Is Injection Therapy for Stress Urinary Incontinence Dead? Yes

Point–CounterPoint Is Injection Therapy for Stress Urinary Incontinence Dead? Yes Urethral bulking agents were first developed in the early 1970s and refined in an age before mid-urethral slings as a less-invasive therapy for female stress urinary incontinence. At their inception, the only alternative therapies available to women were either vastly more invasive, as in the case of open culposuspension and autologous fascial sling, or of questionable durability, as in the case of vaginal needle suspensions. Secondary to the ease in placement and perceived low rates of complication, this type of therapy persisted and continued to evolve, despite the known deficiencies in efficacy and durability.1-3 However, since the introduction by Ulmsten in 19954 of the transvaginal tape (TVT) procedure, a true alternative to more invasive procedures has evolved. Modern mid-urethral slings not only have low complication rates, but also equal rates of efficacy compared with previous standards of therapy that bulking agents have aspired to but never achieved. The TVT is considered by some to be the new reference standard of therapy for stress urinary incontinence and, in assuming that role, has obviated the need for injectable therapy. Before the introduction of the TVT procedure, colposuspension was the most widely performed operation for stress urinary incontinence. Long-term follow-up studies of colposuspension have quoted an 81.6% cure rate in 5-10 years of follow-up.5 In 2002, Ward et al.6,7 introduced Level 1 evidence showing the TVT procedure to be as effective as colposuspension for the treatment of urodynamic stress incontinence. They have recently published the 5-year follow-up data to that series, confirming their conclusions in the long term.8 A review of studies investigating the efficacy of injectable materials, such as collagen and carbon-coated zirconium beads, is more challenging because of the variable outcomes criteria and the lack of uniform definitions of pathophysiology. Current evidence has suggested that approximately 75% of women will have improvement or be cured by injection therapy in the short term.9 Although these rates seem comparable initially, with collagen, these efficacy rates are known to decline to 58% and 46% at 1 and 3 years, respectively.3 Thus, in terms of efficacy, the TVT procedure is clearly superior. Most series studying the TVT procedure have controlled for intrinsic sphincter deficiency, which corresponds to a detrusor leak point pressure of ⬍60 cm H2O or a maximum urethral closure pressure of ⬍20 cm H2O. © 2009 Elsevier Inc. All Rights Reserved

This is because the TVT was thought to work best for patients with urethral hypermobility as the cause of their incontinence. Coincidentally, it is in this population of patients that collagen was first approved for use in 1994. Hence, in these patients, a case could possibly be made that treatment with an injectable material might be preferred. However, the TVT has shown efficacy in these patients as well, with 2-year cure rates of ⱕ86%. Longterm data from this cohort showed a decrease in efficacy to 55% at 7 years; however, this duration of effect is clearly longer than that which can be achieved with injectable agents.10 Patients undergo intervention for urinary incontinence for a variety of reasons, and each patient has her own set of goals for the treatment. The ability of the surgeon and procedure to meet these goals with a minimal amount of complications and side effects determines the patient’s experience. Until recently, these goals had not yet been studied and hence had not been defined for our unique subset of patients. Using the data from the Stress Incontinence Surgical Efficacy Study, the Urinary Incontinence Treatment Network studied patient expectations after standardized preoperative counseling before incontinence surgery. They found that 98% of women had the expectation that their urine leakage would be completely or almost completely eliminated. They also found that 83% of women who reported preoperative urgency expected significant improvement in these symptoms after surgery, despite previous counsel that this result was not reliably predictable.11 These high preoperative expectations for success favor the TVT over injectable therapy for giving patients the best possibility of short- and long-term success, with a minimum of complications. De novo symptoms of urgency, although present at rates of 4%-15%12-15 for TVT, remain acceptably low, especially in the light of no available comparable data for injectable agents. The TVT has been proved to be an effective treatment of female stress urinary incontinence and associated with few complications. However, because the technique relies on blind retropubic passage of trocars, and this passage carries the risk of such serious complications as bowel perforation, an alternative procedure was developed. Delorme16 described the transobturator tape (TOT) midurethral sling in 2001. The trocars used with this technique completely avoid the retropubic space, UROLOGY 73: 9 –10, 2009 • 0090-4295/09/$34.00 doi:10.1016/j.urology.2008.05.049

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favoring passage through the soft tissues of the obturator fossa. This virtually eliminates the possibility of bowel or bladder injury and has made the TOT sling a popular alternative. In 2008, Level 1 evidence was introduced demonstrating that the TOT sling is not inferior to the TVT for the treatment of stress urinary incontinence, including patients with intrinsic sphincter deficiency. That study also showed that the TOT sling results in fewer bladder perforations.17 The complication rates quoted within this randomized controlled trial showed a urinary retention rate of 5.8% for TVT and 2.6% for TOT, reoperation for sling release of 1% for TVT and 0% for TOT, a transfusion rate of 1% for TVT and 0% for TOT, a bladder perforation rate of 8% for TVT and 0% for TOT, a bowel perforation rate of 0% for both procedures, and a 0% rate of leg/obturator complications for both groups. The midurethral TVT and TOT slings are effective treatments of female stress urinary incontinence, with high rates of short- and long-term efficacy, in addition to a low complication and side effect profile. When considered in the context of an outpatient procedure that can be performed under local anesthesia in as little as 20 minutes, the need for a slightly quicker, less-effective treatment that must be repeated every 4-6 months is greatly diminished. The mid-urethral sling remains the best studied, prospectively and retrospectively, incontinence therapy known. Despite this critical review, they have shown superiority as an incontinence therapy. In short, for the vast majority of patients, injection therapy for stress urinary incontinence is dead. Wesley G. Kong, M.D. Sandip P. Vasavada, M.D. Center for Female Pelvic Medicine and Reconstructive Surgery Glickman Urological and Kidney Institute Cleveland Clinic Cleveland, Ohio References 1. Jarvis GJ. Surgery for genuine stress incontinence. Br J Obstet Gynaecol. 1994;101:371-374. 2. Bergman A, Elia G. Three surgical procedures for genuine stress incontinence: Five-year follow-up of a prospective randomized study. Am J Obstet Gynecol. 1995;173:66-71.

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3. Herschorn S, Steele DJ, Radomski SB. Followup of intraurethral collagen for female stress urinary incontinence. J Urol. 1996;156: 1305-1309. 4. Ulmsten U. Intravaginal slingpasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75-82. 5. Feyereisl J, Dreher E, Haenggi W, et al. Long-term results after Burch colposuspension. Am J Obstet Gynecol. 1994;171:647-653. 6. Ward K, Hilton P, and the United Kingdom and Ireland TensionFree Vaginal Tape Trial Group. Prospective multicenter randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002;325:67-74. 7. Ward KL, Hilton P, and the United Kingdom and Ireland TensionFree Vaginal Tape Trial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: Two-year follow-up. Am J Obstet Gynecol. 2004;190:324-331. 8. Ward KL, Hilton P, and the United Kingdom and Ireland TensionFree Vaginal Tape Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. Br J Obstet Gynaecol. 2008;115:226-233. 9. Chapple CR, Wein AJ, Brubaker L, et al. Stress incontinence injection therapy: What is best for our patients? Eur Urol. 2005; 48:552-565. 10. Jeon MJ, Jung HJ, Chung SM, et al. Comparison of the treatment outcome of pubovaginal sling, tension-free vaginal tape, and transobturator tape for stress urinary incontinence with intrinsic sphincter deficiency. Am J Obstet Gynecol 2008;199:76.e1-4. 11. Mallett VT, Brubaker L, Stoddard AM, et al. The expectations of patients who undergo surgery for stress incontinence. Am J Obstet Gynecol. 2008;198:308.e1-6. 12. Abdel-Fattah M, Barrington JW, Arunkalaivanan AS. Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence: A prospective randomized threeyear follow-up study. Eur Urol. 2004;46:629-635. 13. Abouassaly R, Steinberg JR, Lemieux M, et al. Complications of tension-free vaginal tape surgery: A multi-institutional review. BJU Int. 2004;94:110-113. 14. Fischer A, Fink T, Zachmann S, et al. Comparison of retropubic and outside-in transobturator sling systems for the cure of female genuine stress urinary incontinence. Eur Urol. 2005;48:799-804. 15. Levin I, Groutz A, Gold R, et al. Surgical complications and medium-term outcome results of tension-free vaginal tape: A prospective study of 313 consecutive patients. Neurourol Urodyn. 2004; 23:7-9. 16. Delorme E. Transobturator urethral suspension: Mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11:1306-1313. 17. Barber MD, Kleeman S, Karram MM, et al. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: A randomized controlled trial. Obstet Gynecol. 2008;111:611-621.

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