Letters Diagnosis and Surgical Treatment of Stress Urinary Incontinence To the Editor: We are indebted to the authors for a thorough review of the diagnosis and treatment of stress urinary incontinence (SUI).1 However, we disagree with the author’s comments on singleincision midurethral slings. The study referenced by the authors on the role of single-incision midurethral slings in the treatment of SUI (Madsen et al)2 was a cohort study comparing the MiniArc (single-incision midurethral sling) with the ALIGN (retropubic midurethral sling). This study was not representative of all single-incision slings, which vary significantly in the robustness of their anchoring mechanisms. Also, there is inherent responder and recall bias in this type of cohort study. There are many randomized controlled trials (RCTs) (level I evidence) that have demonstrated equal efficacy when comparing single-incision midurethral slings with retropubic midurethral slings.3 We assert that more recent singleincision transobturator slings have evolved into devices that offer the simplicity of the earlier-developed single-incision sling and mini-slings and the durability of a standard transobturator sling without the extension of arms through the adductor muscles. A recent meta-analysis of RCTs comparing single-incision slings with standard Guidelines for Letters. Letters posing a question or challenge to an article appearing in Obstetrics & Gynecology should be submitted within 8 weeks of the article’s publication online. Letters received after 8 weeks will rarely be considered. Letters should not exceed 350 words, including signatures and 5 references. A word count should be provided. The maximum number of authors permitted is four, and a corresponding author should be designated (and contact information listed). Letters will be published at the discretion of the Editor. The Editor may send the letter to the authors of the original paper so their comments may be published simultaneously. The Editor reserves the right to edit and shorten letters. A signed author agreement form is required from all authors before publication. Letters should be submitted using the Obstetrics & Gynecology online submission and review system, Editorial Manager (http://ong.edmgr.com).
VOL. 125, NO. 4, APRIL 2015
midurethral slings for SUI has shown that, after excluding RCTs evaluating TVTSecur, there was no evidence of significant difference between single-incision midurethral slings and standard mid urethral sling in patient-reported cure rates and objective cure rates. This study also revealed significantly lower postoperative pain scores and earlier return to normal activities and work. Although long-term data are not available for “mini-slings,” a hypothesis can be formulated regarding the biological feasibility of their success based on what we already know to be true for transobturator tension-free vaginal tape. It would be difficult to postulate that the robust anchoring system of the more recent transobturator single-incision midurethral slings would not perform at least as well as the mesh arms of the transobturator tension-free vaginal tape. At the Institute for Female Pelvic Medicine and Reconstructive Surgery, we have been able to perform singleincision midurethral slings in the office setting, achieving optimal patient satisfaction and a decrease in health care costs. Financial Disclosure: The authors did not report any potential conflicts of interest.
Vincent R. Lucente, MD, MBA Sonya N. Ephraim, MD Institute for Female Pelvic Medicine and Reconstructive Surgery, St. Luke’s Hospital and Health Network, Allentown, Pennsylvania
REFERENCES 1. Garely AD, Noor N. Diagnosis and surgical treatment of stress urinary incontinence. Obstetrics Gynecol 2014;124:1011–27. 2. Madsen AM, El-Nashar SA, Woelk JL, Klingele CJ, Gebhart JB, Trabuco EC. A cohort study comparing a single-incision sling with a retropubic midurethral sling. Int Urogynecol J 2014;25:351–8. 3. Abdel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. Eur Urol 2011;60:468–80.
In Reply: Drs. Lucente and Ephraim disagree with our comments on single-incision midurethral slings. Our opinion on singleincision midurethral slings was, “Com-
pared with midurethral slings, minislings show lower success rates, lower patient satisfaction, and higher reoperation rates. Long-term data are lacking and continued surveillance will be needed.”1 A recent Cochrane review2 evaluated 31 trials with 3,290 women. Most of these studies involved the TVT-Secur single-incision sling. Because of high failure rates and complications, the TVTSecur was withdrawn from the market. In general, the review revealed singleincision midurethral slings to be inferior compared with retropubic and transobturator slings with respect to continued incontinence rates (41% compared with 26% and 30% compared with 11%). In this large meta-analysis, the singleincision midurethral sling group had a higher rate of vaginal mesh exposure, bladder and urethral erosion, and operative blood loss. The Cochrane conclusion is, “When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made.” In 2008, Dr. Lucente published the first study on single-incision midurethral slings.3 The study looked at the early results of the TVT-Secur. Before that publication, the TVT-Secur had been presented in seven abstracts with a total of 495 patients. The objective cure rate was 80.1%, and the complication rates were very low (most at 1% or less). Dr. Lucente concluded that the major advantage to using the TVTSecur would be reduced patient discomfort in the immediate postoperative period, with efficacy rates equal to traditional midurethral slings. Dr. Lucente notes that, “long term follow-up is warranted and comparative studies are needed to determine its true efficacy.” The road to failure is paved with good intentions. Nobody in the field of pelvic reconstructive surgery wants to harm patients, especially Dr. Lucente and his team. Our opinion reflects his (almost verbatim). We are simply advocating for data rather than the experiences of a few clinical centers. If the success of single-incision midurethral slings is dependent on superior surgical skills possessed by few in our specialty, this needs to be clarified. As the authors of a Clinical Expert Series article, we can state that we need to
OBSTETRICS & GYNECOLOGY
Copyright ª by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
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VOL. 125, NO. 4, APRIL 2015
midurethral slings for SUI has shown that, after excluding RCTs evaluating TVTSecur, there was no evidence of significant difference between single-incision midurethral slings and standard mid urethral sling in patient-reported cure rates and objective cure rates. This study also revealed significantly lower postoperative pain scores and earlier return to normal activities and work. Although long-term data are not available for “mini-slings,” a hypothesis can be formulated regarding the biological feasibility of their success based on what we already know to be true for transobturator tension-free vaginal tape. It would be difficult to postulate that the robust anchoring system of the more recent transobturator single-incision midurethral slings would not perform at least as well as the mesh arms of the transobturator tension-free vaginal tape. At the Institute for Female Pelvic Medicine and Reconstructive Surgery, we have been able to perform singleincision midurethral slings in the office setting, achieving optimal patient satisfaction and a decrease in health care costs. Financial Disclosure: The authors did not report any potential conflicts of interest.
Vincent R. Lucente, MD, MBA Sonya N. Ephraim, MD Institute for Female Pelvic Medicine and Reconstructive Surgery, St. Luke’s Hospital and Health Network, Allentown, Pennsylvania
REFERENCES 1. Garely AD, Noor N. Diagnosis and surgical treatment of stress urinary incontinence. Obstetrics Gynecol 2014;124:1011–27. 2. Madsen AM, El-Nashar SA, Woelk JL, Klingele CJ, Gebhart JB, Trabuco EC. A cohort study comparing a single-incision sling with a retropubic midurethral sling. Int Urogynecol J 2014;25:351–8. 3. Abdel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. Eur Urol 2011;60:468–80.
In Reply: Drs. Lucente and Ephraim disagree with our comments on single-incision midurethral slings. Our opinion on singleincision midurethral slings was, “Com-
pared with midurethral slings, minislings show lower success rates, lower patient satisfaction, and higher reoperation rates. Long-term data are lacking and continued surveillance will be needed.”1 A recent Cochrane review2 evaluated 31 trials with 3,290 women. Most of these studies involved the TVT-Secur single-incision sling. Because of high failure rates and complications, the TVTSecur was withdrawn from the market. In general, the review revealed singleincision midurethral slings to be inferior compared with retropubic and transobturator slings with respect to continued incontinence rates (41% compared with 26% and 30% compared with 11%). In this large meta-analysis, the singleincision midurethral sling group had a higher rate of vaginal mesh exposure, bladder and urethral erosion, and operative blood loss. The Cochrane conclusion is, “When one single-incision sling was compared with another, evidence was insufficient to suggest a significant difference between any of the slings in any of the comparisons made.” In 2008, Dr. Lucente published the first study on single-incision midurethral slings.3 The study looked at the early results of the TVT-Secur. Before that publication, the TVT-Secur had been presented in seven abstracts with a total of 495 patients. The objective cure rate was 80.1%, and the complication rates were very low (most at 1% or less). Dr. Lucente concluded that the major advantage to using the TVTSecur would be reduced patient discomfort in the immediate postoperative period, with efficacy rates equal to traditional midurethral slings. Dr. Lucente notes that, “long term follow-up is warranted and comparative studies are needed to determine its true efficacy.” The road to failure is paved with good intentions. Nobody in the field of pelvic reconstructive surgery wants to harm patients, especially Dr. Lucente and his team. Our opinion reflects his (almost verbatim). We are simply advocating for data rather than the experiences of a few clinical centers. If the success of single-incision midurethral slings is dependent on superior surgical skills possessed by few in our specialty, this needs to be clarified. As the authors of a Clinical Expert Series article, we can state that we need to
OBSTETRICS & GYNECOLOGY
Copyright ª by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
979
