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1.
J Urol ; 210(4): 678-687, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37490615

RESUMO

PURPOSE: Glans vascular compromise had previously been considered a rare but devastating complication of the subcoronal incision for inflatable penile prosthesis surgery. Here, we describe the largest series of subcoronal implants to date to assess contemporary complication rates. MATERIALS AND METHODS: A retrospective review of subcoronal prosthesis placements by a single surgeon from Seoul, South Korea, was performed. Patients were randomly assigned either Coloplast Titan or AMS 700 device per institutional practice. RESULTS: A total of 898 patients who underwent subcoronal implants from May 2015 to March 2022 were analyzed. Median follow-up was 41 months (IQR 40). Preoperative patient comorbidities included diabetes (36.6%) and Peyronie's disease (4%). The most common complication was transient distal penile edema (74.7%). Transient incisional paresthesia (20.6%) was more common in patients with diabetes (31.9% vs 13.9%, P < .01). Five cases (0.5%) of distal penile skin necrosis were reported in patients who had previously been circumcised. Of these, 3 were managed successfully with wet-to-dry dressing, 1 required skin grafting, and 1 required device explant. Device infection without incisional compromise occurred in 2 cases (0.2%). There were no instances of glans necrosis or ischemia observed in this cohort. Of the first-time implants (817, 90.9%), most (62.3%) were successfully completed under local anesthetic alone, with the remainder of surgeries completed with the addition of adjunctive conscious sedation. CONCLUSIONS: Subcoronal incision for first-time or revision penile implant surgery is not a risk factor for glans ischemia or necrosis and can be safely completed under local anesthetic with or without conscious sedation.


Assuntos
Diabetes Mellitus , Disfunção Erétil , Doenças do Pênis , Implante Peniano , Induração Peniana , Prótese de Pênis , Masculino , Humanos , Prótese de Pênis/efeitos adversos , Implante Peniano/efeitos adversos , Anestésicos Locais , Pênis/cirurgia , Induração Peniana/complicações , Doenças do Pênis/etiologia , Doenças do Pênis/cirurgia , Necrose/etiologia , Necrose/cirurgia , Satisfação do Paciente , Disfunção Erétil/etiologia
2.
BJU Int ; 131(6): 729-733, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36633050

RESUMO

OBJECTIVE: To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three-piece inflatable penile prosthesis (IPP), the Rigicon Infla10®, to summarize early outcomes. METHODS: A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons. RESULTS: The mean ± sd (range) follow-up was 21.2 ± 11 (5-36) months and the mean ± sd patient age was 58.5 ± 8.7 years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21 months after the original implant date. Kaplan-Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36 months were 95.6%, 94.7% and 93.7%, respectively. CONCLUSIONS: The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.


Assuntos
Disfunção Erétil , Implante Peniano , Induração Peniana , Prótese de Pênis , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Prótese de Pênis/efeitos adversos , Estudos Retrospectivos , Implante Peniano/métodos , Induração Peniana/complicações , Reoperação , Satisfação do Paciente , Desenho de Prótese , Disfunção Erétil/etiologia
3.
J Urol ; 200(1): 171-177, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29408215

RESUMO

PURPOSE: Removal of an infected penile implant often results in corporeal fibrosis, irreversible penile shortening and dissatisfaction with future implant surgery. Salvage surgery may avoid these problems but to our knowledge no study to date has evaluated these specific end points. We evaluated patients who presented to our center with an infected implant to determine the impact of salvage surgery on penile length. MATERIALS AND METHODS: We evaluated consecutive patients undergoing removal of an infected penile prosthesis with immediate salvage or delayed reimplantation using a comprehensive, prospective database. Total corporeal length prior to and following immediate salvage or delayed reimplantation were compared. The impact of patient age, comorbidities, bacterial species, initial penile length and time to reimplantation on subsequent total corporeal length was evaluated. RESULTS: The cohort consisted of 40 patients. Overall 81% of salvaged cases were successful, resulting in a mean 0.6 cm (95% CI 0.20 to 1.1) reduction in total corporeal length. Delayed reimplantation resulted in a mean 3.7 cm (95% CI 2.9-4.5) total corporeal length loss. In patients who underwent delayed reimplantation the total corporeal length reduction was directly proportionate to the initial penis size of the patient. No statistically significant impact on penile length was attributable to patient age, diabetes, bacterial species or time to reimplantation. CONCLUSIONS: When possible, salvage surgery should be offered to patients with an infected penile implant. Our data confirmed that successful salvage surgery preserves penile length. When a device is explanted and replaced at a later date, patients can expect to lose 15% to 30% of penile length irrespective of age, diabetes, type of infecting organism and time to reimplantation.


Assuntos
Remoção de Dispositivo , Disfunção Erétil/cirurgia , Prótese de Pênis/efeitos adversos , Pênis/patologia , Infecções Relacionadas à Prótese/cirurgia , Terapia de Salvação , Idoso , Estudos de Coortes , Fibrose , Humanos , Masculino , Pessoa de Meia-Idade , Tamanho do Órgão , Implante Peniano , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/etiologia , Reoperação , Fatores de Tempo
4.
J Sex Med ; 15(5): 789-796, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29523479

RESUMO

BACKGROUND: After radical prostatectomy (RP), erectile dysfunction, often necessitating the need for inflatable penile prosthesis (IPP) insertion, and urinary incontinence and climacturia can ensue. AIM: To assess the efficacy and safety of the mini-jupette, a mesh used to approximate the medial aspects of the 2 corporotomies at the time of IPP insertion, for the management of climacturia and urine leakage in patients with minimal incontinence. METHODS: We conducted a pilot multicenter study of patients with post-RP erectile dysfunction and climacturia and/or mild urinary incontinence (≤2 pads/day [ppd]) undergoing IPP insertion with concomitant placement of a mini-jupette graft. OUTCOMES: Pre- and postoperative erectile function, continence and climacturia, and overall surgical outcomes were assessed. RESULTS: 38 patients underwent the mini-jupette procedure. The mean age of the population was 65.3 years (SD = 7.7). 30 had post-RP climacturia and 32 patients had post-RP incontinence (mean = 1.3 ppd, SD = 0.8). 31 patients received Coloplast Titan, 4 received AMS 700 LGX, and 3 received AMS 700 CX IPPs. Mean corporotomy size was 2.9 cm (SD = 1.0). Mean graft measurements were 3.2 cm (SD = 0.9) for width, 3.3 cm (SD = 1.3) for length, and 11.0 cm2 (SD = 5.1) for surface area. At a mean follow-up of 5.1 months (SD = 6.9), there were 5 postoperative complications (13.2%) of which 4 required explantation. Climacturia and incontinence were subjectively improved in 92.8% and 85.7%, respectively. Mean ppd decreased by 1.3 postoperatively. CLINICAL IMPLICATIONS: The Andrianne mini-jupette is a feasible adjunct to IPP placement that can be used for subsets of patients with post-RP climacturia and/or minimal incontinence. STRENGTHS AND LIMITATIONS: Strengths of this study include the novel nature of this intervention, the multi-institutional nature of the study, and the promising results demonstrated. Limitations include the retrospective nature of the study and the heterogeneity of the techniques and grafts used by different surgeons involved. CONCLUSION: Longer follow-up and larger patient cohorts are needed to confirm the long-term safety and benefits of this intervention. Yafi FA, Andrianne R, Alzweri L, et al. Andrianne Mini-Jupette Graft at the Time of Inflatable Penile Prosthesis Placement for the Management of Post-Prostatectomy Climacturia and Minimal Urinary Incontinence. J Sex Med 2018;15:789-796.


Assuntos
Disfunção Erétil/etiologia , Disfunção Erétil/cirurgia , Implante Peniano/métodos , Prostatectomia/efeitos adversos , Incontinência Urinária/etiologia , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Prótese de Pênis , Projetos Piloto , Período Pós-Operatório , Estudos Retrospectivos
5.
J Sex Med ; 13(11): 1750-1757, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27770856

RESUMO

INTRODUCTION: Since the inception of the inflatable penile prosthesis, a new era has been ushered in for the management of erectile dysfunction. Despite multiple innovations to improve function and reliability, there are no current data comparing the biomechanical properties of these devices. AIM: To compare the resistance of the Coloplast Titan (Minneapolis, MN, USA) with that of the AMS 700 LGX (Minnetonka, MN, USA) penile prosthesis cylinders to longitudinal (penetration) and horizontal (gravity) forces. METHODS: We compared two cylinder sizes from each company: the Coloplast Titan (18 and 22 cm) and the AMS 700 LGX (18 and 21 cm). To evaluate axial rigidity, which simulates forces during penetration, we performed a longitudinal load compression test to determine the load required to cause the cylinder to kink. To test horizontal rigidity, which simulates the horizontal forces exerted by gravity, we performed a modified cantilever test and measured the degrees of bend for each device. All devices were tested at 10, 15, and 20 PSI to simulate in vivo pressures. MAIN OUTCOME MEASURES: The main outcome measurement for the longitudinal load test (penetration) was the force required for the inflated cylinder to bend, thereby affecting its rigidity. The main outcome for the horizontal rigidity test (gravity) was the angle of displacement, in which a smaller angle represents a more horizontally rigid device. RESULTS: Longitudinal column testing (penetration) demonstrated that less force was required for the AMS device to kink compared with the Coloplast implant across all three fill pressures tested. The Coloplast Titan also had a smaller angle of displacement at the modified cantilever test (gravity) compared with the AMS implant across all fill pressures. CONCLUSION: The Coloplast Titan demonstrated greater resistance to longitudinal (penetration) and horizontal (gravity) forces in this study. The AMS device was very sensitive to fill pressures. In contrast, the Coloplast Titan's ability to resist these forces was less dependent on the device fill pressure.


Assuntos
Disfunção Erétil/terapia , Prótese de Pênis/normas , Desenho de Prótese , Humanos , Masculino , Pressão , Falha de Prótese , Reprodutibilidade dos Testes
6.
World J Urol ; 34(7): 993-8, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26475275

RESUMO

INTRODUCTION: We sought to determine whether measured corporal length (MCL) or implanted device size (IDS) has changed. METHODS: Data were obtained from the two major penile implant companies from the years of 2005-2010 and analyzed. While we requested similar data, companies supplied information at their discretion with MCL provided by American Medical Systems and IDS provided by Coloplast. Intra-patient corporal discrepancies, disease state effects, rear tip extenders (RTEs) use and place of implantation were also provided in some part by companies. RESULTS: MCL and IDS increased during the study period. Despite the general trend of MCL/IDS, clinically significant (0.5 cm or greater) decreases in MCLs were noted in patients with Peyronie's disease (PD) or a history of radical pelvic surgery (excludes prostatectomy). In only 2.7 % of cases was there an intra-patient discrepancy in cylinder size (>1 cm). IDS was longer in the USA (US, 19.4 cm) compared to outside the US (OUS, 17.7 cm, p < 0.0001). Cylinders were implanted without RTEs in 48.3 % of US cases and 73.7 % of OUS cases (p < 0.0001). In Coloplast devices there was an overall statistically significant change in the use of 16 cm (less utilized) and 20 and 22 cm (more utilized) cylinder lengths during the study period in US implants. CONCLUSION: MCL and IDS increased during the study period. Men with a history of PD or radical pelvic surgery are at highest risk to have shorter MCL and to possibly receive shorter implants. Intra-patient IDS inconsistency is rare and should prompt investigation.


Assuntos
Disfunção Erétil/cirurgia , Prótese de Pênis , Pênis/anatomia & histologia , Humanos , Masculino , Tamanho do Órgão , Desenho de Prótese
7.
Can J Urol ; 21(5): 7465-9, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25347372

RESUMO

INTRODUCTION: High submuscular (HSM) inflatable penile prosthesis (IPP) reservoir insertion is a new technique that involves placing the reservoir high beneath the muscles of the abdominal wall. We queried a variety of surgeons to assess their impressions of how HSM reservoir placement compares with traditional space of Retzius (SOR) placement. MATERIALS AND METHODS: A nationwide group of urologists trained in HSM reservoir placement was surveyed to assess preferences and concerns compared to SOR placement. Using a Likert scale survey, we compared HSM to traditional SOR placement with regard to ease of implementation, surgical preference, and patient safety. Results were analyzed according to numbers of implants performed by the surgeons. RESULTS: A total of 25 urologists from eight states participated in this survey (12 residents and 13 attending surgeons). Overall, surgeons report that HSM placement is safer (p < 0.001). The participants believed it conveyed lower risk to visceral (p < 0.001) and vascular (p < 0.001) structures. Moreover it was easier to learn (p = 0.008) and to teach (p = 0.002). The majority (17/25, 68%) prefer HSM reservoir placement, while 4/25 (16%) are neutral, and 4/25 (16%) prefer SOR. Among high volume implanters (> 20 implants/year), 7/9 (78%) prefer the HSM technique and report that it is safer (p = 0.001) with lower risk of visceral (p = 0.010) and vascular (p < 0.001) injuries. CONCLUSIONS: Urologists trained in HSM reservoir placement report that this technique is readily implemented, strongly preferred, and safer for patients.


Assuntos
Atitude do Pessoal de Saúde , Implante Peniano/métodos , Padrões de Prática Médica/estatística & dados numéricos , Urologia/estatística & dados numéricos , Humanos , Implante Peniano/efeitos adversos , Prótese de Pênis
8.
Int J Impot Res ; 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-38388785

RESUMO

Over the years, numerous non-surgical and surgical treatment options have been explored for Peyronie's disease. Current options may result in incomplete correction of the deformity, which can be bothersome to the patient. This is a two-center case series of three patients who had previously undergone treatment for Peyronie's disease. Patient 1 underwent plication with extratunical grafting. Patient 2 underwent a series of Xiaflex® injections and then subsequent surgical plication for residual curvature. Patient 3 underwent a series of Xiaflex® injections. The Himplant® subcutaneous silicone penile prosthesis was placed in a standardized manner through a scrotal incision in all cases to mask residual penile deformities and enhance penile girth after Peyronie's disease treatment. Patients were contacted and asked 18 questions regarding satisfaction and erectile function with the responses recorded. This pilot study presents findings of high patient satisfaction, increases in flaccid penile length and girth, and an acceptable profile of adverse events following Himplant® placement. Based on our limited experience, we would consider offering Himplant® implantation when residual curvature is <40° and the penile indentation does not cause instability/buckling during penetrative sexual activity. Further research and larger studies are warranted to validate these findings and assess long-term outcomes and patient-reported satisfaction.

9.
Int J Impot Res ; 2024 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-38443555

RESUMO

Erectile dysfunction is a major postoperative complication following radical prostatectomy. Various treatments for post- radical prostatectomy erectile dysfunction including nonsurgical phosphodiesterase-5 inhibitors, intraurethral alprostadil, intracavernosal injections and penile implant prosthesis, often yield suboptimal results. In this prospective single-center case series, we examine the efficacy and outcomes of Himplant®, a subcutaneous silicone penile implant, placement in four patients with post-radical prostatectomy erectile dysfunction who experienced limited benefits with phosphodiesterase-5 inhibitors. Patient data including demographics, prostate cancer diagnoses, erectile dysfunction characteristics, previous treatments, and outcomes were collected. Himplant® placement was performed in a standardized manner through a high scrotal incision in all cases. Follow-up evaluations were conducted to assess the effectiveness of the procedure and any associated complications. Patients were contacted and asked 15 questions regarding satisfaction and erectile function with the responses recorded. This study presents findings of high patient satisfaction, increases in flaccid penile length and girth, no incidence of adverse events, and improved erectile function following Himplant® placement post-radical prostatectomy. Accordingly, we suggest Himplant® placement in patients who are frustrated by their penile appearance and suffering from erectile dysfunction after radical prostatectomy. Further multicenter studies are warranted to validate these findings and assess long-term outcomes and patient-reported satisfaction.

10.
Int J Impot Res ; 2024 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-38714783

RESUMO

Testicular prosthesis implantation is a valuable solution for the physical, cosmetic, and psychological challenges associated with testicular loss which may affect males of any age. We evaluated the safety and reliability of the new Rigicon Testi10TM testicular prosthesis in adults and adolescents by performing an IRB-approved retrospective study of data drawn from Patient Information Forms (PIFs). A total of 427 patients (382 adults and 45 adolescents) had at least one testicular prosthesis implanted. Only one adult patient required revision surgery due to rupture of the Rigicon Testi10 TM saline-filled prosthesis. A 40-year-old patient was found to have a leaking prosthesis approximately one week postoperatively, which was suspected to be due to inadvertently punctured by the surgeon during the sterile saline filling process. There were no post-implantation revisions required for adolescent patients. According to our results, Kaplan-Meier calculation of survival from removal or revision was 99.8% for all patients at 54 months (99.7% for adults and 100% for adolescents). The complication rates among patients in this study are lower than those reported in previous published studies. Our study underscores the generally safe nature of testicular prosthesis implantation, as well as the very rare incidence of revision surgery for this new device.

11.
J Urol ; 200(6): 1343, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30195812
12.
J Sex Med ; 10(10): 2566-70, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22974168

RESUMO

INTRODUCTION: The traditional surgical approach for revision of a malfunctioning artificial urinary sphincter (AUS) includes removal and replacement of all device components, identical to that employed in the setting of an infected or eroded AUS. AIMS: To describe outcomes of our technique in which we intentionally leave behind the original pressure-regulating balloon (PRB) at time of AUS revision in a clinically non-infected setting. METHODS: We retrospectively reviewed our combined institutional series of 35 patients who underwent 36 AUS revisions in which the original pressure-regulating balloon was left undisturbed. We removed and replaced the defective cuff and pump through a single peno-scrotal incision for most patients requiring revision of a non-infected AUS. The new PRB was then placed on the opposite side through this single incision. MAIN OUTCOME MEASURES: Assessment of outcomes, complication, and infection rate of this surgical series. RESULTS: All of the patients had the original pressure-regulating balloon placed through an inguinal counter-incision. Mean follow-up time was 14 months (2-33 months). Overall complication rate for the revision series was 11%. No infections or complications occurred secondary to the retained PRB. CONCLUSION: Follow-up of our series provides evidence that retention of the original PRB at the time of non-infected AUS revision is safe. Potential advantages include elimination of a counter incision and technically challenging exploration. By eliminating these aspects, the potentially resultant decreased operative time may help counter the theoretical yet unproven risk of infection from leaving the old PRB in place.


Assuntos
Remoção de Dispositivo/métodos , Falha de Prótese , Incontinência Urinária por Estresse/cirurgia , Esfíncter Urinário Artificial , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pressão , Prostatectomia , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Estresse Mecânico , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Incontinência Urinária por Estresse/etiologia
13.
Int J Impot Res ; 35(2): 82-89, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33273715

RESUMO

The use of semirigid rod penile prosthesis for the management of erectile dysfunction was first described over 85 years ago. Since then, there have been numerous design advancements leading to improved overall durability, concealability, rigidity, and natural feel. However, the inflatable penile prosthesis (IPP) still has a higher patient satisfaction rate and is currently the most commonly inserted prostheses in the United States. There are still certain situations and conditions where the simplicity of a rod may be preferred over an IPP. A pair of semirigid rods has been shown to have less risk of malfunction and need for revision surgery. In addition, patients with poor manual dexterity, those undergoing a salvage for infection prosthesis and those with a prolonged (> 48 h) priapic episode may be better served with a rod than an IPP. Finally, in patients compromised by infection or priapism, the rods can later successfully be exchanged for an IPP with potentially longer, wider cylinders with resultant greater patient satisfaction.


Assuntos
Disfunção Erétil , Implante Peniano , Prótese de Pênis , Masculino , Humanos , Estados Unidos , Estudos Retrospectivos , Disfunção Erétil/cirurgia , Satisfação do Paciente
14.
Int J Impot Res ; 35(4): 1-8, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33273716

RESUMO

Since penile prostheses only provide axial rigidity, correction of penile deformity and enlargement of the visible penis during implant surgery may be desired. Evolving techniques of tunica expansion have made it possible to avoid grafting and preservation of the cylindrical appearance without bulges and indentations. After two decades of devising individualized solutions for patients and continuous enhancements of existing surgical solutions, Dr. Paulo Egydio has arrived at his Tunica Expansion Procedure (TEP). This strategy is his newest iteration of a lengthening techniques without grafting accompanied by penile prosthesis implantation. The TEP Strategy permits surgeons to use their own intuitive reasoning to determine the best pattern of multiple, small, staggered incisions to promote length and girth enlargement.


Assuntos
Doenças do Pênis , Implante Peniano , Induração Peniana , Prótese de Pênis , Masculino , Humanos , Induração Peniana/cirurgia , Doenças do Pênis/cirurgia , Pênis/cirurgia , Implante Peniano/métodos , Estética
15.
Int J Impot Res ; 35(5): 419-427, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33328619

RESUMO

Achieving a thriving sexual medicine practice with a high volume of penile implants is both challenging and rewarding for the prosthetic surgeon. It is not an easy feat to accomplish. Techniques of practice building from physician referrals and marketing to the patient have changed remarkably in the era of social media. Peer-to-peer continues to be a critical source of physician referrals, but methods of "getting the word out" to patients have drastically altered. Internal marketing to one's own patients and external passing of information to prospective clients requires a robust presence on the internet. This workshop will focus on the achievement of high-volume implant practices in the age of the World Wide Web. Despite accomplishing this triumph through use of digital media, it is important to continue personal attainments to maintain your ethical image amongst your physician peers and the general public.


Assuntos
Internet , Mídias Sociais , Humanos , Estudos Prospectivos , Marketing
16.
Int J Impot Res ; 35(6): 512-518, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33750937

RESUMO

Penile prosthesis infection remains a rare but devastating complication of implantation. Historically, management of device infection was always extirpation. While certainly effective, device removal leaves an unhappy patient with a shortened penis. In this last part of a three-part series on the topic of penile prosthesis infection, we seek to highlight new and emerging ideas of infection management which have allowed surgeons the option of preserving the implanted status in select patients.


Assuntos
Doenças do Pênis , Implante Peniano , Prótese de Pênis , Masculino , Humanos , Implante Peniano/efeitos adversos , Doenças do Pênis/cirurgia , Pênis/cirurgia
17.
Int J Impot Res ; 2023 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-37543658

RESUMO

The Rigicon ContiClassic® is a new sphincteric device designed to treat male stress urinary incontinence. This study evaluates the surgical outcomes and safety profile of the first 116 patients who received the implant between September 2021 and April 2022. Data were collected from patient information forms completed at the time of the implant and submitted by implanting surgeons, nursing staff in the Operating Room or company representatives present during the surgery. The study analyzed patient demographics, surgical details, and etiology of incontinence. The mean age of patients was 68.3 years +/- 9.65 yrs. Minimum age was 23 and maximum age was 83. The most common reason for implantation was urinary incontinence (58.6%) after radical prostatectomy. The results showed a revision rate of 6.90%, with three cases of fluid loss, four cases of iatrogenic mistaken sizing, and one case of patient dissatisfaction. There were no reported infections. Kaplan-Meier calculation showed survival rate of 93.2% at 12 months. This study shows the early safety outcomes for the Rigicon ContiClassic® sphincter device to be comparable to others presently on the market.

18.
Urology ; 180: 257-261, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37517678

RESUMO

OBJECTIVE: To report the incidence of the reoperation surgeries of nearly all the Rigicon Infla10 implants performed since device introduction in 1/2019. Inflatable penile prosthesis has some of the highest survival from revision surgery of any medical device implanted in humans [1]. We expand on previous Rigicon Infla10 research, adding more patients and increasing follow-up duration [2]. MATERIALS AND METHODS: 535 patients had Rigicon Infla10 devices implanted from 1/2019 to 8/2022. 103 surgeons from 26 centers in 15 countries participated in the study. Patient information forms were analyzed from virtually all implantations. Explantation or revision surgery for mechanical failure, infection, other medical reasons, and patient dissatisfaction were cataloged. SPSS 25.0 (IBM) was used for the statistical analysis of Kaplan Meier survival statistics. RESULTS: Mean follow-up was 24.2months (7-43months). Mean patient age was 56years. Reoperation was necessary for 3.5% of subjects. Revision for mechanical failure occurred in 2.24% (12/535). The rate of explant for patient dissatisfaction was 0.56% (3/535). Revision for component out of place was 0.37% (2/535) with an infection rate and unsuccessful Peyronie's correction being 0.19% (1/535). Survival from requiring another corrective surgery at 1, 2, and 3years was 96.4%, 95.0%, and 94.0%, respectively. These initial survival rates compare favorably to devices currently available, which have been repeatedly enhanced to improve reliability. CONCLUSION: In its first 2-3years of availability, The Rigicon Infla10 inflatable penile prosthesis shows freedom from revision comparable to existing enhanced devices that have been on the market for decades.


Assuntos
Disfunção Erétil , Implante Peniano , Prótese de Pênis , Humanos , Pessoa de Meia-Idade , Masculino , Prótese de Pênis/efeitos adversos , Reoperação , Reprodutibilidade dos Testes , Implante Peniano/efeitos adversos , Disfunção Erétil/etiologia , Satisfação do Paciente , Estudos Retrospectivos , Desenho de Prótese , Falha de Prótese
19.
Int J Impot Res ; 2023 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-37679463

RESUMO

Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.

20.
J Urol ; 188(5): 1855-60, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22999690

RESUMO

PURPOSE: This systematic review was done to compare the effectiveness of infection retardant coated inflatable penile prostheses vs noncoated devices. MATERIALS AND METHODS: We systematically reviewed PubMed® and Galileo® to identify all relevant case studies. The postoperative infection incidence rate was compared for coated and noncoated inflatable penile prostheses to determine whether coating the implant affects the rate of surgical implant infection. RESULTS: Included in analysis were 14 clinical case studies in a total of 9,910 patients with a first time implant, including 5,214 inflatable penile prostheses without an infection retardant coating and 4,696 coated inflatable penile prostheses impregnated with minocycline/rifampin (3,158), rifampin/gentamycin immersion (181), vancomycin/gentamycin immersion (181) and a hydrophilic coating only (1,176). For noncoated vs coated prostheses the infection rate was 2.32% vs 0.89% (p <0.01), including 0.63%, 0.55%, 4.42% and 1.11% for minocycline/rifampin, rifampin/gentamycin immersion, vancomycin/gentamycin immersion and hydrophilic coatings, respectively. CONCLUSIONS: This analysis documents a significant advantage of using coated compared to noncoated inflatable penile prostheses to prevent postoperative device infection. Infection retardant coatings that allow antibiotics to elute off the device components decrease the incidence of device infection by approximately 50%. Future studies must address novel techniques, such as preventing bacterial adhesion, to further decrease infectious etiologies.


Assuntos
Antibacterianos/administração & dosagem , Prótese de Pênis , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/prevenção & controle , Materiais Revestidos Biocompatíveis , Humanos , Incidência , Masculino , Desenho de Prótese
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