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Successful Placement of Penile Prostheses in Men With Severe Corporal Fibrosis Following Vacuum Therapy Protocol
Successful Placement of Penile Prostheses in Men With Severe Corporal Fibrosis Following Vacuum Therapy Protocol Peter N. Tsambarlis, MD, Fahad Chaus, MD, and Laurence A. Levine, MD
ABSTRACT
Introduction: Penile prosthesis (PP) implantation in men with severe corporal fibrosis presents a significant surgical challenge. For the past 7 years, we have used a novel, preoperative protocol of daily vacuum therapy (VT) using a vacuum erection device for at least 3 months before PP placement for men with severe corporal fibrosis from PP infection or ischemic priapism. Aim: To evaluate this standardized preoperative regimen. Methods: We retrospectively reviewed all patients who underwent three-piece PP placement at our institution from 2008 through 2015. Of these, 13 men had severe corporal fibrosis from prior PP infection (11 of 13) or prolonged ischemic priapism (2 of 13). Our protocol included VT for 10 to 15 minutes at least two times daily in all patients for at least 3 months (mean ¼ 3.5 months). Main Outcome Measures: We report on our surgical experience and post-VT stretched flaccid penile length (SFPL) compared with baseline SFPL. Results: All 13 men underwent successful three-piece PP placement with standard-size cylinders without additional surgical maneuvers. There was one infection and one erosion requiring revision. Daily average use of VT was 32.5 minutes. SFPL increased 0.92 cm (range ¼ 0e2 cm, SD ¼ 0.76 cm) after VT and three-piece PP placement compared with preoperative SFPL. These men also noted improved quality of life and sexuality as measured by postoperative office interviews. Conclusion: The use of VT before surgery appears to result in softening of corporal fibrosis and facilitates placement of a PP regardless of the period from developing corporal fibrosis to starting VT. We strongly recommend preoperative corporal tissue rehabilitation with VT to improve surgical outcomes and to decrease difficulty during PP implantation in men with severe corporal fibrosis. J Sex Med 2016;-:1e3. Copyright 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. Key Words: Erectile Dysfunction; Vacuum Erection Devices; Vacuum Therapy; Inflatable Penile Prosthesis; Corporal Fibrosis; Men With Erectile Dysfunction and Corporal Fibrosis
INTRODUCTION Extensive corporal fibrosis is one of the most challenging situations encountered by the penile prosthetic surgeon. Corporal fibrosis most often follows the explantation of a previously infected penile prosthesis (PP) or is secondary to ischemic priapism.1,2 Multiple surgical approaches have been developed to facilitate PP implantation in patients with challenging anatomy.3e6 In our series, we prescribed a preoperative regimen of vacuum therapy (VT) with the goal of placing standard-size cylinders in Received August 3, 2016. Accepted November 7, 2016. Department of Urology, Rush University Medical Center, Chicago, IL, USA Copyright ª 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jsxm.2016.11.304
J Sex Med 2016;-:1e3
all patients without the use of extensive surgical techniques such as extended or secondary corporotomies, corporal excavation, the use of cavernotomes, or grafting to close the corporotomies. The potential of this regimen is supported by its use in other fibrotic conditions, such as Peyronie’s disease, to restore length and the fact that VT has been previously used to allow for successful penetrative intercourse after explantation of an infected PP.7,8
METHODS We retrospectively reviewed all patients who underwent PP placement at our institution from 2008 through 2015. Of these, 13 men had severe corporal fibrosis diagnosed by physical examination and in-office ultrasound. The etiology of corporal fibrosis was PP infection (11 of 13) or ischemic priapism (2 of 13). All patients were counseled on the use of VT. The device is 1
2
applied for 10 to 15 minutes at least two times daily for a minimum of 3 months before attempting PP placement. All patients underwent implantation with our standard penoscrotal approach using Brooks dilators (Coloplast, Humlebaek, Denmark) to dilate the corpora up to 12 mm. If a channel was not readily identified, then we used Metzenbaum scissors to establish channels to the distal and proximal corporal tips before dilating with the Brooks dilators. We report on our operative experience with this regimen and evaluate the postoperative stretched flaccid penile length (SFPL) compared with baseline SFPL, which was measured from the pubis to the corona on the dorsal surface with the penis positioned perpendicular to the body. This was verified by two evaluators, one of whom was the surgeon.
RESULTS All 13 men who used VT underwent successful three-piece PP placement with standard-size cylinders. The daily average use of VT was 32.5 minutes for an average of 3.5 months. VT was initiated 3 to 21 months after the initial insult that incited the severe corporal fibrosis (mean ¼ 10.5 months, SD ¼ 5.8 months). SFPL was maintained or increased in all 13 patients (range ¼ 0e2 cm) after VT and PP placement. The average increase in SFPL was 0.92 cm (SD ¼ 0.76 cm). This trended toward statistical significance (P ¼ .20). Table 1 presents additional details. All 13 patients underwent successful three-piece PP placement using standard-size cylinders without the need for additional surgical maneuvers. There were two morbidities identified in our cohort. One patient had his PP explanted because of infection 26 months after it was placed. After recovering from his explantation, he restarted VT and underwent reimplantation 7 months after explantation. His most recent device has been working well for more than 2.5 years. The other underwent explantation for erosion of the tubing in his scrotum 2 months after placement of his PP. All patients, excluding the one who developed erosion, reported being satisfied and able to participate in penetrative sexual activity at their last follow-up visit.
DISCUSSION Corporal fibrosis presents a significant surgical challenge to the prosthetic surgeon. Several published series have used narrow cylinders effectively in this population. At times, however, the use of narrow cylinders did not eliminate the need for extended corporotomies, corporal excavation, or the use of specialized dilators with cutting blades. With these extensive techniques, there were still complications including perforations, infections, and permanent length loss.4e6,9 In one study without narrow cylinders, PPs were implanted after extensive corporal reconstruction, but the infection rate was 30%.3
Tsambarlis et al
Table 1. Patient characteristics
Patient
Time from insult Duration of Pre-VT Postoperative to initiation of VT (mo) VT (mo) SFPL SFPL
1 2 3 4 5 6 7 8 9 10 11 12 13 Average
12 10.5 10 9 8 10 11 11 8 10 6 9 13 9.81
12 12.5 10 9 10 10.5 13 11.5 9 11 7.5 10 13.5 10.73
20 8 3 9 21 13 6 8 4 17 7 9 12 10.5
4 4 3 3 4 3 3 4 4 3 4 4 3 3.5
SFPL ¼ stretched flaccid penile length; VT ¼ vacuum therapy.
We suggest an alternative approach that can be used with relative ease. Although we expect that many centers are using this technique, we are the first to report on a series of patients undergoing a standardized regimen of VT to facilitate PP placement after developing severe corporal fibrosis. Our experience supports the use of VT in this patient population before attempting PP placement. We believe VT, which pulls blood into the penis causing tumescence, also softens the fibrotic tissue over time if used routinely.10 There also can be an additional benefit provided by mechanically placing the fibrosed tissue on tension. Our experience supports this, because patients who underwent VT before surgery had corpora that were more suitable for dilation. Overall, no additional maneuvers were required intraoperatively to successfully place PPs with standardsize cylinders in our 13 patients. This protocol appears to be effective regardless of the period from the initial insult to the initiation of VT. Furthermore, length loss is a known sequelae of corporal fibrosis, regardless of the cause. In addition to facilitating placement of a new PP, our regimen provided every patient who used this regimen with at least maintenance of his SFPL compared with pre-VT SFPL. Patient satisfaction using this regimen was high. Each of these men had a frustrating and emotionally taxing setback to his sexual health, with many experiencing multiple insults including surgeries, prosthesis infections, and priapism. Nevertheless, we were able to achieve a high satisfaction rate using our standardized regimen. The main limitation of our study is its size because extensive corporal fibrosis is an uncommon condition. Although small, the number of patients accrued in this study is similar to that of previously published work on corporal fibrosis. We also believe J Sex Med 2016;-:1e3
3
Vacuum Therapy and Penile Prosthesis Placement
this limitation is mitigated by the opportunity to present a standardized, easy to execute, low cost, and, thus far, successful preoperative regimen that has not been previously described. In this small series, VT appeared to effectively facilitate PP placement in patients with corporal fibrosis regardless of the period from the inciting event to the initiation of VT. However, we recommend initiating this protocol as early as possible in men at risk of corporal fibrosis after PP explantation or refractory priapism. We also found this standardized preoperative regimen minimized the need for more extensive maneuvers such as use of cavernotomes, corporal scar excavation, and multiple and/or extended corporotomies, with the secondary benefit of providing these men with at least maintenance of their penile length. Further studies with prospective, multicenter trials will be necessary to confirm this approach. Corresponding Author: Laurence A. Levine, MD, Department of Urology, Rush University Medical Center, 1725 W Harrison Street, Suite 352, Chicago, IL 60612, USA. Tel: 312-563-3480; E-mail: [email protected] Conflicts of Interest: L.L. has served as a consultant and speaker for Boston Scientific and Coloplast. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine (b) Acquisition of Data Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine (c) Analysis and Interpretation of Data Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine Category 2 (a) Drafting the Article Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine
J Sex Med 2016;-:1e3
(b) Revising It for Intellectual Content Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine Category 3 (a) Final Approval of the Completed Article Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine
REFERENCES 1. Macaluso JN, Sullivan JW. Priapism: review of 34 cases. Urology 1985;26:233-236. 2. Montague DK. Periprosthetic infection. J Urol 1987;138: 68-69. 3. Knoll LD, Furlow WL. Corporeal reconstruction and prosthetic implantation for impotence associated with non-dilatable corporeal cavernosal fibrosis. Acta Urol Belg 1992;60:15-25. 4. Knoll D, Furlow WL, Benson RC, et al. Management of nondilatable cavernous fibrosis with the use of a downsized inflatable penile prosthesis. J Urol 1995;153:3665. 5. Carbone DJ, Daitch JA, Angermeier KW, et al. Management of severe corporal fibrosis with implantation of prosthesis via a transverse scrotal approach. J Urol 1998;159:125-127. 6. Montague DK, Angermeier KW. Corporal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis. Urology 2006;67:1072-1075. 7. Raheem AA, Garaffa G, Raheem TA, et al. The role of vacuum pump therapy to mechanically straighten the penis in Peyronie’s disease. BJU Int 2010;106:1178-1180. 8. Moul J, McLeod D. Negative pressure devices in the explanted penile prosthesis population. J Urol 1989;142:729-731. 9. Mooreville M, Adrian S, Delk J, et al. Implantation of inflatable penile prosthesis in patients with severe corporeal fibrosis: introduction of a new cavernotome. J Urol 1999;162: 2054-2057. 10. Martinez-Salamanca J, Mueller A, Moncada I, et al. Penile prosthesis surgery in patients with corporal fibrosis: a state of the art review. J Sex Med 2011;8:1880-1889.
ABSTRACT
Introduction: Penile prosthesis (PP) implantation in men with severe corporal fibrosis presents a significant surgical challenge. For the past 7 years, we have used a novel, preoperative protocol of daily vacuum therapy (VT) using a vacuum erection device for at least 3 months before PP placement for men with severe corporal fibrosis from PP infection or ischemic priapism. Aim: To evaluate this standardized preoperative regimen. Methods: We retrospectively reviewed all patients who underwent three-piece PP placement at our institution from 2008 through 2015. Of these, 13 men had severe corporal fibrosis from prior PP infection (11 of 13) or prolonged ischemic priapism (2 of 13). Our protocol included VT for 10 to 15 minutes at least two times daily in all patients for at least 3 months (mean ¼ 3.5 months). Main Outcome Measures: We report on our surgical experience and post-VT stretched flaccid penile length (SFPL) compared with baseline SFPL. Results: All 13 men underwent successful three-piece PP placement with standard-size cylinders without additional surgical maneuvers. There was one infection and one erosion requiring revision. Daily average use of VT was 32.5 minutes. SFPL increased 0.92 cm (range ¼ 0e2 cm, SD ¼ 0.76 cm) after VT and three-piece PP placement compared with preoperative SFPL. These men also noted improved quality of life and sexuality as measured by postoperative office interviews. Conclusion: The use of VT before surgery appears to result in softening of corporal fibrosis and facilitates placement of a PP regardless of the period from developing corporal fibrosis to starting VT. We strongly recommend preoperative corporal tissue rehabilitation with VT to improve surgical outcomes and to decrease difficulty during PP implantation in men with severe corporal fibrosis. J Sex Med 2016;-:1e3. Copyright 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. Key Words: Erectile Dysfunction; Vacuum Erection Devices; Vacuum Therapy; Inflatable Penile Prosthesis; Corporal Fibrosis; Men With Erectile Dysfunction and Corporal Fibrosis
INTRODUCTION Extensive corporal fibrosis is one of the most challenging situations encountered by the penile prosthetic surgeon. Corporal fibrosis most often follows the explantation of a previously infected penile prosthesis (PP) or is secondary to ischemic priapism.1,2 Multiple surgical approaches have been developed to facilitate PP implantation in patients with challenging anatomy.3e6 In our series, we prescribed a preoperative regimen of vacuum therapy (VT) with the goal of placing standard-size cylinders in Received August 3, 2016. Accepted November 7, 2016. Department of Urology, Rush University Medical Center, Chicago, IL, USA Copyright ª 2016, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jsxm.2016.11.304
J Sex Med 2016;-:1e3
all patients without the use of extensive surgical techniques such as extended or secondary corporotomies, corporal excavation, the use of cavernotomes, or grafting to close the corporotomies. The potential of this regimen is supported by its use in other fibrotic conditions, such as Peyronie’s disease, to restore length and the fact that VT has been previously used to allow for successful penetrative intercourse after explantation of an infected PP.7,8
METHODS We retrospectively reviewed all patients who underwent PP placement at our institution from 2008 through 2015. Of these, 13 men had severe corporal fibrosis diagnosed by physical examination and in-office ultrasound. The etiology of corporal fibrosis was PP infection (11 of 13) or ischemic priapism (2 of 13). All patients were counseled on the use of VT. The device is 1
2
applied for 10 to 15 minutes at least two times daily for a minimum of 3 months before attempting PP placement. All patients underwent implantation with our standard penoscrotal approach using Brooks dilators (Coloplast, Humlebaek, Denmark) to dilate the corpora up to 12 mm. If a channel was not readily identified, then we used Metzenbaum scissors to establish channels to the distal and proximal corporal tips before dilating with the Brooks dilators. We report on our operative experience with this regimen and evaluate the postoperative stretched flaccid penile length (SFPL) compared with baseline SFPL, which was measured from the pubis to the corona on the dorsal surface with the penis positioned perpendicular to the body. This was verified by two evaluators, one of whom was the surgeon.
RESULTS All 13 men who used VT underwent successful three-piece PP placement with standard-size cylinders. The daily average use of VT was 32.5 minutes for an average of 3.5 months. VT was initiated 3 to 21 months after the initial insult that incited the severe corporal fibrosis (mean ¼ 10.5 months, SD ¼ 5.8 months). SFPL was maintained or increased in all 13 patients (range ¼ 0e2 cm) after VT and PP placement. The average increase in SFPL was 0.92 cm (SD ¼ 0.76 cm). This trended toward statistical significance (P ¼ .20). Table 1 presents additional details. All 13 patients underwent successful three-piece PP placement using standard-size cylinders without the need for additional surgical maneuvers. There were two morbidities identified in our cohort. One patient had his PP explanted because of infection 26 months after it was placed. After recovering from his explantation, he restarted VT and underwent reimplantation 7 months after explantation. His most recent device has been working well for more than 2.5 years. The other underwent explantation for erosion of the tubing in his scrotum 2 months after placement of his PP. All patients, excluding the one who developed erosion, reported being satisfied and able to participate in penetrative sexual activity at their last follow-up visit.
DISCUSSION Corporal fibrosis presents a significant surgical challenge to the prosthetic surgeon. Several published series have used narrow cylinders effectively in this population. At times, however, the use of narrow cylinders did not eliminate the need for extended corporotomies, corporal excavation, or the use of specialized dilators with cutting blades. With these extensive techniques, there were still complications including perforations, infections, and permanent length loss.4e6,9 In one study without narrow cylinders, PPs were implanted after extensive corporal reconstruction, but the infection rate was 30%.3
Tsambarlis et al
Table 1. Patient characteristics
Patient
Time from insult Duration of Pre-VT Postoperative to initiation of VT (mo) VT (mo) SFPL SFPL
1 2 3 4 5 6 7 8 9 10 11 12 13 Average
12 10.5 10 9 8 10 11 11 8 10 6 9 13 9.81
12 12.5 10 9 10 10.5 13 11.5 9 11 7.5 10 13.5 10.73
20 8 3 9 21 13 6 8 4 17 7 9 12 10.5
4 4 3 3 4 3 3 4 4 3 4 4 3 3.5
SFPL ¼ stretched flaccid penile length; VT ¼ vacuum therapy.
We suggest an alternative approach that can be used with relative ease. Although we expect that many centers are using this technique, we are the first to report on a series of patients undergoing a standardized regimen of VT to facilitate PP placement after developing severe corporal fibrosis. Our experience supports the use of VT in this patient population before attempting PP placement. We believe VT, which pulls blood into the penis causing tumescence, also softens the fibrotic tissue over time if used routinely.10 There also can be an additional benefit provided by mechanically placing the fibrosed tissue on tension. Our experience supports this, because patients who underwent VT before surgery had corpora that were more suitable for dilation. Overall, no additional maneuvers were required intraoperatively to successfully place PPs with standardsize cylinders in our 13 patients. This protocol appears to be effective regardless of the period from the initial insult to the initiation of VT. Furthermore, length loss is a known sequelae of corporal fibrosis, regardless of the cause. In addition to facilitating placement of a new PP, our regimen provided every patient who used this regimen with at least maintenance of his SFPL compared with pre-VT SFPL. Patient satisfaction using this regimen was high. Each of these men had a frustrating and emotionally taxing setback to his sexual health, with many experiencing multiple insults including surgeries, prosthesis infections, and priapism. Nevertheless, we were able to achieve a high satisfaction rate using our standardized regimen. The main limitation of our study is its size because extensive corporal fibrosis is an uncommon condition. Although small, the number of patients accrued in this study is similar to that of previously published work on corporal fibrosis. We also believe J Sex Med 2016;-:1e3
3
Vacuum Therapy and Penile Prosthesis Placement
this limitation is mitigated by the opportunity to present a standardized, easy to execute, low cost, and, thus far, successful preoperative regimen that has not been previously described. In this small series, VT appeared to effectively facilitate PP placement in patients with corporal fibrosis regardless of the period from the inciting event to the initiation of VT. However, we recommend initiating this protocol as early as possible in men at risk of corporal fibrosis after PP explantation or refractory priapism. We also found this standardized preoperative regimen minimized the need for more extensive maneuvers such as use of cavernotomes, corporal scar excavation, and multiple and/or extended corporotomies, with the secondary benefit of providing these men with at least maintenance of their penile length. Further studies with prospective, multicenter trials will be necessary to confirm this approach. Corresponding Author: Laurence A. Levine, MD, Department of Urology, Rush University Medical Center, 1725 W Harrison Street, Suite 352, Chicago, IL 60612, USA. Tel: 312-563-3480; E-mail: [email protected] Conflicts of Interest: L.L. has served as a consultant and speaker for Boston Scientific and Coloplast. Funding: None.
STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine (b) Acquisition of Data Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine (c) Analysis and Interpretation of Data Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine Category 2 (a) Drafting the Article Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine
J Sex Med 2016;-:1e3
(b) Revising It for Intellectual Content Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine Category 3 (a) Final Approval of the Completed Article Peter N. Tsambarlis; Fahad Chaus; Laurence A. Levine
REFERENCES 1. Macaluso JN, Sullivan JW. Priapism: review of 34 cases. Urology 1985;26:233-236. 2. Montague DK. Periprosthetic infection. J Urol 1987;138: 68-69. 3. Knoll LD, Furlow WL. Corporeal reconstruction and prosthetic implantation for impotence associated with non-dilatable corporeal cavernosal fibrosis. Acta Urol Belg 1992;60:15-25. 4. Knoll D, Furlow WL, Benson RC, et al. Management of nondilatable cavernous fibrosis with the use of a downsized inflatable penile prosthesis. J Urol 1995;153:3665. 5. Carbone DJ, Daitch JA, Angermeier KW, et al. Management of severe corporal fibrosis with implantation of prosthesis via a transverse scrotal approach. J Urol 1998;159:125-127. 6. Montague DK, Angermeier KW. Corporal excavation: new technique for penile prosthesis implantation in men with severe corporeal fibrosis. Urology 2006;67:1072-1075. 7. Raheem AA, Garaffa G, Raheem TA, et al. The role of vacuum pump therapy to mechanically straighten the penis in Peyronie’s disease. BJU Int 2010;106:1178-1180. 8. Moul J, McLeod D. Negative pressure devices in the explanted penile prosthesis population. J Urol 1989;142:729-731. 9. Mooreville M, Adrian S, Delk J, et al. Implantation of inflatable penile prosthesis in patients with severe corporeal fibrosis: introduction of a new cavernotome. J Urol 1999;162: 2054-2057. 10. Martinez-Salamanca J, Mueller A, Moncada I, et al. Penile prosthesis surgery in patients with corporal fibrosis: a state of the art review. J Sex Med 2011;8:1880-1889.