|Year : 2023 | Volume
| Issue : 1 | Page : 12-20
Prosthetics in urology: Current status and future directions
Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu, India
|Date of Submission||19-Mar-2022|
|Date of Decision||01-Jun-2022|
|Date of Acceptance||26-Aug-2022|
|Date of Web Publication||29-Dec-2022|
Department of Urology, Christian Medical College and Hospital, Vellore, Tamil Nadu
Source of Support: None, Conflict of Interest: None
| Abstract|| |
The field of genitourinary prosthetics has evolved rapidly to become the standard of care for conditions such as incontinence and refractory erectile dysfunction. Its scope has expanded to encompass newer indications such as Peyronie's disease and gender-affirming surgeries. This review, based on the Urological Society of India's Best Essay Award 2022, aims to elaborate on the advances in the field of urological prosthetics in the past 20 years as well as to provide an insight into ongoing research and what one can expect to see in the next decade, particularly in the area of penile and testicular prosthetics as well as treatment of incontinence. A PubMed and patent search was performed to achieve these objectives. Future considerations include improving acceptance, reliability, making them more accessible for developing countries and improving training and education to improve outcomes.
|How to cite this article:|
Cheriyan A. Prosthetics in urology: Current status and future directions. Indian J Urol 2023;39:12-20
| Introduction|| |
The word prosthesis is derived from the Greek words-pro and tithenai in the 16th century (which mean “in addition” and “to place,” respectively). A prosthesis is an artificial device that substitutes a defective or an absent body part and attempts to restore its structure and function. From the accounts of prosthetic limbs used by Queen Vishpala in the Rig Veda and the books of Greek Historian Herodotus, the field of prosthetics has evolved beyond orthopedics and trauma to various other medical fields, including urology.
Increase in longevity due to advancements in medical care has made optimal management of conditions such as incontinence and erectile dysfunction (ED) vital for maintaining a normal quality of life. The scope of prosthetics in urology includes penile prostheses (PP), artificial urinary sphincters (AUS), slings, and testicular prostheses (TP), as shown in [Figure 1].
The objective of this review is to describe the current role of prosthetics, recent advances, and future trends in the field of urological prosthetics. This review is based on the Urological Society of India's Best Essay for 2022.
| Methods|| |
A PubMed search was performed for English language articles using the search terms-”urological prosthesis,” “penile prosthetics,” “urinary sphincters,” “testicular prosthesis,” and “slings.” After screening the available abstracts, relevant full-text articles that addressed the search terms were selected for this review. A Google patent search was also performed to identify newer concepts and patents filed since 2010 related AUS and, penile and TP.
| Current Status of Prosthetics in Urology|| |
History of penile implants
While Ambroise Pare is credited with making the first penile implant in the 16th century, the first documented use for ED was by Nikolaj Bogoraz, a Russian surgeon, who in 1936 fashioned an implant using a rib cartilage. However, the modern era of PP was marked by the introduction of an inflatable penile prosthesis (IPP) in 1972 by Scott et al. A few years later, a semirigid rod prosthesis by Small and Carrion was marketed. Subsequent modifications to Scott's inflatable prosthesis led to the AMS 700 in 1983. PP for the treatment of ED have the highest patient and partner satisfaction rates. Although there was a dip in PP sales in 1998 when sildenafil was approved by the Food and Drug Administration (FDA), sales eventually improved once it was evident that conservative therapy was not universally effective., Applications have now expanded to Peyronie's disease and gender-affirming surgeries.
Types of penile implants
Two types of PP are available – hydraulic (2 or 3-piece) and semi-rigid implants. The main manufacturers for the penile implant are Coloplast (Minneapolis, MA) and Boston Scientific (Marlborough, MA) in the USA. Data from these manufacturers indicate that around 85% of all penile implant surgeries worldwide are performed within the United States with IPPs accounting for over 80% of these implants., In contrast, cheaper semi-rigid implants are more popular in Asia.
Semi-rigid implants consist of malleable rods made of a core (spiral wire or silicone), an outer jacket, and a provision for rear tip extenders to adjust the size of the implant. The AMS 600 Spectra and the Coloplast Genesis, the two most popular devices, reported patient and partner satisfaction rates comparable to IPP. The AMS Spectra was replaced by the AMS Tactra in 2019, which has a dual-layer silicone exterior with a nitinol core, resulting in better axial rigidity.
Some of the popular malleable implants are the Rigi10 by Rigicon (USA), Zephyr ZSI 100 (Switzerland), Shah implant (India), Silimed penile prosthesis (Brazil), and the Promedon tube prosthesis (Argentina). The Shah implant, first reported in a patient who underwent total phallic reconstruction, is an affordable alternative in developing countries like India. The soft tip and a malleable hinge reduce the risk of erosions, while the addition of a removable sleeve makes it versatile and cost-efficient.
Inflatable penile prosthesis
IPPs have a more natural appearance in the flaccid and erect state. A three-piece prosthesis has a scrotal pump, a reservoir that is typically placed in the Retzius space or submuscular space below the rectus, and two inflatable cylinders. The AMS 700 series and the Coloplast Titan series are the only three-piece inflatable implants approved for use in the United States (US). Ambicor, the most popular two-piece IPP, is an upgraded version of the now-discontinued AMS Dynaflex (a one-piece IPP). Although axial rigidity is inferior to the three-piece IPP, reliability and patient satisfaction are over 90%. Ambicor can be considered in patients who desire an IPP, but a reservoir cannot be placed due to prior surgeries.
One of the major concerns with penile implant surgeries are the reoperation rates. Data of 14969 men who underwent IPP insertion with a median follow-up of 95 months showed an overall reoperation rate of 6.4%. Both Coloplast and AMS have incorporated various modifications over the past two decades to reduce complications and improve the durability and ease of use of both malleable and IPP which have been incorporated in newer models [Figure 2]. Current IPPs are durable and enable a good quality of life even at a 20-year follow-up.
|Figure 2: Few of the penile prostheses currently available in the market. (a) AMS 700™ with Inhibizone coating, (b) Ambicor two-piece implant, (c) Tactra malleable implant. (Images are used with written permission from Boston Scientific Corporation)|
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The introduction of antibiotic and hydrophilic coated implants has reduced the infection rates to 0.3%–2.7% from around 3%–5% in the early 2000s. “No touch” techniques have further reduced infection rates to as low as 0.46%. Some of the recent advances are summarized in [Table 1].,,,,
Artificial urinary sphincter
Male stress urinary incontinence (SUI) is a relatively rare condition in community-dwelling men, with a prevalence of 3.78% in those aged 45–65 years of age. The most common cause for male SUI is postprostatectomy incontinence (PPUI) and the incidence is 4% to 39%, which is a major factor affecting the quality of life.
The earliest description of an “Artificial sphincter” was by Foley in 1947, when he devised a pneumatic clamp for men with nocturnal enuresis. The AUS in its current form (AMS 800TM), was a result of various upgrades to the one described in 1972 by Scott et al. In 1977, Furlow introduced the concept of primary deactivation of the cuff to prevent erosions. Further developments and upgrades were directed toward reducing cuff pressures and improving mechanical reliability. The AMS 800 is the only AUS device that has both FDA and CE approval for severe UI. It is a highly durable, safe, and effective option based on published reports.
This three-piece device consists of an inflatable cuff with different sizes, a hydraulic pump to activate the pump, and a pressure-regulating balloon (PRB). Squeezing the pump draws the fluid from the cuff into the PRB, allowing the person to void.
Even though AMS 800 is considered the gold standard for PPUI, a systematic review showed that complications such as mechanical failure (6.2%), urethral atrophy (7.9%), and infection and erosion (8.5%) result in reintervention rates as high as 26%.
The important drawbacks of AMS 800 that need to be addressed are (i) constant urethral cuff pressure that can compromise the vascularity of the urethra, (ii) multiple components that increase the chance of mechanical failure and infections, (iii) affordability, and (iv) the need for manual dexterity. Newer devices such as Zephyr 375, Victo, and Victo + are promising, but long-term outcomes are awaited. [Table 2] shows the artificial sphincters currently available for clinical use.,,
Bulbourethral slings were initially designed to provide a less invasive alternative to AUS. Many patients prefer a sling to AUS as it does not have mechanical components and one does not need to rely on cognitive ability. The slings currently in use are summarized in [Table 3].,,,,,,,,
|Table 3: Summary of slings available for treatment of male urinary incontinence|
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Adjustable balloon device – ProACT
The ProACT system consists of two silicone balloons with titanium ports accessible through the scrotum, implanted using minimally invasive methods. Continence is achieved by adjusting the balloon which in turn adjusts the urethral resistance. In a recent meta-analysis, 81.9% of patients showed improvement in continence, and pad usage reduced from 4 to 1.1 pads/day.
Contemporary minimally invasive options for surgical management of female SUI include autologous fascia pubovaginal slings (AF-PVS) and various synthetic mid-urethral slings (transvaginal tape [TVT], transobturator tape–in and out), and mini slings. Retropubic TVT is safe and effective even on long-term follow-up. Overall adverse events are low for mid-urethral slings irrespective of the route used. AF-PVS is currently used as a second-line option for failed mid-urethral slings. AUS is theoretically the best option for intrinsic sphincter deficiency, however, better studies are required to establish its definitive role in the treatment of female SUI.
The first testicular implant was made of vittalium (an alloy of cobalt, chromium, and molybdenum). Although it helped with the psychological aspects of testicular loss, the metallic feel was unpleasant. Focus had then shifted to the development of natural feel implants. The next 10 years saw the use of various materials such as polymethylacrylate, glass spheres, and Dacron, but these options did not gain popularity. Silicone gel-filled implants were introduced in the 1970s were widely used until 1992, when the FDA temporarily halted the use of all silicon prostheses, based on adverse effects reported with silicone-gel-filled breast implants.,
Currently, Coloplast Torosa, a saline-filled implant, is the only FDA-approved testicular prosthesis in the USA and has the highest acceptance worldwide. It is a saline-filled TP, available in various sizes, which aims to restore the natural appearance and feel. It also has a suture tab to secure the device at the desired position within the scrotum and an inflation port to adjust the firmness. Other manufacturers include the Rigicon (USA), Promedon (Argentina), and Uromed (Germany). These implants are made of silicone outer shell containing either saline, silicone gel, or solid elastomer.
Although TP implantation is safe and recipients of testicular implants report satisfaction rates of 73%–100% and subjective improvement of body image in over 50%, there appears to be a disconnect between its use and its potential.,, A testicular prosthesis is not offered in 35%–50% of patients,, and this number is likely to be higher in developing countries.
The feeling of shame or loss of masculinity was particularly high in those who were never offered a TP as compared to patients who were offered and rejected. Among those who were unsatisfied with TP, the TP firmness, implant size, and positioning too high in the scrotum are the main factors.
| Unmet Needs and Ongoing Projects|| |
Milestones in the evolution of prosthetic technology are summarized in [Figure 3]. There are various ongoing investigations to improve prosthetic technology and one of the most prominent themes is automation while ensuring optimal performance, cost, and reliability.
|Figure 3: Important milestones in the evolution of urological prostheses|
Click here to view
An area of interest is the automation of the penile prosthesis, enabling the patient to control the device remotely. AMS has obtained various patents for this device and this may be available soon. One of these devices has a piezo-electric pump activated by a magnetic field. A vibrating penile implant to improve partner satisfaction has also been evaluated but the longevity of battery-powered devices without needing replacement is of concern.
Although various implant coatings have reduced infection rates, revision of an infected implant and tackling biofilms has remained problematic. A calcium-sulphate cast with tobramycin and vancomycin has been described as a temporary placeholder for the management of infected penile implants to preserve penile length and corporal space. Ultrasound-targeted microbubble destruction for the treatment of biofilms in titanium implants has been attempted in orthopedics. The addition of the human beta-defensin-3 peptide seems to augment its action against Staphylococcus biofilms. It remains to be seen whether similar technology is effective against biofilms in silicone prostheses. Alternatively, while it may not be possible to prevent biofilms, a novel approach to facilitating bio-film formation by nonpathogenic bacteria is intriguing.
As technology and material science evolves, doing away with reservoirs and hydraulic technology which make it cumbersome and allow scope for malfunction is a direction worth investigating. One such potential technology is the shape-memory alloy, which can be activated by magnetic induction, which will be discussed later.
Artificial urinary sphincters
Similar to PP, automation, reduced need for dexterity, and improving reliability are the need of the hour. The Politano-Sayet-Sutherland device is fluid-free and can be controlled with a handheld remote, allowing postimplant adjustments and remote telemonitoring. Another novel idea is a small electronic pump that can be remotely operated using Bluetooth technolog, y retro-compatible with AMS 800. The magnetic artificial sphincter is a prototype that uses an external magnet to manipulate an internal magnet housed within the scrotum, which controls the urethral compression cuff.
The high rates of urethral erosions may be inherent to the constant urethral compression and novel proof-of-concept devices, such as the emAUS and ARTUS, have tried to address this. These electromechanical devices apply sequential alternating or “piano mode” compression to the urethra to avoid damage to urethral vascularity and early reports are encouraging., An automatic sphincter system that dynamically adapts to changes in the intravesical pressures is also being studied.
On examining recently filed patents online, a two-piece system by Coloplast (#15/153,737) where fluid is stored within the cuff, and an AUS with sensors to provide a second closure pressure (#WO2019169277A1) based on dynamic input seem promising. Other notable innovations in the cuff technology include an iris-diaphragm-like cuff (#ES14171954.2T) and a novel system that has a backboard and a pair of end-walls (#16/255,837) by Coloplast.
Compared to AUS and PP, the scope of innovations is much smaller since it is a simpler device. One of the novel ideas in this field is the testosterone-eluting double-layer silicon TP. This silicon prosthesis with controlled release of testosterone undecanoate was effective and safe in castrated rats.
Female-to-male gender-affirming surgeries are increasing in frequency and pose unique challenges. Various implants, both hydraulic and semi-rigid have been used such as AMS700CS, Ambicor, Coloplast Genesis, and Titan. However, one of the major concerns is higher rates of complications in the transgender population with malposition and erosions in as many as 22.7%. The Zephyr ZSI 475 FTM was designed specifically for phalloplasty, and the outcomes were recently published. It has a rounded distal tip mimicking the glans and a steel plate to anchor the implant to the pubis. Although the design has theoretical benefits, well-planned trials will be required to make any conclusions about the outcomes and patient satisfaction. A testicular prosthesis may be placed at the same sitting as the phalloplasty or in a delayed manner. Recent reports favor delayed implantation of smaller and lighter TP.
| Application of Newer Technology|| |
Shape memory alloys and nanotechnology
A shape-memory alloy (SMA) is based on the property of certain alloys to change crystal structure at characteristic temperatures. A nickel–titanium alloy implant changes its configuration on the application of heat within an acceptable physiological range either via surface probe or magnetic induction. Early in vitro results of this SMA implant show axial rigidity comparable to that of IPP. In the inactive state, they mimic the flaccid state, unlike other malleable implants. Although it is in the early stages of research, it has the potential to be an affordable and reliable alternative to IPP with fewer parts and easier activation, and potentially lower mechanical failure rates.
SMA wires have been used in AUS prototypes where SMA wires are programmed to occlude the urethra in “piano mode.” Although promising, concerns about thermal insulation, the need for a high-power battery, and the time lag for activation need to be addressed. Few of these concerns may be addressed by artificial muscle sphincters made of nanostructures based on electrically activated polymers.
Role of 3D printing
3D printing technology to study cadaver penis shapes to improve the shape of existing PP, or even to provide personalized implants is no longer a flight of fancy. Applications of 3D printing being investigated include customized SMA penile prosthesis and well as 3D printed scaffolds seeded with stem cells to develop bioengineered vascularized corpora., 3D printing can be used to engineer native tissue-like meta-materials for natural feeling testicular prosthetics. Such implants do not require silicone or liquid infills.
3D printing has been utilized to replicate male pelvic structures including their relative tissue densities using polyvinyl alcohol. These are cost-effective compared to cadaver models and can be used to train a low-volume surgeon or a resident in PP and AUS surgeries.,
Regenerative medicine and tissue engineering
The safety of stem cell therapies, especially in oncological patients such as those with PPUI and ED is a concern due to the risk of latent carcinogenesis and tumor recurrence. The cost and invasiveness of harvesting bone-marrow-derived mesenchymal stem cells, which is the gold standard for adult stems cells is also prohibitive. In vivo stem cell implantation has a very low survival rate as they upregulate MHC-II expression. The use of cell implantable 3D biological scaffolds is believed to allow precise delivery as well as a favorable environment for the stem cells. Despite these limitations, better understanding, and advancements in material science, the scope is limitless. For instance, various trials have been registered in an attempt to regenerate the urethral sphincter and to salvage the function of erectile tissue. Another group demonstrated the potential of biodegradable synthetic polymers to serve as scaffolds for autologous chondrocytes, which can be used for autologous PP.
Although the pace of prosthetic research has increased in the last decade, prosthetic research is protracted and expensive and often many of the smaller manufacturers may not have the financial strength to steer their innovations from bench to bedside. For instance, only AMS and Coloplast have approved three-piece inflatable implants in the US which is the largest market for penile implants. This remains a real-life hurdle for many of the inventions. Due to the above reasons, costs are unlikely to reduce unless volumes or competition between manufacturers increases significantly.
Strict and expensive regulatory procedures in the US and Europe are a double-edged sword. While lesser established prosthetic companies are unable to afford the rigorous testing required for regulatory clearances in the US and European markets, they are being utilized in other countries without published long-term outcomes or safety profiles. Therefore, regulatory reforms are required to make it standardized and less cumbersome while ensuring patients' safety.
Unlike fields like oncology, there are no standard guidelines or certifications for a surgeon practicing prosthetic urology and it may be important to liaison with device manufacturers to improve accessibility and training.
| Conclusions|| |
Although the basic concepts behind current urological prostheses are decades old, recent advances have made them reliable and safe. While novel retro-compatible devices may enable better automation, the focus needs to be on newer technologies such as SMA that will also reduce the number of components and improve reliability, affordability, and ease of implantation. Nanotechnology and advances in material science may completely change the landscape in the coming decades. However, practical hurdles such as affordability, wider distribution, and acceptance are yet to be addressed.
I thank Boston Scientific Corporation for permitting the use of their product images for this review.
Financial support and sponsorship: Nil.
Conflicts of interest: There are no conflicts of interest.
| References|| |
Thurston AJ. Paré and prosthetics: The early history of artificial limbs. ANZ J Surg 2007;77:1114-9.
Schultheiss D, Gabouev AI, Jonas U. Nikolaj A. Bogoraz (1874-1952): Pioneer of phalloplasty and penile implant surgery. J Sex Med 2005;2:139-46.
Scott FB, Bradley WE, Timm GW. Management of erectile impotence. Use of implantable inflatable prosthesis. Urology 1973;2:80-2.
Small MP. Small-Carrion penile prosthesis: A report on 160 cases and review of the literature. J Urol 1978;119:365-8.
Carson CC, Mulcahy JJ, Govier FE. Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: Results of a long-term multicenter study. AMS 700CX Study Group. J Urol 2000;164:376-80.
Goldstein I, Burnett AL, Rosen RC, Park PW, Stecher VJ. The serendipitous story of sildenafil: An unexpected oral therapy for erectile dysfunction. Sex Med Rev 2019;7:115-28.
Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998;338:1397-404.
Baas W, O'Connor B, Welliver C, Stahl PJ, Stember DS, Wilson SK, et al.
Worldwide trends in penile implantation surgery: Data from over 63,000 implants. Transl Androl Urol 2020;9:31-7.
Li K, Brandes ER, Chang SL, Leow JJ, Chung BI, Wang Y, et al.
Trends in penile prosthesis implantation and analysis of predictive factors for removal. World J Urol 2019;37:639-46.
Akdemir F, Okulu E, Kayıgil Ö. Long-term outcomes of AMS Spectra®
penile prosthesis implantation and satisfaction rates. Int J Impot Res 2017;29:184-8. Available from: https://www.nature.com/articles/ijir201716
. [Last accessed on 2021 Jul 10].
Shah R. Twenty-five years of the low-cost, noninflatable, Shah Indian penile prosthesis: The history of its evolution. Indian J Urol 2021;37:113-5. [Full text]
Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis: Results of a 2 center study. J Urol 2001;166:932-7.
Onyeji IC, Sui W, Pagano MJ, Weinberg AC, James MB, Theofanides MC, et al.
Impact of surgeon case volume on reoperation rates after inflatable penile prosthesis surgery. J Urol 2017;197:223-9.
Chierigo F, Capogrosso P, Dehò F, Pozzi E, Schifano N, Belladelli F, et al.
Long-term follow-up after penile prosthesis implantation-survival and quality of life outcomes. J Sex Med 2019;16:1827-33.
Gon LM, de Campos CC, Voris BR, Passeri LA, Fregonesi A, Riccetto CL. A systematic review of penile prosthesis infection and meta-analysis of diabetes mellitus role. BMC Urol 2021;21:35.
Eid JF, Wilson SK, Cleves M, Salem EA. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology 2012;79:1310-5.
Salem EA, Wilson SK, Neeb A, Delk JR, Cleves MA. Mechanical reliability of AMS 700 CX improved by parylene coating. J Sex Med 2009;6:2615-20.
Wilson SK, Zumbe J, Henry GD, Salem EA, Delk JR, Cleves MA. Infection reduction using antibiotic-coated inflatable penile prosthesis. Urology 2007;70:337-40.
Thirumavalavan N, Cordon BH, Gross MS, Taylor J, Eid JF. Rear tip extenders and penile prosthesis rigidity: A laboratory study of coloplast prostheses. J Sex Med 2018;15:1030-3.
Shaw T, Garber BB. Coloplast titan inflatable penile prosthesis with one-touch release pump: Review of 100 cases and comparison with genesis pump. J Sex Med 2011;8:310-4.
Hakky T, Lentz A, Sadeghi-Nejad H, Khera M. The evolution of the inflatable penile prosthesis reservoir and surgical placement. J Sex Med 2015;12 Suppl 7:464-7.
Shamliyan TA, Wyman JF, Ping R, Wilt TJ, Kane RL. Male urinary incontinence: Prevalence, risk factors, and preventive interventions. Rev Urol 2009;11:145-65.
Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, et al.
Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol 2012;62:405-17.
Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, et al.
Retropubic, laparoscopic, and robot-assisted radical prostatectomy: A systematic review and cumulative analysis of comparative studies. Eur Urol 2009;55:1037-63.
Foley FE. An artificial sphincter; a new device and operation for control of enuresis and urinary incontinence. J Urol 1947;58:250-9.
Scott FB, Bradley WE, Timm GW. Treatment of urinary incontinence by implantable prosthetic sphincter. Urology 1973;1(3):252-9. doi: 10.1016/0090-4295(73) 90749-8. PMID: 4802066.
Furlow WL. Implantation of a new semiautomatic artificial genitourinary sphincter: Experience with primary activation and deactivation in 47 patients. J Urol 1981;126:741-4.
Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN, Young Academic Urologists Functional Urology Group. 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.
Giammò A, Falcone M, Blecher G, Ammirati E, Geretto P, Manassero A, et al.
A novel artificial urinary sphincter (VICTO®) for the management of postprostatectomy urinary incontinence: Description of the surgical technique and preliminary results from a multicenter series. Urol Int 2021;105:414-20.
Ostrowski I, Ciechan J, Sledz E, Dys W, Golabek T, Chłosta PL. Four-year follow-up on a Zephyr Surgical Implants 375 artificial urinary sphincter for male urinary incontinence from one urological centre in Poland. Cent European J Urol 2018;71:320-5.
Lima RS, Barros EG, Souza CA, de O Vilar F, Lima SV. Periurethral constrictor: Late results of the treatment of post prostatectomy urinary incontinence. Int Braz J Urol 2011;37:483-7.
Mumm JN, Klehr B, Rodler S, Kretschmer A, Vilsmaier T, Westhofen T, et al.
Five-year results of a prospective multicenter trial: AdVance XP for postprostatectomy-incontinence in patients with favorable prognostic factors. Urol Int 2021;105:421-7.
Comiter CV, Rhee EY, Tu LM, Herschorn S, Nitti VW. The virtue sling – A new quadratic sling for postprostatectomy incontinence-results of a multinational clinical trial. Urology 2014;84:433-8.
McCall AN, Rivera ME, Elliott DS. Long-term follow-up of the virtue quadratic male sling. Urology 2016;93:213-6.
Malval B, Rebibo JD, Baron M, Nouhaud FX, Pfister C, Cornu JN, et al.
Long-term outcomes of I-Stop TOMS™ male sling implantation for post-prostatectomy incontinence management. Prog Urol 2017;27:1084-90.
Dalpiaz O, Knopf HJ, Orth S, Griese K, Aboulsorour S, Truss M. Mid-term complications after placement of the male adjustable suburethral sling: A single center experience. J Urol 2011;186:604-9.
Bochove-Overgaauw DM, Schrier BP. An adjustable sling for the treatment of all degrees of male stress urinary incontinence: Retrospective evaluation of efficacy and complications after a minimal followup of 14 months. J Urol 2011;185:1363-8.
Siracusano S, Visalli F, Favro M, Tallarigo C, Saccomanni M, Kugler A, et al.
Argus-T Sling in 182 male patients: Short-term results of a multicenter study. Urology 2017;110:177-83.
Sousa-Escandón A, Cabrera J, Mantovani F, Moretti M, Ioanidis E, Kondelidis N, et al
. Adjustable suburethral sling (male remeex system) in the treatment of male stress urinary incontinence: A multicentric European study. Eur Urol 2007;52:1473-9.
Friedl A, Mühlstädt S, Zachoval R, Giammò A, Kivaranovic D, Rom M, et al.
Long-term outcome of the adjustable transobturator male system (ATOMS): Results of a European multicentre study. BJU Int 2017;119:785-92.
Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta-analysis. Neurourol Urodyn 2019;38:2051-9.
Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J 2013;24:1265-9.
Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2017;7:CD006375.
Girsdansky J, Newman HF. Use of a vitallium testicular implant. Am J Surg 1941;53:514.
Lattimer JK, Vakili BF, Smith AM, Morishima A. A natural-feeling testicular prosthesis. J Urol 1973;110:81-3.
Robinson OG Jr., Bradley EL, Wilson DS. Analysis of explanted silicone implants: A report of 300 patients. Ann Plast Surg 1995;34:1-6.
Zilberman D, Winkler H, Kleinmann N, Raviv G, Chertin B, Ramon J, et al.
Testicular prosthesis insertion following testicular loss or atrophy during early childhood-technical aspects and evaluation of patient satisfaction. J Pediatr Urol 2007;3:461-5.
Dieckmann KP, Anheuser P, Schmidt S, Soyka-Hundt B, Pichlmeier U, Schriefer P, et al.
Testicular prostheses in patients with testicular cancer – Acceptance rate and patient satisfaction. BMC Urol 2015;15:16.
Adshead J, Khoubehi B, Wood J, Rustin G. Testicular implants and patient satisfaction: A questionnaire-based study of men after orchidectomy for testicular cancer. BJU Int 2001;88:559-62.
Robinson R, Tait CD, Clarke NW, Ramani VA. Is it safe to insert a testicular prosthesis at the time of radical orchidectomy for testis cancer: An audit of 904 men undergoing radical orchidectomy. BJU Int 2016;117:249-52.
Clifford TG, Burg ML, Hu B, Loh-Doyle J, Hugen CM, Cai J, et al.
Satisfaction with testicular prosthesis after radical orchiectomy. Urology 2018;114:128-32.
Skoogh J, Steineck G, Cavallin-Ståhl E, Wilderäng U, Håkansson UK, Johansson B, et al.
Feelings of loss and uneasiness or shame after removal of a testicle by orchidectomy: A population-based long-term follow-up of testicular cancer survivors. Int J Androl 2011;34:183-92.
Swords K, Martinez DR, Lockhart JL, Carrion R. A preliminary report on the usage of an intracorporal antibiotic cast with synthetic high purity CaSO4 for the treatment of infected penile implant. J Sex Med 2013;10:1162-9.
Li S, Zhu C, Fang S, Zhang W, He N, Xu W, et al.
Ultrasound microbubbles enhance human β-defensin 3 against biofilms. J Surg Res 2015;199:458-69.
Nandakumar V, Chittaranjan S, Kurian VM, Doble M. Characteristics of bacterial biofilm associated with implant material in clinical practice. Polym J 2013;45:137-52.
Angelo G, Peter S, Christopher G. Mp88-02 development of a novel artificial urinary sphincter (aus): The precision medical devices (pmd) flow control device (fcd) for management of sphincteric deficiency using bluetooth technology. J Urol 2015;193:e1092.
Biardeau X, Hached S, Loutochin O, Campeau L, Sawan M, Corcos J. Montreal electronic artificial urinary sphincters: Our futuristic alternatives to the AMS800™. Can Urol Assoc J 2017;11:E396-404.
Navneet M, Mahdi M, Mohsen S, Krishna B, Nivedita D. Pd49-02 magnetic artificial sphincter (mars): A novel urinary sphincter for stress urinary incontinence. J Urol 2016;195:e1180-1.
Valerio M, Jichlinski P, Dahlem R, Tozzi P, Mundy AR. Experimental evaluation of an electromechanical artificial urinary sphincter in an animal model. BJU Int 2013;112:E337-43.
Ludwig TA, Reiss P, Wieland M, Becker A, Fisch M, Chun FK, et al.
The ARTUS device: The first feasibility study in human cadavers. Can J Urol 2015;22:8100-4.
Lamraoui H, Bonvilain A, Robain G, Combrisson H, Basrour S, Moreau-Gaudry A, et al.
Development of a novel artificial urinary sphincter: A versatile automated device. IEEEASME Trans Mechatron 2010;15:916-24.
Chen HX, Yang S, Ning Y, Shao HH, Ma M, Tian RH, et al.
Novel double-layer Silastic testicular prosthesis with controlled release of testosterone in vitro
, and its effects on castrated rats. Asian J Androl 2017;19:433-8.
] [Full text]
Preto M, Blecher G, Timpano M, Gontero P, Falcone M. The frontier of penile implants in phalloplasty: Is the ZSI 475 FTM what we have been waiting for? Int J Impot Res 2020;33:779-83.
Pigot GL, Al-Tamimi M, Ronkes B, van der Sluis TM, Özer M, Smit JM, et al.
Surgical outcomes of neoscrotal augmentation with testicular prostheses in transgender men. J Sex Med 2019;16:1664-71.
Le B, McVary K, McKenna K, Colombo A. A novel thermal-activated shape memory penile prosthesis: Comparative mechanical testing. Urology 2017;99:136-41.
Müller B, Deyhle H, Mushkolaj S, Wieland M. The challenges in artificial muscle research to treat incontinence. Swiss Med Wkly 2009;139:591-5.
An G, Guo F, Liu X, Wang Z, Zhu Y, Fan Y, et al.
Functional reconstruction of injured corpus cavernosa using 3D-printed hydrogel scaffolds seeded with HIF-1α-expressing stem cells. Nat Commun 2020;11:2687.
Le B, McVary K, Colombo A. 223 use of 3D printing to prototype a custom shape memory alloy penile prosthesis. J Sex Med 2018;15:S75-6.
Skewes J, Chen MY, Forrestal D, Rukin NJ, Woodruff MA. 3D printing improved testicular prostheses: Using lattice infill structure to modify mechanical properties. Front Surg 2021;8:626143.
van Renterghem K, Ghazi A. 3D pelvic cadaver model: A novel approach to surgical training for penile implant surgery. Int J Impot Res 2020;32:261-3.
Patrick S, Rachel M, Michael W, Gareth W, Divya A, Alexander C, et al.
V07-12 development of a high fidelity 3-piece inflatable penile prosthetic (ipp) model using 3d-printing and hydrogel molding. J Urol 2020;203 Suppl 4:e646.
Adamowicz J, Kluth LA, Pokrywczynska M, Drewa T. Tissue engineering and its potential to reduce prostate cancer treatment sequelae-narrative review. Front Surg 2021;8:644057.
Kim BS, Yoo JJ, Atala A. Engineering of human cartilage rods: Potential application for penile prostheses. J Urol 2002;168:1794-7.
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]