Curr Urol Rep (2014) 15:421 DOI 10.1007/s11934-014-0421-6
PROSTATE CANCER (D PAREKH, SECTION EDITOR)
Management of Urinary Incontinence after Radical Prostatectomy Thomas R. Jarvis & Jaspreet S. Sandhu
Published online: 24 May 2014 # Springer Science+Business Media New York 2014
Abstract In the year following a radical prostatectomy, most men recover from any initial urinary incontinence. Nonetheless, incontinence greatly affects a man’s quality of life during that time, as it does for those who have persistent incontinence thereafter. Urological assessment should be thorough in order to ensure that no treatable etiology exists aside from stress incontinence. Conservative measures can then be applied from the earliest stages, and offer benefit for those with mild to moderate symptoms. Failing this, a wide variety of surgical options can be considered. For effective outcomes, a clinician must ensure that surgical decision-making is based on current evidence and patient preference, and that it considers possible morbidities. Keywords Prostate cancer . Radical prostatectomy . Urinary incontinence . Surgery . Post-prostatectomy incontinence
Introduction Urinary incontinence following radical prostatectomy (RP) is a chronic debilitating physical and social illness for many men. The risk of post-prostatectomy incontinence (PPI) can range from 3 % to 49 % at one year following surgery [1, 2]. This is despite the development of surgical techniques that aim to improve urinary and sexual functional outcomes while maintaining good oncological control [3]. Meanwhile, the quality of life (QOL) of men with PPI remains significantly impaired [4]. Furthermore, QOL is worse for urinary symptoms following an RP than that of This article is part of the Topical Collection on Prostate Cancer T. R. Jarvis : J. S. Sandhu (*) Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA e-mail: [email protected]
matched patients who had alternative curative treatments, such as radiotherapy [5]. The management of PPI needs to be based on scientific evidence and must be tailored to meet a patient’s specific condition and preferences (Fig. 1). This medical and surgical treatment should complement patient support from other allied health professionals, in particular nursing staff and physical therapists, to ensure holistic patient-centered care.
Etiology and Natural History PPI is predominantly stress urinary incontinence [6], and is multifactorial. It is associated with patient factors (advanced age, increased body mass index, increased prostate volume, decreased membranous urethral length, previous transurethral resection of the prostate), surgical factors (neurovascular bundle resection, surgeon inexperience), and post-operative factors (anastomotic stricture, salvage radiotherapy) [7]. Saranchuk et al. [8] demonstrated a natural improvement in PPI with time, with 87 % full continence at one year and 93 % at two years, underscoring efforts to avoid surgical treatment for men prior to one year following the RP.
Evaluation Evaluation of PPI has never been standardized. A thorough history and examination, together with specific tailored investigations, should aim to document the cause, degree, and significance of the PPI to the patient. It should also aim to exclude reversible causes such as urinary tract infection, bladder neck contracture, urothelial carcinoma, and overactive bladder. Assessment of the degree of continence is also variable, and depends upon the definition of urinary incontinence and
421, Page 2 of 6
Curr Urol Rep (2014) 15:421
Fig. 1 The management of PPI
the methodology used to collect the data [9]. Objective measures (24-hour pad weights or number of pads per day) are essential in choosing treatment options and monitoring outcomes. A QOL tool is useful, even outside the research setting. Urodynamic studies are used to determine bladder capacity, compliance, detrusor overactivity, and urodynamic stress incontinence. Cystoscopy is performed to exclude bladder neck contracture (present in up to 10 % of patients [10]). Most experts believe that an unstable BNC is a contraindication to anti-incontinence surgery, and would treat and ensure stability of BNC prior to addressing incontinence [11].
Conservative Management Conservative management should always be instigated as initial management of PPI, and can be commenced early.
[12]. Filocamo et al. [13] reported results of a randomized trial that demonstrated improved continence with PFME at six months compared to control (94.6 % vs. 65 %, p=200 cases, which poses challenges for urologists who are not in high-volume centers. Other than improved surgical training, reoperations can be minimized by improved patient selection and by following strict operating room and postoperative protocols. A recent systematic review of the AUS identified a mean infection and erosion rate of approximately 8.5 % (range 3.3– 27.8 %) [40••]. An antibiotic-coated version was introduced in 2008 in an attempt to reduced perioperative infection. In a review of 426 consecutive patients, however, de Cógáin et al. [42] argue that this did not alter the infection rate, and only added unnecessary cost. Because urethral erosion often occurs in the context of urethral instrumentation and/or catheterization, avoidance of these interventions or prior knowledge of the device may reduce these rates. The use of patient
Curr Urol Rep (2014) 15:421
MedicAlert bracelets (www.medicalert.org) to prevent inadvertent urethral catheterization might help in this regard [43, 44]. If an infection does occur, the entire device should be removed, and most surgeons wait 3–6 months before implanting another AUS. In the case of erosions, a urethral catheter needs to be left indwelling for about three weeks to allow the urethra to heal. Linder et al. [45] compared the outcomes of primary AUS implantations (n=497) to those of salvage cases (previous AUS removal due to erosion or infection [n=69]). While there was an increased risk of device infection or erosion requiring explantation in salvage cases (6.4 % vs. 19 %, p=0.002), there was no difference in reoperation rate (17.5 % vs. 25 %, p= 0.17) or five-year device survival (68 % vs. 76 %, p=0.38). Device malfunction rates range from 2.0 % to 13.8 % [40], and generally occur between 11 and 68 months post-insertion. “Urethral atrophy” should also be included in this group. Mechanical failure or recurrent PPI due to urethral atrophy usually leads to entire device or specific malfunctioning component replacement. The concurrent placement of an inflatable penile prosthesis (IPP) with an AUS (or transobturator male sling) has been reported to more completely restore organ function in a single procedure. Segal et al. [46] undertook a retrospective comparison of 55 combined placements with 336 single-IPP and 279 single-AUS placements. There were no significant differences in rates of infection, erosion, or malfunction, although there was an increase in surgical time.
New and Experimental Therapies Variations on the AMS 800 AUS that reduce the complexity of implantation of the traditional device and simplify its mechanism are currently being investigated, although long-term data is lacking [47]. The FlowSecure AUS device (Barloworld Scientific Ltd., Stone, UK) and ZSI 375 (Zephyr Surgical Implants, Geneva, Switzerland) are examples of these. While any advance in this field should be welcomed, urologists must resist the temptation to use these well-marketed devices or treatments prior to results of further rigorous clinical studies. The Pro-ACT device (Uromedica, Minneapolis, MN, USA) consists of two volume-adjustable balloons placed paraurethrally at the bladder neck for urethral compression. They have the advantage of being less invasive to place and adjustable in an outpatient setting. Kjær et al. [48] reported “dry rates’ of 50 % at a mean follow-up of 58 months (range 1–80 months) in 114 patients. Complications (balloon leakage, infection, balloon migration, or urethral erosion) were seen in 20 % of patients, although these were all treated by outpatient removal. With a better guidance device, Crivellaro et al. [49] demonstrated improved dry rates of up to 71 % in 30 patients at one year.
Curr Urol Rep (2014) 15:421
Stem cell treatments (derived from adipose tissue, muscle, or bone marrow) are in the early stages of research and clinical application in humans. To date, limited studies have been performed on males with PPI [50]. Gotoh et al. [51] recently published one-year results of periurethral injections of autologous adipose-derived stem cells in 11 patients. Although the “bulking effect” wore off soon after injection and continence deteriorated, there was then a progressive improvement over one year, and ultimately a mean 59.8 % decrease in 24-hour pad weights in 8 of 11 patients; one patient with mild PPI became continent. There were no significant complications reported. While these and similar results are exciting [52], they are short-term and have not been compared head-to-head with simple bulking agents alone.
Page 5 of 6, 421
3.
4.
5.
6.
7. 8. 9.
Conclusions The management of urinary incontinence after RP remains challenging. Patients require careful assessment with the use of urodynamic studies to exclude causes other than SUI. Conservative measures can be applied immediately from the day of RP. Surgical management should not be considered until after at least one year, when spontaneous recovery of continence is less likely. The AUS remains the gold standard, while evidence for male slings for mild to moderate incontinence is strengthening. All new devices should be utilized only after considering their efficacy, durability, morbidity, and impact on quality of life. Finally, while we await the silver bullet to cure this morbid condition, the careful handling of patients’ expectations is paramount.
10.
11.
12.
13.
14.••
Compliance with Ethics Guidelines Conflict of Interest Dr. Thomas R. Jarvis declares no potential conflicts of interest. Dr. Jaspreet S. Sandhu is a consultant for AMS. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.
15.
16.
17.
References
18.
Papers of particular interest, published recently, have been highlighted as: •• Of outstanding importance
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of Aphrodite nerve-sparing: an analysis of 154 consecutive patients. BJU Int. 2006;97:467–72. Sacco E, Prayer-Galetti T, Pinto F, et al. Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long-term follow-up. BJU Int. 2006;97:1234–41. Katz G, Rodriguez R. Changes in continence and health-related quality of life after curative treatment and watchful waiting of prostate cancer. Urology. 2007;69:1157–60. van Tol-Geerdink JJ, Leer JWH, van Oort IM, et al. Quality of life after prostate cancer treatments in patients comparable at baseline. Br J Cancer. 2013;108:1784–9. Kielb SJ, Clemens JQ. Comprehensive urodynamic evaluation of 146 men with incontinence after radical prostatectomy. Urology. 2005;66:392–6. Sandhu JS, Eastham JA. Factors predicting early return of continence after radical prostatectomy. Curr Urol Rep. 2010;11:191–7. Saranchuk JW, Kattan MW, Elkin E, et al. Achieving optimal outcomes after radical prostatectomy. Clin Oncol. 2005;23:4146–51. Krupski TL, Saigal CS, Litwin MS. Variation in continence and potency by definition. J Urol. 2003;170:1291–4. Sandhu JS, Gotto GT, Herran LA, et al. Age, obesity, medical comorbidities and surgical technique are predictive of symptomatic anastomotic strictures after contemporary radical prostatectomy. J Urol. 2011;185:2148–52. Gousse AE, Tunuguntla HS, Leboeuf L, et al. Two-stage management of severe postprostatectomy bladder neck contracture associated with stress incontinence. Urology. 2005;65:316–9. Van Kampen M, De Weerdt W, Van Poppel H, et al. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000;355:98. Filocamo MT. Li Marzi V, Del Popolo G, et al: Effectiveness of early pelvic floor rehabilitation treatment for post-prostatectomy incontinence. Eur Urol. 2005;48:734. Goode PS, Burgio KL, Johnson II TM, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence. JAMA. 2011;305: 151–9. This randomized study is the first to clearly demonstrate the benefit of pelvic floor muscle exercises for men with PPI persisting beyond one year of radical prostatectomy. It encourages the use of conservative measures in this group before considering surgery, or type of surgery. Lucas MG, Bosch RJ, Burkhard FC, et al. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. 2012;62:1130–42. Cornu JN, Merlet B, Ciofu C, et al. Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomized, placebo-controlled trial. Eur Urol. 2011;59:148–54. Wein A. Re: Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebocontrolled trial. J Urol. 2012;187:2156–7. Moore KN, Schieman S, Ackerman T, et al. Assessing comfort, safety, and patient satisfaction with three commonly used penile compressive devices. Urology. 2004;6:150–4. Ratcliff CG, Cohen L, Pettaway CA. Treatment regret and quality of life following radical prostatectomy. Support Care Cancer. Advance online publication. doi:10.1007/s00520-013-1906-4. Kim PH, Pinheiro LC, Atoria CL, et al. Trends in the use of incontinence procedures after radical prostatectomy: a population based analysis. J Urol. 2013;189:602–8. Westney OL, Bevan-Thomas R, Palmer JL, et al. Transurethral collagen injections for male intrinsic sphincter deficiency: the University of Texas-Houston experience. J Urol. 2005;174:994. Gomes CM, Broderick GA, Sanchez-Ortiz RF, et al. Artificial urinary sphincter for post-prostatectomy incontinence: impact of
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for the treatment of post-prostatectomy incontinence. J Urol. 2003;170:1252–4. Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by an implantable prosthetic urinary sphincter. J Urol. 1974;112:75–80. Van der Aa F, Drake MJ, Kasyan GR, et al. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013;63: 681–9. This recent systematic review reviews the strengths and pitfalls of a device that has been used for many years. It reveals difficulties with some previous studies, in particular their definition of continence and “success”. 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. de Cógáin MR, Elliott DS. The impact of an antibiotic coating on the artificial urinary sphincter infection rate. J Urol. 2013;190:113–7. Anusionwu II, Wright EJ. Indications for revision of artificial urinary sphincter and modifiable risk factors for device related morbidity. Neurourol Urodyn. 2013;32:63–5. Sandhu JS. Artificial Urinary Sphincter: The Workhorse for Treatment of Male Stress Urinary Incontinence. Eur Urol. 2013;63:690–1. Linder BJ, de Cogain M, Elliott DS. Long-term device outcomes for artificial urinary sphincter reimplantation following prior explantation for erosion or infection. J Urol. 2013. Advance online publication. doi:10.1016/j.juro.2013.08.089. Segal RL, Cabrini MR, Harris ED, et al. Combined inflatable penile prosthesis-artificial urinary sphincter implantation: no increased risk of adverse events compared to single or staged device implantation. J Urol. 2013. Advance online publication. doi:10.1016/j. juro.2013.06.084. Chung E, Ranaweera M, Cartmill R. Newer and novel artificial urinary sphincters (AUS): the development of alternatives to the current AUS device. BJUI. 2012; Supl.4:5-11. Kjær L, Fode M, Nørgaard N, et al. Adjustable continence balloons: clinical results of a new minimally invasive treatment for male urinary incontinence. Scand J Urol Nephrol. 2012;46:196–200. Crivellaro S, Tosco L, Palazzetti A, et al. Geometrical stepperguided navigation system for Pro-ACT implant under transrectal ultrasound control: preliminary data. Urol Int. 2012;89:473–9. Gilberti C, Gallo F, Schenone M, et al. Stem cell therapy for male urinary incontinence. Urol Int. 2013;90:249–52. Gotoh M, Yamamoto T, Kato M, et al. Regenerative treatment of male stress urinary incontinence by periurethral injection of autologous adipose-derived regenerative cells: 1-year outcomes in 11 patients. Int J Urol. 2013. Advance online publication. doi:10.1016/ j.juro.2013.06.084. Goldman HB, Sievert KD, Damaser MS, et al. Will we ever use stem cells for the treatment of SUI? ICI-RS 2011. Neurourol Urodyn. 2012;31:386–9.
PROSTATE CANCER (D PAREKH, SECTION EDITOR)
Management of Urinary Incontinence after Radical Prostatectomy Thomas R. Jarvis & Jaspreet S. Sandhu
Published online: 24 May 2014 # Springer Science+Business Media New York 2014
Abstract In the year following a radical prostatectomy, most men recover from any initial urinary incontinence. Nonetheless, incontinence greatly affects a man’s quality of life during that time, as it does for those who have persistent incontinence thereafter. Urological assessment should be thorough in order to ensure that no treatable etiology exists aside from stress incontinence. Conservative measures can then be applied from the earliest stages, and offer benefit for those with mild to moderate symptoms. Failing this, a wide variety of surgical options can be considered. For effective outcomes, a clinician must ensure that surgical decision-making is based on current evidence and patient preference, and that it considers possible morbidities. Keywords Prostate cancer . Radical prostatectomy . Urinary incontinence . Surgery . Post-prostatectomy incontinence
Introduction Urinary incontinence following radical prostatectomy (RP) is a chronic debilitating physical and social illness for many men. The risk of post-prostatectomy incontinence (PPI) can range from 3 % to 49 % at one year following surgery [1, 2]. This is despite the development of surgical techniques that aim to improve urinary and sexual functional outcomes while maintaining good oncological control [3]. Meanwhile, the quality of life (QOL) of men with PPI remains significantly impaired [4]. Furthermore, QOL is worse for urinary symptoms following an RP than that of This article is part of the Topical Collection on Prostate Cancer T. R. Jarvis : J. S. Sandhu (*) Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA e-mail: [email protected]
matched patients who had alternative curative treatments, such as radiotherapy [5]. The management of PPI needs to be based on scientific evidence and must be tailored to meet a patient’s specific condition and preferences (Fig. 1). This medical and surgical treatment should complement patient support from other allied health professionals, in particular nursing staff and physical therapists, to ensure holistic patient-centered care.
Etiology and Natural History PPI is predominantly stress urinary incontinence [6], and is multifactorial. It is associated with patient factors (advanced age, increased body mass index, increased prostate volume, decreased membranous urethral length, previous transurethral resection of the prostate), surgical factors (neurovascular bundle resection, surgeon inexperience), and post-operative factors (anastomotic stricture, salvage radiotherapy) [7]. Saranchuk et al. [8] demonstrated a natural improvement in PPI with time, with 87 % full continence at one year and 93 % at two years, underscoring efforts to avoid surgical treatment for men prior to one year following the RP.
Evaluation Evaluation of PPI has never been standardized. A thorough history and examination, together with specific tailored investigations, should aim to document the cause, degree, and significance of the PPI to the patient. It should also aim to exclude reversible causes such as urinary tract infection, bladder neck contracture, urothelial carcinoma, and overactive bladder. Assessment of the degree of continence is also variable, and depends upon the definition of urinary incontinence and
421, Page 2 of 6
Curr Urol Rep (2014) 15:421
Fig. 1 The management of PPI
the methodology used to collect the data [9]. Objective measures (24-hour pad weights or number of pads per day) are essential in choosing treatment options and monitoring outcomes. A QOL tool is useful, even outside the research setting. Urodynamic studies are used to determine bladder capacity, compliance, detrusor overactivity, and urodynamic stress incontinence. Cystoscopy is performed to exclude bladder neck contracture (present in up to 10 % of patients [10]). Most experts believe that an unstable BNC is a contraindication to anti-incontinence surgery, and would treat and ensure stability of BNC prior to addressing incontinence [11].
Conservative Management Conservative management should always be instigated as initial management of PPI, and can be commenced early.
[12]. Filocamo et al. [13] reported results of a randomized trial that demonstrated improved continence with PFME at six months compared to control (94.6 % vs. 65 %, p=200 cases, which poses challenges for urologists who are not in high-volume centers. Other than improved surgical training, reoperations can be minimized by improved patient selection and by following strict operating room and postoperative protocols. A recent systematic review of the AUS identified a mean infection and erosion rate of approximately 8.5 % (range 3.3– 27.8 %) [40••]. An antibiotic-coated version was introduced in 2008 in an attempt to reduced perioperative infection. In a review of 426 consecutive patients, however, de Cógáin et al. [42] argue that this did not alter the infection rate, and only added unnecessary cost. Because urethral erosion often occurs in the context of urethral instrumentation and/or catheterization, avoidance of these interventions or prior knowledge of the device may reduce these rates. The use of patient
Curr Urol Rep (2014) 15:421
MedicAlert bracelets (www.medicalert.org) to prevent inadvertent urethral catheterization might help in this regard [43, 44]. If an infection does occur, the entire device should be removed, and most surgeons wait 3–6 months before implanting another AUS. In the case of erosions, a urethral catheter needs to be left indwelling for about three weeks to allow the urethra to heal. Linder et al. [45] compared the outcomes of primary AUS implantations (n=497) to those of salvage cases (previous AUS removal due to erosion or infection [n=69]). While there was an increased risk of device infection or erosion requiring explantation in salvage cases (6.4 % vs. 19 %, p=0.002), there was no difference in reoperation rate (17.5 % vs. 25 %, p= 0.17) or five-year device survival (68 % vs. 76 %, p=0.38). Device malfunction rates range from 2.0 % to 13.8 % [40], and generally occur between 11 and 68 months post-insertion. “Urethral atrophy” should also be included in this group. Mechanical failure or recurrent PPI due to urethral atrophy usually leads to entire device or specific malfunctioning component replacement. The concurrent placement of an inflatable penile prosthesis (IPP) with an AUS (or transobturator male sling) has been reported to more completely restore organ function in a single procedure. Segal et al. [46] undertook a retrospective comparison of 55 combined placements with 336 single-IPP and 279 single-AUS placements. There were no significant differences in rates of infection, erosion, or malfunction, although there was an increase in surgical time.
New and Experimental Therapies Variations on the AMS 800 AUS that reduce the complexity of implantation of the traditional device and simplify its mechanism are currently being investigated, although long-term data is lacking [47]. The FlowSecure AUS device (Barloworld Scientific Ltd., Stone, UK) and ZSI 375 (Zephyr Surgical Implants, Geneva, Switzerland) are examples of these. While any advance in this field should be welcomed, urologists must resist the temptation to use these well-marketed devices or treatments prior to results of further rigorous clinical studies. The Pro-ACT device (Uromedica, Minneapolis, MN, USA) consists of two volume-adjustable balloons placed paraurethrally at the bladder neck for urethral compression. They have the advantage of being less invasive to place and adjustable in an outpatient setting. Kjær et al. [48] reported “dry rates’ of 50 % at a mean follow-up of 58 months (range 1–80 months) in 114 patients. Complications (balloon leakage, infection, balloon migration, or urethral erosion) were seen in 20 % of patients, although these were all treated by outpatient removal. With a better guidance device, Crivellaro et al. [49] demonstrated improved dry rates of up to 71 % in 30 patients at one year.
Curr Urol Rep (2014) 15:421
Stem cell treatments (derived from adipose tissue, muscle, or bone marrow) are in the early stages of research and clinical application in humans. To date, limited studies have been performed on males with PPI [50]. Gotoh et al. [51] recently published one-year results of periurethral injections of autologous adipose-derived stem cells in 11 patients. Although the “bulking effect” wore off soon after injection and continence deteriorated, there was then a progressive improvement over one year, and ultimately a mean 59.8 % decrease in 24-hour pad weights in 8 of 11 patients; one patient with mild PPI became continent. There were no significant complications reported. While these and similar results are exciting [52], they are short-term and have not been compared head-to-head with simple bulking agents alone.
Page 5 of 6, 421
3.
4.
5.
6.
7. 8. 9.
Conclusions The management of urinary incontinence after RP remains challenging. Patients require careful assessment with the use of urodynamic studies to exclude causes other than SUI. Conservative measures can be applied immediately from the day of RP. Surgical management should not be considered until after at least one year, when spontaneous recovery of continence is less likely. The AUS remains the gold standard, while evidence for male slings for mild to moderate incontinence is strengthening. All new devices should be utilized only after considering their efficacy, durability, morbidity, and impact on quality of life. Finally, while we await the silver bullet to cure this morbid condition, the careful handling of patients’ expectations is paramount.
10.
11.
12.
13.
14.••
Compliance with Ethics Guidelines Conflict of Interest Dr. Thomas R. Jarvis declares no potential conflicts of interest. Dr. Jaspreet S. Sandhu is a consultant for AMS. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.
15.
16.
17.
References
18.
Papers of particular interest, published recently, have been highlighted as: •• Of outstanding importance
19.
1.
2.
Karakiewicz PI, Tanguay S, Kattan MW, et al. Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men. Eur Urol. 2004;46:188–94. Kaul S, Savera A, Badani K, et al. Functional outcomes and oncological efficacy of Vattikuti Institute prostatectomy with Veil
20.
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