© Borgis - Postępy Nauk Medycznych 11/2016, s. 846-851
*Michał A. Skrzypczyk1, Damian Sujecki1, Łukasz Nyk2, Maciej Zbrzeźniak1, Stanisław Szempliński1, Jakub Dobruch1, 2
Artificial urinary sphincter – new devices in male urinary incontinence treatment
Nowe konstrukcje zwieraczy hydraulicznych wykorzystywane w leczeniu nietrzymania moczu u mężczyzn
12nd Unit of Didactics, Department of Urology, Centre of Postgraduate Medical Education, Professor W. Orłowski Independent Public Teaching Hospital, Warsaw
Head of Department: Jakub Dobruch, MD, PhD
21st Unit of Didactics, Department of Urology, Centre of Postgraduate Medical Education, European Health Centre Otwock
Head of Department: Jakub Dobruch, MD, PhD
Częstość występowania nietrzymania moczu (ang. urinary incontinence – UI) wśród mężczyzn wynosi od 4,81 do 32,17% i wzrasta wraz z wiekiem. UI może być następstwem leczenia chirurgicznego mężczyzn dotkniętych łagodnym rozrostem gruczołu krokowego (ang. benign prostate hyperplasia – BPH) i/lub rakiem gruczołu krokowego (ang. prostate cancer – PCa). Najczęściej stosowanym i do niedawna jedynym sposobem leczenia nietrzymania moczu u mężczyzn była implantacja sztucznego zwieracza cewki moczowej (ang. artificial urinary sphincter – AUS) typu AMS 800 (American Medical System). Ze względu na różnice w stopniu nasilenia nietrzymania moczu, niemałą liczbę powikłań oraz koszty związane ze wszczepieniem AUS, w ostatnich latach powstało szereg nowych urządzeń dedykowanych chorym dotkniętym UI. Konstrukcje te posiadają nowe rozwiązania technologiczne, które powinny zapewnić co najmniej podobne wyniki czynnościowe i doprowadzić do zmniejszenia liczby powikłań towarzyszących wszczepieniu AUS. W opracowaniu przedstawiono przegląd nowych urządzeń stosowanych w leczeniu mężczyzn chorych na wysiłkowe nietrzymanie moczu.
The incidence of male stress urinary incontinence (UI) ranges from 4.81 to 32.17% and usually increases with age. UI can be a consequence of surgical treatment of benign prostate hyperplasia (BPH) and/or prostate cancer (PCa). The American Medical System type 800 (AMS800) has been the most common and, until recently, the only artificial urinary sphincter (AUS) available for UI surgical treatment. Due to differences in UI grades and a considerable number of complications as well as costs associated with AUS implantation, several new devices for UI treatment have been introduced in the recent years. These devices offer novel technological solutions, which in theory should provide at least similar functional outcomes and lower complications associated with the classical AMS sphincter. The study provides a review of new devices for male stress UI treatment.
Male urinary incontinence (UI) is a rare condition. Depending on the characteristics of patients, the incidence of male stress urinary incontinence ranges from 4.81 to 32.17% (1) and usually increases with age (2, 3).
UI can be a consequence of surgical treatment of benign prostate hyperplasia (BPH). In patients treated with transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP) or open enucleation of adenoma (OEA), a low-grade urinary incontinence or total urinary incontinence develop in 2.2 and 1%, 1.8 and 0.1% as well as 1.9 and 0.5% of cases, respectively (4).
Patients treated with radical prostatectomy (RP) due to prostate cancer (PCa) develop UI more frequently. The incidence of UI after RP, irrespective of the technique adopted (open, laparoscopic or robotic), is similar and ranges from 1 to 40%, but discrepancies between subsequent series result from differences in defining UI and the length of the follow-up (5-7).
If a PCa patient undergoes external beam radiotherapy (EBRT) or brachytherapy (BT), UI occurs in 0-18.8% and 0-13% of patients, respectively (8-11).
Irrespective of the UI cause, 6-9% of cases are managed surgically (12-15).
Artificial urinary sphincter (AUS) implantation is the basic treatment method. Until recently, the only device used in such cases was American Medical System type 800 (AMS800). It was introduced to common practice in 1983 and has been used ever since in a nearly identical form (16). AMS800 guarantees full continence and/or quality of life improvement in 79% (61-100%) of patients. In long-term follow-up, effects are permanent. The re-intervention rate resulting from AUS infection or urethral erosion ranges from 3.3 to 27.8% (17).
Due to differences in UI grades and a considerable number of complications as well as costs associated with AUS implantation, several new devices for UI treatment have been introduced in the recent years.
High efficacy of suburethral slings in female UI made this technique also used in male patients. They create a subcystic barrier that improves continence and guarantees efficient micturition. These implants can be divided into two basic types: non-adjustable and adjustable tapes with adjustable pressure on the urethra.
Suburethral non-adjustable slings
The first tape of this type, which currently is no longer used, is the InVance tape.
A transobturator suburethral non-adjustable AdVance (American Medical Systems) (fig. 1) sling is a monofilament and polypropylene mesh. It is implanted transperineally. The main part of the mesh (the suburethral one) is fitted on the ventral surface of the proximal bulbous urethra, and the tape arms are passed through the obturator foramina. The AdVance system ensures full continence or guarantees considerable improvement in 62-77% of patients in a 3-year follow-up. The implantation technique is relatively simple, which makes the complication rate rather low (18, 19).
Fig. 1. Suburethral AdVance sling (American Medical Systems)
I-STOP TOMS (CL Medical) (fig. 2) is another tennon-adjustable suburethral sling. It differs from the previous model in construction and location under the urethra, but the principle underlying its action seems to be similar. Grise et al., in the first study on safety and efficacy of the I-STOP TOMS system, report that 60/69 patients (87%) experienced continence improvement after a year of follow-up. In the investigated group, 41 (59.4%), 14 (20.3%) and 5 (7.3%) patients did not use any pads, used 1 pad or more than 1 pad, respectively. No severe complications were noted. The cavernous bodies were damaged during implantation in 4% of patients. Generally, 91% of patients were satisfied or very satisfied after the procedure (20).
Fig. 2. I-STOP TOMS system (CL Medical)
Suburethral tension adjustable slings (devices)
In the case of first-generation slings, patients observed gradual deterioration in continence with time. Another problem was hypercontinence in the initial period post-surgery, which occurred in 12-21% of patients (19, 21).
Factors that might be responsible for these phenomena include the lack of a standardized way of adjusting tension during the procedure and post-surgery. The introduction of new-generation devices, characterized by a possibility to regulate pressure on the urethra, was supposed to solve the problem.
Argus system (Promedon)
One of the first devices of this type was Argus (fig. 3) in which a silicone pad placed suburethrally could be pulled up postoperatively thanks to arms inserted using the retropubic approach. The blocking mechanism was fixed in the rectus fascia. The Argus sling was implanted in 101 patients. After a median follow-up of 2.2 years, the rate of fully dry patients was 79.2% (80/101). Tape adjustment was necessary in 39 cases (38.6%) approximately 104.3 days after the initial implantation. Twenty-nine patients required sling tightening, which was conducted under regional anaesthesia, whereas 10 patients had it loosened under general anaesthesia. The sling had to be removed in 16 patients (15.8%) due to urethral erosion or infection.
Fig. 3. Argus system (Promedon)
Phorbas system (Promedon)
The Phorbas sling (fig. 4) constitutes the development of the Argus system. It combines the idea of a transobturator tape and suburethral pad with pressure on the urethra that can be adjusted by changing the volume of fluid that fills the suburethral element. This manoeuvre is performed in a simple way by puncturing the port placed in the scrotal subcutaneous tissue. The arms and suburethral element are made of silicone, which makes potential explantation easy. Treatment outcomes after using this system have been presented only during a conference. Among 21 patients with moderate to severe UI, the condition subsided in 71.4% of cases (12 patients need no pads, 3 patients use only one pad). On average, patients required the system to be inflated 1.9 times (0-4). Apart from two cases of wound infection, there were no significant complications. None of the devices needed explantation. In a relatively short follow-up (3-18 months, average 5.9 months), urethral erosion or hypercontinence was not observed (22).
Fig. 4. Suburethral Phorbas system (Promedon)
ATOMS system (AMI)
The ATOMS system (fig. 5) is similar to the device presented above in terms of its construction and general idea of action. The major difference lies in the application of a polypropylene mesh to make the sling arms. The suburethral pad inflation degree is regulated by fluid injected through a titanium port within the scrotal subcutaneous tissue (23).
Fig. 5. ATOMS system (AMI)
In one of the first studies, 99 patients with the ATOMS system implanted were observed for 17.8 months (average). Full continence was observed in 63% and improvement, expressed as using 1-2 pads daily, was seen in 29% of patients. The system required 3.8 (average) corrections of suburethral pad inflation in order to achieve a satisfactory treatment effect. The rate of complications was not significant. The most frequent undesirable effects included oedema of the perineum, scrotum and thighs. There were 4 (4%) cases of infection which, in each case, entailed the removal of the device (24).
ProAct balloon system (Medtronic)
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