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ABSTRACT: To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery.
Women with predominant stress urinary incontinence (SUI) as part of the trial of mid-urethral slings (TOMUS) were characterized preoperatively including: demographics, body mass index (BMI), responses to the Medical and Epidemiologic Social Aspects of Aging (MESA) and Urogenital Distress Inventory (UDI) questionnaires, pad weight (PW), incontinence duration, prior SUI surgery, prolapse, strength of pelvic contraction, Q-tip test, uroflow, cystometrogram, and detrusor pressures at maximum flow (Pdet at Qmax). Multivariate regression analysis and modeling confirmed variables with significant correlations with maximal urethral closure pressure (MUCP), functional urethral length (FUL), and Valsalva leak point pressure (VLPP).
Five-hundred thirty-nine women were included in the analysis. In multivariable analyses, PW (P = 0.045) and age (P < 0.0001) were negatively correlated with MUCP (as PW and age increased, MUCP decreased); BMI (P = 0.02) and Pdet at Qmax (P < 0.0001) were positively correlated with MUCP (as BMI and Pdet at Qmax increased, MUCP increased). Age (P = 0.002) was negatively correlated with FUL; Qtip delta (P = 0.006), pelvic organ prolapse quantification examination (POPQ) stage (P = 0.002) and strength of pelvic contraction (P = 0.03) were positively correlated with FUL. Duration of incontinence (P = 0.01) was negatively correlated with VLPP; Qtip delta (P = 0.02), BMI (P = 0.0005) and Pdet at Qmax (P = 0.0005) were positively correlated with VLPP.
Age, BMI, Qtip delta, and Pdet at Qmax were variables that correlated with two or more measures of urethral function. These correlations may help direct future research in female urethral function.
Neurourology and Urodynamics 02/2012; 31(4):496-501. · 2.96 Impact Factor
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Charles W Nager,
Larry Sirls,
Heather J Litman,
Holly Richter,
Ingrid Nygaard,
Toby Chai, Stephen Kraus,
Halina Zyczynski,
Kim Kenton,
Liyuan Huang,
John Kusek,
Gary Lemack
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ABSTRACT: We determined whether baseline urodynamic study variables predict failure after mid urethral sling surgery.
Preoperative urodynamic study variables and postoperative continence status were analyzed in women participating in a randomized trial comparing retropubic to transobturator mid urethral sling. Objective failure was defined by positive standardized stress test, 15 ml or greater on 24-hour pad test, or re-treatment for stress urinary incontinence. Subjective failure criteria were self-reported stress symptoms, leakage on 3-day diary or re-treatment for stress urinary incontinence. Logistic regression was used to assess associations between covariates and failure controlling for treatment group and clinical variables. Receiver operator curves were constructed for relationships between objective failure and measures of urethral function.
Objective continence outcomes were available at 12 months for 565 of 597 (95%) women. Treatment failed in 260 women (245 by subjective criteria, 124 by objective criteria). No urodynamic variable was significantly associated with subjective failure on multivariate analysis. Valsalva leak point pressure, maximum urethral closure pressure and urodynamic stress incontinence were the only urodynamic variables consistently associated with objective failure on multivariate analysis. No specific cut point was determined for predicting failure for Valsalva leak point pressure or maximum urethral closure pressure by ROC. The lowest quartile (Valsalva leak point pressure less than 86 cm H2O, maximum urethral closure pressure less than 45 cm H2O) conferred an almost 2-fold increased odds of objective failure regardless of sling route (OR 2.23, 1.20-4.14 for Valsalva leak point pressure and OR 1.88, 1.04-3.41 for maximum urethral closure pressure).
Women with a Valsalva leak point pressure or maximum urethral closure pressure in the lowest quartile are nearly 2-fold more likely to experience stress urinary incontinence 1 year after transobturator or retropubic mid urethral sling.
The Journal of urology 06/2011; 186(2):597-603. · 4.02 Impact Factor
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Anna C Kirby,
Charles W Nager,
Heather J Litman,
Mary P Fitzgerald, Stephen Kraus,
Peggy Norton,
Larry Sirls,
Leslie Rickey,
Tracey Wilson,
Kimberly J Dandreo,
Jonathan Shepherd,
Philippe Zimmern
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ABSTRACT: To describe perineal surface patch electromyography (EMG) activity during urodynamics (UDS) and compare activity between filling and voiding phases and to assess for a relationship between preoperative EMG activity and postoperative voiding symptoms.
655 women underwent standardized preoperative UDS that included perineal surface EMG prior to undergoing surgery for stress urinary incontinence. Pressure-flow studies were evaluated for abdominal straining and interrupted flow. Quantitative EMG values were extracted from 10 predetermined time-points and compared between fill and void. Qualitative EMG activity was assessed for the percent of time EMG was active during fill and void and for the average amplitude of EMG during fill compared to void. Postoperative voiding dysfunction was defined as surgical revision or catheterization more than 6 weeks after surgery. Fisher's exact test with a 5% two-sided significance level was used to assess differences in EMG activity and postoperative voiding dysfunction.
321 UDS had interpretable EMG studies, of which 131 (41%) had EMG values at all 10 predetermined and annotated time-points. Quantitative and qualitative EMG signals during flow were usually greater than during fill. The prevalence of postoperative voiding dysfunction in subjects with higher preoperative EMG activity during void was not significantly different. Results were similar in the 42 subjects who had neither abdominal straining during void nor interrupted flow.
Perineal surface patch EMG did not measure expected pelvic floor and urethral sphincter relaxation during voiding. Preoperative EMG did not predict patients at risk for postoperative voiding dysfunction.
Neurourology and Urodynamics 05/2011; 30(8):1591-6. · 2.96 Impact Factor
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Holly E Richter,
Heather J Litman,
Emily S Lukacz,
Larry T Sirls,
Leslie Rickey,
Peggy Norton,
Gary E Lemack, Stephen Kraus,
Pamela Moalli,
Mary Pat Fitzgerald,
Kimberly J Dandreo,
Liyuan Huang,
John W Kusek
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ABSTRACT: To identify clinical and demographic factors predictive of midurethral sling failure.
Overall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or retreatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire, incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure and subjective failure only.
Previous UI surgery (odds ratio [OR] 1.99, 95% confidence interval [CI] 1.14-3.47); maximum Q-tip excursion<30° (OR 1.89, 95% CI 1.16-3.05); Medical, Epidemiologic and Social Aspect of Aging questionnaire urge score per 10 points (OR 1.97, 95% CI 1.21-3.21); and pad weight per 10 g (OR 1.06, 95% CI 1.02-1.10) were predictors of overall failure. Having concomitant surgery (OR 0.44, 95% CI 0.22-0.90) was predictive of subjective failure only rather than objective failure. Age per 10 years (OR 1.48, 95% CI 1.14-1.90); Urogenital Distress Inventory score per 10 points (OR 1.09, 95% CI 1.02-1.17); pad weight per 10 g (OR 1.05, 95% CI 1.01-1.10) were predictive of objective failure compared with subjective failure only. Associations of risk factors and failure were similar independent of sling type (retropubic or transobturator).
Twelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039.
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Obstetrics and Gynecology 04/2011; 117(4):913-21. · 4.73 Impact Factor
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ABSTRACT: We aimed to explore operational definitions of mixed urinary incontinence (MUI) for use in incontinence outcomes research for non-surgical patient populations.
A secondary analysis of women with urge incontinence or urge predominant MUI enrolled in the Urinary Incontinence Treatment Network BE-DRI randomized clinical trial was performed. Subjects were characterized at baseline for urinary incontinence severity and incontinence subtype (stress or urge) using the Medical, Epidemiologic, and Social Aspects of Aging (MESA) questionnaire, the Urogenital Distress Inventory, and a 7-day urinary diary. Various different definitions of MUI, ranging from low to high threshold, were created using a combination of these baseline incontinence measures. Prevalence of MUI based on each definition was described and compared to treatment response. Logistic regression analysis was used to estimate the association between the study outcomes and the different definitions of MUI.
The 307 participants in the BE-DRI study had a mean age of 56.9 (± 13.9) years with a mean total MESA score of 21.7 (± 8.9) and a mean total UDI score of 120.5 (± 49.6). The proportion of women diagnosed with MUI varied significantly by definition ranging from 63.5% to 96.4%. Low threshold symptom-based definitions resulted in nearly universal diagnosis of MUI. No strict cut-off value for these baseline measures was identified to predict clinical outcomes.
Current MUI definitions do not adequately categorize clinically relevant UI subgroups. For research purposes we believe it necessary to describe the severity of each incontinence subtype separately in subjects with MUI.
Neurourology and Urodynamics 01/2011; 30(1):47-51. · 2.96 Impact Factor
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Anna C Kirby,
Charles W Nager,
Heather J Litman,
Mary P FitzGerald, Stephen Kraus,
Peggy Norton,
Larry Sirls,
Leslie Rickey,
Tracey Wilson,
Kimberly J Dandreo,
Jonathan P Shepherd,
Philippe Zimmern
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ABSTRACT: The aim of this study was to determine whether preoperative voiding detrusor pressures were associated with postoperative outcomes after stress incontinence surgery.
Opening detrusor pressure, detrusor pressure at maximum flow (p (det) Q(max)), and closing detrusor pressure were assessed from 280 valid preoperative urodynamic studies in subjects without advanced prolapse from a multicenter randomized trial comparing Burch and autologous fascia sling procedures. These pressures were compared between subjects with and without overall success, stress-specific success, postoperative detrusor overactivity, and postoperative urge incontinence using independent sample t tests.
There were no clinically or statistically significant differences in mean preoperative voiding detrusor pressures in any comparison of postoperative outcomes.
We found no evidence that preoperative voiding detrusor pressures predict outcomes in women with stress predominant urinary incontinence undergoing Burch or autologous fascial sling procedures.
International Urogynecology Journal 12/2010; 22(6):657-63. · 1.83 Impact Factor
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Holly E Richter,
Kimberly Kenton,
Liyuan Huang,
Ingrid Nygaard, Stephen Kraus,
Emily Whitcomb,
Toby C Chai,
Gary Lemack,
Larry Sirls,
Kimberly J Dandreo,
Anne Stoddard
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ABSTRACT: We compared urinary incontinence severity measures and the impact of stress urinary incontinence in normal, overweight and obese women.
Baseline characteristics of subjects in the SISTEr (655) and the TOMUS (597) were analyzed. Body mass index was defined as normal (less than 25 kg/m(2)), overweight (25 to less than 30 kg/m(2)) and obese (30 kg/m(2) or greater). Independent urinary incontinence severity measures included a 3-day diary including incontinence episode frequency, Urogenital Distress Inventory scores and Valsalva leak point pressure from urodynamic testing. Impact was measured using the Incontinence Impact Questionnaire. Multivariable regression models were fit for each severity measure (Urogenital Distress Inventory, incontinence episode frequency, Valsalva leak point pressure and Incontinence Impact Questionnaire) on weight category. Covariates included age, race, diabetes and variables significantly associated with body mass index on bivariate analysis.
Mean age (SD) of participants was 51.9 (10.3) in SISTEr and 52.9 (11.0) in TOMUS. In each trial 45% of subjects were obese. In SISTEr multivariable regression analyses showed that higher weight category was independently associated with higher mean Urogenital Distress Inventory score (p = 0.003), incontinence episode frequency (p <0.0001), Valsalva leak point pressure (p = 0.003) and Incontinence Impact Questionnaire score (p = 0.0004). In TOMUS higher weight category was not associated with Urogenital Distress Inventory score (p = 0.24) but was associated with higher incontinence episode frequency (p = 0.0003), Valsalva leak point pressure (p = 0.0006) and Incontinence Impact Questionnaire score (p <0.0001).
Obese women undergoing surgery for stress urinary incontinence report more incontinence episodes, more symptom distress and worse quality of life despite better measure of urethral function (higher Valsalva leak point pressure) on urodynamics.
The Journal of urology 12/2009; 183(2):622-8. · 4.02 Impact Factor
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ABSTRACT: Women with urge predominant urinary incontinence received active intervention (drug therapy alone or combined with behavioral therapy) for 10 weeks, then stopped all therapy and were followed for 6 months more. In this planned secondary analysis, we aimed to identify predictors of therapeutic success at 10 weeks (> or =70% reduction in incontinence) and of ability to discontinue treatment and sustain improvements 6 months later.
Using data from 307 women, we performed logistic regression to identify predictors for outcomes described above.
After controlling for group, only younger age was associated with short-term success (OR 0.8, 95% CI 0.66, 0.96). At 6 months, controlling for group and short-term outcome, only greater anterior vaginal wall prolapse was associated with successful discontinuation (POP-Q point Aa; OR 1.33, 95% CI 1.03, 1.7).
These findings are not of sufficient strength to justify withholding conservative therapies but might be used to promote realistic expectations when counseling patients.
International Urogynecology Journal 01/2009; 20(5):489-97. · 1.83 Impact Factor
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ABSTRACT: The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women.
Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women.
Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network.
Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence.
Neurourology and Urodynamics 12/2008; 28(3):170-6. · 2.96 Impact Factor
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Holly E Richter,
Ananias Diokno,
Kimberly Kenton,
Peggy Norton,
Michael Albo, Stephen Kraus,
Pamela Moalli,
Toby C Chai,
Philippe Zimmern,
Heather Litman,
Sharon Tennstedt
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ABSTRACT: We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence.
Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (261) was defined as self-report of stress urinary incontinence by the Medical, Epidemiological, and Social Aspects of Aging questionnaire, positive stress test or re-treatment for stress urinary incontinence. Nonstress failure (66) was defined as positive 24-hour pad test (more than 15 ml) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure.
Severity of urge incontinence symptoms (p = 0.041), prolapse stage (p = 0.013), and being postmenopausal without hormone therapy (p = 0.023) were significant predictors for stress failure. Odds of nonstress failure quadrupled for every 10-point increase in Medical, Epidemiological, and Social Aspects of Aging questionnaire urge score (OR 3.93 CI 1.45, 10.65) and decreased more than 2 times for every 10-point increase in stress score (OR 0.36, CI 0.16, 0.84). The associations of risk factors and failure remained similar regardless of surgical group.
Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy. Higher urge scores predicted failure by nonstress specific outcomes.
The Journal of urology 04/2008; 179(3):1024-30. · 4.02 Impact Factor
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ABSTRACT: The purpose of this study was to describe how clinical pelvic-floor muscle (PFM) strength (force-generating capacity) is related to patient characteristics, lower urinary tract symptoms, and fecal incontinence symptoms.
Data were obtained from 643 women who were participating in a randomized surgical trial for treatment of stress urinary incontinence.
Patient demographic variables, baseline urinary and fecal incontinence symptom questionnaires, urodynamic data and urinary diary data, pad test results, and standardized assessment of pelvic organ support were compared with PFM strength as described by the Brink scoring system. Bivariate analysis of factors associated with the Brink scale score was done using analysis of variance and linear regression. Multivariate analysis included patient variables that were significant on bivariate analysis.
The mean Brink scale score was 9 (SD=2) and did not vary widely in this large, but highly select, patient sample. We found a weak, but statistically strong, relationship between age and Brink score. Brink scores were not related to diary and pad test measures of incontinence severity.
Overall, PFM strength was good in this sample of women with stress incontinence. Scores tended to be similar, and it is possible that the Brink scale does not reflect real clinical differences in PFM strength.
Physical Therapy 11/2007; 87(10):1316-24. · 3.11 Impact Factor
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ABSTRACT: The objective of this study was to identify clinical and demographic factors associated with incontinence-related quality of life (QoL) in 655 women with stress urinary incontinence who elected surgical treatment. The following factors were examined for their association with QoL as measured with the Incontinence Impact Questionnaire (IIQ): number of incontinence (UI) episodes/day; self-reported type of UI symptoms (stress and urge); sexual function as measured by the Prolapse/Urinary Incontinence Sexual Questionnaire; symptom bother as measured by the Urogenital Distress Inventory; as well as other clinical and sociodemographic factors. A stepwise least-squares regression analysis was used to identify factors significantly associated with QoL. Lower QoL was related to the greater frequency of stress UI symptoms, increasing severity, greater symptom bother, prior UI surgery or treatment, and sexual dysfunction (if sexually active). Health and sociodemographic factors associated with lower incontinence-related QoL included current tobacco use, younger age, lower socioeconomic status, and Hispanic ethnicity.
International Urogynecology Journal 06/2007; 18(5):543-9. · 1.83 Impact Factor
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Michael Albo,
Lisa Wruck,
Jan Baker,
Linda Brubaker,
Toby Chai,
Kimberly J Dandreo,
Ananias Diokno,
Patricia Goode, Stephen Kraus,
John W Kusek,
Gary Lemack,
Jerry Lowder,
William Steers
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ABSTRACT: 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.
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 alpha=0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test.
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 H(2)O. 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.
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.
The Journal of Urology 06/2007; 177(5):1810-4. · 3.75 Impact Factor
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ABSTRACT: To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases.
A quality control process was developed that included protocol development, certification of urodynamic testers, central review to assess compliance with protocol and quality, protocol modifications, standardization of equipment and signal configuration, development of an electronic signal repository, and the development of UDS Interpretation Guidelines.
We describe our experience and process in the development and implementation of a standardized UDS protocol in a multicenter surgical trial for stress urinary incontinence. The process included our protocol development, quality control measures, standardization processes, electronic signal repository, and the need for UDS Interpretation Guidelines. A urodynamic testing procedures protocol was implemented successfully by 20 urodynamic testers at nine continence treatment centers. The protocol provides explicit and detailed guidelines for equipment, calibration, patient position, specific annotations, lay language bladder sensation parameters, visual leak point pressure techniques, modifications for prolapse, and data recording. A UDS Interpretation Guidelines document provides specific suggestions for validity and plausibility determination, expected ranges of urodynamic variables, and reasonable agreement of measuring systems. Both documents are available to urodynamic investigators on the Urinary Incontinence Treatment Network website (http://www.uitn.net/resourcesforphysicians.htm).
Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation guidelines.
Urology 02/2007; 69(1):63-7; discussion 67-8. · 2.43 Impact Factor
