Neurourology and Urodynamics 34:251–254 (2015)
The Advance Transobturator Male Sling for Post-Prostatectomy Incontinence: Subjective and Objective Outcomes With 3 Years Follow Up Casey G. Kowalik,* Jessica M. DeLong, and Arthur P. Mourtzinos Lahey Hospital & Medical Center, Institute of Urology, Burlington, Massachusetts Aims: To determine patient-perceived and clinical outcomes of the AdVance sling at 3 years follow-up in men with postprostatectomy incontinence (PPI). Methods: Data was prospectively collected of men with PPI treated with the AdVance male sling between February 2008 and March 2010. Twenty-four-hour pad counts and weights and patient completed validated questionnaires were obtained pre-operatively and at 3 years. The primary outcome was improvement in pad count with secondary outcomes of questionnaire scores and patient perception of success. Results: At a median follow-up of 39 months (IQR: 36–44), we identified 30 men meeting inclusion criteria who had the AdVance male sling placed for mild to severe PPI. Eighteen (60%) patients were cured (no pad usage or one pad for security) and an additional 4 (13%) showed improvement (50% reduction in pad usage). Eight (27%) patients failed: six patients underwent seven salvage procedures including urethral bulking with collagen (n ¼ 1), Virtue perineal sling (n ¼ 1), and artificial urinary sphincter (n ¼ 5). There were 16 post-operative complications: 13 Clavien I, 2 Clavien II, and 1 Clavien IIIb. Conclusions: AdVance male sling is an effective treatment option for PPI evidenced by objective improvements in 24-hr pad count and pad weight and patient perceived success via validated questionnaires. Neurourol. Urodynam. 34:251–254, 2015. # 2013 Wiley Periodicals, Inc. Key words: urinary incontinence; male urethral sling; quality of life INTRODUCTION
Post-prostatectomy incontinence (PPI) is a serious condition that significantly affects quality of life. Treatment options include behavioral modifications and surgery. Non-operative management options include limiting fluid intake, timed voiding, and pelvic floor physiotherapy. Based on data from a large population study, up to 5% of patients undergo surgical treatment for incontinence following prostatectomy.1 Surgical options for urinary incontinence in men include urethral slings and artificial urinary sphincter (AUS). The availability of the AdVance (American Medical Systems, Minnetonka, Minnesota, USA) sling in the United States beginning in October 2007 added to the armamentarium of available surgical treatment options for patients. The AdVance sling is a retrourethral transobturator sling (RTS) that is thought to improve continence by repositioning and lengthening the membranous urethra.2 Given its relatively recent introduction, there is minimal published data regarding mid-term outcomes following AdVance sling placement. In this study we determined subjective and objective 3-year outcomes through validated questionnaires and quantitative 24 hr pad counts and weights. We surmised that patient satisfaction, as well as clinical measures of improvement, would be durable at 3 years follow-up.
bladder dysfunction including bladder overactivity or decreased compliance was performed on all patients. In our cohort, UDS was consistent with predominantly stress urinary incontinence in all men and all had evidence of urethral hypermobility. No patient had evidence of bladder outlet obstruction on cystoscopy. All patients were asked to report 24hr pad counts and pad weights, as well as complete validated questionnaires pre-operatively and during follow-up. Patients were asked to bring to clinic all pads used over a 24-hr period in a double bagged sealed container for weighing by the surgeon. Lastly, patients were asked to give their impression of improvement from their pre-operative symptoms as a percentage. Inclusion criteria for this study were completion of preoperative and 3-year validated questionnaires and documentation of 24-hr pad count and pad weight. The questionnaires utilized were the Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI), which are both valid and reliable instruments for assessing symptom severity and quality of life in patients with urinary incontinence.3 Pre-operative discussion regarding the risks and benefits of both the AdVance sling and artificial urinary sphincter was undertaken with all men. In men with severe pre-operative incontinence, it was specifically discussed that the AdVance male sling is generally most successful in men with mild to moderate incontinence. All men were aware of the possibility of additional procedures if their incontinence was not cured.
MATERIALS AND METHODS
A retrospective review of an Institutional Review Board approved prospectively maintained database was queried for men undergoing AdVance RTS for PPI by a single surgeon (APM) between February 2008 and March 2010. All men had at least 3 years follow-up. A pre-operative evaluation consisting of a detailed history and physical examination, cystoscopy to evaluate for urethral stricture or bladder neck contracture, and urodynamic studies (UDS) to evaluate for associated #
2013 Wiley Periodicals, Inc.
Christopher Chapple led the peer-review process as the Associate Editor responsible for the paper. Conflict of interest: none. Correspondence to: Casey G. Kowalik, MD, Lahey Hospital & Medical Center, Institute of Urology, 41 Mall Road, Burlington, MA 01805. E-mail: [email protected] Received 28 July 2013; Accepted 11 November 2013 Published online 7 December 2013 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22539
252
Kowalik et al.
Patients were classified by pre-operative incontinence severity with mild defined as 1–2 pads per day (PPD), moderate as 3–5 PPD, and severe 6 PPD or the need for an external collection device, such as a condom catheter. The primary outcome was pad count at 3 years. Cure was defined as no longer requiring pads or wearing a pad for security reasons if it remained dry. We defined improvement as a 50% pad count reduction. Patients with a 200 g was associated with sling failure. Our data correlates with these findings as 6 of the 7 (86%) of patients with pre-operative 24 hr pad weight >200 g failed and five of these patients went on to have salvage procedures. In our study, of the three patients with prior radiation history, one was classified as having sling failure at 3 years while the other two patients are dry. Recent data examining RTS outcomes of previously irradiated patients is conflicting. Rehder et al.5 studied 22 patients with previous irradiation. There was a higher percentage of failed slings in irradiated patients (45%) compared to non-radiated patients (34%), but this did not reach statistical significance (P ¼ 0.0723). Another study including 23 patients with a history of pelvic radiation undergoing AdVance sling showed a trend in sling failure with P ¼ 0.053 after multivariate analysis.10 Bauer et al.13 examined the outcomes of 24 patients after radical prostatectomy and adjuvant radiation. There was no comparison group, but success rates were poor with a cure rate of 25% and a 50% failure rate. These studies lack large numbers of patients, but nonetheless, patients with prior radiotherapy present a challenging clinical problem, with a likely increased risk of sling failure. BMI 30 was not associated with higher rates of sling failure suggesting its efficacy even in obese patients. This opposes the results of a study by Grimsby et al.14 which included 31 patients, 9 of whom had a BMI 30. In their study, normal weight and overweight patients had a significantly higher rate of successful treatment than obese (BMI 30) patients. However, based on our results, BMI 30 should not be a contraindication to RTS placement. Complications
The most common post-operative complication was acute urinary retention affecting 30% of patients. This is higher than other reported series, however all patients in our cohort had their first voiding trial within 24 hr of their procedure whereas the protocol in other studies was to leave the catheter in for a period of time ranging from 3 to 4 days.6,11 In all except one of the patients, the urinary retention resolved within 1 week. The high rate of acute urinary retention prompted a change in our protocol and now all patients keep their urethral catheters for 3 days. Since this time, we have not had any patients experience
Neurourology and Urodynamics DOI 10.1002/nau
urinary retention following catheter removal. Patients with urinary retention were not more likely to be cured at 3 years (P ¼ 0.25). Study Limitations
The most notable limitation of this study is the small sample size. One patient did not reach 3 years follow-up, which could introduce an exclusion bias. However analysis of the available data demonstrates that both subjective and objective outcomes are durable at 3 years follow-up. As data matures, longer-term follow-up studies will provide invaluable information regarding durability. In this study, the surgeon’s learning curve was not a factor as the initial cases did not have worse outcomes than the later cases. CONCLUSIONS
The AdVance sling is a safe and effective treatment for men with PPI with durable subjective and objective mid-term follow-up. Patients with pre-operative pad weights >200 g were more likely to have sling failure. Salvage therapy with alternative types of perineal slings or AUS is possible following RTS. Continued evaluation is needed to assess long-term efficacy and precise indications for placement in patients with post-prostatectomy incontinence.
REFERENCES 1. Nam RK, Herschorn S, Loblaw DA, et al. Population based study of long-term rates of surgery for urinary incontinence after radical prostatectomy for prostate cancer. J Urol 2012;188:502–6. 2. Rehder P, Gozzi C. Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol 2007;52: 860–7. 3. Moore KN, Jensen L. Testing of the incontinence impact questionnaire (IIQ-7) with men after radical prostatectomy. J Wound Ostomy Continence Nurs 2000;27:304–12. 4. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: Five-year experience. Ann Surg 2009;250:187–96. 5. Rehder P, Haab F, Cornu J-N, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-Year follow-up. Eur Urol 2012;62:140–5. 6. Suskind AM, Bernstein B, Murphy-Setzko M. Patient-perceived outcomes of the AdVance sling up to 40 months post procedure. Neurourol Urodyn 2011;30:1267–670. 7. Cornu J-N, Sebe P, Ciofu C, et al. The AdVance transobturator male sling for postprostatectomy incontinence: Clinical results of a prospective evaluation after a minimum follow-up of 6 months. Eur Urol 2009;56:923–7. 8. Rehder P, Mitterberger MJ, Pichler R, et al. The 1 year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence. BJU Int 2010;106:1668–72. 9. Li H, Gill BC, Nowacki AS, et al. Therapeutic durability of the male transobturator sling: Midterm patient reported outcomes. J Urol 2012;187: 1331–5. 10. Cornu J-N, Sebe P, Ciofu C, et al. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: Focus on prognostic factors. BJU Int 2010;108:236–40. 11. Bauer RM, Mayer ME, Gratzke C, et al. Prospective evaluation of the functional sling suspension for male postprostatectomy stress urinary incontinence: Results after 1 year. Eur Urol 2009;56:928–33. 12. Cornel EB, Elzevier HW, Putter H. Can advance transobturator sling suspension cure male urinary postoperative stress incontinence? J Urol 2010;183:1459–63. 13. Bauer RM, Soljanik I, F€ ullhase C, et al. Results of the AdVance transobturator male sling after radical prostatectomy and adjuvant radiotherapy. Urology 2011;77:474–9. 14. Grimsby GM, Tyson MD, Wolter CE. Early outcomes of the transobturator male sling based on body mass index. Can J Urol 2012;19:6088–93.
The Advance Transobturator Male Sling for Post-Prostatectomy Incontinence: Subjective and Objective Outcomes With 3 Years Follow Up Casey G. Kowalik,* Jessica M. DeLong, and Arthur P. Mourtzinos Lahey Hospital & Medical Center, Institute of Urology, Burlington, Massachusetts Aims: To determine patient-perceived and clinical outcomes of the AdVance sling at 3 years follow-up in men with postprostatectomy incontinence (PPI). Methods: Data was prospectively collected of men with PPI treated with the AdVance male sling between February 2008 and March 2010. Twenty-four-hour pad counts and weights and patient completed validated questionnaires were obtained pre-operatively and at 3 years. The primary outcome was improvement in pad count with secondary outcomes of questionnaire scores and patient perception of success. Results: At a median follow-up of 39 months (IQR: 36–44), we identified 30 men meeting inclusion criteria who had the AdVance male sling placed for mild to severe PPI. Eighteen (60%) patients were cured (no pad usage or one pad for security) and an additional 4 (13%) showed improvement (50% reduction in pad usage). Eight (27%) patients failed: six patients underwent seven salvage procedures including urethral bulking with collagen (n ¼ 1), Virtue perineal sling (n ¼ 1), and artificial urinary sphincter (n ¼ 5). There were 16 post-operative complications: 13 Clavien I, 2 Clavien II, and 1 Clavien IIIb. Conclusions: AdVance male sling is an effective treatment option for PPI evidenced by objective improvements in 24-hr pad count and pad weight and patient perceived success via validated questionnaires. Neurourol. Urodynam. 34:251–254, 2015. # 2013 Wiley Periodicals, Inc. Key words: urinary incontinence; male urethral sling; quality of life INTRODUCTION
Post-prostatectomy incontinence (PPI) is a serious condition that significantly affects quality of life. Treatment options include behavioral modifications and surgery. Non-operative management options include limiting fluid intake, timed voiding, and pelvic floor physiotherapy. Based on data from a large population study, up to 5% of patients undergo surgical treatment for incontinence following prostatectomy.1 Surgical options for urinary incontinence in men include urethral slings and artificial urinary sphincter (AUS). The availability of the AdVance (American Medical Systems, Minnetonka, Minnesota, USA) sling in the United States beginning in October 2007 added to the armamentarium of available surgical treatment options for patients. The AdVance sling is a retrourethral transobturator sling (RTS) that is thought to improve continence by repositioning and lengthening the membranous urethra.2 Given its relatively recent introduction, there is minimal published data regarding mid-term outcomes following AdVance sling placement. In this study we determined subjective and objective 3-year outcomes through validated questionnaires and quantitative 24 hr pad counts and weights. We surmised that patient satisfaction, as well as clinical measures of improvement, would be durable at 3 years follow-up.
bladder dysfunction including bladder overactivity or decreased compliance was performed on all patients. In our cohort, UDS was consistent with predominantly stress urinary incontinence in all men and all had evidence of urethral hypermobility. No patient had evidence of bladder outlet obstruction on cystoscopy. All patients were asked to report 24hr pad counts and pad weights, as well as complete validated questionnaires pre-operatively and during follow-up. Patients were asked to bring to clinic all pads used over a 24-hr period in a double bagged sealed container for weighing by the surgeon. Lastly, patients were asked to give their impression of improvement from their pre-operative symptoms as a percentage. Inclusion criteria for this study were completion of preoperative and 3-year validated questionnaires and documentation of 24-hr pad count and pad weight. The questionnaires utilized were the Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI), which are both valid and reliable instruments for assessing symptom severity and quality of life in patients with urinary incontinence.3 Pre-operative discussion regarding the risks and benefits of both the AdVance sling and artificial urinary sphincter was undertaken with all men. In men with severe pre-operative incontinence, it was specifically discussed that the AdVance male sling is generally most successful in men with mild to moderate incontinence. All men were aware of the possibility of additional procedures if their incontinence was not cured.
MATERIALS AND METHODS
A retrospective review of an Institutional Review Board approved prospectively maintained database was queried for men undergoing AdVance RTS for PPI by a single surgeon (APM) between February 2008 and March 2010. All men had at least 3 years follow-up. A pre-operative evaluation consisting of a detailed history and physical examination, cystoscopy to evaluate for urethral stricture or bladder neck contracture, and urodynamic studies (UDS) to evaluate for associated #
2013 Wiley Periodicals, Inc.
Christopher Chapple led the peer-review process as the Associate Editor responsible for the paper. Conflict of interest: none. Correspondence to: Casey G. Kowalik, MD, Lahey Hospital & Medical Center, Institute of Urology, 41 Mall Road, Burlington, MA 01805. E-mail: [email protected] Received 28 July 2013; Accepted 11 November 2013 Published online 7 December 2013 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22539
252
Kowalik et al.
Patients were classified by pre-operative incontinence severity with mild defined as 1–2 pads per day (PPD), moderate as 3–5 PPD, and severe 6 PPD or the need for an external collection device, such as a condom catheter. The primary outcome was pad count at 3 years. Cure was defined as no longer requiring pads or wearing a pad for security reasons if it remained dry. We defined improvement as a 50% pad count reduction. Patients with a 200 g was associated with sling failure. Our data correlates with these findings as 6 of the 7 (86%) of patients with pre-operative 24 hr pad weight >200 g failed and five of these patients went on to have salvage procedures. In our study, of the three patients with prior radiation history, one was classified as having sling failure at 3 years while the other two patients are dry. Recent data examining RTS outcomes of previously irradiated patients is conflicting. Rehder et al.5 studied 22 patients with previous irradiation. There was a higher percentage of failed slings in irradiated patients (45%) compared to non-radiated patients (34%), but this did not reach statistical significance (P ¼ 0.0723). Another study including 23 patients with a history of pelvic radiation undergoing AdVance sling showed a trend in sling failure with P ¼ 0.053 after multivariate analysis.10 Bauer et al.13 examined the outcomes of 24 patients after radical prostatectomy and adjuvant radiation. There was no comparison group, but success rates were poor with a cure rate of 25% and a 50% failure rate. These studies lack large numbers of patients, but nonetheless, patients with prior radiotherapy present a challenging clinical problem, with a likely increased risk of sling failure. BMI 30 was not associated with higher rates of sling failure suggesting its efficacy even in obese patients. This opposes the results of a study by Grimsby et al.14 which included 31 patients, 9 of whom had a BMI 30. In their study, normal weight and overweight patients had a significantly higher rate of successful treatment than obese (BMI 30) patients. However, based on our results, BMI 30 should not be a contraindication to RTS placement. Complications
The most common post-operative complication was acute urinary retention affecting 30% of patients. This is higher than other reported series, however all patients in our cohort had their first voiding trial within 24 hr of their procedure whereas the protocol in other studies was to leave the catheter in for a period of time ranging from 3 to 4 days.6,11 In all except one of the patients, the urinary retention resolved within 1 week. The high rate of acute urinary retention prompted a change in our protocol and now all patients keep their urethral catheters for 3 days. Since this time, we have not had any patients experience
Neurourology and Urodynamics DOI 10.1002/nau
urinary retention following catheter removal. Patients with urinary retention were not more likely to be cured at 3 years (P ¼ 0.25). Study Limitations
The most notable limitation of this study is the small sample size. One patient did not reach 3 years follow-up, which could introduce an exclusion bias. However analysis of the available data demonstrates that both subjective and objective outcomes are durable at 3 years follow-up. As data matures, longer-term follow-up studies will provide invaluable information regarding durability. In this study, the surgeon’s learning curve was not a factor as the initial cases did not have worse outcomes than the later cases. CONCLUSIONS
The AdVance sling is a safe and effective treatment for men with PPI with durable subjective and objective mid-term follow-up. Patients with pre-operative pad weights >200 g were more likely to have sling failure. Salvage therapy with alternative types of perineal slings or AUS is possible following RTS. Continued evaluation is needed to assess long-term efficacy and precise indications for placement in patients with post-prostatectomy incontinence.
REFERENCES 1. Nam RK, Herschorn S, Loblaw DA, et al. Population based study of long-term rates of surgery for urinary incontinence after radical prostatectomy for prostate cancer. J Urol 2012;188:502–6. 2. Rehder P, Gozzi C. Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol 2007;52: 860–7. 3. Moore KN, Jensen L. Testing of the incontinence impact questionnaire (IIQ-7) with men after radical prostatectomy. J Wound Ostomy Continence Nurs 2000;27:304–12. 4. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: Five-year experience. Ann Surg 2009;250:187–96. 5. Rehder P, Haab F, Cornu J-N, et al. Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-Year follow-up. Eur Urol 2012;62:140–5. 6. Suskind AM, Bernstein B, Murphy-Setzko M. Patient-perceived outcomes of the AdVance sling up to 40 months post procedure. Neurourol Urodyn 2011;30:1267–670. 7. Cornu J-N, Sebe P, Ciofu C, et al. The AdVance transobturator male sling for postprostatectomy incontinence: Clinical results of a prospective evaluation after a minimum follow-up of 6 months. Eur Urol 2009;56:923–7. 8. Rehder P, Mitterberger MJ, Pichler R, et al. The 1 year outcome of the transobturator retroluminal repositioning sling in the treatment of male stress urinary incontinence. BJU Int 2010;106:1668–72. 9. Li H, Gill BC, Nowacki AS, et al. Therapeutic durability of the male transobturator sling: Midterm patient reported outcomes. J Urol 2012;187: 1331–5. 10. Cornu J-N, Sebe P, Ciofu C, et al. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: Focus on prognostic factors. BJU Int 2010;108:236–40. 11. Bauer RM, Mayer ME, Gratzke C, et al. Prospective evaluation of the functional sling suspension for male postprostatectomy stress urinary incontinence: Results after 1 year. Eur Urol 2009;56:928–33. 12. Cornel EB, Elzevier HW, Putter H. Can advance transobturator sling suspension cure male urinary postoperative stress incontinence? J Urol 2010;183:1459–63. 13. Bauer RM, Soljanik I, F€ ullhase C, et al. Results of the AdVance transobturator male sling after radical prostatectomy and adjuvant radiotherapy. Urology 2011;77:474–9. 14. Grimsby GM, Tyson MD, Wolter CE. Early outcomes of the transobturator male sling based on body mass index. Can J Urol 2012;19:6088–93.
