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Results of Studies

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Published SISTEr:

  1. Albo M, Wruck L, Baker J, Brubaker L, Chai T, Dandreo K, Diokno A, Goode P, Kraus S, Kusek J, Lemack G, Lowder J, Steers W. The relationships among measures of incontinence severity in women undergoing surgery for stress urinary incontinence. J Urol. 2007, 177(5): 1810-4.

    • Numerous measures of UI severity exist, but there is no universally accepted standard for the assessment of incontinence severity.

    • A self-reported symptom measure (MESA) correlates well with other measures of severity, including UI-specific quality of life measures (UDI, IIQ), number of incontinence episodes, pad weight, empty bladder stress test.

    • An objective measure of severity, valsalva leak point pressure (VLPP), does not correlate strongly with these measures of severity, suggesting that it is a poor measure of UI severity or it relates to severity differently than the other measures.

  2. Albo, ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald MP, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W.  Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007;356(21):2143-55.

    • The autologous fascial sling results in a higher rate of successful treatment of stress incontinence than does the Burch colposuspension.

    • Women who underwent the sling procedure had more urinary tract infections, difficulty voiding, and postoperative urge incontinence than did women who received the Burch colposuspension.

  3. Brubaker L, Chiang S, Zyczynski H, Norton P, Kalinoski DL, Stoddard A, Kusek JW, Steers W. The impact of stress incontinence surgery on female sexual function. Am J Obstet Gynecol. 2009;200(5):562 e1-7.

    • Sexually active women who experience improvements in stress urinary incontinence can anticipate improvements in sexual function.

    • Approximately 2/3 of women undergoing participating in this study were sexually active prior to their surgery.

  4. Brubaker L, Stoddard A, Richter H, Zimmern P, Moalli P, Kraus SR, et al. Mixed incontinence: comparing definitions in women having stress incontinence surgery. Neurourol Urodyn. 2009;28(4):268-73.

    • The term mixed urinary incontinence, when defined for research purposes, is problematic and broadly inclusive; this analysis demonstrated that it is important to describe both subcomponents of mixed urinary incontinence.

    • The use of the term mixed urinary incontinence in women planning stress incontinence surgery should be replaced by quantification of both urge and stress incontinence.

  5. Burgio KL, Brubaker L, Richter HE, Wai CY, Litman HJ, France DB, et al. Patient satisfaction with stress incontinence surgery. Neurourol Urodyn.29(8):1403-9.

    • Two years after surgery for treatment of stress urinary incontinence, patient satisfaction was associated with greater reduction in stress incontinence symptoms and greater reductions in symptom distress.

    • Lower odds of patient satisfaction were associated with greater urge incontinence symptoms at baseline, detrusor overactivity at two years, and a positive stress test at two years.

    • Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact.

  6. Chai TC, Albo ME, Richter HE, Norton PA, Dandreo KJ, Kenton K, Lowder JL, Stoddard AM. Complications in women undergoing Burch colposuspension versus autologous rectus fascial sling for stress urinary incontinence. J Urol. 2009;181(5):2192-7.

    • Concomitant surgeries increased both serious adverse and adverse events

    • UTI was more common in patients undergoing sling than Burch

    • Complications was related to surgical and not patient factors.

  7. Fitzgerald MP, Burgio K, Borello-France D, Menefee S, Schaffer J, Kraus SR, Mallet VT, Xu Y. Pelvic floor strength in women with incontinence as assessed by the brink scale. Phys Ther. 2007;87(10):1316-24.

    • The objective of this analysis was to describe how clinical pelvic floor muscle (PFM) strength is related to patient characteristics, lower urinary tract symptoms and fecal incontinence symptoms in women enrolled in the SISTEr trial.

    • We used baseline data from women participating in the SISTEr trial. 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 to PFM strength as described by the Brink scoring system. Bivariate analysis of factors associated with the Brink score was done using analysis of variance and linear regression. Multivariate analysis included patient variables that were significant on bivariate analysis.

    • The range of Brink score in SISTEr participants was small (mean Brink score 9, standard deviation 2) and overall, PFM strength was good in this highly select group of stress incontinent patients. This may have limited our ability to detect important relationships, and may reflect a weakness in the suitability of the Brink scoring system as a clinical and/or research tool. It is possible the Brink scale does not reflect real clinical differences in PFM strength.

    • We found a weak but statistically strong relationship between age and Brink score, but Brink scores were not related to diary and pad test measures of incontinence severity.

  8. Kenton K, Richter H, Litman H, Lukacz E, Leng W, Lemack G, Chai T, Arisco A, Tennstedt S, Steers W. Risk factors associated with urge incontinence after continence surgery. J Urol. 2009;182(6):2805-9.

  9. Kirby AC, Nager CW, Litman HJ, Fitzgerald MP, Kraus S, Norton P, et al. Preoperative voiding detrusor pressures do not predict stress incontinence surgery outcomes. Int Urogynecol J Pelvic Floor Dysfunct.

    • In order to assess the value of preoperative voiding detrusor pressures in predicting postoperative outcomes after stress incontinence surgery, we measured opening detrusor pressures, detrusor pressures at maximum flow, and closing detrusor pressures in preoperative urodynamics studies performed during SISTEr. We found no relationship between preoperative voiding detrusor pressures and postoperative success, detrusor overactivity, or treatment for urge incontinence after Burch or autologous fascial sling continence surgeries.

    • We found no difference in the presence of preoperative after-contractions in subjects who received treatment for postoperative urge incontinence compared to those who did not.

    • In order to assess the value of preoperative voiding detrusor pressures in predicting postoperative outcomes after stress incontinence surgery, we measured opening detrusor pressures, detrusor pressures at maximum flow, and closing detrusor pressures in preoperative urodynamics studies performed during SISTEr.

    • We found no relationship between preoperative voiding detrusor pressures and postoperative success, detrusor overactivity, or treatment for urge incontinence after Burch or autologous fascial sling continence surgeries.

    • We found no difference in the presence of preoperative after-contractions in subjects who received treatment for postoperative urge incontinence compared to those who did not.

  10. Kraus S, Chai T, FitzGerald MP, Leng W, Mallett V, Markland A, Stoddard A, Tennstedt S. Race and Ethnicity Do Not Contribute to Differences in Preoperative Urinary Incontinence Severity or Symptom Bother in Women Who Undergo Stress Incontinence Surgery. Am J Obstet Gynecol. 2007;197(1):92 e1-6.

    • Patients

      • 480 (73%) non-hispanic whites
      • 72 (11%) Hispanic
      • 44 (6.7%) non-Hispanic black
      • 58 (8.9%) other

    • Initial differences (Non-hispanic Black reported most bother)

    • But after controlling for SES, BMI & Severity

      • No differences were seen in UI severity
      • No differences seen in UI symptom bother

  11. Lemack G, Brubaker L, Chai T, Kerr L, Kraus S, Moalli P, Nager C, Sirls L, Stoddard, A, Xu Y. Clinical and demographic factors associated with valsalva leak point pressure among women undergoing burch bladder neck suspension or autologous rectus fascial sling procedures. Neurourol Urodyn. 2007;26(3):392-6.

    • Using a multivariate analysis, the only demographic parameters found to correlate with VLPP were age (negative correlation; older age - lower VLPP), and BMI (positive correlation; higher BMI - higher VLPP).

    • The only urodynamic correlates were Qmax (negative correlation) and maximum cystometric capacity (positive).

    • The finding that many other demographic parameters thought to possibly correlate with complexity of incontinence and therefore severity (ie prior incontinence surgeries) did not in fact correlate with VLPP, and that Qmax did, suggests that VLPP may provide information about urethral function, but not necessarily severity of incontinence.

  12. Lemack GE, Kraus S, Litman H, FitzGerald MP, Chai T, Nager C, Sirls L, Zyczynski H, Baker J, Lloyd K, Steers WD for the UITN. Normal preoperative urodynamic testing does not predict voiding dysfunction after  Burch colposuspension versus pubovaginal sling. J Urol. 2008;180(5):2076-80.

    • Urodynamic predictors of postoperative objective voiding dysfunction were sought.

    • The vast majority of patients with voiding dysfunction were in the sling arm of SISTEr.

    • No preoperative urodynamic parameter (flow rate, voiding pressure during maximum flow, post void residual, straining, capacity, etc.) was predictive of the development of voiding dysfunction in either Burch or sling patients, a group of patients who, at baseline, appeared to be at an overall relatively low risk for the development of voiding dysfunction postoperatively.

  13. Mallet V, Brubaker L, Stoddard AM, Borello-France D, Tennstedt S, Hall L, Hammontree L. The expectations of patients who undergo surgery for stress incontinence. Am J Obstet Gynecol. 2008;198(3):308 e1-6.

    • Clinical counseling did not lead to reasonable expectations in patients who underwent urinary stress incontinence surgery.

    • Patients with inappropriate treatment expectations may be at increased risk for dissatisfaction with optimal care.

  14. Markland AD, Kraus SR, Richter HE, Nager CW, Kenton K, Kerr L, Xu Y. Prevalence and risk factors of fecal incontinence in women undergoing stress incontinence surgery. Am J Obstet Gynecol. 2007;197(6):662 e1-7.

    • In the SISTEr surgical trial, 16% of women with SUI also had isolated liquid and solid FI at least monthly.

    • Factors associated with fecal incontinence in multivariable analysis included decreased anal sphincter tone on physical examination, menopausal status, and prior surgery for urinary incontinence.

    • Given the high rate of fecal incontinence in this cohort, evaluation of FI symptoms before surgical intervention for urinary incontinence is important.

  15. Nager C, Albo M, FitzGerald MP, Howden N, Kraus S, McDermott S, Norton P, Sirls L, Varner E, Wruck L, Zimmern P. Reference urodynamic values for stress incontinent women. Neurourol Urodyn. 2007;26(3):333-40.

    • Ten percent of women who qualified for stress incontinence surgery with a positive cough stress test on physical exam did not demonstrate urodynamic stress incontinence (USI) and less than 10% of subjects in this study demonstrated detrusor overactivity.

    • Results from a large cohort of women with SUI are now available for quantitative plausibility assessments or as reference values when interpreting urodynamic studies.

  16. Nager C, Albo M, FitzGerald MP, Kraus S, McDermott S, Richter H, Zimmern P. Process for development of multicenter urodynamic studies. Urology. 2007;69(1):63-7; discussion 7-8.

    • UDS Interpretation Guidelines and a standardized UDS protocol are available to urodynamic investigators on the Urinary Incontinence Treatment Network website: http://www.uitn.net/physicians.asp

    • Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation

  17. Nager CW, Fitzgerald MP, Kraus SR, Chai TC, Zyczynski H, Sirls L, Lemack GE, Lloyd LK, Litman HJ, Stoddard AM, Baker J, Steers W. Urodynamic measures do not predict stress continence outcomes after surgery for stress urinary incontinence in selected women. J Urol. 2008;179(4):1470-4.

    • We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence.

    • The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence.

  18. Richter H, Boreham M, Brubaker L, Burgio K, Dandreo K, Johnson H, Mallett V, Markland A, Menefee S, Moalli P, Stoddard A for the Urinary Incontinence Treatment Network. Factors associated with incontinence frequency in a surgical cohort of stress incontinent women. Am J Obstet Gynecol. 2005;193(6):2088-93.

    • A baseline analysis of SISTEr Trial subjects.
      • in a multivariable model, severity of incontinence was positively associated with BMI (P=0.0003) and current smoking (p=0.01)
      • severity of incontinence was negatively associated with prolapse stage (p<0.0001) and Q-tip displacement (p=0.042)
      • in a surgical population, incontinence severity was independently associated with 2 modifiable risk factors, obesity and tobacco use, as well as pelvic support
  19. Richter HR,  Diokno A, Kenton K, Albo M, Kraus SR, Moalli P, Chai TC, Litman HJ, Tennstedt S. Predictors of treatment failure 24 months after surgery for stress urinary incontinence. J Urol. 2008;179(3):1024-30.

    • A secondary analysis of subjects in the SISTEr Trial
      • 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 of stress failure
      • odds of nonstress failure quadrupled for every 10 point increase in MESA urge subscale 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)
      • associations of risk factors and failure were similar regardless of surgical group (Burch or autologous rectus fascial sling)
  20. Richter HE, Goode PS, Brubaker L, Zyczynski H, Stoddard AM, Dandreo KJ, Norton PA. Two-year outcomes after surgery for stress urinary incontinence in older compared with younger women. Obstet Gynecol. 2008;112(3):621-9.

    • A secondary analysis of subjects in the SISTEr trial.
      • 2 year outcomes of women at least 65 years of age were compared to those younger than 65 years
      • older women were more likely to have a positive stress test (OR3.7, 95% CI: 1.7, 7.97); less subjective improvement in stress and urge symptoms (8 point lesser decrease on MESA, 95% CI: 1.5, 14.1; 7 point lesser decrease, 95% CI: 1.5, 12.2, respectively); and were more likely to undergo surgical retreatment for stress incontinence (OR 3.9, 95% CI: 1.3, 11.48)
      • there was no difference in short-term perioperative outcomes between younger and older women
  21. Sanses TV, Brubaker L, Xu Y, Kraus SR, Lowder JL, Lemack GE, et al. Preoperative hesitating urinary stream is associated with postoperative voiding dysfunction and surgical failure following Burch colposuspension or pubovaginal rectus fascial sling surgery. Int Urogynecol J Pelvic Floor Dysfunct.

  22. Steers W, Richter H, Nyberg L, Kusek J, Kraus S, Dandreo K, Chai T, Brubaker L. Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network. Neurourol Urodyn. 2009;28(3):170-6.

  23. Subak LL, Brubaker L, Chai TCC, Creasman JM, Diokno AC, Goode PS, Kraus SR, Kusek JW, Leng WW, Lucakz ES, Norton P, Tennstedt S. High costs of urinary incontinence among women electing surgery to treat stress incontinence. Obstet Gynecol. 2008;111(4):899-907.

    • Among 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) randomized surgical trial:
      • Women spent a mean of $750 per year for incontinence management
      • Costs increased significantly with incontinence frequency and mixed vs. stress incontinence
      • Women with incontinence had a significant decrement in quality of life (HUI3 0.73)
      • Women were willing to pay nearly $1400 per year for incontinence cure.
  24. Tennstedt S for the Urinary Incontinence Treatment Network. Design of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Urology. 2005;66(6):1213-7.

  25. Tennstedt S, Borello-France D, FitzGerald MP, Goode P, Kraus S, Kusek J, Mallett V, Nager C, Stoddard A, Xu Y, Zimmern P for the Urinary Incontinence Treatment Network. Quality of life in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(5):543-9.

    • Prior to surgery, lower incontinence-related quality of life (QoL) was related to the greater frequency of stress UI symptoms, increasing UI 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.

  26. Tennstedt SL, Litman HJ, Zimmern P, Ghetti C, Kusek JW, Nager CW, Mueller ER, Kraus SR, Varner E. Quality of life after surgery for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(12):1631-8.

    • After surgery, incontinence-specific QoL improvement was related to decreased UI symptom bother, greater improvement in UI severity, younger age, Hispanic ethnicity and receiving Burch surgery.

    • Among sexually active women, worsening sexual function had a negative impact on QoL.

    • Improved QoL was explained most by UI symptom improvement.

  27. Walsh L, Zimmern P, Pope N, Shariat S. Comparison of the Q-tip test and voiding cystourethrogram to assess urethral hypermobility among women enrolled in a randomized clinical trial of surgery for stress urinary incontinence. J Urol. 2006;176(2):646-9; discussion 50.

  28. Zimmern P, Albo M, FitzGerald MP, McDermott S, Nager C. Interrater reliability of filling cystometrogram interpretation in a multicenter study. J Urol. 2006;175(6):2174-7.

    • With proper quality control measures in place and a set of standardized interpretative guidelines, excellent inter-rater reliability between local and central reviewers can be achieved for numerical cystometrogram variables.

  29. Zyczynski H, Boreham M, Kenton K, Khandwala S, Lloyd LK, Menefee S, Stoddard A. Correlation of Q-Tip Values and Point Aa in Stress-Incontinent Women. Obstet Gynecol. 2007;110(1):39-43.

    • Nearly one third of women with urethral hypermobility by Q-tip test appear to have good bladder neck support by POP-Q exam (Aa ? -2cm).

    • No POPQ Aa value can rule out urethral mobility

    • Point Aa ? -1 should not be used as a surrogate for good urethral support as it does not predict the absence of urethral hypermobility

Published BE-DRI:

  1. Design of the Behavior Enhances Drug Reduction of Incontinence (BE-DRI) Study. Contemp Clin Trials. 2007;28(1):48-58.

  2. Borello-France D, Burgio K, Goode PS, Kenton K, Markland AD, Balasubramanyam A, Stoddard AM. Adherence to Behavioral Interventions for Urge Incontinence When Combined with Drug Therapy: Adherence Rates, Barriers, and Correlates. Phys Ther. 2010 Jul 29. [Epub ahead of print].

  3. Brubaker L, Stoddard A, Richter H, Zimmern P, Moalli P, Kraus SR, Norton P, Lukacz E, Sirls L, Johnson H. Mixed incontinence: comparing definitions in women having stress incontinence surgery. Neurourol Urodyn. 2009;28(4):268-73.

    • The term mixed urinary incontinence, when defined for research purposes, is problematic and broadly inclusive; this analysis demonstrated that it is important to describe both subcomponents of mixed urinary incontinence.

    • The use of the term mixed urinary incontinence in women planning stress incontinence surgery should be replaced by quantification of both urge and stress incontinence.

  4. Burgio KL for the Urinary Incontinence Treatment Network. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008;149(3):161-9.

    • Combining antimuscarinic drug therapy with supervised behavioral training did not improve the ability of women with urge predominant incontinence to discontinue medication and maintain improvements in urinary incontinence 8 months later.

    • The addition of behavioral training to drug therapy is of possible benefit for reducing incontinence frequency during active treatment; a higher proportion of patients in combined therapy achieved ?70% reduction of incontinence than in drug therapy alone at 10 weeks.

    • Combined therapy yielded better outcomes than drug therapy alone on patient satisfaction, patient-perceived improvement, and reducing other bladder symptoms.

  5. Burgio KL, Kraus SR, Borello-France D, Chai TC, Kenton K, Goode PS, Xu Y, Kusek JW. The effects of drug and behavior therapy on urgency and voiding frequency. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Jun;21(6):711-9.

    • In women with urge-predominant incontinence, urinary urgency scores decreased significantly with both drug therapy alone and combined drug + behavioral therapy.

    • Combined drug and behavioral therapy did not improve urgency more than drug alone, but did produce better outcomes on 24-hour voiding frequency.

    • Improvement in urgency was associated with greater baseline urgency and black ethnicity.

    • Improvement in voiding frequency was associated with combined treatment, higher baseline frequency, and lower baseline incontinence episode frequency.

  6. Fitzgerald MP, Lemack G, Wheeler T, Litman HJ. Nocturia, nocturnal incontinence prevalence, and response to anticholinergic and behavioral therapy. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(11):1545-50.

    • The objective of this analysis was to determine whether participants in either arm of the BEDRI trial experienced reduction in the frequency of nocturia and/or nocturnal leakage episodes during treatment.

    • We analyzed urinary diary data relating to nocturia and nocturnal incontinence before and after 8 weeks of study treatment in the BEDRI trial. Chi-square tests assessed whether nocturia and nocturnal incontinence prevalence varied by treatment arm and paired t tests assessed the change in mean frequency of nocturia and nocturnal leakage.

    • Among 305 women, 210 (69%) had an average of at least one nocturia episode at baseline. There were small but statistically significant differences (p<0.001) in mean nocturia frequency and nocturnal incontinence frequency with both treatments after 8 weeks, but no significant difference between study treatment groups.

    • We concluded that among BEDRI participants, who had low levels of nocturia at baseline, neither study treatment had significant clinical impact on either nocturic frequency or nocturnal incontinence.

  7. Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE, et al. Correlates and predictors of patient satisfaction with drug therapy and combined drug therapy and behavioral training for urgency urinary incontinence in women. International urogynecology journal and pelvic floor dysfunction.22(3):327-34.

  8. Markland AD, Richter HE, Kenton KS, Wai C, Nager CW, Kraus SR, Xu Y, Tennstedt SL. Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study. Am J Obstet Gynecol. 2009;200(4):424 e1-8.

    • Fecal incontinence is common among women with urge incontinence (18% have urinary and fecal incontinence).

    • Significant impairments in quality of life are seen in women with fecal and urge urinary incontinence.

    • Factors affecting the pelvic floor, such as a prior vaginal delivery, posterior compartment pelvic organ prolapse, and increased body weight, may be associated with fecal incontinence in women with urge urinary incontinence.

  9. Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(5):489-97.

    • A secondary analysis of subjects in the BE-DRI Trial
      • after controlling for group, only younger age was associated with short-term success of treatment for urge incontinence (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 drug discontinuation (POP-Q point Aa; OR 1.33, 95% CI: 1.03, 1.7)
      • this information might be used to promote realistic expectations when counseling patients on the benefits of medication and behavioral therapy for the treatment of urge urinary incontinence

  10. Zimmern P, Litman H, Mueller E, Norton P, Goode P. Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women. BJU international. 2010 Jun;105(12):1680-5.

    • General fluid instructions may contribute to the reduction in UUI symptoms for women taking anticholinergic medications, but additional individualized instructions along with other behavioral therapies did little to improve outcome further.

Published TOMUS:

  1. Albo ME for the Urinary Incontinence Treatment Network. The Trial Of Mid-Urethral Slings (TOMUS): Design and methodology. J Applied Res. 2008, 8:1-13.

  2. Brubaker L, Rickey L, Xu Y, Ghetti C, Lemack G, Norton P, Nagaraju P, Markland A, Kahn M. Symptoms of Combined Prolapse and Urinary Incontinence in Large Surgical Cohorts. Obstet Gynecol. 2010 Feb;115(2 Pt 1):310-6.

  3. Nager CW, Kraus SR, Kenton K, Sirls L, Chai TC, Wai C, Sutkin G, Leng W, Litman H, Huang L, Tennstedt S, Richter HE; Urodynamics, the supine empty bladder stress test, and incontinence severity. Neurourol Urodyn. [Epub ahead of print]. 2010.

    • VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST.

    • This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity.

  4. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus Transobturator Midurethral Slings for Stress Incontinence. N Engl J Med 2010.Jun 3;362(22):2066-76.

    • 597 women with symptoms of predominant stress urinary incontinence and a positive cough stress test underwent urodynamic evaluation (surgeons were blinded to these results)

    • Baseline measures included: sociodemographic characteristics, past clinical characteristics of UI, physical examination

    • Self report of urinary incontinence (subjective outcomes) included the MESA questionnaire and 3-day bladder diary; objective outcomes included a 24 hour pad test and stress test

    • Outcomes collected at 2 and 6 weeks; 6 and 12 months post randomization

    • Primary Outcomes at 12 months consisted of Objective Cure: negative stress test, negative 24 hour pad test, no retreatment; and Subjective Cure: no self reported SUI symptoms, no leakage on 3-day voiding diary and no retreatment

    • Other outcomes included patient satisfaction and adverse events using the Dindo classification system

    • 294 women in each group provided 80% power at a 5% significance level using a 2-sided equivalence test of proportions with an equivalence margin of + 12%. If entire 95% CI for difference in the 2 cure rates were in this equivalence margin, equivalence declared

    • Objective treatment success rates were 80.8% in the retropubic group and 77.7% in the transobturator group (3.0 percentage point difference; 95% CI, -3.6 to 9.6, meeting the prespecified criteria for equivalence.

    • Subjective success rates were similar, 62.2% in the retropubic group and 55.8% in the transobturator group (6.4 percentage-point difference; 95% CI, -1.6 to 14.3), but did not meet the prespecified criteria for equivalence.

    • Rates of voiding dysfunction requiring surgery were 2.7% in the retropubic group and 0% in those receiving a transobturator sling, p=0.004.

    • Rates of neurologic symptoms were 4.0% of subjects in the retropubic group and 9.4% of subjects in the transobturator group, p=0.01.

    • There were no differences between the 2 groups in post-operative urge incontinence rates, satisfaction with procedure results of impact on quality of life.

  5. Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai T, Lemack G, Sirls L, Dandreo K, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life.  J Urol. 2010 Feb, 183(2):622-8.

    • A baseline analysis of subjects in the SISTEr and TOMUS trials.

      • baseline urinary incontinence severity measures and the impact of stress incontinence were compared in normal, overweight and obese women in the SISTEr (N=655) and TOMUS (N=597) trial; analyses were performed for each trial separately
      • in SISTEr subjects, multivariable regression analyses showed that higher weight category was independently associated with higher mean UDI score (p=0.003), incontinence episode frequency (p<0.0001), valsalva leak point pressure (p=0.003) and IIQ (p=0.0004).
      • in TOMUS subjects, higher weight category was associated with higher incontinence episode frequency (p=0.0003), valsalva leak point pressure (p=0.0006) and IIQ (p<0.0001).
      • obese women undergoing surgery for stress incontinence report more incontinence episodes, more symptom distress and worse quality of life despite better measures of urethral function (higher valsalva leak point pressure) on urodynamics
  6. Sirls LT, Tennstedt S, Albo M, Chai T, Kenton K, Huang L, et al. Factors associated with quality of life in women undergoing surgery for stress urinary incontinence. J Urol.184(6):2411-5.

Published MIMOSA:

  1. Brubaker L, Moalli P, Richter HE, Albo M, Sirls L, Chai T, et al. Challenges in designing a pragmatic clinical trial: the mixed incontinence -- medical or surgical approach (MIMOSA) trial experience. Clin Trials. 2009;6(4):355-64.

    • The paper described the design of the MIMOSA trial, a randomized trial comparing two initial approaches to the treatment of mixed urinary incontinence.

    • The use of a pragmatic design posed challenges, including the feasibility of randomizing participants to surgical vs. non-surgical initial treatment.

Published ValUE:

  1. Nager CW, Brubaker L, Daneshgari F, Litman HJ, Dandreo KJ, Sirls L, Lemack GE, Richter HE, Leng W, Norton P, Kraus SR, Chai TC, Chang D, Amundsen CL, Stoddard AM, Tennstedt SL. Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations. Contemp Clin Trials. 2009;30(6):531-9.

    • Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges.

    • A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach