The whole truth about phaloprosthetics or an expert's thoughts on penile prosthetics in Russia. What is penile prosthesis and features of the treatment of impotence by a radical method Preparation for surgery
Phalloprosthesis is a modern surgical technique. The first attempts to install prostheses in the penis were made in the 30s of the last century, but the method gained practical significance only after the use of silicone implants began. Bioinert silicone rarely caused complications and was well suited for the manufacture of various designs. Since then, the field of penile prosthesis 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 departments of andrology.
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. Phalloprosthesis is performed for erectile dysfunction caused by atherosclerosis, angiopathy in diabetes mellitus, other vascular disorders in arterial diseases and persistent metabolic disorders. The method is also used for impotence resulting from interventions on the pelvic organs.
Psychogenic impotence, resistant to repeated courses of conservative therapy, is considered as an indication for penile prosthetics. The intervention is carried out in the presence of medical contraindications to drug and non-drug methods of erection stimulation and if the listed methods are personally unacceptable for the patient. In addition, penile prosthetics is performed after the creation of an artificial penis when changing sex.
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 phalloprosthesis 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 prosthetics
The andrologist examines the patient and draws up an examination plan taking into account the identified pathology. When determining indications, the results of cavernosography, cavernosometry, papaverine test, ultrasound of the penis, caverject test are used. After analyzing the results of the examination, the doctor selects the prosthesis of the right size, taking into account the anatomical structure of the male penis. On the evening before and in the morning on the day of penile prosthetics, the area of the external genitalia should be treated with a disinfectant solution. Hair in the area of operation must be removed. 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. Falloprosthetics 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 a memory allows the prosthesis to maintain a certain position. Before the onset of sexual intercourse, the patient raises the penis with his hand, and after the completion of sexual contact, lowers the organ downwards.
Phalloprosthetics 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 placed in the cavernous bodies of the penis. For the onset of an erection, the patient presses the pump several times, the liquid enters the reservoirs through the tubes, the penis becomes hard and increases in size. To return the penis to a non-erect state, the patient bends the organ and holds it for several seconds until the fluid moves back into the pump.
Installing an inflatable three-component prosthesis is the most modern way to provide an artificial erection. A three-piece prosthesis consists of hollow cylinders, a pump and a fluid reservoir. The cylinders are placed in the cavernous bodies, the pump is implanted in the scrotum, the reservoir is placed behind the pubic joint. To achieve an erection, the patient repeatedly presses on one area of the scrotum, to eliminate an erection - on another.
The installation of all types of prostheses is carried out under general anesthesia. In most cases, a subpubic, penoscrotal, or subcoronal approach is used to install a prosthesis in the penis; less commonly, ventral, dorsal, perineal, or suprapubic approaches are used. During phalloprosthetics, the fascia of the penis is peeled off to the albuginea, then the cavernous bodies are dissected and channels are formed for the installation of implants.
In patients with fibrosis of the penis, if necessary, the reconstruction of the cavernous bodies is performed. When using an inflatable prosthesis, a pump pocket is formed in the scrotum. When phalloprosthesis with a three-component implant, a cavity for the reservoir is created in the area of the pubic joint. The bleeding vessels are coagulated, the components of the prosthesis are placed, and the operability of the implant is checked. Wounds are sutured and covered with sterile dressings. The duration of the operation is 1.5-2 hours.
After penile prosthesis
For several days, the patient is advised to stay in bed. Dressings are carried out, parenteral administration of analgesics and antibacterial agents is carried out. The sutures are removed on the 7-10th day. The duration of hospitalization varies from 2-3 to 7-10 days, depending on the specific clinic and operation technique. Sexual intercourse is allowed after 1.5 months.
Abundant bleeding, damage to the urethra and neurovascular bundles are rare. In the early postoperative period, pain, swelling and infection of the wound are possible. Excited penis after the operation on average becomes shorter by 1.5 cm. Feelings of 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. Phalloprosthetics cannot cure impotence, after the removal of the implant, an independent erection is impossible.
Three-piece hydraulic penile prostheses
Of the currently available phalloprostheses, these prostheses are the most advanced in terms of natural erection and maintaining the resting state of the penis. They contain two cylinders placed in the cavernous bodies, a reservoir placed in the area behind the pubis, and a pressure pump placed in the scrotum. All components are connected to each other by tubes. To get an erection, you need to squeeze the pump several times, and to put the penis in a calm state, press the pump's bleed valve.
Such prostheses are produced by companies:
A clear advantage of these penis prostheses is their best functional result and penis appearance. 30 year product warranty.
- AMS 700CX
- AMS 700 LGX
- Coloplast Titan OTR
- Coloplast Titan Touch
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Two-piece hydraulic penile prostheses
This type of prosthesis consists of two cylinders with built-in reservoirs installed in the cavernous bodies, and a pump installed in the scrotum. The pump is connected to the cylinders by tubes. To achieve an erection, you need to squeeze the pump several times, while the fluid from the reservoirs enters the cylinders and hardens them. To remove the state of erection, the penis must be bent and held in this position for several seconds until maximum relaxation is obtained.
This type of penile prosthesis has a more natural erection and a more natural state of rest. However, two-component prostheses are inferior in their qualities to three-component ones, and therefore they are used quite rarely today.
Two-component hydraulic penile prostheses are produced by AMS Ambicor (Ambicor).
Semi-rigid (plastic) penile prostheses
Such a 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 a plastic memory that ensures that the specified position of the penis is maintained. When the moment of 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 permanent rigidity.
Examples of such penile prostheses are prostheses manufactured by companies:
- AMS Spectra Concealable (Spectra);
- Coloplast Genesis Malleable Penile Prosthesis (Genesis);
- Promedon Tube Malleable Penile Prosthesis
The cost of implantation of the prosthesis
penis - 120,800 rubles
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As shown in the previous chapters of the work, the improvement of methods of conservative treatment of ED, as well as their active advertising, has dramatically increased the attractiveness of ED treatment, and made it easier for such patients to make a decision to seek medical help. Accordingly, the number of patients in whom the 1st and 2nd lines of ED therapy turned out to be ineffective increased, since conservative ED therapy in the vast majority of cases is not curative.
B1 related to this; the urologist, as a representative of the surgical specialty, becomes an expert, to whom patients who are not effectively treated conservatively get. The most effective treatment for ED in these patients is AF, which results in the highest patient and partner satisfaction compared to all other ED treatments (112).
In this section of the work, the results of our research on the optimization of PF methods will be presented. comparative assessment of the success of operations of uncomplicated and complicated FI-
The material for this chapter was based on the results, examinations and treatment of 88 patients with severe ED who underwent penile prosthesis. The patient underwent removal and re-prosthetics of the neophallus due to necrosis of the glans penis In total, implanted: 65 PFP (of which 40 were simple implantations and 25 complicated) ^ 29TFUR (of which 24 were simple and 5 complicated). phalloprosthesis is given in chapter 2.
At. 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) started 24 hours before surgery.
- On the evening before the operation and in the morning on the day of the operation, thoroughly wash the body using antiseptic soap.
- Shaving the surgical field immediately before the operation.
- Careful processing of the surgical field with a 5% solution of povidone iodide for at least 10 minutes.
- Use of disposable surgical underwear and double gloves.
- Periodic - washing 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.
- Restriction of movements 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 one-component HFUR Dynaflex (AMS, USA) was most often performed through paracoronal access, less often through dorsal infrapubic and longitudinal penoscrotal access (Fig. 13, A, B, C).
Rice. 13. Variants of the most commonly used approaches for implantation of PFP and single-component HFUR. A. Paracoronal access. B. Dorsal infrapubic approach. B. Longitudinal penoscrotal approach
The choice of access was carried out taking into account the upcoming features of the operation and the wishes of the patient. For example, in case of PFP implantation against the background of cavernous fibrosis or iatrogenic oleogranuloma, only paracoronal access was used, which allows to fully expose the entire stem part of the penis (deglavating), 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 infrapubic approach, which we tried to avoid due to the possibility of damage to the dorsal neurovascular bundle. After exposing the cavernous bodies and applying holders to them, a longitudinal cavernosotomy was performed (Fig. 14).
Rice. fourteen. Longitudinal cavernosotomy on the right with transverse penoscrotal access.
The cavernous bodies of the penis were bougied with straight specially made metal bougies of a predetermined diameter up to the maximum length and diameter. The length of the awakened corpora cavernosa was measured with a special instrument (sizer) in relation to one of the selected holders applied to the albuginea of the corpora cavernosa (Fig. 15).
Rice. fifteen. Sizer (in the middle) and bougie for penile prosthetics.
In accordance with the data of these measurements, a PFP of the required length and diameter was selected, which was implanted in the cavernous bodies of the penis. If necessary, before implantation, the length and diameter of the PFP from AMS (USA) could be changed using the so-called extender caps put 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 albuginea of the cavernous bodies was sutured with separate sutures Vicryl 3.0 (Ethicon, UK), the wound was sutured in layers. We have never used pressure bandages on the penis, because. thorough hemostasis was always achieved, and the pressure of the bandage could cause a deterioration in blood supply, lymphatic drainage and swelling of the penis. After the operation, the penis was located parallel to the inguinal fold. Sex life after uncomplicated PFP implantation was allowed to be resumed 1-1.5 months after the operation.
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, C) or (more often) transverse (Fig. 16) penoscrotal approaches The advantages of penoscrotal approaches for the implantation of three-component HFUR are, first of all, in the ability to comfortably and efficiently implant all the components of the phalloprosthesis (cylinders, reservoir, pump, connecting tubes) through one access, in the invisibility of the postoperative scar, in the ability to adequately position connecting tubes of the penile prosthesis in such a way that they are removed from the skin and practically not palpable, in the possibility of fixing the pump of the penile prosthesis in the desired location 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 slightly deforming scar) at the later stages of the work, we used the transverse penoscrotal approach.
Rice. 16. Transverse penoscrotal approach
HFUR implantation was carried out by us with some modifications, which, in our opinion, technically simplified and accelerated the operation, as well as contributed to its better cosmetic and functional result, and a decrease in the frequency of PI.
During implantation of HFUR, as well as during implantation of PFP, bougienage and measurement of the length of the corpora cavernosa, selection of cylinders of the appropriate length and diameter were first performed. If necessary, caps - extenders were used to lengthen the cylinders, which were put on the proximal ends of the cylinders. Further, the order and technique of implantation of two- and three-component HFUR differed. During implantation of two-component HFUR pre-filled with 0.9% NaCl solution at the factory, the next stages of the operation were creating a pocket in the scrotum for the pump, implantation of the cylinders, suturing the albuginea over the cylinders, implantation of the pump connected to the cylinders at the factory, testing the phalloprosthesis and closing the wound. When implanting three-component HFUR AMS-700 and Mentor Alpha I and their modifications after bougienage of the cavernous bodies, we tamponated 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 proceeded to prepare the components of the prosthesis for implantation. This preparation consisted of the removal of air from cylinders of preselected length and diameter, a reservoir of preselected volume, and a scrotal pump. After the air was removed, the connecting tubes of the falloprosthesis components were clamped with Mosquito-type clamps with silicone tubes previously put on the jaws.
The first of the components of the three-component HFUR, we carried out the implantation of the reservoir, which, using the penoscrotal approach we used, was performed according to the S.K. Wilson et al. (177). This technique does not require a separate incision for reservoir implantation, as with the dorsal infrapubic approach. The 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 somewhat medially to the external opening of the inguinal canal. To facilitate this maneuver, the baby Deaver retractor (Fig. 17) was used, which was specially recommended for this purpose by the author of the technique.
Rice. 17. Implantation of a three-component HFUR reservoir (left) and a special retractor baby Deaver (right).
Upon completion of the reservoir implantation, it was filled with a sterile 0.9% NaCl solution, trying to avoid air bubbles entering the reservoir, the reservoir connecting tube was re-clamped as described above.
The next stage of the implantation of three-component HFUR is the implantation of cylinders, which is performed in the same way as with the implantation of two-component penile prostheses. First, the proximal part of the cylinders was implanted into the pedicles of the cavernous bodies. Since HFUR cylinders are implanted unfilled or soft, a special tool 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 embedded with threads inserted into its eye, fixed to the distal part of the HFUR cylinder.
Rice. eighteen. Furlow inserter (left) and insertion of a Keith needle into it (right).
For these threads, after puncturing the head of the penis with a Keith needle from the inside of the distal part of the cavernous bodies through the head of the penis outward using the Furlow inserter pusher, the HFUR cylinder is drawn into the distal part of each of the cavernous bodies. Closing of the albuginea of the cavernous bodies was carried out with separate Vicryl 3.0 or 2.0 sutures with special care aimed at preventing puncture and irreversible damage to the cylinder by the needle. The use of the so-called cylinder defense tool (cylinder defense tool), which is available both in reusable sterilized (Fig. 19 a) and disposable (included in the set of penloprosthesis) versions, helps to prevent damage to the HFUR cylinder during suturing of the albuginea of the cavernous bodies (Fig. 19). 6).
Rice. 19 Suturing of the albuginea of the cavernous body over the HFUR cylinder.
a) Reusable device. b) Use of a disposable device
The last of the components 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 HFUR components were cut to the required length so that they did not form bends, connected with special locks, and fixed using crimping forceps-connectors (Fig. 21).
Rice. 21. A tool for connecting tubes of a three-component HFUR (left) and its use (right).
After that, the clamps from the connecting tubes were removed. The normal function of the three-component HFUR was monitored (filling, emptying), the correct positioning of all HFUR components was checked, the functional (hardness of artificial erection) and cosmetic (absence of deformations) implantation result was monitored. Careful control of hemostasis was mandatory, especially bleeding from cavernous spaces. If necessary, additional sutures were placed on the 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 falloprosthesis. The functional result of implantation of a three-component HFUR (erection and detumescence) is shown in Figure 22.
Rice. 22. Condition after implantation of three-component HFUR: erection (left) and detumescence (right).
A Foley catheter was placed before surgery in the bladder 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 reservoir implantation.
- With complicated AF against the background of cavernous fibrosis, iatrogenic oleogranuloma of the penis, prosthetic infection.
- In some cases of AF, when problems with independent urination after surgery were expected.
The catheter was removed in some cases immediately after the operation, usually before the patient was discharged, maximum the next morning after the operation. In one case of intraoperative urethral perforation, the patient had an epicystostomy, which was removed 2 weeks after surgery. After HFUR implantation for 1-2 days. after the operation, the rigidity cylinders of the phalloprosthesis 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 HFUR.
In the first week after the operation, dressings were performed once a day, 2-3 days, the dressing was removed on the 5-6th day, and the stitches on the 10-12th day after the operation. It was recommended to resume sexual life after uncomplicated AF after 30-45 days, after complicated ones not earlier than 60 days after the operation.
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 previously unsuccessfully treated in other medical institutions.
The reasons for complicated implantation of penile prostheses were as follows: 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 failures - 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, incision and excision of the scars of the cavernous bodies were added to the standard stages of the operation. Bougienage of the corpora cavernosa was started with a bougie at least 9 mm in diameter 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 bougie-cavernotomes 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 preferred extensive cavernosotomies and visually controlled dissection (Fig. 23) and excision of the scar tissue of the corpora cavernosa, rather than blind forced bougienage.
Rice. 23. Extensive corporotomy in cavernous fibrosis.
Table 15 Characteristics of complicated penile prosthesis
Cause of complicated AF |
Usage |
Usage |
Cavernous fibrosis: Operation without plasty of the tunica albuginea of cavernous bodies Operation with plasty of the tunica albuginea of 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 |
||
Replacing a penile prosthesis due to mechanical problems |
||
With an insufficient diameter of the cavernous space and the impossibility of closing the albuginea of the cavernous bodies above the falloprosthesis cylinder (Fig. 24), an attempt was first made to implant a falloprosthesis of a narrower diameter, if any. Thus, AMS-600M narrow-diameter PFP were implanted in 5 patients, Mentor Alpha NB narrow-diameter HFUR - 2, and AMS-700 CXM - in one patient. In all cases, we consider the implantation of a narrow-diameter phalloprosthesis in cavernous fibrosis to be more preferable than the plasty of the albuginea if it is impossible to close it over the implanted standard phalloprosthesis.
Rice. 24 A defect in the albuginea of the left cavernous body sutured over the prosthesis requiring plastic replacement.
If it was impossible due to pronounced cavernous fibrosis to close the albuginea over the cylinders of phalloprostheses of even a narrow diameter or in the absence of such models of phalloprostheses, various types of corporoplasty were used. When closing defects of the albuginea, in 10 cases we used the variant of corporoplasty proposed by us with the skin of the foreskin on the nourishing pedicle.
The skin flap was taken 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 cavernous bodies. After sampling, the epidermis of the skin of the foreskin of the flap was removed (die-epidermization) and the defect of the tunica albuginea of the cavernous bodies was closed with a section of the dia-epidermalized skin of the foreskin on the nourishing pedicle, fixing the skin to the defect of the albuginea with single PDS 3.0 sutures (Ethicon, UK). The appearance of the preputial skin flap is shown in Figure 25.
Rice. 25. A preputial skin flap on a pedunculated tunica dartos used for corporoplasty.
The advantage of this technique was the availability of plastic material (skin of the foreskin), the absence of possible rejection reactions (autograft), sufficient strength, low probability of necrosis and scarring of the autograft (blood-supplied flap), no need to use expensive synthetic and other heterografts. A relative disadvantage of the technique can be considered the need for skills to collect a preputial skin flap on a feeding leg.
In 3 cases, we used for corporoplasty patches and tubular vascular prostheses made of tetrafluoroethylene (an analogue of GoreTex material, USA) manufactured by Ecoflon (St. Petersburg).
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 the surrounding tissues to the infected components of the penile prosthesis, the presence of purulent discharge from the wound or the development of purulent fistulas), in all cases, antibiotic therapy was prescribed with drugs active against Staphylococcus epidermidis (Sraphylococcus Epidermidis), which is the cause of most cases of prosthetic infection (36, 181). We used drugs such as vancomycin, ciprofloxacin, cefazolin and cephalexin. If the signs of prosthetic infection did not disappear during antibiotic therapy, or if they resumed after antibiotic therapy was discontinued, the replacement of the infected phalloprosthesis with a new one was considered mandatory. The key stages of the simultaneous replacement of an infected phalloprosthesis were:
- Access outside the infected wound.
- Removal of all components of an infected phalloprosthesis, other foreign objects (threads, plastic materials, etc.), tissues involved in the inflammatory process.
- Abundant washing under pressure of cavernous cavities and other locations of the components of an infected phalloprosthesis with solutions of antibacterial drugs. The total volume of solutions is not less than 5 liters.
- Reimplantation of a new penile prosthesis.
As antiseptic solutions for washing, we consistently used:
- 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.
- A solution of 1.5% hydrogen peroxide.
- A solution of povidone iodide (Betadine, Egis, Hungary) and 0.9% sodium chloride solution in a ratio of 1/1.
- A solution of 1.5% hydrogen peroxide.
- 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.
Such a 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 (abundant washing under pressure). Reimplantation of the penile prosthesis was carried out in the usual manner immediately after the completion of washing (Fig. 26) and the change of surgical linen and surgical gloves.
Rice. 26. Abundant washing of cavernous cavities with antiseptic solutions after removal of an infected phalloprosthesis.
After the simultaneous replacement of an 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. Later, upon receipt of the results of microbiological examination of materials from an infected wound, other antibiotics could be prescribed.
Replacement of penile prostheses due to mechanical problems was carried out through an access similar to that through which the previous penile prosthesis was implanted. Before replacing the phalloprosthesis, the cavities in which its components were located were washed with 0.5 - 1.0 l of an antibiotic solution of the formulation described above. If previous cavernosotomy was sutured with non-absorbable sutures, the latter were removed, as they could serve as a source of infection associated with a foreign body.
In case of complicated implantation against the background of perforation of the albuginea of the cavernous bodies and the urethra, we performed the following sequence of actions:
- A trocar epicystostomy Cystofix (Bard, USA) was installed;
- The defect of the albuginea was sutured with single sutures PDS 3.0 (Ethicon, UK), and the urethra with single sutures Vicryl 4.0 Ethicon, UK).
- A tunica dartos flap of the penis was mobilized and placed between the sutured defects of the albuginea and urethra.
- A phalloprosthesis was implanted.
Although the standard tactic after urethral perforation is epicystostomy, urethral suturing, and delayed implantation (DID), due to the small amount of damage, we considered it possible to stick to the tactics described above.
In all 40 cases of uncomplicated PFP implantation, patients were allowed to go 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 the operation. Of these, one patient with signs of ischemia of the glans penis after implantation of the PFH against the background of severe congenital cavernous fibrosis, was hospitalized in One more patient with signs of early infection of the wound after PFP implantation against the background of intracavernous oleogranuloma spent 3 weeks in the hospital, during which the removal of the phalloprosthesis was performed and massive antibiotic therapy was carried out.
Thus, AF on an outpatient basis and in the daily hospital regime was carried out by us 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 out 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 PAF and HFUR.
Out of 40 simple PFP implantations, 34 patients and their partners (85%) showed 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 having sex 14 months after the operation due to 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 insignificant.There were no revisions and replacements of penile prostheses.
Out of 25 complicated PAF implantations, 16 patients and their partners (64%) showed high satisfaction with the results of treatment, 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 on the background of cavernous fibrosis and corporoplasty with tetrafluoroethylene (Ecoflon, St. Petersburg), who had a history of erosion through the urethra of a domestic phalloprosthesis in the form of a silicone rod, infection of the AMS - 650 phalloprosthesis installed by us occurred 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 1 more patient, the falloprosthesis became infected 1 year after implantation. He had implantation against the background of severe congenital cavernous fibrosis and corporoplasty of the albuginea of both cavernous bodies throughout with synthetic material (tetrafluoroethylene). Within 1 year after the operation, the patient, who had never had a sexual life before, was able to successfully conduct it. After the development of a prosthetic infection, 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 means to perform repeated reconstructive operations.
Necrosis of the head of the penis developed in 1 patient after PFP implantation against the background of severe total congenital cavernous fibrosis. This required the removal of the phalloprosthesis 12 days after the operation and the subsequent reconstructive and restorative operation of microsurgical plastic surgery of the distal part of the penis with a skin-subcutaneous-fascial flap of the forearm on a feeding leg, which was performed by Dr. Sokolshchik M.M. (Medical and Surgical Center of the Ministry of Health and Social Development of the Russian Federation, Moscow). After successful engraftment of the flap after 6 months. reimplantation of AMS-600M PAF was performed with simultaneous reconstruction of artificially created "cavernous spaces" using tubular vascular prostheses made of synthetic material (tetrafluoroethylene). Sokolshchik M.M. (Medical and Surgical Center of the Ministry of Health and Social Development of the Russian Federation, Moscow) and Doctor of Medical Sciences, Professor Shcheplev P.A. (Central Clinical Hospital of the Administration of the President of the Russian Federation, Moscow). After this operation, we achieved a complete sexual rehabilitation of a patient who had never had a sexual life before, and after the operation was able to start a family.
One patient had perforation of the intercavernous septum of the albuginea of the cavernous bodies of the penis and urethra. After suturing the perforations, a successful implantation of the phalloprosthesis was carried out 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 PFP (AMS-650 - 2; Mentor AcuForm - 2). All cases are called. Staph. epidermidis. After preliminary antibacterial therapy with vancomycin, a successful one-stage replacement of phalloprostheses (according to the method described above) was carried out with similar ones 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 sexual life of patients.
One patient (4%) developed a prosthetic infection due to the fact that he hid the fact of surgical treatment of purulent periodontitis, which he performed 5 days before the operation. He underwent a successful one-stage replacement of the two-component HFUR Ambicor (AMS, USA) with the one-component HFUR Dynaflex of 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 phalloprosthesis pump implanted in the scrotum. As a result of 2-week intravenous therapy with vancomycin 1.0 g 2 times a day, the subclinical infection was stopped. Patients continue normal sexual life.
In 1 patient, the pump of the three-component HFUR AMS-700 CX became infected. The pump was explanted and successfully replaced 4 months later, 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 scrotum skin to the falloprosthesis pump implanted in the scrotum. As a result of 2-week intravenous therapy with vancomycin 1.0 g 2 times a day, the subclinical infection was stopped. The patient continues a normal sexual life.
An illustration of the presented statistical data and clinical cases can be the data of a longitudinal examination of our patients using the EDITS test (Table 16).
Table 16 Results of testing (EDITS questionnaire, option 1) of patients with ED after various options for penile prosthesis during observation (M±m) Note 1. Reliability of differences between 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 the case of reoperation or treatment of complications of AF (see above), the initial examination was performed after 6 months. after these manipulations. As can be seen from the presented table, in most patients of all the groups considered, after 6 months. After the operation, there was a significant optimization of the quality of sexual life. Mean self-assessments of satisfaction with the treatment 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 options for conservative treatment (see Table 4.1). In addition, the analysis of the obtained results showed that already in the early period of observation, significantly (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. Deserving special attention, in our opinion, is a regularity regarding minor differences in patient satisfaction from surgical treatment with complicated and uncomplicated AF (Fig. 27). Thus, in the case of the use of PAF, the overall subjective assessment of the quality of sexual life of patients six months after uncomplicated implantations was only 6.2% higher than that recorded in the group of patients with complicated AF (“zero” level). In the corresponding groups of patients who were implanted with HFUR, this difference was even smaller, averaging 5.4%.
Rice. 27. Relative differences in the degree of satisfaction with the treatment in patients with ED with uncomplicated and complicated AF. Therefore, already six months after the operation, the degree of normalization of the sexual life of patients with uncomplicated implantation of phalloprostheses and with complicated AF differed slightly. This fact, in our opinion, once again convincingly indicates that the technique of complicated AF we propose is a highly effective radical method of helping patients with extremely severe forms of ED. Characteristically, the differences in the quality of sexual life of patients after uncomplicated and complicated implantation of AF after a year of observation were even more smoothed out, being within 1-1.5%, which confirms our conclusion. Naturally, we understand that in a number of positions, 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 surveys, in our opinion, should be considered a gradual increase in the average estimates of patient satisfaction with the treatment performed during the year after surgery compared with the previous testing (Fig. 28).
Rice. Fig. 28. Relative shifts of 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 with the previous examination) At the same time, these trends were more pronounced in patients who underwent surgery for complicated AF. Thus, in patients who underwent uncomplicated implantation of PAF 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 methods of treatment, during the year of observation, there were directly opposite trends (see Chapter 4). This fact indicates fundamental differences in the dynamics of the quality of sexual life in surgical and non-surgical options for the treatment of ED. As stated earlier, we have examined many of our patients in the future. At the same time, during at least a 3-year follow-up period, in the vast majority of patients whom we had the opportunity to observe, there was no significant change in the parameters of the EDITS test. Additional1 confirmation of the revealed patterns regarding the success of various options for surgical treatment of ED was the data obtained from the analysis of the EDITS questionnaires (option 2) filled out by the sexual partners of our patients in the selected observation periods (Table 17). Yes, 6 months later. after surgery, the vast majority of our patients' sexual partners experienced a fairly high satisfaction with the new sexual possibilities 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 with. In patients with complicated AF using both variants of implants, the quality of sexual life of the examined patients was somewhat worse than after uncomplicated implantation. However, already a year after surgical treatment, these differences were almost completely leveled, which was noted in the future. Table 17 The results of testing sexual partners of patients of the compared groups using EDITS questionnaires (option 2) during the observation process (M ± m) Variant of AF in a sexual partner (number of examined) Examination period Test scores (%) After 6 ms. 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 rate of complicated AF operations performed by us, which practically does not differ from that in uncomplicated implantations.
In a comparative analysis of the data obtained from the respondents of the surveyed groups, it turned out that treatment options using HFUR turned out to be more successful in terms of sexual satisfaction of sexual partners, which allows us to consider this variant of AF as the most effective.
Interesting, in our opinion, is the fact that, in general, the EDITS test scores obtained from the examination of sexual partners in the vast majority of cases were at a higher level than that of their husbands. When interviewing the examined women, it turned out that this was due to the naturalness and good quality of erection in their sexual partner, subjectively felt by them, 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 most patients was an extremely important positive factor optimizing their psychological state and increasing self-esteem, which was proved during a series of psychophysiological studies traditional for this work.
In table. 18 shows the dynamics of the “psychophysiological index of the severity of ED” (“psychological distress index”) used by us in patients of the selected groups during the observation process.
Table 18. Dynamics of the “index of psychological distress” (c.u.) in patients with severe forms of ED during follow-up (M±m)
Note 1. Differences from baseline are significant (p<0,001) во всех группах.
Note 2. Reliability of differences between 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 expected, the results of the study of patients in the initial (before surgery) state indicated extremely negative (the maximum value of the described index is 3 c.u.) deviations in the psychophysiological status of most patients associated with severe psychological distress from impaired copulative function.
Studies conducted six months after the operation showed a significant optimization of the psychophysiological status of patients in all groups examined, which correlated with satisfaction with the treatment. Thus, these trends were 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 in the quality of patients' sexual life among other radical methods, but also leads to the most pronounced optimization of their psychophysiological state.
As for the lower effect of the operations performed with complicated AF in terms of 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 need a particularly delicate attitude on the part of medical personnel, and in some cases they require psychotherapeutic assistance in the system of preoperative preparation measures.
We consider it very encouraging and important to confirm the scientific provisions presented in this paper that already a year after the surgical intervention, according to the methods we used, the degree of psychological distress was at a level approaching that in persons of the corresponding groups with uncomplicated implantation of penile prostheses. . At the same time, in patients with implanted HFUR, these positive trends were more pronounced, which once again indirectly confirmed our position on the greater success of treatment using these phalloprostheses.
Summing up 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 than conservative therapy on the quality of sexual life of such patients, their psychophysiological status. In complicated AF, these tendencies manifest themselves almost to the same extent as in the case of uncomplicated AF, however, they reach their maximum development somewhat later after the operation, which should be taken into account when predicting and evaluating the effectiveness of the treatment.