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AdVance Sling in Postprostatectomy Urinary Incontinence: More Data Available and Some Questions Still Open
EUROPEAN UROLOGY 62 (2012) 146–147
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 140–145 of this issue
AdVance Sling in Postprostatectomy Urinary Incontinence: More Data Available and Some Questions Still Open Giacomo Novara *, Vincenzo Ficarra Department of Surgical, Oncological, and Gastroenterological Sciences, Urology Clinic, University of Padua, Padua, Italy
Stress urinary incontinence (SUI) is a common consequence of radical prostatectomy. Despite improvements in anatomic knowledge and surgical techniques [1,2], the reported postprostatectomy SUI (PPSUI) rates still range from 5% to 48% [3], with 6–9% of patients ultimately seeking treatments for PPSUI [4]. Conservative management, including lifestyle interventions, pelvic floor muscle training with or without biofeedback, and bladder training are commonly adopted, especially during the first year following surgery when the chances of subsequent continence recovery are higher [5]. Although recent data suggest that behavioral therapy may also be effective in patients with long-lasting PPSUI [6], and some reports are available on the use of duloxetine in PPSUI [7], many patients with persistent PPSUI eventually need surgical treatment. High-quality evidence is lacking in the field. However, the artificial urinary sphincter (AUS) is currently regarded as the most effective long-term surgical treatment, with continence rates ranging from 70% to 90% after 5 yr and from 60% to 80% after 7 yr [4]. However, placement of AUS is a costly procedure, associated with a very long learning curve, and it is followed by a high risk of long-term complications, including erosions, infections, mechanical failures, and reoperations [8]. Consequently, those patients who are considered not ideal for AUS are routinely treated by less invasive procedures, mainly urethral bulking agents, adjustable balloons (ProACT), or male slings (bone-anchored systems, readjustable systems, or retrourethral transobturator slings) [3,4]. In the present issue of European Urology, Rehder et al. report a multi-institutional prospective study including the experience of three major urologic centers in the treatment of PPSUI with AdVance, a retrourethral transobturator sling.
Data on 156 patients at a median follow-up duration of 39 mo were proposed. The authors demonstrated that about 75% of the treated patients were either cured (cure defined as wearing no pad or a single safety pad) or improved (improvement defined as wearing one or two pads per day and a reduction in daily pad use of 50%). A total of 109 complications were observed, but the vast majority of these complications (mainly mild perineal pain) were of low grade, with a single patient requiring reoperation to explant an infected sling during symphysitis [9]. The study is important for several reasons. First, although several other reports on short-term outcomes of AdVance sling were available (see references 12, 13, 19, and 20 in the paper), intermediate-term data had not been previously reported. For the first time, the present study showed that functional outcomes (including both continence rates and micturition performance) were stable in the first 3 yr after surgery. Second, the study showed that in the same time frame, the device was reasonably safe. A single case of a late complication and no cases of erosion were reported, and the high methodological accuracy of data collection excluded underreporting of major complications. On the whole, those pieces of information are of major relevance and were very much needed, considering the relative young age of patients with PPSUI and their long life expectancy. Third, the availability of a relatively large multi-institutional series allowed the authors to perform some predictive analyses that may be useful to understand the most appropriate indications for the surgical procedure. The use of preoperative pads as a proxy of PPSUI severity was the only independent predictor of success, which means the higher the number of pads used before surgery, the lower the chance of being successfully
DOI of original article: http://dx.doi.org/10.1016/j.eururo.2012.02.038 * Corresponding author. Department of Surgical, Oncological, and Gastroenterological Sciences, Urology Clinic, University of Padua, Via Giustiniani 2, 35100, Padua, Italy. Tel. +39 049 8211250; Fax: +39 049 8218757. E-mail address: [email protected], [email protected] (G. Novara). 0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.eururo.2012.03.054
EUROPEAN UROLOGY 62 (2012) 146–147
treated by an AdVance sling. Similarly, a nonstatistically significant trend was observed in patients who had received radiation therapy, which means those patients might be at a higher risk of failure. Consequently, those categories of patients should be counseled realistically about the expected functional outcomes following AdVance and might benefit from other treatments. The present study clearly answers an important clinical question. However, some major issues still await answers. For the same reasons that make the present analysis appealing, data at even longer follow-up are needed, and the authors are encouraged to extend the follow-up duration of their analyses. Because very few centers have reported data on the AdVance sling so far, further validation studies involving other institutions are needed. More studies evaluating the efficacy and safety of the AdVance sling in comparison with other treatment modalities (duloxetine therapy, other male slings, adjustable balloons, or AUS) are also greatly needed. The best way to treat patients who had previously failed male slings, adjustable balloons, or AUS is unclear, and the current evidence is very limited [10]. Finally, it is not clear which is the best approach for patients who had received radiation therapy because those patients seem to be at a higher risk of failure following every surgical procedure. It seems unlikely that all those questions could be answered in the context of randomized controlled trials, but prospective nonrandomized comparative studies with similar inclusion and exclusion criteria, and adopting similar validated outcome measures might be more easily achievable and are awaited.
References [1] Walz J, Burnett AL, Costello AJ, et al. A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy. Eur Urol 2010;57:179–92. [2] Murphy DG, Bjartell A, Ficarra V, et al. Downsides of robot-assisted laparoscopic radical prostatectomy: limitations and complications. Eur Urol 2010;57:735–46. [3] Bauer RM, Gozzi C, Hu¨bner W, et al. Contemporary management of post prostatectomy incontinence. Eur Urol 2011;59:985–96. [4] Herschorn S, Bruschini H, Comiter C, et al. Surgical treatment of stress incontinence in men. Neurourol Urodyn 2010;29:179–90. [5] Abdollah F, Sun M, Suardi N, et al. Prediction of functional outcomes after nerve-sparing radical prostatectomy: results of conditional survival analyses. Eur Urol 2012;62:42–52. [6] Goode PS, Burgio KL, Johnson 2nd TM, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA 2011;305:151–9. [7] Cornu JN, Merlet B, Ciofu C, et al. Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial. Eur Urol 2011;59:148–54. [8] Sandhu JS, Maschino AC, Vickers AJ. The surgical learning curve for artificial urinary sphincter procedures compared to typical surgeon experience. Eur Urol 2011;60:1285–90. [9] Rehder P, Haab F, Cornu JN, Gozzi C, Bauer RM. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol 2012;62:140–5. [10] Soljanik I, Becker AJ, Stief CG, Gozzi C, Bauer RM. Repeat retrourethral transobturator sling in the management of recurrent postprostatectomy stress urinary incontinence after failed first male sling. Eur Urol 2010;58:767–72.
Conflicts of interest: The authors have nothing to disclose.
147
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 140–145 of this issue
AdVance Sling in Postprostatectomy Urinary Incontinence: More Data Available and Some Questions Still Open Giacomo Novara *, Vincenzo Ficarra Department of Surgical, Oncological, and Gastroenterological Sciences, Urology Clinic, University of Padua, Padua, Italy
Stress urinary incontinence (SUI) is a common consequence of radical prostatectomy. Despite improvements in anatomic knowledge and surgical techniques [1,2], the reported postprostatectomy SUI (PPSUI) rates still range from 5% to 48% [3], with 6–9% of patients ultimately seeking treatments for PPSUI [4]. Conservative management, including lifestyle interventions, pelvic floor muscle training with or without biofeedback, and bladder training are commonly adopted, especially during the first year following surgery when the chances of subsequent continence recovery are higher [5]. Although recent data suggest that behavioral therapy may also be effective in patients with long-lasting PPSUI [6], and some reports are available on the use of duloxetine in PPSUI [7], many patients with persistent PPSUI eventually need surgical treatment. High-quality evidence is lacking in the field. However, the artificial urinary sphincter (AUS) is currently regarded as the most effective long-term surgical treatment, with continence rates ranging from 70% to 90% after 5 yr and from 60% to 80% after 7 yr [4]. However, placement of AUS is a costly procedure, associated with a very long learning curve, and it is followed by a high risk of long-term complications, including erosions, infections, mechanical failures, and reoperations [8]. Consequently, those patients who are considered not ideal for AUS are routinely treated by less invasive procedures, mainly urethral bulking agents, adjustable balloons (ProACT), or male slings (bone-anchored systems, readjustable systems, or retrourethral transobturator slings) [3,4]. In the present issue of European Urology, Rehder et al. report a multi-institutional prospective study including the experience of three major urologic centers in the treatment of PPSUI with AdVance, a retrourethral transobturator sling.
Data on 156 patients at a median follow-up duration of 39 mo were proposed. The authors demonstrated that about 75% of the treated patients were either cured (cure defined as wearing no pad or a single safety pad) or improved (improvement defined as wearing one or two pads per day and a reduction in daily pad use of 50%). A total of 109 complications were observed, but the vast majority of these complications (mainly mild perineal pain) were of low grade, with a single patient requiring reoperation to explant an infected sling during symphysitis [9]. The study is important for several reasons. First, although several other reports on short-term outcomes of AdVance sling were available (see references 12, 13, 19, and 20 in the paper), intermediate-term data had not been previously reported. For the first time, the present study showed that functional outcomes (including both continence rates and micturition performance) were stable in the first 3 yr after surgery. Second, the study showed that in the same time frame, the device was reasonably safe. A single case of a late complication and no cases of erosion were reported, and the high methodological accuracy of data collection excluded underreporting of major complications. On the whole, those pieces of information are of major relevance and were very much needed, considering the relative young age of patients with PPSUI and their long life expectancy. Third, the availability of a relatively large multi-institutional series allowed the authors to perform some predictive analyses that may be useful to understand the most appropriate indications for the surgical procedure. The use of preoperative pads as a proxy of PPSUI severity was the only independent predictor of success, which means the higher the number of pads used before surgery, the lower the chance of being successfully
DOI of original article: http://dx.doi.org/10.1016/j.eururo.2012.02.038 * Corresponding author. Department of Surgical, Oncological, and Gastroenterological Sciences, Urology Clinic, University of Padua, Via Giustiniani 2, 35100, Padua, Italy. Tel. +39 049 8211250; Fax: +39 049 8218757. E-mail address: [email protected], [email protected] (G. Novara). 0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.
http://dx.doi.org/10.1016/j.eururo.2012.03.054
EUROPEAN UROLOGY 62 (2012) 146–147
treated by an AdVance sling. Similarly, a nonstatistically significant trend was observed in patients who had received radiation therapy, which means those patients might be at a higher risk of failure. Consequently, those categories of patients should be counseled realistically about the expected functional outcomes following AdVance and might benefit from other treatments. The present study clearly answers an important clinical question. However, some major issues still await answers. For the same reasons that make the present analysis appealing, data at even longer follow-up are needed, and the authors are encouraged to extend the follow-up duration of their analyses. Because very few centers have reported data on the AdVance sling so far, further validation studies involving other institutions are needed. More studies evaluating the efficacy and safety of the AdVance sling in comparison with other treatment modalities (duloxetine therapy, other male slings, adjustable balloons, or AUS) are also greatly needed. The best way to treat patients who had previously failed male slings, adjustable balloons, or AUS is unclear, and the current evidence is very limited [10]. Finally, it is not clear which is the best approach for patients who had received radiation therapy because those patients seem to be at a higher risk of failure following every surgical procedure. It seems unlikely that all those questions could be answered in the context of randomized controlled trials, but prospective nonrandomized comparative studies with similar inclusion and exclusion criteria, and adopting similar validated outcome measures might be more easily achievable and are awaited.
References [1] Walz J, Burnett AL, Costello AJ, et al. A critical analysis of the current knowledge of surgical anatomy related to optimization of cancer control and preservation of continence and erection in candidates for radical prostatectomy. Eur Urol 2010;57:179–92. [2] Murphy DG, Bjartell A, Ficarra V, et al. Downsides of robot-assisted laparoscopic radical prostatectomy: limitations and complications. Eur Urol 2010;57:735–46. [3] Bauer RM, Gozzi C, Hu¨bner W, et al. Contemporary management of post prostatectomy incontinence. Eur Urol 2011;59:985–96. [4] Herschorn S, Bruschini H, Comiter C, et al. Surgical treatment of stress incontinence in men. Neurourol Urodyn 2010;29:179–90. [5] Abdollah F, Sun M, Suardi N, et al. Prediction of functional outcomes after nerve-sparing radical prostatectomy: results of conditional survival analyses. Eur Urol 2012;62:42–52. [6] Goode PS, Burgio KL, Johnson 2nd TM, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA 2011;305:151–9. [7] Cornu JN, Merlet B, Ciofu C, et al. Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial. Eur Urol 2011;59:148–54. [8] Sandhu JS, Maschino AC, Vickers AJ. The surgical learning curve for artificial urinary sphincter procedures compared to typical surgeon experience. Eur Urol 2011;60:1285–90. [9] Rehder P, Haab F, Cornu JN, Gozzi C, Bauer RM. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol 2012;62:140–5. [10] Soljanik I, Becker AJ, Stief CG, Gozzi C, Bauer RM. Repeat retrourethral transobturator sling in the management of recurrent postprostatectomy stress urinary incontinence after failed first male sling. Eur Urol 2010;58:767–72.
Conflicts of interest: The authors have nothing to disclose.
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