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Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse
Journal Watch Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse
COMMENT
Ingrid Nygaard, M.D., Linda Brubaker, M.D., Halina M. Zyczynski, M.D., et al. JAMA. 2013 May 15;309(19):2016-24. http://dx.doi.org/ 10.1001/jama.2013.4919
SUMMARY
T
his study is the long-term follow-up of the original randomized, masked Colpopexy and Urinary Reduction Efforts (CARE) trial of women with symptomatic pelvic organ prolapse (POP) and without stress urinary incontinence (SUI) who underwent abdominal sacrocolpopexy between 2002 and 2005. These women were randomized to concomitant Burch urethropexy or no urethropexy as a prophylactic intervention for the possible development of de novo SUI.1 There were 322 patients originally enrolled in the CARE trial. Of these, 215 were available for extended CARE trial and 126 patients (39%) were available at 7 years for follow-up. Of the 126 patients, 90 were available for in-person history, physical examination, and quality of life interviews. The remaining 36 were only available through phone for interviews. The original trial demonstrated that the addition of the Burch urethropexy reduced stress incontinence from 44% to 24% at 3 months by objective and symptomatic measures.1 In addition, cure of apical prolapse was 95%. This result was durable at 2 years follow-up.2 This present study is the first to look at long-term outcomes of abdominal sacrocolpopexy. This extended study had strict criteria to define failure, which was no prolapse 1 cm beyond the hymen and <2 cm descent of the vaginal apex for anatomic failure and no bulge symptoms or retreatment of POP with surgery or a pessary for symptomatic failure.3 SUI was defined as 1 or more SUI symptoms on surveys or the need for an anti-incontinence procedure or a urethral bulking agent. With the use of these strict definitions, the probability of POP repair failure was 48% with urethropexy and 34% without urethropexy for composite POP (treatment difference of 13.4%; 95% confidence interval, 9.6% to 32.2%).3 For SUI, the probability of failure was 62% with urethropexy and 77% without urethropexy. Although the rate of failure for prolapse increased annually in each group, only 5% of patients underwent repeat prolapse surgery.3 In addition, the mesh erosion rate increased to 10.5% at 7 years; this was defined ª 2013 Elsevier Inc. All Rights Reserved
by any exposed suture or mesh material in the vagina or viscera.3
Approximately 1 in every 4 women will be affected by some form of pelvic floor disorder; this includes urinary incontinence, fecal incontinence, or POP.4 This trial is the first to examine the long-term outcomes of the “gold standard” for repair of POP e the abdominal sacrocolpopexy. The initial CARE trial, with its follow-up at 2 years, demonstrated the durability of the sacrocolpopexy with a 95% cure rate and objective decreased SUI from 44% to 24%.1,2 In this trial, the 7-year data demonstrate high failure rates of both sacrocolpopexy and urethropexy. Although there was a high failure rate as per the blinded assessors, only 5% of patients underwent repeat prolapse surgery. In this cohort, there was a reported 10.5% mesh erosion rate, which is substantially higher than 6% noted in the CARE trial follow-up at 2 years. There are several factors that may have played a role in the increased rate. These include concomitant procedures, mesh material composition, and surgical technique. In this series, the type of mesh was not standardized and as such, could have led to a higher rate of mesh erosion. Today, most surgeons performing sacrocolpopexies use type 1 monofilament polypropylene, whereas in this series, woven or multifilament grafts that have a known higher erosion rate were used.5 In addition, only 39% of the original study participants were available for evaluation at the 7-year time point, which demonstrates how difficult it is to get long-term data in even motivated patients. Although the long-term results of the extended CARE trial may seem somewhat disappointing, the rates of reoperation were low in this cohort. The rate of satisfaction was also relatively high in the group, although loss to follow-up may make this measure subject to bias. This trial does help pelvic surgeons understand and help counsel their patients toward realistic expectations of outcomes. With strict criteria, the chance of failure in prolapse and incontinence in 7 years is considerable, although reoperation rates were quite low. Patients must understand that these repairs do not have lifetime guarantees and will gradually have decreased efficacy, but may not become bothersome. In addition, given the 10.5% erosion risk in this series, which may be high owing to various factors, patients need to be aware of the risks of mesh that are inherent to a foreign material and that even in the best of hands with lightweight modern material, there is always going to be some risk of complication or erosion. With these factors in mind, patient satisfaction is
UROLOGY 82: 757e758, 2013 0090-4295/13/$36.00 http://dx.doi.org/10.1016/j.urology.2013.06.036
757
the primary goal in both prolapse and incontinence procedures and the surgeries we have to offer today afford patients safe and effective relief from symptoms of POP. Dean Elterman, M.D., F.R.C.S.C. Division of Urology University Health Network Department of Surgery University of Toronto Toronto, Ontario Canada Bilal Chughtai, M.D. Department of Urology Weill Cornell Medical College New York, NY
758
References 1. Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. New Eng J Med. 2006;354:1557-1566. 2. Brubaker L, Nygaard I, Richter HE, et al. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obs Gynecol. 2008;112:49-55. 3. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA. 2013;309:2016-2024. 4. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300: 1311-1316. 5. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obs Gynecol. 2008;199:688. e1-688.e5.
UROLOGY 82 (4), 2013
COMMENT
Ingrid Nygaard, M.D., Linda Brubaker, M.D., Halina M. Zyczynski, M.D., et al. JAMA. 2013 May 15;309(19):2016-24. http://dx.doi.org/ 10.1001/jama.2013.4919
SUMMARY
T
his study is the long-term follow-up of the original randomized, masked Colpopexy and Urinary Reduction Efforts (CARE) trial of women with symptomatic pelvic organ prolapse (POP) and without stress urinary incontinence (SUI) who underwent abdominal sacrocolpopexy between 2002 and 2005. These women were randomized to concomitant Burch urethropexy or no urethropexy as a prophylactic intervention for the possible development of de novo SUI.1 There were 322 patients originally enrolled in the CARE trial. Of these, 215 were available for extended CARE trial and 126 patients (39%) were available at 7 years for follow-up. Of the 126 patients, 90 were available for in-person history, physical examination, and quality of life interviews. The remaining 36 were only available through phone for interviews. The original trial demonstrated that the addition of the Burch urethropexy reduced stress incontinence from 44% to 24% at 3 months by objective and symptomatic measures.1 In addition, cure of apical prolapse was 95%. This result was durable at 2 years follow-up.2 This present study is the first to look at long-term outcomes of abdominal sacrocolpopexy. This extended study had strict criteria to define failure, which was no prolapse 1 cm beyond the hymen and <2 cm descent of the vaginal apex for anatomic failure and no bulge symptoms or retreatment of POP with surgery or a pessary for symptomatic failure.3 SUI was defined as 1 or more SUI symptoms on surveys or the need for an anti-incontinence procedure or a urethral bulking agent. With the use of these strict definitions, the probability of POP repair failure was 48% with urethropexy and 34% without urethropexy for composite POP (treatment difference of 13.4%; 95% confidence interval, 9.6% to 32.2%).3 For SUI, the probability of failure was 62% with urethropexy and 77% without urethropexy. Although the rate of failure for prolapse increased annually in each group, only 5% of patients underwent repeat prolapse surgery.3 In addition, the mesh erosion rate increased to 10.5% at 7 years; this was defined ª 2013 Elsevier Inc. All Rights Reserved
by any exposed suture or mesh material in the vagina or viscera.3
Approximately 1 in every 4 women will be affected by some form of pelvic floor disorder; this includes urinary incontinence, fecal incontinence, or POP.4 This trial is the first to examine the long-term outcomes of the “gold standard” for repair of POP e the abdominal sacrocolpopexy. The initial CARE trial, with its follow-up at 2 years, demonstrated the durability of the sacrocolpopexy with a 95% cure rate and objective decreased SUI from 44% to 24%.1,2 In this trial, the 7-year data demonstrate high failure rates of both sacrocolpopexy and urethropexy. Although there was a high failure rate as per the blinded assessors, only 5% of patients underwent repeat prolapse surgery. In this cohort, there was a reported 10.5% mesh erosion rate, which is substantially higher than 6% noted in the CARE trial follow-up at 2 years. There are several factors that may have played a role in the increased rate. These include concomitant procedures, mesh material composition, and surgical technique. In this series, the type of mesh was not standardized and as such, could have led to a higher rate of mesh erosion. Today, most surgeons performing sacrocolpopexies use type 1 monofilament polypropylene, whereas in this series, woven or multifilament grafts that have a known higher erosion rate were used.5 In addition, only 39% of the original study participants were available for evaluation at the 7-year time point, which demonstrates how difficult it is to get long-term data in even motivated patients. Although the long-term results of the extended CARE trial may seem somewhat disappointing, the rates of reoperation were low in this cohort. The rate of satisfaction was also relatively high in the group, although loss to follow-up may make this measure subject to bias. This trial does help pelvic surgeons understand and help counsel their patients toward realistic expectations of outcomes. With strict criteria, the chance of failure in prolapse and incontinence in 7 years is considerable, although reoperation rates were quite low. Patients must understand that these repairs do not have lifetime guarantees and will gradually have decreased efficacy, but may not become bothersome. In addition, given the 10.5% erosion risk in this series, which may be high owing to various factors, patients need to be aware of the risks of mesh that are inherent to a foreign material and that even in the best of hands with lightweight modern material, there is always going to be some risk of complication or erosion. With these factors in mind, patient satisfaction is
UROLOGY 82: 757e758, 2013 0090-4295/13/$36.00 http://dx.doi.org/10.1016/j.urology.2013.06.036
757
the primary goal in both prolapse and incontinence procedures and the surgeries we have to offer today afford patients safe and effective relief from symptoms of POP. Dean Elterman, M.D., F.R.C.S.C. Division of Urology University Health Network Department of Surgery University of Toronto Toronto, Ontario Canada Bilal Chughtai, M.D. Department of Urology Weill Cornell Medical College New York, NY
758
References 1. Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. New Eng J Med. 2006;354:1557-1566. 2. Brubaker L, Nygaard I, Richter HE, et al. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obs Gynecol. 2008;112:49-55. 3. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA. 2013;309:2016-2024. 4. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300: 1311-1316. 5. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obs Gynecol. 2008;199:688. e1-688.e5.
UROLOGY 82 (4), 2013