The whole truth about penile prosthetics or an expert’s thoughts about penile prosthetics in Russia. What is penile prosthesis and the features of treating impotence using the radical method? Preparation for surgery
Penile prosthesis is a modern surgical technique. The first attempts to install prostheses into the penis were made in the 30s of the last century, but the method gained practical significance only after the start of the use of silicone implants. Bioinert silicone rarely caused complications and was well suited for the manufacture of various structures. Since then, the field of penile prosthetics began to develop rapidly, first rigid, and then semi-rigid and inflatable multi-component prostheses appeared. Today, implantation of a prosthesis is a routine operation, carried out in most large clinics and specialized andrology departments.
Indications
Indications for intervention are Peyronie's disease, fibrosis of the cavernous bodies, congenital anomalies and underdevelopment of the penis, post-traumatic deformities of the penis. Penile replacement is performed for erectile dysfunction caused by atherosclerosis, angiopathy due to diabetes mellitus, other vascular disorders due to arterial diseases and persistent metabolic disorders. The method is also used for impotence resulting from interventions on the pelvic organs.
Psychogenic impotence that is resistant to repeated courses of conservative therapy is considered as an indication for penile replacement. The intervention is carried out in the presence of medical contraindications to medicinal and non-medicinal methods of stimulating erection and if the listed methods are personally unacceptable for the patient. In addition, penile prosthesis is performed after the creation of an artificial penis during gender reassignment.
Contraindications
The list of general contraindications includes acute respiratory diseases, severe chronic somatic pathology, decompensated diabetes mellitus, blood clotting disorders and local purulent processes (abscesses, boils, etc.) regardless of their location. Contraindications to penile prosthesis from the genitourinary system include purulent processes in the scrotum and penis, acute inflammatory diseases, exacerbation of chronic pathologies of the genitourinary organs (cystitis, urethritis, orchitis, balanoposthitis, etc.), as well as priapism.
Preparation for penile prosthesis
The andrologist examines the patient and draws up an examination plan taking into account the identified pathology. When determining the indications, the results of cavernosography, cavernosometry, papaverine test, ultrasound of the penis, and caverject test are used. After analyzing the examination results, the doctor selects a prosthesis of the required size, taking into account the characteristics of the anatomical structure of the man’s penis. The evening before and the morning of the day of penile prosthesis, the area of the external genitalia should be treated with a disinfectant solution. Hair in the surgical area must be removed. The intervention is performed on an empty stomach.
Methodology
There are three main types of penile prostheses: rigid, plastic and inflatable. Rigid structures are practically not used at present. Elastic and inflatable (two- or three-component) implants are used. Penile prosthesis with an elastic (one-component) prosthesis is carried out by implanting multilayer silicone cylinders, in the center of which there is a metal rod with shape memory. The presence of such memory allows the prosthesis to maintain a certain position. Before sexual intercourse, the patient raises the penis with his hand, and after completing sexual intercourse, lowers the organ downwards.
Penile prosthesis with an inflatable two-component prosthesis is carried out using a design that includes a pump and two cylinders with reservoirs. The pump is installed in the scrotum, the cylinders are installed in the cavernous bodies of the penis. To achieve an erection, the patient presses the pump several times, the liquid flows through the tubes into the reservoirs, the penis becomes hard and increases in size. To return the penis to a non-erect state, the patient flexes the organ and holds it for several seconds until the fluid moves back into the pump.
Installation of an inflatable three-component prosthesis is the most modern way to provide an artificial erection. The three-component prosthesis consists of hollow cylinders, a pump and a fluid reservoir. The cylinders are placed in the corpora cavernosa, the pump is implanted in the scrotum, and the reservoir is placed behind the symphysis pubis. To achieve an erection, the patient repeatedly presses on one area of the scrotum, and to eliminate the erection, on another.
Installation of all types of prostheses is carried out under general anesthesia. In most cases, subpubic, penoscrotal or subcoronal access is used to install a prosthesis into the penis; less commonly, ventral, dorsal, perineal or suprapubic approaches are used. During penile prosthetics, the fascia of the penis is peeled off to the tunica albuginea, then the cavernous bodies are dissected and channels are formed for installing implants.
Patients with penile fibrosis undergo corpora cavernosa reconstruction if necessary. When using an inflatable prosthesis, a pocket is created in the scrotum for the pump. When performing penile prosthetics with a three-component implant, a cavity for a reservoir is created in the area of the symphysis pubis. Coagulation of bleeding vessels is carried out, components of the prosthesis are placed, and the functionality of the implant is checked. The wounds are sutured and covered with sterile dressings. The duration of the operation is 1.5-2 hours.
After penile prosthetics
The patient is advised to remain in bed for several days. Dressings are carried out, and parenteral administration of analgesics and antibacterial agents is carried out. The sutures are removed after 7-10 days. The duration of hospitalization ranges from 2-3 to 7-10 days, depending on the specific clinic and surgical technique. Sexual intercourse is allowed after 1.5 months.
Heavy bleeding, damage to the urethra and neurovascular bundles are rare. In the early postoperative period, pain, swelling and infection of the wound are possible. The erect penis after surgery becomes, on average, 1.5 cm shorter. The sensations of the partners correspond to a natural erection. Within 10 years, about 20% of inflatable penile prostheses fail. It is possible to replace the device with another implant. Penile prosthesis cannot cure impotence; after removal of the implant, independent erection is impossible.
Three-component hydraulic penile prosthesis
Of the currently available penile prostheses, these prostheses are the most advanced in terms of natural erection and maintaining a state of rest of the penis. They contain two cylinders installed in the cavernous bodies, a reservoir installed in the area behind the pubis, and a pressure pump installed in the scrotum. All components are connected to each other by tubes. To obtain an erection, you need to squeeze the pump several times, and to transfer the penis to a calm state, press the deflation valve of the pump.
Such prostheses are produced by companies:
The clear advantage of these penile prostheses is their best functional result and the appearance of the penis. Product warranty is 30 years.
- AMS 700 CX
- AMS 700 LGX
- Coloplast Titan OTR
- Coloplast Titan Touch
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Two-component hydraulic penile prostheses
This type of prosthesis consists of two cylinders with built-in reservoirs installed in the corpora cavernosa, and a pump installed in the scrotum. The pump is connected to the cylinders using tubes. To achieve an erection, you need to squeeze the pump several times, while fluid from the reservoirs enters the cylinders and gives them hardness. To relieve an erection, the penis must be bent and held in this position for several seconds until maximum relaxation is achieved.
This type of penile prosthesis has a more natural erection and a more natural state of rest. However, two-component prostheses are inferior in quality to three-component ones, and therefore are used quite rarely today.
Two-component hydraulic penile prostheses are produced by AMS Ambicor (Ambicor).
Semi-rigid (plastic) penile prosthesis
This prosthesis consists of two silicone cylinders, each of which is inserted into its own cavernous body. Unlike rigid prostheses, a plastic prosthesis contains metal guides, so it has plastic memory, ensuring that the specified position of the penis is maintained. When the moment of sexual intercourse comes, the direction of the penis is changed by hand. The advantage of a plastic prosthesis is a more natural appearance of the penis while maintaining its functions. The disadvantage of these prostheses is their constant rigidity.
Examples of such penile prostheses are prostheses produced by the following companies:
- AMS Spectra Concealable (Spectra);
- Coloplast Genesis Malleable Penile Prosthesis (Genesis);
- Promedon Tube Malleable Penile Prosthesis
Cost of prosthesis implantation surgery
penis - 120,800 rubles
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Dr. Menshchikov Konstantin Anatolievich
As was shown in previous chapters of the work, the improvement of methods of conservative treatment of ED, as well as their active advertising, has sharply increased the attractiveness of ED treatment and made it easier for such patients to decide to seek medical help. Accordingly, the number of patients in whom 1st and 2nd lines of treatment for ED were ineffective has increased, since conservative therapy for ED in the vast majority of cases is not curative.
B1 in connection with this; The urologist, as a representative of the surgical specialty, becomes an expert who receives patients who have not been effectively treated conservatively. The most effective method of treating ED in such patients is FP, after which the highest satisfaction of patients and their partners is observed compared to all other methods of treating ED (112).
This section of the work will present the results of our research on the optimization of FS methods. comparative assessment of the success of operations of uncomplicated and complicated financial
The material for this chapter is based on the results of examination and treatment of 88 patients with severe ED who underwent penile prosthetics. As noted in Chapter 2, 5 of them required re-implantation of penile prostheses due to the development of a prosthetic infection, 1 the patient underwent removal and re-prosthetics of the neophallus due to necrosis of the glans penis; In total, the following were implanted: 65 PFP (of which 40 were simple implantations and 25 complicated)^ 29 TFUR (of which 24 simple and 5 complicated). Detailed characteristics of the types of implanted penile prostheses is given in Chapter 2.
At. After implantation of penile prostheses, we followed a modified prophylactic perioperative protocol aimed at preventing prosthetic infection (PI) and is now generally accepted in the practice of leading specialists involved in AF (43, 124, 180, 181). It included the following activities:
- Prophylactic antibiotic therapy (cefazolin 1.0 intramuscularly every 8 hours; vancomycin 1.0 intravenously every 12 hours) was started 24 hours before surgery.
- The evening before the operation and the morning of the operation, thoroughly wash the body using antiseptic soap.
- Shaving the surgical field immediately before surgery.
- Thorough treatment of the surgical field with a 5% solution of povidone iodide for at least 10 minutes.
- Use of disposable surgical gowns and double gloves.
- Periodic rinsing of the surgical field with a solution containing 0.5 g of vancomycin or 1.0 g of cefazolin and 40 mg of gentamicin per 1.0 l of 0.9% NaCl solution.
- Limiting movement in the operating room.
- Use of oral antibiotic therapy in the postoperative period (ciprofloxacin 0.5 g every 12 hours or cephalexin 0.5 g every 8 hours - 14 days).
Implantation of PFP AMS-600, AMS-600M, AMS-650, (AMS, USA) and AcuForm (Mentor, USA), as well as single-component Dynaflex HFUR (AMS, USA) was most often carried out through paracoronal access, less often through dorsal infrapubical and longitudinal penoscrotal approaches (Fig. 13, A, B, C).
Rice. 13. Options for the most commonly used approaches when implanting PFPs and single-component HFURs. A. Paracoronal access. B. Dorsal infrapubical approach. B. Longitudinal penoscrotal approach
The choice of access was made taking into account the upcoming features of the operation and the wishes of the patient. For example, when implanting PFP against the background of cavernous fibrosis or iatrogenic oleogranuloma, only paracoronal access was used, which allows you to fully expose the entire shaft of the penis (decapitation), which is necessary for excision of scars and removal of foreign bodies.
In the case of simple or uncomplicated implantations, as well as when the patient did not want to perform circumcision, the prosthesis was installed through a longitudinal or transverse penoscrotal or dorsal infrapubical approach, which we tried to avoid due to the possibility of damage to the dorsal neurovascular bundle. After exposing the corpora cavernosa and placing supports on them, a longitudinal cavernosotomy was performed (Fig. 14).
Rice. 14. Longitudinal cavernosotomy on the right with a transverse penoscrotal approach.
The cavernous bodies of the penis were bouged with straight, specially made metal bougies of a predetermined diameter to the maximum length and diameter. The length of the awakened cavernous bodies was measured with a special instrument (sizer) in relation to one of the selected holders applied to the tunica albuginea of the cavernous body (Fig. 15).
Rice. 15. Sizer (in the middle) and bougie for penile prosthesis.
In accordance with the data of these measurements, the PFP of the required length and diameter was selected, which was implanted into the cavernous bodies of the penis. If necessary, before implantation, the length and diameter of the PFP (AMS (USA)) could be changed using so-called extender caps placed on the proximal part of the PFP (length) or by removing the cuff from the PFP cylinder (diameter). After implantation of both PFP rods, the tunica albuginea of the corpora cavernosa was sutured with separate Vicryl 3.0 sutures (Ethicon, UK), and the wound was sutured in layers. We have never used pressure bandages on the penis, because... careful hemostasis was always achieved, and the pressure of the bandage could cause deterioration of blood supply, lymphatic drainage and swelling of the penis. After the operation, the penis was located parallel to the inguinal fold. Sexual life after uncomplicated PFP implantation was allowed to resume 1-1.5 months after surgery.
Implantation of two-component (Ambicor, AMS, USA) and three-component (AMS-700CX, AMS, USA and Mentor Alpha I, Mentor, USA > HFUR) was carried out only through the longitudinal (Fig. 5.1, B) or (more often) transverse (Fig. 16) penoscrotal approaches. The advantages of penoscrotal approaches for implantation of three-component HFURs are, first of all, the ability to comfortably and efficiently implant all components of the phalloprosthesis (cylinders, reservoir, pump, connecting tubes) through one access, the inconspicuousness of the postoperative scar, and the ability to adequately position connecting tubes of the penile prosthesis in such a way that they are removed from the skin and practically cannot be palpated, in the possibility of fixing the penile prosthesis pump in the desired place of the scrotum, and, finally, in the possibility of better exposure of the cavernous bodies (69). Due to a better cosmetic result (less noticeable and a scar with little deformation) at later stages of work we used the transverse penoscrotal approach.
Rice. 16. Transverse penoscrotal approach
We carried out HFUR implantation with some modifications, which, in our opinion, technically simplified and accelerated the operation, and also contributed to its better cosmetic and functional result, and a decrease in the frequency of PI.
When implanting the HFUR, as well as when implanting the PFP, bougienage and measurement of the length of the cavernous bodies were first performed, and the selection of cylinders of the appropriate length and diameter was performed. If necessary, to lengthen the cylinders, caps were used - extenders, which were put on the proximal ends of the cylinders. Further, the order and technique of implantation of two- and three-component HFURs differed. When implanting two-component HFURs pre-filled at the factory with a 0.9% NaCl solution, the next stages of the operation were creating a pocket in the scrotum for the pump, implanting the cylinders, suturing the tunica albuginea over the cylinders, implanting the pump connected at the factory to the cylinders, testing the penile prosthesis and closing the wound. When implanting three-component HFURs AMS-700 and Mentor Alpha I and their modifications after bougienage of the corpora cavernosa, we tamponed them with turundas soaked in a solution for washing the surgical field, the composition of which is described above, covered the surgical field with a sterile towel and began preparing the components of the prosthesis for implantation. This preparation consisted of removing air from cylinders of pre-selected length and diameter, a reservoir of pre-selected volume and a scrotal pump. After removing the air, the connecting tubes of the penile prosthesis components were clamped with Mosquito-type clamps with silicone tubes pre-attached to the jaws.
The first of the components of the three-component HFUR was the implantation of the reservoir, which, using the penoscrotal access we used, was performed according to the S.K. method. Wilson et al. (177). This technique does not require a separate incision for reservoir implantation, as with the dorsal infrapubical approach. A reservoir of the required volume (60, 90 and 120 ml) is installed in the prevesical space (Pirogov-Retzius space) after perforation of the fascia transversalis with Melzenbaum scissors and the surgeon’s finger slightly medial to the external opening of the inguinal canal. To facilitate this maneuver, a baby Deaver retractor was used (Fig. 17), specially recommended for this purpose by the author of the technique.
Rice. 17. Implantation of a three-component HFUR reservoir (left) and a special baby Deaver retractor (right).
Upon completion of implantation of the reservoir, it was filled with a sterile 0.9% NaCl solution, trying to avoid air bubbles entering the reservoir, and the connecting tube of the reservoir was re-clamped in the manner described above.
The next stage of the three-component HFUR implantation operation is the implantation of cylinders, which is performed in the same way as during the implantation of two-component penile prostheses. First, the proximal part of the cylinders was implanted into the pedicles of the corpora cavernosa. Since the HFUR cylinders are implanted unfilled or soft, a special instrument is used to insert them into the distal part of the cavernous space - the Furlow inserter (Fig. 18), into which a special Keith needle is inserted with threads inserted into its eye, fixed to the distal part of the HFUR cylinder.
Rice. 18. Furlow inserter (left) and installation of a Keith needle into it (right).
Using these threads, after puncturing the head of the penis with a Keith needle from the inside of the distal part of the corpora cavernosa through the head of the penis to the outside using the pusher of the Furlow inserter, the HFUR cylinder is pulled into the distal part of each of the cavernous bodies. Closure of the tunica albuginea of the corpora cavernosa was performed with separate 3.0 or 2.0 Vicryl sutures, with extreme care to prevent puncture and irreversible needle damage to the cylinder. Prevention of damage to the GFUR cylinder when suturing the tunica albuginea of the cavernous bodies is helped by the use of the so-called cylinder defense tool, which is available in both reusable sterilizable (Fig. 19 a) and disposable (included in the penile prosthesis) versions (Fig. 19 6).
Rice. 19 Suturing the tunica albuginea of the corpus cavernosum over the HFUR cylinder.
a) Reusable device. b) Use of a disposable device
The last component of the three-component HFUR was implanted with a scrotal pump, which was placed in a pre-created “pocket” in the tunica dartos in the middle of the scrotum (posterior or anterior to the testicles). The place for the pump in the scrotum was created taking into account cosmetic (invisibility) and functional (ease of use) requirements (Fig. 20).
Rice. 20. Implantation of a scrotal pump of a three-component HFUR.
Next, the connecting tubes of all three components of the HFUR were cut to the required length so that they did not form bends, connected with special locks and fixed using crimping pliers-connectors (Fig. 21).
Rice. 21. Tool for connecting tubes of a three-component HFUR (left) and its use (right).
After which the clamps were removed from the connecting tubes. The normal function of the three-component HFUR was monitored (filling, emptying), the correct positioning of all components of the HFUR was checked, and the functional (hardness of the artificial erection) and cosmetic (lack of deformation) result of implantation was monitored. Careful monitoring of hemostasis, especially bleeding from cavernous spaces, was mandatory. If necessary, additional sutures were placed on cavernosotomies. The wound was sutured in layers with Vicryl threads (3.0 and 4.0).
We tried not to leave any drainage in the postoperative wound, as we believed that this could increase the risk of infection of the penile prosthesis. The functional result of implantation of a three-component HFUR (erection and detumescence) is shown in Fig. 22.
Rice. 22. State after implantation of a three-component HFUR: erection (left) and detumescence (right).
A Foley catheter was placed in the bladder before surgery in the following cases:
- In all cases of implantation of three component HFUR, when it is necessary to empty the bladder in order to prevent damage to the latter during implantation of the reservoir.
- In case of complicated AF due to cavernous fibrosis, iatrogenic oleogranuloma of the penis, prosthetic infection.
- In some cases of AF, when problems with independent urination were expected after surgery.
The catheter was removed in some cases immediately after surgery, usually before the patient was discharged, or at most the next morning after surgery. In one case of intraoperative urethral perforation, the patient had an epicystostomy installed, which was removed 2 weeks after surgery. After implantation of the HFUR for 1-2 days. After the operation, the rigidity cylinders of the penile prosthesis were left filled (erection), which ensured hemostasis and prevention of bleeding from the cavernous spaces. From 2-3 days after the operation and for a period of 4 weeks, the rigidity cylinders were deflated (detumescence), and the reservoir was filled in order to form an adequate scar capsule around it and subsequent prevention of autoinflation (self-inflation or involuntary erection) of the HFUR.
In the first week after the operation, dressings were performed once every 2-3 days, the bandage was removed on the 5-6th day, and the sutures on the 10-12th days after the operation. It was recommended to resume sexual activity after uncomplicated AF after 30-45 days, after complicated ones no earlier than 60 days after surgery.
Complicated implantation of penile prostheses occurred in 34 cases out of 94 AF (36.2%). We attribute such a high frequency of complicated implantations in our practice to the fact that our clinic is known among patients and doctors as specialized in the field of surgical treatment of ED, and patients with the most severe cases of ED, as well as those who have previously been unsuccessfully treated in others, often contact us and are referred. medical institutions.
The reasons for complicated implantation of penile prostheses were the following: cavernous fibrosis - 20 cases, iatrogenic subcutaneous fascial and intracavernous oleogranuloma of the penis - 5 cases, prosthetic infection - 5 cases, replacement of the penile prosthesis due to mechanical problems - 3 cases and implantation against the background of intraoperative perforation of the intercavernous septum and urethra - 1 case.
The structure of complicated implantations is illustrated in Table. 15. In cases of AF against the background of cavernous fibrosis, dissection and excision of the scars of the cavernous bodies were added to the standard stages of the operation. Bougienage of the corpora cavernosa began with bougie with a diameter of at least 9 mm to reduce the risk of perforation of the cavernous bodies and/or urethra. At the same time, we avoided forced bougienage or the use of special cavernotome bougies due to the fact that the use of these techniques and instruments, in our opinion, shared by other authors (126), increases the risk of perforation of the cavernous bodies and urethra. Thus, we preferred to create space in the cavernous bodies and dissect scars under visual control and gave preference to extensive cavernosotomies and visually controlled dissection (Fig. 23) and excision of scar tissue of the cavernous bodies rather than blind forced bougienage.
Rice. 23. Extensive corporotomy for cavernous fibrosis.
Table 15. Characteristics of complicated penile prosthesis
Cause of complicated AF |
Usage |
Usage |
Cavernous fibrosis: Surgery without plastic surgery of the tunica albuginea of the cavernous bodies Surgery with plastic surgery of the tunica albuginea of the cavernous bodies |
||
Iatrogenic subcutaneous fascial and intracavernous oleogranuloma of the penis |
||
Prosthetic infection |
||
Implantation against the background of intraoperative perforation of the intercavernous septum and urethra |
||
Replacement of a penile prosthesis due to mechanical problems |
||
If the diameter of the cavernous space was insufficient and it was impossible to close the tunica albuginea of the corpora cavernosa above the cylinder of the penile prosthesis (Fig. 24), an attempt was first made to implant a penile prosthesis of a narrower diameter, if available. Thus, narrow-diameter AMS-600M PFPs were implanted in 5 patients, narrow-diameter Mentor Alpha NB HFPUs were implanted in 2 patients, and AMS-700 CXM were implanted in one patient. We consider implantation of penile prostheses of narrow diameter in case of cavernous fibrosis in all cases more preferable than plastic surgery of the tunica albuginea if it is impossible to close it over the implanted standard penile prosthesis.
Rice. 24 Defect of the tunica albuginea of the left cavernous body sutured over the prosthesis, requiring plastic replacement.
If it is impossible, due to severe cavernous fibrosis, to close the tunica albuginea over the cylinders of penile prostheses, even of a narrow diameter, or in the absence of such models of penile prostheses, various variants of corporoplasty were used. When closing defects in the tunica albuginea, in 10 cases we used our proposed version of corporoplasty with the skin of the foreskin on a feeding pedicle.
The skin graft was harvested according to the method developed by J. McAninch (106) for plastic replacement of urethral strictures. The length and width of the flap were determined by the size of the defect in the tunica albuginea of the corpora cavernosa. After harvesting, the epidermis of the skin of the foreskin of the flap was removed (diepidermization) and the defect in the tunica albuginea of the corpora cavernosa was closed with a section of diepidermized skin of the foreskin on the feeding pedicle, fixing the skin to the defect in the tunica albuginea with single PDS 3.0 sutures (Ethicon, UK). The appearance of the preputial skin flap is shown in Fig. 25.
Rice. 25. Preputial skin flap on the feeding pedicle of tunica dartos, used for corporoplasty.
The advantages of this technique were considered to be the availability of plastic material (foreskin skin), the absence of possible rejection reactions (autograft), sufficient strength, low probability of necrosis and scarring of the autograft (blood-supplied flap), and the absence of the need to use expensive synthetic and other heterografts. A relative disadvantage of the technique is the need for skills to harvest a preputial skin flap on a pedicle.
In 3 cases, we used patches and tubular vascular prostheses made of tetrafluoroethylene (analogue of GoreTex material, USA) produced by Ecoflon (St. Petersburg) for corporoplasty.
In the presence of obvious signs of prosthetic infection (pain in the area of the implanted components of the penile prosthesis, hyperemia and fixation of surrounding tissues to the infected components of the penile prosthesis, the presence of purulent discharge from the wound or the development of purulent fistulas), antibiotic therapy was prescribed in all cases with drugs active against epidermal staphylococcus (Sraphylococcus Epidermidis), which accounts for most cases of prosthetic infection (36, 181). We used drugs such as vancomycin, ciprofloxacin, cefazolin and cephalexin. If, during antibiotic therapy, signs of prosthetic infection did not disappear, or if they resumed after antibiotic therapy was discontinued, replacing the infected penile prosthesis with a new one was considered mandatory. The key stages of the immediate replacement of an infected penile prosthesis were:
- Access outside the infected wound.
- Removal of all components of the infected penile prosthesis, other foreign objects (threads, plastic materials, etc.), tissues involved in the inflammatory process.
- Abundant rinsing under pressure of the cavernous cavities and other locations of the components of the infected penile prosthesis with solutions of antibacterial drugs. The total volume of solutions is at least 5 liters.
- Reimplantation of a new penile prosthesis.
We consistently used the following as antiseptic solutions for washing:
- A solution containing 1.0 g of cefazolin or 0.5 g of vancomycin in combination with 80 mg of gentamicin per 1.0 liter of sterile 0.9% sodium chloride solution.
- A solution of 1.5% hydrogen peroxide.
- Povidone iodide solution (Betadine, Egis, Hungary) and 0.9% sodium chloride solution in a 1/1 ratio.
- A solution of 1.5% hydrogen peroxide.
- A solution containing 1.0 g of cefazolin or 0.5 g of vancomycin in combination with 80 mg of gentamicin per 1.0 l of sterile 0.9% sodium chloride solution.
This sequence of application of solutions contributed to the removal of infection (antibiotics, povidone iodide, hydrogen peroxide) and the washing of non-viable tissues and foreign bodies (extensive rinsing under pressure). Reimplantation of the penile prosthesis was carried out in the usual manner immediately after completion of washing (Fig. 26) and changing of surgical linen and surgical gloves.
Rice. 26. Copious rinsing of the cavernous cavities with antiseptic solutions after removal of the infected penile prosthesis.
After immediate replacement of the infected penile prosthesis, all patients were prescribed oral antibiotic therapy with ciprofloxacin 0.5 g twice a day or cephalexin 0.5 g three times a day for 2-4 weeks. In the future, upon receipt of the results of microbiological examination of materials from the infected wound, other antibiotics could be prescribed.
Replacement of penile prostheses due to mechanical problems was carried out through an approach similar to that through which the previous penile prosthesis was implanted. Before replacing the penile prosthesis, the cavities in which its components were located were washed with 0.5 - 1.0 liters of an antibiotic solution of the recipe described above. If previous cavernosotomies were sutured with nonabsorbable sutures, the latter were removed because they could serve as a source of foreign body infection.
In case of complicated implantation due to perforation of the tunica albuginea of the corpora cavernosa and urethra, we performed the following sequence of actions:
- A Cystofix trocar epicystostomy (Bard, USA) was installed;
- The defect in the tunica albuginea was sutured with single sutures PDS 3.0 (Ethicon, UK), and the urethra with single sutures Vicryl 4.0 Ethicon, UK).
- The tunica dartos flap of the penis was mobilized and placed between the sutured defects of the tunica albuginea and the urethra.
- A penile prosthesis was implanted.
Although the standard tactics after urethral perforation are the installation of an epicystostomy, suturing the urethra and delayed implantation (DI), due to the insignificant amount of damage, we considered it possible to focus on the tactics described above.
In all 40 cases of uncomplicated PFP implantation, patients were sent home on the day of surgery as soon as the effects of the anesthesia used disappeared.
All patients with complicated AF and with implanted HFUR" (a total of 54 cases) were left in the hospital until the morning of the next day after surgery. Of these, one patient with signs of ischemia of the glans penis after implantation of the PFUR against the background of severe congenital cavernous fibrosis, underwent inpatient treatment in for 2 weeks, during which the penile prosthesis was removed.Another patient with signs of early wound infection after PFP implantation against the background of intracavernous oleogranuloma spent 3 weeks in the hospital, during which the penile prosthesis was removed and massive antibacterial therapy was carried out.
Thus, we performed AF on an outpatient basis and in an overnight hospital setting in 92 cases (97.9%). Inpatient treatment lasting more than 1 day. in the immediate postoperative period, for medical reasons, it was required in 2 of 94 cases (2.1%).
The final stage of this study was devoted to a comparative longitudinal assessment of the quality of sexual life of patients who underwent surgery for simple and complicated AF using PFP and HFUR.
Of the 40 simple PFP implantations, 34 patients and their partners (85%) reported high satisfaction with the results of the operation. Only 1 (2.5%) of the operated patients (a 73-year-old man) had a desire to stop sexual activity 14 months after surgery due to1 a significant decrease in libido due to the development of a pituitary tumor (hyperprolactinoma). Another 3 people (7.5%) complained of instability and bending of the penis during intercourse in the “partner on top” position for 1 year after implantation, then they stopped complaining about it and adapted. Partners of 3 patients (7.5% ) complained about the unnatural feeling of the partner's penis (“cold penis”), but considered these problems to be unimportant. There were no revisions or replacements of penile prostheses.
Of the 25 complicated PFP implantations, 16 patients and their partners (64%) showed high satisfaction with the treatment results, which was almost at the same level as after successful uncomplicated implantations.
In 1 (4%) patient (implantation against the background of penile oleogranuloma), wound suppuration with tissue destruction developed in the early postoperative period. The prosthesis was removed 2 weeks after implantation, and re-implantation was not carried out due to the patient's lack of desire to continue sexual activity.
In 1 patient, against the background of cavernous fibrosis and corporoplasty with tetrafluoroethylene (Ecoflon, St. Petersburg), who had a history of erosion through the urethra of a domestic penile prosthesis in the form of a silicone rod, the AMS-650 penile prosthesis we installed became infected after 3 months. after implantation. The prosthesis and synthetic patches were removed. Re-implantation was not carried out due to the tragic death of the patient.
In another 1 patient, the penile prosthesis became infected 1 year after implantation. He had implantation against the background of severe congenital cavernous fibrosis and corporoplasty of the tunica albuginea of both cavernous bodies along the entire length with synthetic material (tetrafluoroethylene). Within 1 year after the operation, the patient, who had never previously been sexually active, was able to successfully engage in sexual activity. After prosthetic infection developed, the prosthesis and synthetic patches were removed. Re-implantation was not carried out due to the fact that the patient did not have the financial resources to perform repeated reconstructive operations.
In 1 patient, after PFP implantation against the background of severe total congenital cavernous fibrosis, necrosis of the head of the penis developed after surgery. This required removal of the penile prosthesis 12 days after the operation and subsequent reconstructive surgery of microsurgical plastic surgery of the distal part of the penis with a cutaneous subcutaneous fascial forearm flap on a pedicle, which was performed by MD. Falconer M.M. (Medical and surgical center of the Ministry of Health of the Russian Federation, Moscow). After successful engraftment of the flap after 6 months. reimplantation of the AMS-600M PFP was performed with simultaneous reconstruction of artificially created “cavernous spaces” using tubular vascular prostheses made of synthetic material (tetrafluoroethylene). The operation was carried out jointly with Dr. med. Sokolshchik M.M. (Medical and Surgical Center of the Ministry of Health of the Russian Federation, Moscow) and Doctor of Medical Sciences, Professor P.A. Shcheplev. (Central Clinical Hospital of the Administration of the President of the Russian Federation, Moscow). After this operation, we achieved complete sexual rehabilitation of a patient who had never previously been sexually active, and after the operation was able to start a family.
In 1 patient, there was perforation of the intercavernous septum of the tunica albuginea of the cavernous bodies of the penis and urethra. After suturing the perforations, the penile prosthesis was successfully implanted with a high result.
In 4 patients (16%) after implantation against the background of cavernous fibrosis, a prosthetic infection developed in the period from 1 to 16 months after implantation of the PFP (AMS-650 - 2; Mentor AcuForm - 2). All cases are caused. Staph. Epidermidis. After preliminary antibacterial therapy with vancomycin, a successful simultaneous replacement of penile prostheses (according to the method described above) with similar ones was carried out with a good result.
Of the 24 uncomplicated HFUR implantations, 20 (83.3%) were successful, that is, they were not accompanied by complications and normalized the patients’ sex life.
One patient (4%) developed a prosthetic infection due to the fact that he concealed the fact of surgical treatment of purulent periodontitis, which he performed 5 days before surgery. He successfully replaced a two-component HFUR Ambicor (AMS, USA) with a single-component HFUR Dynaflex from the same company.
Another 2 patients (8%) had a subclinical prosthetic infection, which was expressed in increasing pain in the period from 1 to 6 months after the operation of fixing the skin of the scrotum to the penile prosthesis pump implanted into the scrotum. As a result of 2 weeks of intravenous therapy with vancomycin 1.0 g 2 times a day, the subclinical infection was stopped. Patients continue to have a normal sex life.
In 1 patient, the pump of the three-component HFUR AMS-700 CX became infected. The pump was explanted and successfully replaced after 4 months, after which the patient regained his sexual activity.
Of the 5 complicated HFUR implantations, only 1 patient developed a subclinical prosthetic infection, which was expressed in increasing pain in the period from 1 to 6 months after the operation of fixing the skin of the scrotum to the penile prosthesis pump implanted in the scrotum. As a result of 2 weeks of intravenous therapy with vancomycin 1.0 g 2 times a day, the subclinical infection was stopped. The patient continues to have a normal sex life.
The presented statistical data and clinical cases can be illustrated by data from a longitudinal examination of our patients using the EDITS test (Table 16).
Table 16. Testing results (EDITS questionnaire, option 1) of patients with ED after various options for penile prosthesis during observation (M±m) Note 1. Significance of differences in the corresponding indicators (p<0,05): * - между этапами исследования; + -между осложненным и
неосложненным ФП; х - между соответствующими группами пациентов, у которых
использованы разные варианты фаллопротезов. Note 2. In case of reoperation or treatment of complications of AF (see above), the initial examination was carried out after 6 months. after these manipulations are completed. As can be seen from the table presented, in the majority of patients of all groups considered, already after 6 months. After the operation, there was a significant optimization of the quality of sexual life. Average self-assessments of satisfaction with the treatment performed during this observation period were within 75-80% of the maximum possible, which turned out to be significantly higher than in the case of using various conservative treatment options (see Table 4.1). In addition, analysis of the results showed that already in the early period of observation there was a significant (p<0,05) более высокими
самооценки удовлетворенности от проведенного лечения оказались у пациентов,
которым были имплантированы ГФУР (в среднем на 5-8%) как при простом, так и
при осложненном ФП. Причем в наибольшей степени это касалось показателей по
2-му и 3-му доменам теста, характеризующих удобство пользования
фаллопротезом и уверенность больного в своих возможностях совершить половой
акт. Следует подчеркнуть, что именно по этимг доменам в случае использования
консервативных вариантов лечения ЭД регистрировались наиболее низкие
самооценки (см. табл. 4.1), что свидетельствует о принципиально иных
субъективных отношениях к выбранному методу оптимизации половой жизни при
пользовании консервативными способами лечения и фаллопротезами уже на ранней
стадии наблюдения. In our opinion, worthy of special attention is the pattern regarding minor differences in patient satisfaction from surgical treatment for complicated and uncomplicated AF (Fig. 27). Thus, in the case of using PFP, the overall subjective assessment of the quality of sexual life of patients six months after uncomplicated implantations was only 6.2% higher than the same indicator recorded in the group of patients with complicated AF (“zero” level). In the corresponding groups of patients who were implanted with HFURs, this difference was even smaller, averaging 5.4%.
Rice. 27. Relative differences in the degree of satisfaction with treatment in patients with ED with uncomplicated and complicated AF. Consequently, already six months after the operation, the degree of normalization of the sexual life of patients with uncomplicated implantation of penile prostheses and with complicated AF differed slightly. This fact, in our opinion, once again convincingly indicates that the technique we propose for complicated AF is a highly effective radical way of helping patients with extremely severe forms of ED. It is characteristic that the differences in the quality of sexual life of patients after uncomplicated and complicated AF implantations after a year of observation were even more smoothed out, being in the range of 1-1.5%, which confirms our conclusion. Naturally, we understand that in a number of respects, for example, in the number of patients with complicated HFUR implantation, an increase in the number of observations is necessary to confirm this conclusion, but even with such a small number of patients, our results still look quite encouraging. Another important phenomenon noted as a result of longitudinal examinations, in our opinion, should be considered a gradual increase in the average ratings of patient satisfaction with treatment during the year after surgery compared to previous testing (Fig. 28).
Rice. 28. Relative changes in the integral indicator of the EDITS test in patients with severe forms of ED with various types of AF one year after surgery (in% compared to the previous examination) Moreover, these trends were more pronounced in patients who underwent surgery for complicated AF. Thus, in patients who underwent uncomplicated implantation of PFP and HFUR, the average increase in the integral indicator of the EDITS test was 1.2-1.5%, while in patients with complicated AF it was 5.5-6.2%. It should be recalled that in patients who used conservative treatment methods, directly opposite trends were observed during the year of observation (see Chapter 4). This fact indicates fundamental differences in the dynamics of the quality of sexual life between surgical and non-surgical treatment options for ED. As stated earlier, we carried out examinations of many of our patients in the future. However, during at least a 3-year follow-up period, the vast majority of patients whom we had the opportunity to observe did not show significant changes in the parameters of the EDITS test. Additional confirmation of the identified patterns regarding the success of various options for surgical treatment of ED was the data obtained from the analysis of EDITS questionnaires (option 2), filled out by the sexual partners of our patients during the selected observation periods (Table 17). So, after 6 months. After surgery, the vast majority of sexual partners of our patients experienced fairly high satisfaction with the new sexual capabilities of their partners,1 significantly exceeding that when prescribing conservative treatment for ED (see Chapter 4). It was noted that in the early period after surgery. In patients with complicated AF using both types of implants, the quality of sexual life of those examined was slightly worse than after uncomplicated implantations. However, already a year after surgical treatment, these differences were almost completely leveled out, which was noted in the future. Table 17. Results of testing sexual partners of patients in the compared groups using EDITS questionnaires (option 2) during observation (M±m) Variant of AF in a sexual partner (number of patients examined) Examination period Test indicators (%) In 6 mss. after operation 1 year after surgery average rating average rating Uncomplicated AF (n=40) Complicated AF (n=23) Uncomplicated AF (n=24) Complicated AF (n=5)
Note. See notes to table. 16.
These facts, in our opinion, once again confirm the conclusion about the high success of our operations for complicated AF, which is practically no different from that during uncomplicated implantations.
In a comparative analysis of the data obtained from respondents in the surveyed groups, it turned out that treatment options using HFUR were more successful in terms of sexual satisfaction of sexual partners, which allows us to consider this option of FP as the most effective.
Interesting, in our opinion, is the fact that in general, the EDITS test scores obtained when examining sexual partners were, in the vast majority of cases, at a higher level than those of their husbands. When surveying women, it turned out that this was due to the subjectively felt naturalness and good quality of erection in their sexual partner, the completion of sexual intercourse, the possibility of spontaneous sex, etc. Naturally, the high satisfaction of sexual partners with the new quality of sexual life for the majority of patients was an extremely important positive factor that optimizes their psychological state and increases self-esteem, which was proven during a series of psychophysiological studies traditional for this work.
In table Figure 18 shows the dynamics of the “psychophysiological index of severity of ED” (“index of psychological distress”) we used in patients of the selected groups during the observation process.
Table 18. Dynamics of the “psychological distress index” (cu) in patients with severe forms of ED during observation (M±t)
Note 1. Differences compared to the initial state are significant (p<0,001) во всех группах.
Note 2. Significance of differences in the corresponding indicators (p<0,05): * - по сравнению со 2-м этапом исследования; + - между осложненным и неосложненным ФП; х - между соответствующими группами пациентов, у которых использованы разные варианты фаллопротезов.
Note 3. See note 2 to table. 16.
As one would expect, the results of the study of patients in the initial (preoperative) state indicated extremely negative (the maximum value of the described index is 3.00) deviations in the psychophysiological status of the majority of patients associated with severe psychological distress from impaired copulative function.
Studies conducted six months after surgery showed a significant optimization of the psychophysiological status of patients in all studied groups, which correlated with satisfaction from the treatment. Thus, these trends turned out to be more pronounced in patients who underwent uncomplicated implantation of penile prostheses, and in the group of patients where HFUR was used, the value of the described index was significantly lower. Taking into account the data obtained, we consider this particular treatment option for severe forms of ED to be the method of choice, since its use is not only the most convenient and physiological, accompanied by the best improvement among other radical methods in the quality of the patients’ sexual life, but also leads to the most pronounced optimization of their psychophysiological state.
As for the smaller effect of operations on complicated AF in reducing the psychological distress of patients, this is apparently due to the initially greater degree of its severity in such patients. As our direct observations have shown, these patients require especially sensitive treatment from medical personnel, and in some cases require psychotherapeutic assistance in the system of preoperative preparation measures.
We consider the fact that just a year after surgery using the methods we used, the degree of severity of psychological distress was at a level approaching that of individuals in the corresponding groups with uncomplicated implantation of penile prostheses to be very encouraging and important for confirming the scientific positions presented in this work. . At the same time, in patients with implanted HFURs, these positive trends turned out to be more pronounced, which once again indirectly confirmed our position about the greater success of treatment using these penile prostheses.
To briefly summarize the data presented in this section of the study, it should be emphasized that AF is the most effective way to treat severe forms of ED, accompanied by a significantly greater positive effect on the quality of sexual life of such patients and their psychophysiological status than conservative therapy. With complicated AF, these trends appear almost to the same extent as when using uncomplicated AF, but reach their maximum development at a slightly later date from the moment of surgery, which should be taken into account when predicting and assessing the effectiveness of the treatment.