ORIGINAL ARTICLE
Cost Utility Analysis of Urethral Bulking Agents Versus Midurethral Sling in Stress Urinary Incontinence Cynelle M. Kunkle, MD,* Jennifer L. Hallock, MD,* Xiaohan Hu, MD, MPH,† Joan Blomquist, MD,‡ Stephen F. Thung, MD,§ and Erika F. Werner, MD, MS* ║ Objective: The aim of this study was to determine the cost utility of urethral bulking agents (BA) compared with midurethral slings (MUS) in the treatment of stress urinary incontinence (SUI) in patients without urethral hypermobility. Methods: A decision tree was constructed to compare the cost utility of urethral BA versus MUS in the setting of SUI without urethral hypermobility. Probability estimates for success, failure, and complications were obtained from the published literature. Immediate-term, short-term, and longer-term complications were accounted for over a 1-year time horizon in the model. One-way and 2-way sensitivity analyses and Monte Carlo simulations were performed to assess the robustness of our results. Results: Our model demonstrated that MUS cost $436,465 more than BA for every 100 women treated in 1 year. Using MUS compared with BA leads to an incremental cost-effectiveness ratio of $70,400 per utility gained. Assuming a willingness to pay of $50,000, this makes MUS not cost-effective as a first-line treatment in many situations. When MUS costs less than $5132, it becomes a cost-effective first-line treatment, and when it costs less than $2035, it is cost saving. Conclusions: Bulking agents are more cost-effective than MUS over a 1-year time horizon in the treatment of SUI in patients without urethral hypermobility. In women who lack urethral hypermobility, BA remain a cost-effective option in this patient population. Key Words: bulking agents, cost utility, midurethral sling, stress incontinence, urethral hypermobility (Female Pelvic Med Reconstr Surg 2015;21: 154–159)
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tress urinary incontinence (SUI), the involuntary leakage of urine on effort or exertion, affects approximately 4% to 35% of women.1 This condition severely impacts quality of life and places a substantial economic burden on individuals as well as our health care system.2–4 The estimated annual direct cost of urinary incontinence in women in the United States is $12.43 billion. The surgical treatment of choice for SUI with urethral hypermobility is the midurethral sling (MUS).5,6 A sling placed at the midurethra, via the retropubic or transobturator approach, has been shown to have high cure rates and shorter operative and recovery times compared with other procedures such as bladder neck sling, open colposuspension, or laparoscopic colposuspension.7–10 The exact pathophysiology of SUI has not been completely deciphered; however, we believe that support to the middle region of the urethra
From the *Department of Gynecology and Obstetrics, School of Medicine, and †Bloomberg School of Public Health, The Johns Hopkins University; ‡Department of Gynecology, Greater Baltimore Medical Center, Baltimore, MD; §The Ohio State University, Columbus, OH; and ║Alpert Medical School at Brown University, Providence, RI. Reprints: Cynelle M. Kunkle, MD, Women's Center for Pelvic Health, 4940 Eastern Ave, 301 Bldg, 3100 Baltimore, MD 21224. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Abstract presented at the American Urogynecologic Society 34th annual scientific meeting, Las Vegas, NV, October 2013. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000173
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via the anterior vaginal wall and connective tissue is critical to maintaining continence and is often disrupted in patients with SUI. This hammock theory11 explains why we would expect the MUS to be successful. However, it is likely that other potential causes such as neurologic compromise exist. For example, some women with SUI do not have urethral hypermobility and thus may represent a subset of women with different characteristics. In fact, many researchers have discovered lower success rates in patients who undergo MUS with SUI who lack urethral hypermobility.12,13 Historically, injection of urethral bulking agents (BA) has been an alternative therapy for treating SUI. This is particularly true in patients who wish to avoid more invasive surgery or elderly patients who cannot tolerate surgery. Injection of BA is often performed in the office and is less invasive than an MUS.14 Various agents are approved by the US Food and Drug Administration (FDA) to improve urethral coaptation after cystoscopic administration, including calcium hydroxylapatite particles (Coaptite; Bioform, San Mateo, Calif), polydimethylsiloxane (Macroplastique; Uroplasty, Minneapolis, Minn), and pyrolytic carbon-coated zirconium oxide beads (Durasphere; Advanced UroScience Inc, St Paul, Minn).15,16 No BA has been shown to be superior to the other.16 Women with SUI without urethral hypermobility is a subset of patients in whom urethral BA has been shown to be quite efficacious; however, the exact management approach to these patients has not been clear.14 There is little evidence comparing MUS to BA, in patients with or without urethral hypermobility.15–18 We were most interested in exploring what the first-line treatment should be in this population of patients, thus we explored the most cost-effective strategy over a 1-year time horizon. Our primary objective was to assess the cost utility of urethral BA compared with MUS for the treatment of SUI in patients without urethral hypermobility.
MATERIALS AND METHODS A decision analytic model was designed using TreeAge Pro 2013 (TreeAge Software Inc, Williamstown, Mass) comparing the injection of urethral BA to MUS for patients with SUI without urethral hypermobility (Fig. 1). This study was deemed exempt from review by the Johns Hopkins Office of Human Subjects Research Institutional Review Board. The study commenced by first describing a hypothetical population (Table 1) and was based on a health care perspective. This population was defined as adult women with SUI in the absence of urethral hypermobility, with or without low leak point pressures on formal urodynamic testing. In our first strategy, patients were treated with a urethral BA in the office setting. In our second strategy, patients were treated with an MUS in the operating room. Complication and success rates for each strategy were estimated when possible from randomized controlled trials obtained through a PubMed search of English language peer-reviewed journals performed in December of 2012. We searched using medical subject headings (MeSH) terms “stress urinary incontinence,” “intrinsic sphincter deficiency,” “fixed urethra,” and “urethral bulking agents” and included the key words “midurethral sling” and “contigen.” Abstracts were reviewed to
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
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Cost Analysis of BA vs MUS in SUI
FIGURE 1. Simplified version of decision tree comparing MUS and BA for treatment of SUI without urethral hypermobility.
eliminate unsuitable articles. For MUS, we included in our analysis only full text articles in English comparing MUS to another management option, in women with stress predominant urinary incontinence, and which provided data on outcomes and/or complications. For BA, we included in our analysis only English language abstracts or full text articles comparing FDA-approved urethral BA to another management option in women with urodynamic SUI and which provided data on outcomes and/or complications.16 For the purposes of this analysis, we assumed that the populations of © 2015 Wolters Kluwer Health, Inc. All rights reserved.
women with or without urethral hypermobility were comparable, given the paucity of studies on women without urethral hypermobility or data comparing MUS to BA. Given the small sample size of the studies as well as low rates of some complications, the data were pooled to determine probability estimates and sensitivity ranges for rates of success, failure, and complications.17,19–50 Utility values for complications were based on previously published data from a study by Shepherd et al.51 In this study, utility values for specific outcomes were obtained from an expert panel www.fpmrs.net
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TABLE 1. Characteristics of the Hypothetical Patient Population Characteristic
Detail
•Adult women •Predominant symptom of SUI, with or without urge incontinence History •With or without previous surgical treatment for incontinence •No history of neurological conditions •No causes of acute or reversible incontinence •No symptomatic pelvic organ prolapse Physical examination •Normal screening neurological examination •Without urethral hypermobility Office testing •Normal urine analysis •Normal postvoid residual •Positive or negative supine cough stress test General
of urogynecologists using previously validated physician-assigned utilities from a similar condition. These values ranged from 0 to 1, with 1 defined as perfect health.
reflect the cost of providing medical services to Medicare patients and is widely used in economic evaluations to measure the cost of health care services (Table 3).52 The range of cost was more or less 10% of the baseline estimates as has been previously described in the literature (Table 4).51 Because of the difficulty in obtaining reliable estimates of nonmedical indirect cost, these were excluded from our analysis.
Outcomes Outcomes measured included total cost per strategy for 100 women, total utilities gained with each strategy for 100 women treated, and the incremental cost-effectiveness ratio (ICER) defined as the marginal cost per utility (health quality) gained. The ICER compares the difference in cost to the difference in effectiveness between 2 treatment strategies. We assumed a willingness to pay of $50,000 per utility gained. Thus a strategy was considered cost-effective if the ICER was less than $50,000, a wellaccepted threshold. One-way and 2-way sensitivity analyses and Monte Carlo simulations were performed to assess the robustness of our results. Monte Carlo is a computational algorithm that relies on repeated random sampling, which simultaneously varies all variables across their extreme ranges.
Assumptions Several assumptions were made when developing our model; first, the initial therapies for SUI in the absence of urethral hypermobility include BA or MUS. The choice of MUS was either the transobturator approach or the retropubic approach as these slings have been found to be equivalent in the treatment of SUI.19 Data on “mini” slings were excluded from our analysis due to the paucity of data on the efficacy of those sling types. We described treatment outcomes after MUS as either dry (resolution of symptoms) or wet (no resolution of symptoms). The decision to use these 2 outcomes is based on the fact that these are the 2 most commonly reported outcomes for efficacy of the MUS. To simplify our decision tree, complications of MUS were divided into 3 groups as follows: immediate complications were defined as occurring at the time of surgery, short-term complications were defined as occurring within 6 weeks of surgery, and long-term complications were defined as any complications diagnosed after 6 weeks postoperatively but within the first year. Mathematical formulas were then used to compute combined probabilities for short-term and immediate- and long-term possibilities. For example, if a person underwent MUS and was then dry (Fig. 1), she might experience an immediate complication of hematoma/ hemorrhage with a bladder injury, hematoma/hemorrhage without bladder injury or bladder injury without hematoma/hemorrhage, or no complication at all (Table 2). With respect to the BA, 3 possible outcomes of BAwere dry (resolution of symptoms), wet (no resolution of symptoms), or improved (some resolution of symptoms). These 3 outcomes were included as they are commonly reported to estimate efficacy for this particular therapy. By excluding the clinically relevant outcome of “improved” for BA, and grouping those patients into the “dry” category, the model would inflate the cost utility of BA compared with MUS. Complications from BA were also divided into immediate-term, short-term, and long-term complications; similarly, we determined a combined probability for the possible complications with BA (Table 2).
Cost Estimates of cost parameters for the procedures, management of complications, and physician visits were based on the 2012 Medicare fee schedule. This fee schedule was developed to
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RESULTS Our model demonstrated that MUS cost $436,465 more than BA for every 100 women treated. However, MUS were associated with a 6.2% improved utility in the first year after treatment compared with BA. Using MUS compared with BA leads to an ICER of $70,400 per utility gained. Assuming a willingness to pay of $50,000, this makes MUS not cost-effective as a first-line treatment in our hypothetical population. The model was most sensitive to the cost of MUS placement, the probability of being dry at 1 year after MUS, the probability of postoperative urinary retention, and the probabilities of some long-term complications (SUI, recurrent urinary tract infection, thigh pain, and need for further treatment including reinjection of BA). When MUS costs less than $5132, it becomes a cost-effective first-line treatment, and when it costs less than $2035, it is cost saving (less expensive than BA with improved health quality). Monte Carlo simulation was performed with 10,000 simulations, using the ranges listed in Tables 2, 3 and 4, and showed that BA is cost-effective 47.6%
TABLE 2. Complication Subcategories MUS Immediate Short term
•Hematoma/hemorrhage •Bladder injury •Transient urinary retention •Thigh/groin pain
Long term
•Persistent urinary retention/sling down •De novo urge incontinence •UTI •Mesh complication •Recurrent SUI
BA •Pain •Transient urinary retention •Dysuria •Hematuria transient •UTI •Persistent urinary retention •De novo urge incontinence •Need for reinjection •Need for other treatment (MUS)
UTI, urinary tract infection.
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TABLE 3. Probability and 1-Year Utility Estimates Variable
Base-Case
Probabilities associated with MUS Bladder injury Hemorrhage/hematoma Transient urinary retention Thigh pain Persistent urinary retention/sling take down De novo urge incontinence UTI Mesh erosion Recurrent SUI Dry at 12 mo Probabilities associated with BA Short-term pain Dysuria Hematuria transient UTI Persistent urinary retention requiring self catheterization De novo urge incontinence Need for reinjection Need for other treatment (sling) Dry at 12 mo Improved at 12 mo
Range
Utilities
2.8% 2.6% 9.8% 4.5% 2.5% 8.5% 7.2% 1.7% 18.0% 65.0%
(0–24.4)19–31 (0–10.0)19–21,23–33 (0–13.0)19,21,22,24,26,28,30,32,34 (0–15.3)20,23,25,28,30,35 (0–7.0)20,22,23,25,27,29–32,35–38 (0–16.0)19,20,25–27,34,36 (1.5–8.0)19,21–24,27,29,31 (0–10)19,20,25,26,29–32,34,35,38 (18.0–40.0)39–41 (44.0–81)39,40,42
0.90 0.88 0.90 0.70 0.72 0.71 0.76 0.70 0.72 0.99
4.1% 15.8% 4.8% 10.2% 0.4% 13.5% 47.7% 33.7% 38.7% 81.0%
(1.6–7.7)43,44 (5.0–73.1)43,44 (4.1–7.7)43,44 (0–23.8)17,44,45 (0–4.0)43,44 (2.5–50.0)17,43–47 (12.0–62.0)43–45,47,48 (13.0–42.0)17,44 (36.9–50.0)43,44,49 (80.0–82.4)44,47,50
0.98 0.90 0.98 0.93 0.80 0.71 0.75 0.715 0.99 0.90
UTI, urinary tract infection.
of the time and cost saving 51.8% of the time, and MUS is costeffective less than 1% of the time.
DISCUSSION The treatment of SUI can have a tremendous impact on costs of health care and quality of life. Women with SUI who lack urethral hypermobility represent an important subpopulation. Because there are limited data to guide optimal management in this group of patients, it is vital that we consider the cost and health quality ramifications that different treatment options pose in this unique population. Only 2 randomized controlled trials have directly compared BA to other surgical management, and little has been written comparing the costs of MUS to the currently available FDA-approved BA in women without urethral hypermobility.16–18 Our study shows that under a wide range of circumstances, urethral BA is a more cost-effective initial treatment approach than MUS for women with SUI without urethral hypermobility. Our study also highlights the need for more randomized-controlled trials comparing outcomes in this subgroup of patients. There were a number of parameters that would lead to MUS being more cost-effective than BA. More studies are needed to ensure that the probability estimates used in this decision model based on current literature are indeed accurate. If so, then BA should be the first-line treatment for women with SUI without urethral hypermobility. A limitation of our study is its inherent theoretical design, which relies solely on the quality of published evidence. An additional limitation is that we did not include indirect costs and thus the model is from a health care perspective, not a societal perspective. Furthermore, utility values for outcomes were based on previously published 12-month reports, which are physician assigned and may not accurately reflect patient-defined utilities.51 We limited our time horizon to 1 year to address the question of which treatment strategy is most cost-effective as a first-line agent in © 2015 Wolters Kluwer Health, Inc. All rights reserved.
the first year of treatment. We acknowledge that if a patient gets no relief from 1 treatment, a provider will likely attempt the other treatment. There is little long-term outcome data on either treatment in this patient population. If surgery is found to have
TABLE 4. Cost Estimates Variable Cost associated with MUS Transient urinary retention Persistent urinary retention/sling take down Thigh pain De novo urge incontinence Recurrent UTI Mesh erosion Recurrent SUI/repeat sling Initial cost of sling Cost associated with BA Transient urinary retention Dysuria UTI Persistent urinary retention De novo urge incontinence Cost of BA
Base-Case (2013), $
Range (2013), $
127 7139
114–140 6425–7853
19 138 100 5000 6612 6397
17–21 124–152 90–110 4500–5500 5951–7228 5757–7036
127 14 10 3344 138 1374
115–140 12–15 9–11 3010–3679 124–152 1237–1512
Costs were calculated using data from the 2012 Medicare fee schedule and reported in 2013 US dollars after adjusting for inflation. UTI, urinary tract infection.
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significantly better outcomes at 5 or 10 years, a model with a longer time horizon may prove helpful. With those limitations in mind, our analysis suggests that BA is a more cost-effective initial treatment than MUS for the treatment of SUI without urethral hypermobility. The decision to proceed with a particular treatment strategy is fairly complex and involves the consideration of both tangible and intangible outcomes. Although the specifics of a patient's physiology and pathology have traditionally guided such discussions, the addition of cost and utility into the equation is becoming increasingly common in the context of limited resources. This analysis is timely and necessary as it addresses the approach to a common clinical dilemma at a time when we are being forced to make more costconscious clinical decisions.
REFERENCES 1. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol 2004;6(Suppl 3):S3–S9. 2. Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the Sickness Impact Profile. J Am Geriatr Soc 1991;39(4):378–382. 3. Birnbaum, Leong SA, Oster EF, et al. Cost of stress urinary incontinence. Pharmacoeconomics 2004;22(2):95–105. 4. Wilson L, Brown JS, Shin GP, et al. Annual direct cost of urinary incontinence. Obstet Gynecol 2011;98:398–406. 5. Kane AR, Nager CW. Midurethral slings for stress urinary incontinence. Clin Obstet Gynecol 2008;51(1):124–135. 6. Anger JT, Weinberg AE, Albo ME, et al. Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries. Urology 2009;74(2):283–287. 7. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol 1997;158(3 Pt 1):875–880. 8. Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;(4). CD006375. 9. Ward KL, Hilton PUK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG 2008;115(2):226–233. 10. Jelovsek JE, Barber MD, Karram MM, et al. Randomized trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up. BJOG 2008;115(2):219–225. 11. Delancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol 1994;170(6):1713–1720 discussion 1720–1723. 12. Parden AM, Gleason JL, Jauk V, et al. Incontinence outcomes in women undergoing primary and repeat midurethral sling procedures. Obstet Gynecol 2013;121(2 Pt 1):273–278. 13. Daneshgari F, Kong W, Swartz M. Complications of mid urethral slings: important outcomes for future clinical trials. J Urol 2008;180(5): 1890–1897. 14. Dmochowski RR, Blaivas JM, Gormley EA, et al. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol 2010;183(5):1906–1914.
17. Maher CF, O'Reilly BA, Dwyer PL, et al. Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomised controlled trial. BJOG 2005;112(6):797–801. 18. Corcos J, Collet JP, Shapiro S, et al. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology 2005;65(5):898–904. 19. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010;362(22):2066–2076. 20. Persson J, Teleman P, Etén-Bergquist C, et al. Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure. Acta Obstet Gynecol Scand 2002;81:1066–1073. 21. Aniuliene R. Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence. Medicina (Kaunas) 2009;45:639–643. 22. Freeman R, Holmes D, Hillard T, et al. What patients think: patient-reported outcomes of retropubic versus transobturator mid-urethral slings for urodynamic stress incontinence: a multicenter randomized controlled trial. Int Urogynecol J 2011;22:279–286. 23. Krofta L, Feyereisl J, Otcenásek M, et al. TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial. Int Urogynecol J 2010;21:141–148. 24. Liapis A, Bakas P, Giner M, et al. Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Gynecol Obstet Invest 2006;62:160–164. 25. Scheiner DA, Betschart C, Wiederkehr S, et al. Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings. Int Urogynecol J 2012;23:197–206. 26. Teo R, Moran P, Mayne C, et al. Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women. J Urol 2011;185:1350–1355. 27. Wang F, Song Y, Huang H. Prospective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence with or without pelvic organ prolapse in Southeast China. Arch Gynecol Obstet 2010;281:279–286. 28. Wang YJ, Li FP, Wang Q, et al. Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J 2011;22: 1369–1374. 29. Andonian S, Chen T, St-Denis B, et al. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Eur Urol 2005;47:537–541. 30. Abdel-Fattah M, Ramsay I, Pringle S, et al. Randomized prospective single-blinded study comparing “inside-out” versus “outside-in” transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010;117:870–878. 31. Barber MD, Weidner AC, Sokol AI, et al. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol 2012;119: 328–337. 32. Bai SW, Sohn WH, Chung DL, et al. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and research urogynecology tension-free vaginal tape for stress urinary incontinence. Int J Gynaecol Obstet 2005;91:246–251.
15. Lightner D, Fox J. Bulking agents for urinary incontinence: patient selection, counseling and technique. Expert Rev Obstet Gynecol 2009;4(6):687–694.
33. Hinoul P, Vervest HA, den Boon J, et al. A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence. J Urol 2011; 185:1356–1362.
16. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev 2012;2. CD003881.
34. Tommaselli GA, Di Carlo C, Gargano V, et al. Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J 2010;21:1211–1217.
158
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35. Ross S, Robert M, Swaby C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol 2009;114:1287–1294.
44. Meulen PH, Berghmans LC, Nieman FH, et al. Effects of Macroplastique Implantation System for stress urinary incontinence and urethral hypermobility in women. Int Urogynecol J 2009;20(2):177–183.
36. Oliveira R, Botelho F, Silva P, et al. Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol 2011;59:940–944.
45. Mayer RD, Dmochowski RR, Appell RA, et al. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology 2007;69(5):876–880.
37. Guerrero KL, Emery SJ, Wareham K, et al. A randomized controlled trial comparing TVT, Pelvicol, and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG 2010;117: 1493–1503.
46. Bano F, Barrington JW, Dyer R. Comparison between porcine dermal implant (Permacol) and silicone injection (Macroplastique) for urodynamic stress incontinence. Int Urogynecol J 2005;16:147–150.
38. Hota LS, Hanaway K, Hacker MR, et al. TVT-Secur (hammock) versus TVT-obturator: a randomized trial of suburethral sling operative procedures. Female Pelvic Med Reconstr Surg 2012;18:41–45.
47. Lightner D, Calvosa C, Andersen R, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled double-blind study of Durasphere. Urology 2001;58:12.
39. Richter HE, Litman HJ, Lukacz ES, et al. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol 2011;117(4):913–921.
48. Anders K, Khullar V, Cardozo L, et al. Contigen or Macroplastique? A five year follow-up (Abstract). In: Proceedings of the International Continence Society, 32nd Annual Meeting; 2002 Aug 28-30. Heidelberg, Germany: International Continence Society; 2002:183–184.
40. Fritel X, Zabak K, Pigne A, et al. Predictive value of urethral mobility before suburethral tape procedure for urinary stress incontinence in women. J Urol 2002;168(6):2472–2475.
49. Ghoniem G, Corcos J, Comiter C, et al. Durability of urethral bulking agent injection for female stress urinary incontinence: 2-year multicenter study results. J Urol 2010;183:1444–1449.
41. Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. Eur Urol 2009;55(6):1450–1455.
50. Andersen RCM. Long-term follow-up comparison of Durasphere (trademark) and Contigen (trademark) in the treatment of stress urinary incontinence. J Low Genit Tract Dis 2002;6(4):239–243.
42. Toledo LG, Cabral PH, Casella ML, et al. Prognostic value of urethral mobility and Valsalva leak point pressure for female transobturator sling procedure. Int Braz J Urol 2012;38(5):667–673.
51. Shepherd JP, Lowder JL, Jones KA, et al. Retropubic and transobturator midurethral slings: a decision analysis to compare outcomes including efficacy and complications. Int Urogynecol J 2010;21(7):787–793.
43. Ghoniem G, Corcos J, Comiter C, et al. Crosslinked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study. J Urol 2009;181:204.
52. Subak LL, Brown JS, Kraus SR, et al. Diagnostic Aspects of Incontinence Study Group. The “costs” of urinary incontinence for women. Obstet Gynecol 2006;107(4):908–916.
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Cost Utility Analysis of Urethral Bulking Agents Versus Midurethral Sling in Stress Urinary Incontinence Cynelle M. Kunkle, MD,* Jennifer L. Hallock, MD,* Xiaohan Hu, MD, MPH,† Joan Blomquist, MD,‡ Stephen F. Thung, MD,§ and Erika F. Werner, MD, MS* ║ Objective: The aim of this study was to determine the cost utility of urethral bulking agents (BA) compared with midurethral slings (MUS) in the treatment of stress urinary incontinence (SUI) in patients without urethral hypermobility. Methods: A decision tree was constructed to compare the cost utility of urethral BA versus MUS in the setting of SUI without urethral hypermobility. Probability estimates for success, failure, and complications were obtained from the published literature. Immediate-term, short-term, and longer-term complications were accounted for over a 1-year time horizon in the model. One-way and 2-way sensitivity analyses and Monte Carlo simulations were performed to assess the robustness of our results. Results: Our model demonstrated that MUS cost $436,465 more than BA for every 100 women treated in 1 year. Using MUS compared with BA leads to an incremental cost-effectiveness ratio of $70,400 per utility gained. Assuming a willingness to pay of $50,000, this makes MUS not cost-effective as a first-line treatment in many situations. When MUS costs less than $5132, it becomes a cost-effective first-line treatment, and when it costs less than $2035, it is cost saving. Conclusions: Bulking agents are more cost-effective than MUS over a 1-year time horizon in the treatment of SUI in patients without urethral hypermobility. In women who lack urethral hypermobility, BA remain a cost-effective option in this patient population. Key Words: bulking agents, cost utility, midurethral sling, stress incontinence, urethral hypermobility (Female Pelvic Med Reconstr Surg 2015;21: 154–159)
S
tress urinary incontinence (SUI), the involuntary leakage of urine on effort or exertion, affects approximately 4% to 35% of women.1 This condition severely impacts quality of life and places a substantial economic burden on individuals as well as our health care system.2–4 The estimated annual direct cost of urinary incontinence in women in the United States is $12.43 billion. The surgical treatment of choice for SUI with urethral hypermobility is the midurethral sling (MUS).5,6 A sling placed at the midurethra, via the retropubic or transobturator approach, has been shown to have high cure rates and shorter operative and recovery times compared with other procedures such as bladder neck sling, open colposuspension, or laparoscopic colposuspension.7–10 The exact pathophysiology of SUI has not been completely deciphered; however, we believe that support to the middle region of the urethra
From the *Department of Gynecology and Obstetrics, School of Medicine, and †Bloomberg School of Public Health, The Johns Hopkins University; ‡Department of Gynecology, Greater Baltimore Medical Center, Baltimore, MD; §The Ohio State University, Columbus, OH; and ║Alpert Medical School at Brown University, Providence, RI. Reprints: Cynelle M. Kunkle, MD, Women's Center for Pelvic Health, 4940 Eastern Ave, 301 Bldg, 3100 Baltimore, MD 21224. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Abstract presented at the American Urogynecologic Society 34th annual scientific meeting, Las Vegas, NV, October 2013. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000173
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via the anterior vaginal wall and connective tissue is critical to maintaining continence and is often disrupted in patients with SUI. This hammock theory11 explains why we would expect the MUS to be successful. However, it is likely that other potential causes such as neurologic compromise exist. For example, some women with SUI do not have urethral hypermobility and thus may represent a subset of women with different characteristics. In fact, many researchers have discovered lower success rates in patients who undergo MUS with SUI who lack urethral hypermobility.12,13 Historically, injection of urethral bulking agents (BA) has been an alternative therapy for treating SUI. This is particularly true in patients who wish to avoid more invasive surgery or elderly patients who cannot tolerate surgery. Injection of BA is often performed in the office and is less invasive than an MUS.14 Various agents are approved by the US Food and Drug Administration (FDA) to improve urethral coaptation after cystoscopic administration, including calcium hydroxylapatite particles (Coaptite; Bioform, San Mateo, Calif), polydimethylsiloxane (Macroplastique; Uroplasty, Minneapolis, Minn), and pyrolytic carbon-coated zirconium oxide beads (Durasphere; Advanced UroScience Inc, St Paul, Minn).15,16 No BA has been shown to be superior to the other.16 Women with SUI without urethral hypermobility is a subset of patients in whom urethral BA has been shown to be quite efficacious; however, the exact management approach to these patients has not been clear.14 There is little evidence comparing MUS to BA, in patients with or without urethral hypermobility.15–18 We were most interested in exploring what the first-line treatment should be in this population of patients, thus we explored the most cost-effective strategy over a 1-year time horizon. Our primary objective was to assess the cost utility of urethral BA compared with MUS for the treatment of SUI in patients without urethral hypermobility.
MATERIALS AND METHODS A decision analytic model was designed using TreeAge Pro 2013 (TreeAge Software Inc, Williamstown, Mass) comparing the injection of urethral BA to MUS for patients with SUI without urethral hypermobility (Fig. 1). This study was deemed exempt from review by the Johns Hopkins Office of Human Subjects Research Institutional Review Board. The study commenced by first describing a hypothetical population (Table 1) and was based on a health care perspective. This population was defined as adult women with SUI in the absence of urethral hypermobility, with or without low leak point pressures on formal urodynamic testing. In our first strategy, patients were treated with a urethral BA in the office setting. In our second strategy, patients were treated with an MUS in the operating room. Complication and success rates for each strategy were estimated when possible from randomized controlled trials obtained through a PubMed search of English language peer-reviewed journals performed in December of 2012. We searched using medical subject headings (MeSH) terms “stress urinary incontinence,” “intrinsic sphincter deficiency,” “fixed urethra,” and “urethral bulking agents” and included the key words “midurethral sling” and “contigen.” Abstracts were reviewed to
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
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Cost Analysis of BA vs MUS in SUI
FIGURE 1. Simplified version of decision tree comparing MUS and BA for treatment of SUI without urethral hypermobility.
eliminate unsuitable articles. For MUS, we included in our analysis only full text articles in English comparing MUS to another management option, in women with stress predominant urinary incontinence, and which provided data on outcomes and/or complications. For BA, we included in our analysis only English language abstracts or full text articles comparing FDA-approved urethral BA to another management option in women with urodynamic SUI and which provided data on outcomes and/or complications.16 For the purposes of this analysis, we assumed that the populations of © 2015 Wolters Kluwer Health, Inc. All rights reserved.
women with or without urethral hypermobility were comparable, given the paucity of studies on women without urethral hypermobility or data comparing MUS to BA. Given the small sample size of the studies as well as low rates of some complications, the data were pooled to determine probability estimates and sensitivity ranges for rates of success, failure, and complications.17,19–50 Utility values for complications were based on previously published data from a study by Shepherd et al.51 In this study, utility values for specific outcomes were obtained from an expert panel www.fpmrs.net
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TABLE 1. Characteristics of the Hypothetical Patient Population Characteristic
Detail
•Adult women •Predominant symptom of SUI, with or without urge incontinence History •With or without previous surgical treatment for incontinence •No history of neurological conditions •No causes of acute or reversible incontinence •No symptomatic pelvic organ prolapse Physical examination •Normal screening neurological examination •Without urethral hypermobility Office testing •Normal urine analysis •Normal postvoid residual •Positive or negative supine cough stress test General
of urogynecologists using previously validated physician-assigned utilities from a similar condition. These values ranged from 0 to 1, with 1 defined as perfect health.
reflect the cost of providing medical services to Medicare patients and is widely used in economic evaluations to measure the cost of health care services (Table 3).52 The range of cost was more or less 10% of the baseline estimates as has been previously described in the literature (Table 4).51 Because of the difficulty in obtaining reliable estimates of nonmedical indirect cost, these were excluded from our analysis.
Outcomes Outcomes measured included total cost per strategy for 100 women, total utilities gained with each strategy for 100 women treated, and the incremental cost-effectiveness ratio (ICER) defined as the marginal cost per utility (health quality) gained. The ICER compares the difference in cost to the difference in effectiveness between 2 treatment strategies. We assumed a willingness to pay of $50,000 per utility gained. Thus a strategy was considered cost-effective if the ICER was less than $50,000, a wellaccepted threshold. One-way and 2-way sensitivity analyses and Monte Carlo simulations were performed to assess the robustness of our results. Monte Carlo is a computational algorithm that relies on repeated random sampling, which simultaneously varies all variables across their extreme ranges.
Assumptions Several assumptions were made when developing our model; first, the initial therapies for SUI in the absence of urethral hypermobility include BA or MUS. The choice of MUS was either the transobturator approach or the retropubic approach as these slings have been found to be equivalent in the treatment of SUI.19 Data on “mini” slings were excluded from our analysis due to the paucity of data on the efficacy of those sling types. We described treatment outcomes after MUS as either dry (resolution of symptoms) or wet (no resolution of symptoms). The decision to use these 2 outcomes is based on the fact that these are the 2 most commonly reported outcomes for efficacy of the MUS. To simplify our decision tree, complications of MUS were divided into 3 groups as follows: immediate complications were defined as occurring at the time of surgery, short-term complications were defined as occurring within 6 weeks of surgery, and long-term complications were defined as any complications diagnosed after 6 weeks postoperatively but within the first year. Mathematical formulas were then used to compute combined probabilities for short-term and immediate- and long-term possibilities. For example, if a person underwent MUS and was then dry (Fig. 1), she might experience an immediate complication of hematoma/ hemorrhage with a bladder injury, hematoma/hemorrhage without bladder injury or bladder injury without hematoma/hemorrhage, or no complication at all (Table 2). With respect to the BA, 3 possible outcomes of BAwere dry (resolution of symptoms), wet (no resolution of symptoms), or improved (some resolution of symptoms). These 3 outcomes were included as they are commonly reported to estimate efficacy for this particular therapy. By excluding the clinically relevant outcome of “improved” for BA, and grouping those patients into the “dry” category, the model would inflate the cost utility of BA compared with MUS. Complications from BA were also divided into immediate-term, short-term, and long-term complications; similarly, we determined a combined probability for the possible complications with BA (Table 2).
Cost Estimates of cost parameters for the procedures, management of complications, and physician visits were based on the 2012 Medicare fee schedule. This fee schedule was developed to
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RESULTS Our model demonstrated that MUS cost $436,465 more than BA for every 100 women treated. However, MUS were associated with a 6.2% improved utility in the first year after treatment compared with BA. Using MUS compared with BA leads to an ICER of $70,400 per utility gained. Assuming a willingness to pay of $50,000, this makes MUS not cost-effective as a first-line treatment in our hypothetical population. The model was most sensitive to the cost of MUS placement, the probability of being dry at 1 year after MUS, the probability of postoperative urinary retention, and the probabilities of some long-term complications (SUI, recurrent urinary tract infection, thigh pain, and need for further treatment including reinjection of BA). When MUS costs less than $5132, it becomes a cost-effective first-line treatment, and when it costs less than $2035, it is cost saving (less expensive than BA with improved health quality). Monte Carlo simulation was performed with 10,000 simulations, using the ranges listed in Tables 2, 3 and 4, and showed that BA is cost-effective 47.6%
TABLE 2. Complication Subcategories MUS Immediate Short term
•Hematoma/hemorrhage •Bladder injury •Transient urinary retention •Thigh/groin pain
Long term
•Persistent urinary retention/sling down •De novo urge incontinence •UTI •Mesh complication •Recurrent SUI
BA •Pain •Transient urinary retention •Dysuria •Hematuria transient •UTI •Persistent urinary retention •De novo urge incontinence •Need for reinjection •Need for other treatment (MUS)
UTI, urinary tract infection.
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Cost Analysis of BA vs MUS in SUI
TABLE 3. Probability and 1-Year Utility Estimates Variable
Base-Case
Probabilities associated with MUS Bladder injury Hemorrhage/hematoma Transient urinary retention Thigh pain Persistent urinary retention/sling take down De novo urge incontinence UTI Mesh erosion Recurrent SUI Dry at 12 mo Probabilities associated with BA Short-term pain Dysuria Hematuria transient UTI Persistent urinary retention requiring self catheterization De novo urge incontinence Need for reinjection Need for other treatment (sling) Dry at 12 mo Improved at 12 mo
Range
Utilities
2.8% 2.6% 9.8% 4.5% 2.5% 8.5% 7.2% 1.7% 18.0% 65.0%
(0–24.4)19–31 (0–10.0)19–21,23–33 (0–13.0)19,21,22,24,26,28,30,32,34 (0–15.3)20,23,25,28,30,35 (0–7.0)20,22,23,25,27,29–32,35–38 (0–16.0)19,20,25–27,34,36 (1.5–8.0)19,21–24,27,29,31 (0–10)19,20,25,26,29–32,34,35,38 (18.0–40.0)39–41 (44.0–81)39,40,42
0.90 0.88 0.90 0.70 0.72 0.71 0.76 0.70 0.72 0.99
4.1% 15.8% 4.8% 10.2% 0.4% 13.5% 47.7% 33.7% 38.7% 81.0%
(1.6–7.7)43,44 (5.0–73.1)43,44 (4.1–7.7)43,44 (0–23.8)17,44,45 (0–4.0)43,44 (2.5–50.0)17,43–47 (12.0–62.0)43–45,47,48 (13.0–42.0)17,44 (36.9–50.0)43,44,49 (80.0–82.4)44,47,50
0.98 0.90 0.98 0.93 0.80 0.71 0.75 0.715 0.99 0.90
UTI, urinary tract infection.
of the time and cost saving 51.8% of the time, and MUS is costeffective less than 1% of the time.
DISCUSSION The treatment of SUI can have a tremendous impact on costs of health care and quality of life. Women with SUI who lack urethral hypermobility represent an important subpopulation. Because there are limited data to guide optimal management in this group of patients, it is vital that we consider the cost and health quality ramifications that different treatment options pose in this unique population. Only 2 randomized controlled trials have directly compared BA to other surgical management, and little has been written comparing the costs of MUS to the currently available FDA-approved BA in women without urethral hypermobility.16–18 Our study shows that under a wide range of circumstances, urethral BA is a more cost-effective initial treatment approach than MUS for women with SUI without urethral hypermobility. Our study also highlights the need for more randomized-controlled trials comparing outcomes in this subgroup of patients. There were a number of parameters that would lead to MUS being more cost-effective than BA. More studies are needed to ensure that the probability estimates used in this decision model based on current literature are indeed accurate. If so, then BA should be the first-line treatment for women with SUI without urethral hypermobility. A limitation of our study is its inherent theoretical design, which relies solely on the quality of published evidence. An additional limitation is that we did not include indirect costs and thus the model is from a health care perspective, not a societal perspective. Furthermore, utility values for outcomes were based on previously published 12-month reports, which are physician assigned and may not accurately reflect patient-defined utilities.51 We limited our time horizon to 1 year to address the question of which treatment strategy is most cost-effective as a first-line agent in © 2015 Wolters Kluwer Health, Inc. All rights reserved.
the first year of treatment. We acknowledge that if a patient gets no relief from 1 treatment, a provider will likely attempt the other treatment. There is little long-term outcome data on either treatment in this patient population. If surgery is found to have
TABLE 4. Cost Estimates Variable Cost associated with MUS Transient urinary retention Persistent urinary retention/sling take down Thigh pain De novo urge incontinence Recurrent UTI Mesh erosion Recurrent SUI/repeat sling Initial cost of sling Cost associated with BA Transient urinary retention Dysuria UTI Persistent urinary retention De novo urge incontinence Cost of BA
Base-Case (2013), $
Range (2013), $
127 7139
114–140 6425–7853
19 138 100 5000 6612 6397
17–21 124–152 90–110 4500–5500 5951–7228 5757–7036
127 14 10 3344 138 1374
115–140 12–15 9–11 3010–3679 124–152 1237–1512
Costs were calculated using data from the 2012 Medicare fee schedule and reported in 2013 US dollars after adjusting for inflation. UTI, urinary tract infection.
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significantly better outcomes at 5 or 10 years, a model with a longer time horizon may prove helpful. With those limitations in mind, our analysis suggests that BA is a more cost-effective initial treatment than MUS for the treatment of SUI without urethral hypermobility. The decision to proceed with a particular treatment strategy is fairly complex and involves the consideration of both tangible and intangible outcomes. Although the specifics of a patient's physiology and pathology have traditionally guided such discussions, the addition of cost and utility into the equation is becoming increasingly common in the context of limited resources. This analysis is timely and necessary as it addresses the approach to a common clinical dilemma at a time when we are being forced to make more costconscious clinical decisions.
REFERENCES 1. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol 2004;6(Suppl 3):S3–S9. 2. Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the Sickness Impact Profile. J Am Geriatr Soc 1991;39(4):378–382. 3. Birnbaum, Leong SA, Oster EF, et al. Cost of stress urinary incontinence. Pharmacoeconomics 2004;22(2):95–105. 4. Wilson L, Brown JS, Shin GP, et al. Annual direct cost of urinary incontinence. Obstet Gynecol 2011;98:398–406. 5. Kane AR, Nager CW. Midurethral slings for stress urinary incontinence. Clin Obstet Gynecol 2008;51(1):124–135. 6. Anger JT, Weinberg AE, Albo ME, et al. Trends in surgical management of stress urinary incontinence among female Medicare beneficiaries. Urology 2009;74(2):283–287. 7. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol 1997;158(3 Pt 1):875–880. 8. Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;(4). CD006375. 9. Ward KL, Hilton PUK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG 2008;115(2):226–233. 10. Jelovsek JE, Barber MD, Karram MM, et al. Randomized trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up. BJOG 2008;115(2):219–225. 11. Delancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol 1994;170(6):1713–1720 discussion 1720–1723. 12. Parden AM, Gleason JL, Jauk V, et al. Incontinence outcomes in women undergoing primary and repeat midurethral sling procedures. Obstet Gynecol 2013;121(2 Pt 1):273–278. 13. Daneshgari F, Kong W, Swartz M. Complications of mid urethral slings: important outcomes for future clinical trials. J Urol 2008;180(5): 1890–1897. 14. Dmochowski RR, Blaivas JM, Gormley EA, et al. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol 2010;183(5):1906–1914.
17. Maher CF, O'Reilly BA, Dwyer PL, et al. Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomised controlled trial. BJOG 2005;112(6):797–801. 18. Corcos J, Collet JP, Shapiro S, et al. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology 2005;65(5):898–904. 19. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010;362(22):2066–2076. 20. Persson J, Teleman P, Etén-Bergquist C, et al. Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure. Acta Obstet Gynecol Scand 2002;81:1066–1073. 21. Aniuliene R. Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence. Medicina (Kaunas) 2009;45:639–643. 22. Freeman R, Holmes D, Hillard T, et al. What patients think: patient-reported outcomes of retropubic versus transobturator mid-urethral slings for urodynamic stress incontinence: a multicenter randomized controlled trial. Int Urogynecol J 2011;22:279–286. 23. Krofta L, Feyereisl J, Otcenásek M, et al. TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial. Int Urogynecol J 2010;21:141–148. 24. Liapis A, Bakas P, Giner M, et al. Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Gynecol Obstet Invest 2006;62:160–164. 25. Scheiner DA, Betschart C, Wiederkehr S, et al. Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings. Int Urogynecol J 2012;23:197–206. 26. Teo R, Moran P, Mayne C, et al. Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women. J Urol 2011;185:1350–1355. 27. Wang F, Song Y, Huang H. Prospective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence with or without pelvic organ prolapse in Southeast China. Arch Gynecol Obstet 2010;281:279–286. 28. Wang YJ, Li FP, Wang Q, et al. Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J 2011;22: 1369–1374. 29. Andonian S, Chen T, St-Denis B, et al. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Eur Urol 2005;47:537–541. 30. Abdel-Fattah M, Ramsay I, Pringle S, et al. Randomized prospective single-blinded study comparing “inside-out” versus “outside-in” transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010;117:870–878. 31. Barber MD, Weidner AC, Sokol AI, et al. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol 2012;119: 328–337. 32. Bai SW, Sohn WH, Chung DL, et al. Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and research urogynecology tension-free vaginal tape for stress urinary incontinence. Int J Gynaecol Obstet 2005;91:246–251.
15. Lightner D, Fox J. Bulking agents for urinary incontinence: patient selection, counseling and technique. Expert Rev Obstet Gynecol 2009;4(6):687–694.
33. Hinoul P, Vervest HA, den Boon J, et al. A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence. J Urol 2011; 185:1356–1362.
16. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev 2012;2. CD003881.
34. Tommaselli GA, Di Carlo C, Gargano V, et al. Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J 2010;21:1211–1217.
158
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35. Ross S, Robert M, Swaby C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol 2009;114:1287–1294.
44. Meulen PH, Berghmans LC, Nieman FH, et al. Effects of Macroplastique Implantation System for stress urinary incontinence and urethral hypermobility in women. Int Urogynecol J 2009;20(2):177–183.
36. Oliveira R, Botelho F, Silva P, et al. Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol 2011;59:940–944.
45. Mayer RD, Dmochowski RR, Appell RA, et al. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology 2007;69(5):876–880.
37. Guerrero KL, Emery SJ, Wareham K, et al. A randomized controlled trial comparing TVT, Pelvicol, and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG 2010;117: 1493–1503.
46. Bano F, Barrington JW, Dyer R. Comparison between porcine dermal implant (Permacol) and silicone injection (Macroplastique) for urodynamic stress incontinence. Int Urogynecol J 2005;16:147–150.
38. Hota LS, Hanaway K, Hacker MR, et al. TVT-Secur (hammock) versus TVT-obturator: a randomized trial of suburethral sling operative procedures. Female Pelvic Med Reconstr Surg 2012;18:41–45.
47. Lightner D, Calvosa C, Andersen R, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled double-blind study of Durasphere. Urology 2001;58:12.
39. Richter HE, Litman HJ, Lukacz ES, et al. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol 2011;117(4):913–921.
48. Anders K, Khullar V, Cardozo L, et al. Contigen or Macroplastique? A five year follow-up (Abstract). In: Proceedings of the International Continence Society, 32nd Annual Meeting; 2002 Aug 28-30. Heidelberg, Germany: International Continence Society; 2002:183–184.
40. Fritel X, Zabak K, Pigne A, et al. Predictive value of urethral mobility before suburethral tape procedure for urinary stress incontinence in women. J Urol 2002;168(6):2472–2475.
49. Ghoniem G, Corcos J, Comiter C, et al. Durability of urethral bulking agent injection for female stress urinary incontinence: 2-year multicenter study results. J Urol 2010;183:1444–1449.
41. Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. Eur Urol 2009;55(6):1450–1455.
50. Andersen RCM. Long-term follow-up comparison of Durasphere (trademark) and Contigen (trademark) in the treatment of stress urinary incontinence. J Low Genit Tract Dis 2002;6(4):239–243.
42. Toledo LG, Cabral PH, Casella ML, et al. Prognostic value of urethral mobility and Valsalva leak point pressure for female transobturator sling procedure. Int Braz J Urol 2012;38(5):667–673.
51. Shepherd JP, Lowder JL, Jones KA, et al. Retropubic and transobturator midurethral slings: a decision analysis to compare outcomes including efficacy and complications. Int Urogynecol J 2010;21(7):787–793.
43. Ghoniem G, Corcos J, Comiter C, et al. Crosslinked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study. J Urol 2009;181:204.
52. Subak LL, Brown JS, Kraus SR, et al. Diagnostic Aspects of Incontinence Study Group. The “costs” of urinary incontinence for women. Obstet Gynecol 2006;107(4):908–916.
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