Results of Studies

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.