Management of Artificial Urinary Sphincter Dysfunction

Transcription

1 European Urology European Urology 46 (2004) Management of Artificial Urinary Sphincter Dysfunction Frédéric Maillet, Jean-Marie Buzelin, Olivier Bouchot, Georges Karam * Clinique Urologique, CHU Hôtel-Dieu, Nantes, France Accepted 22 January 2004 Available online 1 March 2004 Abstract Objective: The long-term outcome of artificial urinary sphincter (AUS) is unpredictable because of, among others, the risk of breakdown of one of its components. Our objective was to define a strategy for an accurate diagnosis and an appropriate management of these problems. Patients and Methods: From 1985 to 2000, 298 AUS (AMS 800) have been implanted in 288 patients aged years (8 to 87 years). There were 130 women with urinary stress incontinence, 84 with neurological disorders, 76 following prostatic surgery and 8 for other reasons. Diagnosis was often done following the recurrence of urinary incontinence. The pump was systematically checked and all patients underwent radiographic and urodynamic studies. We have systematically looked for the defective component in order to avoid replacing the entire sphincter. Results: Fifty-five patients (19%) have been re-operated on after a median follow-up of 23 months (11 days 10 years): Thirty-two only once, 20 twice and 3 patients 4 times. There were 55 depressurizations, 18 device dysfunctions without depressurization and 11 removals of the sphincter. Among the 55 depressurizations, 30 were related to a perforation of one component, 24 to a functional but insufficient sphincter and 1 to tubing disconnection. In forty cases, only one component of the AUS was replaced while 2 components were replaced in 10 cases, the entire AUS in 4 cases and no component in one case. Conclusion: The longer the follow-up the greater is the probability of a dysfunction. We systematically continue to look for the defective component and just to replace it instead of the entire sphincter. # 2004 Elsevier B.V. All rights reserved. Keywords: Artificial urinary sphincter; Urinary incontinence; Dysfunction 1. Introduction The concept of artificial urinary sphincter, initiated by Foley in 1947 [1], became rapidly one of the standard treatments of urinary incontinence. The first results published by Scott in 1974 [2] have shown a continence rate of 80% but with a follow-up of only 6 months and 20% of revision [3]. More recently, continence rate with a follow-up of 4 years was 88% [4,5] and 84% at 10 years but with 66% of re-operation [6]. Two types of complications lead to re-operating on patients with an artificial urinary sphincter: Firstly, those requiring removal of the device like infections, urethral, cutaneous or vaginal erosion and secondly * Corresponding author. Tel. þ ; Fax: þ address: gkaram@chu-nantes.fr (G. Karam). those requiring repair. In the latter cases we distinguish between depressurization, characterized by a drop of pressure inside the device due to either fluid leakage (perforation, disconnection or porosity of the device) or to peri-urethral tissue atrophy and dysfunction of the device characterized by the incapacity to use is but without drop of pressure (kinking, inadequate position of the pump,...). Nowadays, there is neither consensus on the diagnosis of these dysfunctions nor on their treatment. Should we replace the entire device without looking for the defective component or search for the defective component and replace it? The aim of this study was to evaluate our diagnosis and therapeutic approach to these dysfunctions within a group of patients with artificial urinary sphincter implanted in our department over a period of 15 years /$ see front matter # 2004 Elsevier B.V. All rights reserved. doi: /j.eururo

2 242 F. Maillet et al. / European Urology 46 (2004) Table 1 General characteristics of the population Aetiology Number Repair (Nb, %) 2. Patients and methods Age (years) Neurological 81 26/81 (32.1%) Stress incontinence /129 (10.8%) Prostatic surgery 71 13/71 (18.3%) Others 7 2/7 (28.6%) Total /288 (19.1%) Sex ratio M/F Table 2 Type of failure, number and average time of occurrence Number (%) Months Depressurization 55 (18%) Perforation of the balloon Cuff Pump 1 Connecting piece Disconnection 1 Peri urethral atrophy Dysfunction 18 (6%) Pump Malposition Kinking 1 Dysuria 1 Between June 1985 and September 2000, 298 artificial urinary sphincters AMS 800 were implanted into 288 patients with urinary incontinence, 123 males and 165 females. The patient s mean age at the time of sphincter implantation was years (8 to 87). The underlying aetiology of incontinence is summarized in Table 1. Among these 288 patients, 55 (19%) had to be re-operated on for dysfunction of their AUS; 48 of them (87%) suffered from recurrence of incontinence. Types of failure are shown in Table 2. There were 55 depressurizations (30 perforations, 1 disconnection, 24 atrophies of peri-urethral tissues) and 18 dysfunctions, of which 16 were related to the pump. The first step of the diagnosis approach was pre-operative including systematic physical, radiological, and urodynamic examination. Patients were questioned about the symptoms that made them suspect a dysfunction. The pump was checked manually by repeated external techniques. Abdominal X-ray and urethral pressure profile (2 channels 10 Ch Bohler s catheter) were systematically realized with the sphincter, successively, in the inflated and the deflated positions to check for a drop of urethral pressure. Abdominal echography was occasionally realized unlike urethroscopy, which was systematically realized prior to surgery. Fig. 1. Check up of the balloon. Fig. 2. Check up of the cuff.

3 F. Maillet et al. / European Urology 46 (2004) an empty cuff and it had to be close to zero. The second was realized after filling the balloon with 22 ml of the mixture already described. If the pressure value was not convenient we added fluid till a 60 to 80 urethral pressure was reached. Once the entire components connected, the sphincter was checked in inflated and deflated positions. Dysfunctions were treated depending on cases: the pump was replaced or put back in the right position; connecting pieces were shortened especially if kinked. Fig. 3. Check up of the pump by pressing. The second step was intra-operative and corresponded to a complete check up to localize and treat the defective component, given thant several components could be involved. This check-up was always realized via small incisions and without taking out the entire components of the sphincter. The balloon was filled with a mixture of sterile water (47%) and sodium ioxitalamate (53%) and checked for leakage (Fig. 1). The cuff was filled with 1 2 ml of the same mixture and, after at least 1 minute, the same amount ought to be pumped out (Fig. 2). Connecting a syringe to each connecting piece enabled us to check the pump. External manipulations of the pump checked the transfer of the fluid from the syringe that replaced the cuff to the syringe that replaced the balloon (Fig. 3). Moreover, these repeated external manipulations allowed the removal of possible air bubbles in the device. The therapeutic approach was realized once the defective component found. In the case of depressurization, we looked for a possible perforation and if found, we replaced only the concerned component. Disconnected pieces were simply reconnected after air removal. Diagnosis of peri urehtral tissue atrophy was mentioned when there was a drop of urethral pressure without a decrease of the fluid volume (size of the balloon on the preoperative X-ray and/or peroperative balloon discharge. In case of peri urethral tissue atrophy, the first possibility was to replace the cuff by a smaller one or the balloon by a bigger one. The second possibility was to over-pressurize the system under systematic preoperative urethral pressure profile control (Fig. 4). The first measure was realized with 2.1. Statistical analyses Data were collected, stored in a database system and analyzed by StatView 1 Macintosh software. Sphincter survival was determined by the Kaplan Meier method while w 2 -test and Student t-test were, respectively used for categorical and continuous variables. Results were considered statistically significant for p < 0: Results Fifty-five patients (19%) have been re-operated on for sphincter dysfunction at least once during their follow-up. There were 28 males and 27 females aged at the time of sphincter implantation of 9 to 78 years (mean ¼ 53 21). Details on type of failure, number and time to occurrence are given in Table 2. Mean time to failure was months for neurological patients vs months for the others ( p ¼ 0:17). Kaplan Meier analyses showed that 26% of patients with a functional sphincter would present a dysfunction of the system within an average period of 5 years and 50% within an average period of 8 years (Fig. 5). Thirty-two out of 55 patients have been re-operated on once, 20 patients twice and 3 patients 4 times. We have performed 73 repairs and 11 removals of the sphincter. Recurrence of incontinence was observed in 88% of cases and in the other 12%, the pump was malpositioned or hard to manipulate. 1,8 Cum. Surv.,6,4, Time (months) Fig. 4. Per operative over pressurization and urodynamics control. Fig. 5. Kaplan Meier analysis of sphincters was based on the presence of at least one failure. The half-time failure was 8 years.

4 244 F. Maillet et al. / European Urology 46 (2004) Nearly 25% of revisions (18/73) were performed for dysfunctions of the sphincter. The pump was concerned in 56% of these revisions. When the pump was malpositioned or turned (upside down), clinical examination was always sufficient to diagnose the case and to allow surgery. If the connecting pieces were kinked, pump was hard to the touch and resisted being pressed. Moreover there was no change in urethral pressure when the pump was manipulated. Pump was also hard to press in all the cases of mechanical dysfunction and it always filled back very slowly. Repeated measures of urethral pressure confirmed the dysfunction in all the cases. In 2 cases the pump was functional and just the air bubbles were removed. In all the other cases the pump was replaced. Depressurization represented 75% (55/73) of all repairs. In all fluid leakage cases, the pump was empty and an X-ray examination confirmed the leakage. On the contrary, the tactile aspect of the pump and the X- ray examination were normal. On the other hand, urodynamic studies did not show any modification of the urethral pressure when the pump was manipulated. One component of the sphincter was replaced in 40 cases (54.8%) and the balloon was the part the most concerned (Table 3). Eleven out of the 55 patients underwent removal of their sphincter in an average of 4 years after the implant (49 41, extremes: 2.5 to 132 months); 9 after one previous repair and 2 after 3 previous repairs. The causes were infection or erosion (7 cases), bladder hyperactivity (2 cases), failure of enterocystoplasty and clean self-catheterism (1 case) and finally failure of over-pressurization (1 case). Table 3 Replacement and other repair procedures One component 40 (54.8%) Balloon 19 Cuff 11 Pump 10 Two components 10 (13.7%) Balloon þ cuff 6 Balloon þ pump 3 Cuff þ pump 1 The entire sphincter 4 (5.5%) Over pressurizing 7 (9.6%) Air bubbles purge 2 (2.7%) Pump reposition 6 (8.2%) Reconnection 3 (4.1%) Unkinking 1 (1.4%) Total 73 (100%) 4. Discussion The main drawback of an artificial device is its breakdown. In this retrospective study, we have shown that a failure of an artificial device, namely AMS 800, regardless of the cause, was almost unavoidable with a probability of 50% at 8 years. Consequently, we should have simple and reliable strategies to accurately diagnose the failure and to repair it. Excluding urethral erosion and infection of the sphincter, Elliot [7] has reported a rate of 17.3% and 28% of revision respectively at 5 and 10 years vs. 24.5% in our study. We have observed that patients with neurological aetiologies had a higher risk of dysfunction than the others, 32% vs. 14% ( p ¼ 0:005, Table 1) but we did not find any rational explanation. The first occurrence was later but the difference was not statistically significant, 45.2 vs months ( p ¼ 0:17). Despite this high rate of complications, continence was achieved in 70 to 90% of cases [8]. Moreover, the well-being of these patients was enhanced by the augmentation enterocystoplasty, justified by a poor bladder compliance, either at the same time or after the implantation of the sphincter [4,9]. In our experience, augmentation enterocystoplasty realized after the implantation of the sphincter was always justified by the occurrence of poor bladder compliance that was normal at the time of implantation. In case of failure, the sphincter was removed and an external uretero-ileostomy was realized. The main question, that should be answered, concerns the management of these technical failures. The answer is not unanimous [10]. On one hand, those who search for the failure to repair it and on the other hand those who replace the entire sphincter [11,12]. This latter option is easier, but in our opinion, more expensive and risky (haematoma, infection) because it requires more extensive dissection. It is based on the impairment of the components with time but there is no way to predict when and which component will be involved. Moreover, we have experienced failure of the pump within a few weeks after surgery and, replacing the entire sphincter did not rule out the risk of failure of the new components in the early post-operative period. For all these reasons, we have opted for an active search for the defective component by using clinical, radiological and urodynamical studies. The defective component was then replaced via a small skin incision giving the lowest infectious risk, the lowest cost and the shortest duration of hospitalization. Perforation of any component and urethral atrophy were not different from that reported by Elliot (75% vs.

5 F. Maillet et al. / European Urology 46 (2004) %) as well as pump dysfunction (25 vs. 30%) [7].To manage failure related to urethral atrophy, 3 possibilities are available; replacing the cuff by a smaller one, replacing the balloon by a higher pressure one [7], and finally the use of double cuff [13,14] which would not increase the long-term risk of urethral erosion. Another possibility we have used in 7 patients consisted in overpressurizing the existing sphincter. We did not observe any urethral erosion related to this over-pressurization. However, three of them had been reoperated on within an average of 30 months for recurrence of urethral atrophy and incontinence. The cuff was then, replaced by a smaller one. Theoretically, over-pressurizing was justified by the coating fibrosis around the components, which alter the compliance of the system, especially of the cuff and by the leakage of the hypo-osmotic fluid through the silicone becoming porous through time. However, the fluid volume needed to restore an effective pressure was previously unknown and the only way to control the result was per-operative UPP that we considered as the major aspect of the repair. Nevertheless, Wang has reported an average of 10 ml of fluid loss in 16 patients with recurrence of incontinence without perforation or dysfunction of the sphincter [15]. On the other hand, when failure was due to urethral atrophy, the results of over-pressurizing were poor. Over-pressurizing, in our experience, had the advantage of being a short procedure using an in position functional system and not requiring a taking out of the entire sphincter. The risk of this procedure, just as the use of a higher-pressure balloon, is the occurrence of urethral erosion. Authors, who advocate simple and efficient repair, have proposed placing the connecting pieces in a sub cutaneous position thus permitting percutaneous access to allow us to readjust the pressure without skin incision [6]. The alternative to these hydrologic problems may be a wire-control and not a fluid-control system [16]. We have no experience in electrical testing as reported by Kreder [17] who considered that it is a simple way to determine if a leak is present within one of the components of the sphincter. However, the global approach is similar but using manual instead of electrical testing; in our experience this way of doing has always been reliable. Finally, the most important point we wanted to report and to develop in our manuscript concerns single replacement rather than full replacement of the sphincter. It was not only based on economical considerations but on the fact that a failure of an AUS is ineluctable through time and has to be accepted as the natural history of the sphincter. Therefore, each surgical operation must be simple, short and reliable. Moreover, as it is utopian to randomize and compare single versus full replacement of the sphincter, the only way to defend our strategy is to report our results that, in addition, are comparable to those of the literature in terms of sphincter survival. The replacement of the only defective component is now our favourite technique provided it is feasible. References [1] Fowley FE. An artificial sphincter: a new device and operation for control of enuresis and urinary incontinence. J Urol 1947;58: [2] Scott FB. Treatment of urinary incontinence by an implantable prosthetic urinary sphincter. J Urol 1974;112: [3] Scott FB. The artificial sphincter in the management of incontinence in the male. Urol Clin North Am 1978;5(2): [4] Singh G, Thomas DG. Enterocystoplasty in the neuropathic bladder. Neurourol Urodyn 1995;14(1):5 10. [5] Singh G, Thomas DG. Artificial urinary sphincter for postprostatectomy incontinence. Br J Urol 1996;77(2): [6] Venn SN, Greenwell TJ, Mundy AR. The long-term outcome of artificial urinary sphincters. J Urol 2000;164(3 Pt 1):702 6 [Discussion 706 7]. [7] Elliott DS, Barrett DM. Mayo Clinic long-term analysis of the functional durability of the AMS 800 artificial urinary sphincter: a review of 323 cases. J Urol 1998;159(4): [8] Kryger JV, Gonzalez R, Barthold JS. Surgical management of urinary incontinence in children with neurogenic sphincteric incompetence. J Urol 2000;163(1): [9] Kronner KM, Rink RC, Simmons G, Kropp BP, Casale AJ, Cain MP. Artificial urinary sphincter in the treatment of urinary incontinence: preoperative urodynamics do not predict the need for future bladder augmentation. J Urol 1998;160(3 Pt 2): [Discussion 1103]. [10] Duncan HJ, McInerney PD, Mundy AR. Late erosion. A new complication of artificial urinary sphincters. Br J Urol 1993; 72(5 Pt 1): [11] Clemens JQ, Schuster TG, Konnak JW, McGuire EJ, Faerber GJ. Revision rate after artificial urinary sphincter implantation for incontinence after radical prostatectomy: actuarial analysis. J Urol 2001;166(4): [12] Fulford SC, Sutton C, Bales G, Hickling M, Stephenson TP. The fate of the modern artificial urinary sphincter with a follow-up of more than 10 years. Br J Urol 1997;79(5): [13] Kowalczyk JJ, Spicer DL, Mulcahy JJ. Erosion rate of the double cuff AMS800 artificial urinary sphincter: long-term followup. J Urol 1996;156(4): [14] Montague DK, Angermeier KW. Artificial urinary sphincter troubleshooting. Urology 2001;58(5): [15] Wang Y, Hadley HR. Management of persistent or recurrent urinary incontinence after placement of artificial urinary sphincter. J Urol 1991;146(4): [16] Elliott DS, Timm GW, Barrett DM. An implantable mechanical urinary sphincter: a new nonhydraulic design concept. Urology 1998; 52(6): [17] Kreder KJ, Webster GD. Evaluation and management of incontinence after implantation of the artificial urinary sphincter. Urol Clin N Am 1991;18(2):

6 246 F. Maillet et al. / European Urology 46 (2004) Editorial Comment S.W. Wilson, Van Buren, AR, USA This paper reports a very important series of men and women sphincter patients followed 15 years. The patient population survival from re-operation for any cause was an admirable 74% five-year survival and 50% eight-year survival. The paper outlines the authors unique method of diagnosing problems. The idea is to carefully find out which component is the culprit and replace only that through a small quick incision. The authors also performed additional revision maneuvers such as overpressurizing the balloon by adding additional fluid or substituting a higher pressure balloon. They recognized the relative lack of efficacy of these adjustments and reported honestly. Despite my admiration for such an extensive series (165 females) with such good outcomes, some criticism can be leveled. The series had no attempt at controls evaluating different and controversial methods of corrective surgery. It also is regrettable that the complications and the systematic approach for correction were not segmented out by sex. Since the device is not FDA approved for female implantation in America, I have no personal experience and there is a paucity of female papers in our literature. It could be that single component removal in females was justified since bladder neck cuff replacement is a more extensive surgery than simple bulbar urethral replacement in males. Nevertheless, this report justifies single component removal in both sexes because complete component removal was risky and complicated by hematoma and increased infection. Most authorities believe the opposite in men patients. The device is constructed of silicone and the remaining parts will wear out necessitating another surgery that could have possibly been avoided. There are no reports in the sphincter literature to confirm this paper s opinion that full device removal is complicated by an increased risk of infection and hematoma. Is it utopian to wish the authors had attempted a control of single versus full system replacement? Since they have one of the largest sphincter experiences in the world in both sexes, one would wish they would immediately begin such a series and report to us in five years.