European Urology 47 (2005)

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1 European Urology European Urology 47 (2005) The Comparison of Artificial Urinary Sphincter Implantation and Endourethral Macroplastique Injection for thetreatment of Postprostatectomy Incontinence M. Abdurrahim Imamoglu*, Can Tuygun, Hasan Bakirtas, Orhan Yiğitbasi, Ahmet Kiper Department of Urology, SSK Ankara Education Hospital, Ankara, Turkey Accepted 24 August 2004 Available online 11 September 2004 Abstract Objectives: To compare the effectiveness of macroplastique injection with artificial urinary sphincter implantation (AUS) for treatment of postprostatectomy incontinence (PPI). Methods: A prospective randomized clinical trial including 45 patients with PPI was performed secondary to radical retropubic prostatectomy (RRP), transvesical prostatectomy (TVP), transurethral prostatectomy (TURP), and TURP with TVP, in 12, 16, 16, 1 patients respectively. Patients were divided into two groups as minimal (group I) and total incontinence (group II) according to the severity of incontinence. Respectively, Group I (n = 21) and group II (n = 24) patients were randomized as AUS implantation (n = 11, n = 11) and macroplastique injection (n = 10, n = 13). Follow-up period was 48 (6 84) months in patients with macroplastique injection and 60 (8 120) months in AUS implantation. The success of the treatment was evaluated by calculating the average number of pads used by the patient per day, the weight of the pads and score of quality of life survey scale for each group both in the preoperative and in the postoperative period. Results: There were statistically significant differences between preoperative and postoperative average pad weight, average number of pads and quality of life scores, both in patients with minimal and total incontinence. In group I there was no statistically significant difference between the two techniques. However, in group II there was a significant difference favoring AUS implantation. Conclusions: Endourethral injection should be the treatment of choice for patients with minimal incontinence, whereas AUS implantation as the first choice for patients with total incontinence. # 2004 Elsevier B.V. All rights reserved. Keywords: Postprostatectomy incontinence; Macroplastique; Artificial urinary sphincter 1. Introduction After transurethral prostatectomy (TURP) or transvesical prostatectomy (TVP), the risk of incontinence is reported to be 0.4 1%. This might increase up to 20 40% following radical retropubic prostatectomy (RRP) [1,2]. After being cured from some major problems such as voiding difficulties and malignancy, these * Corresponding author. Present address: Mesrutiyet Caddesi, Bayindir- 2 sok. 58/5, Kizilay, Ankara, Turkey. Tel address: mai2603@superonline.com (M.A. Imamoglu). patients are confronted with the social and hygienic problems brought forward by incontinence. Currently, problems secondary to postprostatectomy incontinence (PPI) are solved with these popular approaches; injection of urethral bulking agents, implantation of artificial urethral sphincter (AUS) and male sling operations. To the best of our knowledge, there is not any randomized prospective trial comparing the success rate of injection of urethral bulking agents and implantation of AUS reported in the English literature. In this article, we report a comparative study between the implantation of AUS and macroplastique /$ see front matter # 2004 Elsevier B.V. All rights reserved. doi: /j.eururo

2 210 M.A. Imamoglu et al. / European Urology 47 (2005) injection to the urethral sphincter region with regards to their therapeutic efficacies, effects on the quality of life, morbidity and costs in patients with PPI (of both benign and malignant causes). 2. Methods The patients who have complaints of incontinence despite conservative treatment (Kegel exercises, imipramine) following RRP or TURP/TVP lasting a year or six months respectively were included in the study. The selected patients needed more than one pad/day in the last month diary and did not receive any prior surgical treatment for PPI. None of the patients were given radiotherapy for prostate carcinoma. The patients were diagnosed with urodynamic studies, sphincteric EMG and cytoscopic examinations. All patients had a minimum bladder capacity of 150 cc, they did not have detrussor instability or hyperreflexia. They had urethral pressure profiles (UPP) below 20 cmh 2 O and leak point pressures (LPP) below 40 cmh 2 O. Most of these patients had decreased sphincteric activity in EMG and some did not have any activity. The cases were divided into two groups as minimal incontinence (group I) and total incontinence (group II) depending on the symptom scores and weight and average number of pads used per day. Minimal incontinence was defined as total number of pads, total weight of pads and score of quality of life scale less than/equal to 2, 100 g, 30 respectively. The values above these numbers were accepted as total incontinence. The distribution of etiologic factors and treatment modalities between the two groups were given in Table 1. In group I patients (n = 21) were randomized as artificial urethral sphincter implantation (n = 11) and macroplastique injection (n = 10). In group II patients (n = 24) were also randomized as AUS implantation (n = 9) and macroplastique injection (n = 13). Two patients with total incontinence who had urethral strictures including the sphincter were treated with permanent urethral wall stent (Memotherm 1 ANGIOMED). After a follow-up period of 12 months there was not any tissue ingrowth into the lumen. Then, these patients underwent AUS implantation (nonrandomized) and followed for another 12 months. Macroplastique is an injection material composed of polydimethylslioxane elastomer implants as the solute component and hydrogel as the carrier. Macroplastique was injected under general or spinal anesthesia by having the patient in lithotomy position and using 24 Fr, 0 degree cystoscope. An average volume of cc was applied above or around the striated sphincter region of the urethra at 3, 6 and 9 o clock positions submucosally with a special Table 1 The distribution of treatment modalities according to severity and etiology of incontinence Etiologic factor Group I Group II Injection AUS Total Injection AUS Total TUR TVP RRP TUR + TVP 1 1 Total Group I: minimal incontinence, Group II: total incontinence. needle following RRP or TURP/TVP. If the patient was not free of his complaints by the end of the first month, a second application was made. The patients who did not improve after the second attempt were directed to AUS implantation. AUS implantation was performed under general anesthesia and in lithotomy position in all cases. The cuff of the AMS 800 sphincter was placed to the bulbar urethra, the pump to the scrotum and the reservoir balloon with cmh 2 O pressure to the space of Retzius. The urethral catheter that was placed during the operation was taken out on the first postoperative day. The patients were discharged from the hospital within 4 8 (average 6) days. Following 4 6 weeks of deactivation, the system was activated. The patients came to control visits on postoperative 1, 6 and 12 months. For evaluating the success of the treatment, the average number of pads used by the patient per day and the weight of the pads were calculated for each group both in the preoperative and in the postoperative period. Patients who do not need to use pads were regarded as dry. The ones using less than one pad were accepted as socially continent, and who were using more than one pad classified as incontinent. Average pad weight was calculated by adding the weights of the pads the patient had changed when he felt himself uncomfortable while performing daily activities. Quality of life survey scale was utilized in order to evaluate the satisfaction of the patients [4]. The statistical evaluation of the parameters were performed by t-test and p significance test in both groups. 3.Results Mean age of the patients who underwent AUS implantation was 64 (52 76) and mean age of the patients who underwent Macroplastique injection was 62 (55 75) years. The patients with macroplastique injection were followed up for a period of 48 months (6 84), while the patients with AUS implantation were followed up for 60 months (8 120). There was no statistically significant difference between patients with AUS implantation and the ones with macroplastique injection considering UPP (5 15 cmh 2 O) or LPP (0 20 cmh 2 O). Success rates after the treatment were calculated separately for two groups (Table 2). When we made a comparison between the preoperative and postoperative values of the criteria used to evaluate success such Table 2 The distribution of patients according to the severity of incontinence and success rate of treatment modalities Group I Group II Injection AUS Injection AUS Patients (n) Dry 8 (80%) 10 (90.9%) 3 (23.1%) 8 (72.7%) Socially continent 1 (10%) 1 (9.1%) 5 (38.5%) 2 (18.2%) Incontinent 1 (10%) 5 (38.5%) 1 (9.1%) Group I: minimal incontinence, Group II: total incontinence.

3 M.A. Imamoglu et al. / European Urology 47 (2005) Table 3 The comparison of treatment modalities according to success criteria in group I Macroplastique injection Preop Postop p AUS implantation Preop Postop p Average number of pads < <0.001 Average pad weight (g) < <0.001 Quality of life scale < <0.001 Preop: preoperative, postop: postoperative. Table 4 The comparison of treatment modalities according to success criteria in group II Macroplastique injection AUS implantation Preop Postop p Preop Postop p Average number of pads < <0.001 Average pad weight (g) < <0.001 Quality of life scale < <0.001 Preop: preoperative, postop: postoperative. as average pad weight, average number of pads and quality of life scores, both in patients with minimal and total incontinence there were differences of statistically significance (p < 0.05) (Tables 3 and 4). There was no statistically significant difference in the group I between two techniques (p < 0.2). However, when this comparison was made for the group II there was a significant difference favoring AUS implantation (p < 0.01). Of 11 patients who remained incontinent after injection, 5 were selected for AUS implantation. In order to identify whether etiological factors were important for the success of selected treatment techniques, success rates were calculated separately for each and every etiological factor. As a result of such an approach, we have identified that for patients developing incontinence after TURP, submucosal injection therapy was of considerable success, whereas it was less successful in cases that developed incontinence due to open surgical procedures (Tables 5 and 6). Although the complication rates were significantly higher in the AUS group, we could not make a statistical comparison between the two groups, as the types of complications were different for each group. AUS implantation was complicated in five patients with different causes. Implants were taken out in one patient because of infection and in another patient due to the erosion of the cuff. These patients underwent new AUS implantations six months after the removal of older ones. One patient experienced scrotal erosion so the pump was transferred to the contralateral side. In one patient, the pump that was not functional due to mechanical reasons was changed. In another patient, there was migration to the intraperitoneal region, which was corrected with reservoir operation and brought back to the extraperitoneal field. One patient Table 5 The success rate of treatment modalities according to etiology in group I Etiology Patient (n) Dry Socially continent Incontinent Inj. AUS Total Inj. AUS Total Inj. AUS Total Inj. AUS Total TURP TVP RRP TURP + TVP Total Table 6 The success rate of treatment modalities according to etiology in group II Etiology Patient (n) Dry Socially continent Incontinent Inj. AUS Tot. Inj. AUS Tot. Inj. AUS Tot. Inj. AUS Tot. TURP TVP RRP Total

4 212 M.A. Imamoglu et al. / European Urology 47 (2005) treated with macroplastique injection had to be catheterized because of urinary retention and two other patients developed urinary infections. Considering the costs of these procedures, 18 patients had only one injection, and 5 patients were injected twice resulting in a total macroplastique injection volume of cc. Per capita cost for the patient was $2264, taking into account the cost of the injection material, treatment of complications and hospitalization charge. Considering the AUS implantation, per capita cost for the patient was $6142 including the cost of the implant, treatment of complications and hospitalization charge. 4. Discussion Several techniques have been developed with the aim of preserving bladder capacity and compliance and achieving continence in incontinent patients with intact bladder and urethral function. Currently, the popular surgical techniques are the injection of endourethral bulking agents, the implantation of artificial sphincters and male sling operations [5 9]. However, the number of studies evaluating the success rate of these techniques separately for patients with minimal and total incontinence is quite limited if not existent. There are studies reporting success rates of 90% for artificial sphincter implantations [6,7]. In our study total cure rate was 90.9% in group I and 72.7% in group II. When we include the patients who were socially continent and the ones with improved quality of life scores to these, the figures are 100% and 91% respectively. Success rate has been reported to be around 60% for injections [8,9]. In our study, in group I dryness was achieved in 80%, whereas this figure fell down to 23.1% for group II. When socially continent patients with improved quality of life scores were included, these figures were 90% and 62% respectively. One of the most striking findings of our study was that, when success was evaluated by taking into consideration the etiological risk factors, the patients who were incontinent after TURP had considerable success rates with macroplastique injection. Although the number of patients were limited and did not allow for statistical comparison, we have seen that submucosal injection had lower success rates in cases of incontinence due to open surgical procedures. When compared with injection agents, AUS implantation carries morbidity of significant degree [6,7,10,11]. Infection surrounding the prosthesis, erosion of the cuff, and mechanical insufficiency of the device are the main disadvantages of this procedure. Due to such reasons, we had to perform revisions in 5 patients (22.7%) in our study. One of the most important reasons behind the hesitations of the urologists concerning the implantation of AUS is the high rate of complications. There are studies reporting revision rates of 32% and 90% of the revisions were required within the first 3 years [12].It is also reported that prostheses had to be taken out in 37% of the cases within 10 years [13]. Pump problems secondary to mechanical problems seen in long-term follow-ups should also be considered [10,14]. Morbidity rates were quite low in our injection group. The most important considerations for injections are, low success rates and requirement for repetitive injections. Some researchers report definitive results after 4 5 injections, however, a consensus has been reached for not proceeding further in patients who have not experienced any symptomatic improvement despite receiving the second injection [3,15 17]. The authors think that repetitive injections should only be tried in patients with minimal incontinence. Our study was different from the similar studies in the literature in the sense that, preoperative indications were shown to be influential factors on the final success rates. In patients with minimal incontinence similar success rates were obtained from the two techniques with a randomized approach, however in total incontinence AUS implantation had statistically significant success over endourethral injection. Another point to be emphasized is that, in patients who have received macroplastique injection despite having total incontinence, there were significant improvements in the number of pads used, the weight of the pads and quality of life scores, yet they remained mostly incontinent when evaluated with our success criteria. Furthermore, as we had to implant stents to two patients who had recurrent strictures of the urethra, these patients had to be implanted with AUS as well. 5. Conclusions The main message of this article is that degree of PPI is the most important parameter determining the success of the treatment modality chosen. Endourethral injection should be the treatment of choice for patients with minimal incontinence, whereas AUS implantation should be considered as the first choice for patients with total incontinence. Furthermore, the authors conclude that endourethral injection should be the first choice in patients with incontinence after TURP and AUS implantation should be offered to patients experiencing incontinence after open surgical procedures.

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