patient selfassessment of severity.3,12 VLPP was first described as a measure of urethral sphincter function.5 Subsequently a number of studies reported significant correlation between VLPP and measures of incontinence severity including Stamey grade,5,14 SEAPI grade,15 IEF and number of pads.16 Comparisons among these studies and with the data reported here are difficult due to the varying definitions of severity used. Other investigators have reported minimal or absent correlation between VLPP and severity measures.14,17 Nager et al performed correlation analysis on women enrolled in a multicenter trial for a urethral bulking agent.14 They used the Stamey grading system as a subjective measure of severity, the SEAPI-QMM for a QOL measure, a 7-day voiding diary to assess IEF, and VLPP and MUCP as measures of urethral function. While VLPP correlated negatively (– 0.36) with incontinence grade as noted in the preceding paragraph, it did not correlate with PW or QOL. Theofrastous et al performed correlation analysis on several severity measures from 75 women with pure SUI and found weak negative correlations (⫺0.2) between urethral function measurements (VLPP, MUCP), and IEF and PW. They demonstrated no correlation between VLPP and either of the QOL measures (UDI and IIQ).17 The observation that some patients with low MUCP values leaked with Valsalva despite having just voided, led to the development of the SEBST as a potential method to screen patients for ISD without having to perform urodynamics.18 Lobel and Sand defined ISD by MUCP criterion
MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN and reported a sensitivity of 65% to 70%, and a specificity of 67% to 76% for SEBST to diagnose ISD.18 McLennan and Bent defined ISD by VLPP criterion and reported a sensitivity of 79% and a specificity of 62.5%.10 Walter et al subsequently demonstrated that the PVR volume had minimal impact on the usefulness of the SEBST.19 Ultimately the test is thought to have a high negative predictive value for a VLPP less than 60 cm but lacks the sensitivity to make the diagnosis of ISD.10,18,19 Our data demonstrate a statistically significant association between SEBST and VLPP and IEF. However, the subtle differences in VLPP (75 vs 84 cm H2O) and IEF (3.7 vs 2.9) between those with positive and negative SEBST, respectively, are not likely clinically meaningful. There are a number of potential reasons why incontinence severity measures do not correlate strongly. They may measure different domains of urinary incontinence, as has been noted in prior publications of the SISTEr cohort. Richter et al observed that IEF was positively associated with BMI (p ⫽ 0.003),20 whereas Lemack et al performed a multivariate analysis on the factors associated with VLPP and found that VLPP was positively associated with BMI (p ⫽ 0.0129).21 These data suggest that for increasing BMI, severity measured by IEF worsens while severity measured by VLPP improves. In addition, there may be variability inherent to the measures. Patient self-assessment, especially by recall, has well documented limitations.22 Voiding diaries and pad tests potentially suffer from poor patient compliance, the effect the test may have on the patient normal voiding habits, the variation of the condition depending on activity, fluid intake, and proximity to a bathroom. Lastly, VLPP, while perhaps an accurate indicator of outlet resistance, does not necessarily reflect the bother associated with incontinence (patient reported severity) and it does not consider how variations in patient lifestyles may affect their incontinence. For instance, an active woman with VLPP of 100 cm H2O may experience more frequent incontinence or heavier pad use than a woman with a lower VLPP of 60 cm H2O who has a more sedentary lifestyle. The strengths of this study are the large sample size from geographically and ethnically diverse sites across the United States as well as the standardized methods of preoperative assessment and data collection. The primary limitation is that it is not representative of the entire population of women with SUI. Due to the inclusion criteria, the study population does not include 2 subgroups traditionally considered to have more severe incontinence, those with severe urge and those with immobile urethras, nor does it include those women whose symptoms are not severe enough for them to seek surgery. Therefore, patients at both ends of the severity spectrum potentially were excluded from this analysis. These data support the recent recommendations by a number of guidelines panels on the importance of using multiple measures to assess incontinence.23 A number of groups have attempted to combine severity measures into an incontinence score in an effort to more comprehensively assess the entire condition. Tools such as the Sandvik severity index24 and the International Consultation on Incontinence Questionnaire25 have demonstrated correlation with the voiding diary and pad test.3,25 Whether these indexes are more accurate than individual measures requires fur-
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ther investigation. Ultimately, for these scores to be clinically useful, it will be important to link severity measures to quality of life, expectations and satisfaction data.
CONCLUSIONS This analysis of baseline severity measures from a large population of women with predominant SUI suggests that no 2 severity measures are the same. Rather, they appear to measure different aspects of the incontinence condition and, thus, are not interchangeable when characterizing a patient population or assessing outcomes. This has practical implications for clinicians and investigators who are evaluating the results of new therapies. Before comparing results we must confirm that similar measures were used to define the patient population and to assess the outcomes. To facilitate such comparisons standardized measurement tools should be agreed upon and used by all investigators. As there is no gold standard for severity against which these measures can be compared, no conclusions can be drawn about the usefulness of a given measure. In addition, these data do not address the potential value of these measures as predictors of treatment outcomes or to assist in choosing appropriate therapy. Further investigation is recommended to evaluate the relationship between these severity measures and the efficacy and morbidity associated with surgical treatment. APPENDIX Steering Committee Dr. William Steers, University of Virginia, Charlottesville, Virginia; Dr. Ananias C. Diokno and Veronica Mallett, William Beaumont Hospital, Royal Oak and Oakwood Hospital, Dearborn, Michigan; Drs. Linda Brubaker and MaryPat FitzGerald, Loyola University Medical Center, Maywood, Illinois; Drs. Holly E. Richter and L. Keith Lloyd, University of Alabama, Birmingham, Alabama; Drs. Michael Albo and Charles Nager, University of California, San Diego, California; Drs. Toby Chai and Harry W. Johnson, University of Maryland, Baltimore, Maryland; Drs. Halina M. Zyczynski, Michael Chancellor and Wendy Leng, University of Pittsburgh, Pittsburgh, Pennsylvania; Drs. Philippe Zimmern and Gary Lemack, University of Texas Southwestern, Dallas, and Stephen Kraus and R. Duane Cespedes, University of Texas Health Sciences Center, San Antonio, Texas; Drs. Peggy Norton and Lindsey Kerr, University of Utah, Salt Lake City, Utah; Sharon Tennstedt and Anne Stoddard, New England Research Institutes, Watertown, Massachusetts; John W. Kusek and Dr. Leroy M. Nyberg, National Institute of Diabetes and Digestive and Kidney Diseases; and Dr. Anne M. Weber, National Institute of Child Health and Human Development.
Co-Investigators Jan Baker, Diane Borello-France, Kathryn L. Burgio, and Drs. Rowell S. Ashford, II, Seine Chiang, Ash Dabbous, Patricia S. Goode, Lee N. Hammontree, Kimberly Kenton, Salil Khandwala, David Lesser, Karl Luber, Emily Lukacz, Alayne Markland, Shawn Menefee, Pamela Moalli, Mikio Nihira, Kenneth Peters, Curt Powell, Elizabeth Sagan, Joseph Schaffer, Amanda Simsiman, Larry Sirls, Robert Starr and R. Edward Varner.
Study Coordinators Rosemary Bradt, Karen Debes, Rosanna Dinh, Judy Gruss, Lynn Hall, Alice Howell, Kathy Jesse, D. Lynn Kalinoski, Kathryn Koches, Barbara Leemon, Karen Mislanovich, Judith Murray, Shelly O’Meara, Norma Pope, Caren Prather, Sylvia Sluder, Mary Tulke and Gisselle Zazueta-Damian.
Biostatistical Coordinating Center Kimberly J. Dandreo, Liane Tinsley, Leslie Kalish, Susan McDermott, Beth Mohr, Anne Stoddard, co-principal investigator and Sharon Tennstedt, principal investigator.
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MEASURES OF SEVERITY OF STRESS URINARY INCONTINENCE IN WOMEN 11.
Abbreviations and Acronyms BMI IEF IIQ ISD MESA
⫽ ⫽ ⫽ ⫽ ⫽
MUCP PVR PW QOL SEBST SISTEr
⫽ ⫽ ⫽ ⫽ ⫽ ⫽
SUI ⫽ UDI ⫽ UITN ⫽ VLPP ⫽
body mass index incontinence episode frequency Incontinence Impact Questionnaire intrinsic sphincter dysfunction Medical, Epidemiological and Social Aspects of Aging maximum urethral closure pressure post-void residual pad weight quality of life supine empty bladder stress test Stress Incontinence Surgical Treatment Efficacy Trial stress urinary incontinence Urogenital Distress Inventory Urinary Incontinence Treatment Network Valsalva leak point pressure
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