Short-term revision rate of Rigicon Testi10TM testicular prosthesis in adolescents and adults: a retrospective chart review.

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.

Himplant® subcutaneous penile implant improves penile appearance and erectile dysfunction after radical prostatectomy: a case series.

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.

Use of Himplant® for correction of residual deformity following prior treatment of peyronie's disease: a case series.

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.

Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide.

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.

First safety outcomes for rigicon conticlassic® artificial urinary sphincter.

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.

Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices.

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.

Subcoronal Incision for Inflatable Penile Prosthesis Does Not Risk Glans Necrosis.

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.

Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis.

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.

Is there still a place for malleable penile implants in the United States? Wilson's Workshop #18.

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.

Evolution of techniques for aesthetic penile enlargement during prosthesis placement: a chronicle of the Egydio non-grafting strategy.

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.

Implant practice building: tenets to growing a successful and rewarding practice.

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.

Penile implant infection part 3: the changing spectrum of treatment.

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.

Update on the Penuma® an FDA-cleared penile implant for aesthetic enhancement of the flaccid penis.

The Penuma® implant is a medical-grade silicone implant surgically inserted subcutaneously to provide cosmetic improvement of the penile aesthetic. The principal author was invited to provide an update on the usage of the Penuma® implant for penile aesthetics. He collected as yet unpublished data, which is undergoing synchronous submission to Urologic meetings and peer-reviewed publications by a variety of authors for this communication. The objective of this article is to provide updated information regarding the Penuma® aesthetic penile implant. A new scrotal method of implantation named "concealed" is emerging. Through physician comparison of various factors prior to and after the scrotal method intervention, early findings suggest this approach seems to have less visible scar, is quicker and is followed by less seroma formation. As the device is now surgically implanted by surgeons other than its inventor, new developments have appeared authenticating the original published paper in 2018. Patients were contacted via phone and were asked five questions regarding satisfaction with the responses recorded. This new multicenter study shows findings of high patient and partner satisfaction coupled with acceptable adverse outcomes similar to the single-surgeon study. A new penile rehabilitation program has been developed with the aim for the penis appearance to be restored to its pre-operative state if the Penuma® is removed. 12 patients who underwent penile implant removal were followed for 6 months while participating in the penile rehabilitation program. The discipline worked in patients who desired removal for dissatisfaction and is currently under evaluation in patients who require device removal for medical reasons, e.g., infection or suture-related issues. Through new developments, the acceptance of Penuma® in the prosthetic community seems to be further solidified.

Nuances of subcoronal inflatable penile prosthesis for physicians accustomed to penoscrotal approach.

In a special miniseries highlighting the different surgical techniques to the inflatable penile prosthesis (IPP), Wilson's Workshop seeks to bring forth skill considerations for the modern implanter. Each work is authored by a highly regarded surgeon who has truly honed the art of their respective approach. Today, most implanters are comfortable with either the penoscrotal or suprapubic incision. The following work directs the spotlight onto a much newer and less known technique, IPP implant via the subcoronal incision. SHP leads the Urology Center of Excellence in Seoul, South Korea, and has implanted more than 700 IPPs using the subcoronal approach since 2015. Here, he will share the clinical pearls of this novel incision gathered through trial and error over many repetitions. We are hopeful that this work will peak the interest of inquisitive minds and help disseminate improved implant techniques.

Unexpected nuances of the penoscrotal inflatable penile prosthesis.

The inflatable penile prosthesis was first implanted with a large vertical suprapubic incision. Nowadays, three surgical approaches are utilized: penoscrotal, infrapubic, and subcoronal. Globally the penoscrotal approach is used most often. Our first author describes nuances of the high transverse scrotal incision technique gained over 48 years of experience. Many of these methods will interest the reader because they are divergent from the common practice of implanters across the world. These distinctions are designed to diminish the risk of infection, speed up the surgery, and improve outcomes for both the patient and his surgeon.