Long-Term Results of a Prospective Randomized Study ComparingTwo Different AntirefluxTechniques in Orthotopic Bladder Substitution

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1 European Urology European Urology 45 (2004) Long-Term Results of a Prospective Randomized Study ComparingTwo Different AntirefluxTechniques in Orthotopic Bladder Substitution Yasser Osman *, Hassan Abol-Enein, Adel Nabeeh, Mohamed Gaballah, Mahmoud Bazeed Urology & Nephrology Center, Mansoura University, Mansoura, Egypt Accepted 13 August 2003 Published online 27 August 2003 Abstract Purpose: We compared the long-term functional results following two different reflux prevention techniques in orthotopic ileal bladder substitution in a prospective controlled randomized study. Methods: The study included 60 patients for whom orthotopic bladder replacement was indicated. The treated patients were prospectively randomized into two groups: group I (30 patients) underwent ileal W neobladder with serous lined extramural tunnel and group II (30 patients) received hemi-kock pouch with intussuscepted nipple valve. Laboratory evaluation included estimation of serum creatinine while radiological studies included IVU and voiding studies. Urodynamic evaluation was an integral part of our investigation. Results: Patients and tumor characteristics were comparable between both groups. No operative or postoperative mortality were observed in either. Early complications were encountered in 5 (16.7%) and 4 (13.3%) patients in the two treated groups respectively ( p ¼ 0:72) and most were treated conservatively. Twenty patients in group I and 19 in group II were evaluable. The mean follow up was 73:9 6:6and72:9 5:6 months in the treated groups respectively. Day and night time continence was comparable between both groups. Ascending studies demonstrated reflux in 3 (7.7%) of the reimplanted units in group I versus 2 (5.3%) in group II (p ¼ 0:81); IVU showed uretero-ileal anastomotic strictures in 2 renal units with both the serous lined extramural tunnel (5.1%) and the ileal nipple valve (5.3%) techniques ( p ¼ 0:98). One patient in group I had pouch stone compared with 5 in group II ( p ¼ 0:08). Urodynamic characteristics were also comparable in both groups. Conclusion: The study provided evidence that the long-term functional results following serous lined extramural tunnel are as equal as the nipple valve. Furthermore, it spares the use of extra-bowel length, does not need staples and allows retrograde endoscopic procedures. # 2003 Elsevier B.V. All rights reserved. Keywords: Diversion; Antireflux; Serous lined; Nipple valve 1. Introduction In the broadest sense, the goal of any form of urinary diversion should be the preservation of renal function in a manner that is psychologically and socially acceptable. The ideal form of urinary diversion would approximate normal bladder function; provide continence with adequate compliance and facilitate complete emptying * Corresponding author. Tel. þ ; Fax: þ address: y_osman99@yahoo.com (Y. Osman). at convenient intervals. The incorporation of an antireflux system with orthotopic bladder substitution would protect the upper tract from regurgitation of the infected contents of the reservoir and allows rapid maturation of the reservoir [1]. The ideal antireflux procedure should be technically simple, does not need synthetic material and/or extra-bowel length, suitable for normal as well as dilated ureters and has the feasibility of retrograde endoscopic manipulations. There are few prospective randomized trials comparing different antireflux techniques in the urologic /$ see front matter # 2003 Elsevier B.V. All rights reserved. doi: /j.eururo

2 Y. Osman et al. / European Urology 45 (2004) literature. None of them reported long-term outcome [2 5]. From as early as 1986 till 1992, the hemi-kock pouch with intussuscepted ileal nipple valve was the technique of choice in our institution with fairly successful functional outcome [6]. Nevertheless, the technique was not free of complications mainly due to the use of metallic staples [7]. In 1993, serous lined extramural tunnel technique was introduced with initial promising results, being simple and does not need metallic staples [8]. To change the technique that was used for years into a new procedure, a comparison of the two antireflux systems in a prospective controlled randomized study was a must. Herein, we report the long-term results of this trial. 2. Patients and methods 2.1. Patients From July 1995 to April 1997, 89 male patients underwent radical cystectomy and orthotopic substitution in our institution. The indication of cystectomy was invasive bladder cancer in all. Out of those, 60 were included in this prospective randomized trial while 29 were excluded because of hydronephrotic changes in one or both kidneys. Group I (30 patients) underwent ileal W neobladder with serous lined extramural tunnel ureteral implantation technique while group II (30 patients) received urethral hemi-kock pouch with iso-peristaltic ileal nipple valve. All the patients had perfect upper tracts prior to the surgery while patients and tumor characteristics were comparable in both treatment groups Surgical technique Standard radical cystoprostatectomy was performed in all patients as described previously [8]. The patients received either an ileal W neobladder with serous lined extramural tunnel using 40 cm of ileum or urethral Kock pouch utilizing 45 cm. The technical details are the seat of previous publications [8,9] Evaluation Evaluation of the patients included symptoms analysis for daytime continence and enuresis. Continence in our study was defined as complete voluntary control of voiding day and night with no medications or protective pads. Laboratory evaluation included estimation of serum creatinine while radiological studies included IVU to evaluate upper urinary tract configuration, ascending and voiding studies to assess radiological anatomy, capacity of the pouch, and efficiency of the reflux-preventing system and the presence of residual urine. The ascending and voiding studies were carried out by a water soluble contrast saline mixture that was put at 50 cm overhead position and connected to the urethral catheter. The filling is continued till reflux was observed or maximum pouch capacity was reached as estimated by cystometery. Posterio-anterior and oblique views were obtained as well as flourscopic voiding studies and a postvoiding film. Urodynamic evaluation was an integral part of our investigation Statistical analysis Mean values are presented with standard errors of the mean. Statistical analysis was done to compare data using the Student s t-test for parametric variables, Mann-Whitney test for nonparametric variables and w 2 -test for categorical variables with p 0:05 considered statistically significant. 3. Results 3.1. Early complications The operative time for the whole surgery including cystectomy, lymphadenectomy and urinary diversion was 5 to 6 hours and it was comparable between both techniques. No operative or postoperative mortalities were observed in either group. Early complications (within the first three months) included urinary leakage, lymphocele, ileus and DVT. They were encountered in 5 (16.7%) and 4 (13.3%) patients in the two treated groups respectively ( p ¼ 0:72) and most were treated conservatively. In cases with urinary leakage, prolonged catheter drainage was satisfactory and none required percutaneous nephrostomy, while percutaneous drainage of a symptomatic pelvic lymphocele was necessary in one patient in group I Evaluable patients Twenty patients in group I and 19 in group II were evaluable with a minimum follow up of 60 months. One of the patients in group I had history of nephroureterectomy prior to cystectomy. So, only 39 renal units were evaluated in this group. The mean follow up was 73:9 6:6 and 72:9 5:6 months in the treated groups respectively Continence All the evaluable patients in group I (100%) and 18 in group II (95%) were continent during the daytime ( p ¼ 0:30). The remaining patient suffered stress incontinence and showed improvement on imperamine hydrochloride 25 mg at bedtime. Sixteen patients in group I (80%) and 14 in group II (73.7%) were dry during the nighttime without medications or protective pads ( p ¼ 0:64). Out of 4 enuretic patients in group I, one had occasional wetting and the remaining 3 required protective pads nightly. In group II, three patients out of 5 enuretics had occasional wetting and the remaining 2 were frequently wet. None of the treated patients suffered urine retention Laboratory and radiological evaluation At time of final evaluation, mean serum creatinine was 1:3 0:3 and 1:4 0:3 in both groups respectively ( p ¼ 0:28). Ascending studies demonstrated non-refluxing reservoirs in all patients but 3 in group 1 and 1 in group II. Reflux was demonstrated in 3 units out of 39 in group I (7.7%) compared to 2 out of 38 in group II (5.3%) ( p ¼ 0:81) (Table 1). Two of the

3 84 Y. Osman et al. / European Urology 45 (2004) Table 1 Radiological evaluation refluxing units in group I were of 2nd degree while they were of fourth degree in group II secondary to valve dessusception as a result of uretero-ileal anastomotic stenosis. The configuration of the upper tract evaluated by IVU revealed stable upper tracts in 36 out of 39 renal units (92.3%) in group I and in 34 out of 38 units (89.5%) in group II (Table 1). In group I deterioration of the upper tracts was due to anastomotic strictures in 2 units (2 patients) while the remaining unit was due to reflux. In group II upper tract deterioration was attributed to uretero-ileal anastomotic stricture in 2 (1 patient) and due to reflux in the remaining 2 units. It is important to note that the incidence of anastomotic stricture in both groups was comparable (p ¼ 0:98) Pouch stones While 5 patients in group II developed pouch stones, only one patient in the ileal W neobladder group developed pouch stone (p ¼ 0:08). It is noteworthy that all pouch stones in the Kock group were developed over metallic staples. Five patients were managed endoscopically while one patient in group II had huge stone that necessitated open poucholithotomy Urodynamic evaluation Urodynamic evaluation was an integral part of our investigation. Medium fill water cystometery was carried out for all the evaluable patients and showed a low-pressure compliant ileal reservoirs regardless the Table 2 Urodynamic evaluation Group I (Ileal W neobladder) 39 units Group I (Ileal W neobladder) Group II (Kock pouch) 38 units Group II (Kock pouch) p value Stable/improved 36 (92.3%) 34 (89.5%) Deteriorated 3 (7.7%) 4 (10.5%) Stricture 2 (5.1%) 2 (5.25%) p ¼ 0.98 Reflux 1 (2.6%) 2 (5.25%) Reflux 3 (7.7%) 2 (5.25%) p ¼ 0.81 p value Mean max. Pouch capacity (ml) Mean max. pressure at max. capacity (cmh 2 O) Incidence of uninhibited contractions 25.9% 29.1% 0.9 type of pouch used. Urodynamic individual data were comparable between both treatment groups (Table 2). 4. Discussion Following Hinman s principles [10], there is a general agreement that detubularization of the bowel is required to nullify pressure waves created by peristalsis and to obtain maximum capacity from a given length of bowel. Orthotopic bladder replacement would allow normal voiding and obviate the need for urostomy bags or selfcatheterization continent pouches. Preservation of upper tract integrity and function is one of the essential requirements when urinary substitute is indicated. Many authors deny the need of using an anti-reflux mechanism in low-pressure urinary reservoirs. They assumed that these low pressure detubularized reservoirs are mostly sterile with possible complete emptying by Valsalva s maneuver. Moreover, they considered the antireflux techniques more surgically demanding, time consuming and may be associated with higher complications particularly obstruction. Finally, they had shown that harmful effects secondary to reflux was demonstrated only in animal models [11,12]. On the other hand, there are many clinical as well as experimental studies favoring the necessity of antirefluxive uretero-intestinal reimplantation whenever orthotopic urinary diversion is required. Clinically, persistent asymptomatic bacteruria was reported to occur in up to 35% of men undergoing orthotopic diversion [13]. Moreover, there is increasing proportion of women with orthotopic substitutes who require intermittent catheterization with subsequently chronically infected urine [14]. Experimentally, refluxing and non refluxing units were studied in a canine model with low pressure ileocystoplasty reservoirs. This study confirmed that refluxing forms of ureteral implantation were associated with bacteruria in the upper tracts. Although this is an animal model but gives an indirect clue that antireflux system may be important to protect the upper tract from deterioration over time [15]. From another prospect; although it is well accepted that most of the neobladders are low pressure during the storage phase, this could not be considered during Valsalva s maneuver as the pressure was recorded to be as high as ( cmh 2 O) with 44% of patients [16]. Therefore, if there is a simple and efficient antireflux technique that is not surgically challenging or time consuming, it should be used whenever required. Many reflux prevention techniques have been proposed and utilized in ileal bladder substitutions. The technique proposed by Le Duc et al., is attractive in

4 Y. Osman et al. / European Urology 45 (2004) view of its technical simplicity, sparing an extrasegment of bowel and the stapling material is not required. Nevertheless, our own clinical experience [2] as well as those of the others [17] indicates that the complication rate is approximately 20 to 30% resulting from reflux and/or stenosis. Experimental evidence has been provided that the expected creeping of the intestinal mucosa over the implanted ureter was impeded in the presence of urine so, the result is an irregular healing process with scar formation [18]. Studer and coworkers proposed the use of an isoperistaltic long afferent loop for reflux prevention. They maintained that the unidirectional peristalsis of the ureters and the afferent tubular ileal segment sufficiently protect the upper urinary tracts following ileal bladder substitution up to a decade after urinary diversion [19]. However, based on Studer s argument to prevent reflux those patients with an isoperistaltic afferent limb, the intraabdominal pressure on the ureter and the renal pelvis must be similar to that on the reservoir. Force, however, is a function of pressure applied to the surface area (Force ¼ pressure surface area). Because the force on the neobladder is larger (as a result of a larger surface area) than that on either the ureter or the renal pelvis, it is likely that reflux exists during these higher voiding pressure phases [20]. The split cuff technique has been described as an effective and simple way to prevent reflux in continent urinary diversion. In this technique, the ureter is brought through a full thickness incision in the posterior aspect of the reservoir. In a recent report, Sagalowsky reported excellent functional results with low rates of reflux or obstruction. Nevertheless, this technique might not be suitable in cases of short or dilated ureters [21]. When the technique of an intussuscepted ileal nipple valve is properly constructed, it is associated with satisfactory results [6 22]. Nevertheless, on long-term follow up an important number of complications was observed [7]. Late complications with the construction of the intussuscepted ileal nipple valve, particularly stone formation and afferent nipple stenosis, was also reported by other experienced surgeons [23]. Most of these complications were valve related due to metallic stapling which invites stone formation. Furthermore, 15 cm extra-bowel length is required for valve construction. In 1994 Abol-Enein and Ghoneim [8] reported their initial experience in the ileal W neobladder with the novel serous lined extramural tunnel as an antireflux procedure. Later they reported their further clinical experience with a large number of patients and maintained several advantages of the technique with a low complications rate [24]. In the last few years, Stien and Skinner reported upon the orthotopic T-pouch ileal neobladder and cutaneous double-t-pouch ileal reservoir incorporating a serosal lined ileal antireflux technique and concluded that it is an extremely effective and versatile flap-valve technique that can be easily learned and applied to the construction of continent urinary diversions [25]. In 1992, Shaaban et al. [2] showed the superiority of ileal nipple valve over the Le Duc mucosal trough technique in reflux prevention and the stricture tendency. Two separate studies concluded the comparable functional outcome between the afferent tubular ileal segment and either the ileal nipple valve [3] or the split cuff technique [4]. Similar to our study, Hendry compared the serous lined extramural tunnel and the ileal nipple valve in a smaller number of patients. On short-term analysis, he concluded that both techniques had similar satisfactory results whilst the serous lined technique is more economical in the length of ileum used and in operating time [5]. Although all these studies were well constructed as a prospective controlled randomized trials, none of them reported long-term outcome. Long-term analysis of our results revealed comparable incidence of reflux in both techniques. The indications of revisional surgery are either reflux of high grade and/or associated persistent bacteruria with the risk of recurrent pyelonephritis. In this study, one patient with reflux secondary to outflow obstruction in the Kock group was managed by internal urethrotomy and dilation of the uretero-ileal anastomosis followed by revisional surgery. Two patients with low-grade reflux following serous lined extramural tunnel were kept on anti-microbials with no further deterioration on follow up. The third patient refused corrective surgical intervention. Similarly, the incidence of anastomotic stricture in both techniques was of no statistical significant difference. Since the retrograde endoscopic manipulation is feasible in serous-lined ureteral implantation technique, it should be tried whenever indicated. In Kock pouch, it might be difficult to get an easy endoscopic access to the uretero-ileal anastomosis, and open surgical revision is usually the possible alternative. In this series, retrograde endoscopic dilation was successful in 1 out of 2 ureteric strictures following serous lined extramural ureteral implantation. Open surgical revision was mandatory in the other due to ischemia of the distal ureter. Uretero-ileal stricture was observed bilaterally in one patient with ileal nipple valve. Successful open surgical revision was performed. This study confirmed the high incidence of pouch stones with Kock pouch patients. However, its prevalence did not rank to statistical significance when compared with ileal W neobladder. Being both constructed from the ileum and based on the same principles of detubular-

5 86 Y. Osman et al. / European Urology 45 (2004) ization and double folding, urodynamic studies showed low-pressure compliant reservoirs in both groups. 5. Conclusion In conclusion, both techniques are associated with a comparable functional outcome. However, there are several advantages favoring the use of W neobladder with the serous lined extramural tunnel namely, 40 cm long bowel segment is sufficient for creation of the reservoir, metallic staples or synthetic materials are not required. The technique is versatile and applicable for ureters of different calibers. Moreover, the implanted ureters are accessible for all types of endoscopic procedures. References [1] Kock NG, Ghoneim MA, Lycke G, Mahran MR. Replacement of the bladder by the urethral Kock pouch: functional results, urodynamics and radiological features. J Urol 1989;141: [2] Shaaban AA, Gaballah MA, El-Diasty TA, Ghoneim MA. Urethral controlled bladder substitution: a comparison between the intussuscepted nipple valve and the technique of Le Duc as antireflux procedures. J Urol 1992;148: [3] Studer UE, Spiegel T, Casanova GA, Springer J, Gerber E, Ackermann DK, et al. Ileal bladder substitute: antireflux nipple or afferent tubular segment? Eur Urol 1991;20: [4] De Carli P, Micali S, O Sullivan D, Mainiero G, Cusumano G, Fattahi H, et al. Ureteral anastomosis in the orthotopic ileal neobladder: comparison of 2 techniques. J Urol 1997;157: [5] Hendry WF. Bladder replacement by ileocystoplasty after cystectomy for cancer: comparison of two techniques. Br J Urol 1996;78: [6] Ghoneim MA, Shaaban AA, Mahran MR, Kock NG. Further experience with the urethral Kock pouch. J Urol 1992;147: [7] Madbouly K, Abol-Enein H, Ashamallah A, Ghoneim MA. Hemi- Kock pouch for orthotopic substitution: long term evaluation. J Urol 1999;91(Suppl 161) [Abstract 349]. [8] Abol-Enein H, Ghoneim MA. A novel uretero-ileal reimplantation technique: the serous-lined extramural tunnel. A preliminary report. J Urol 1994;151: [9] Ghoneim MA, Kock NG, Lycke G, El-Din ABS. An appliance free, sphincter-controlled substitute: the urethral Kock pouch. J Urol 1987;138: [10] Hinman Jr F. Selection of intestinal segments for bladder substitution: physical and physiological characteristics. J Urol 1988;139: [11] Pantuck AJ, Han K-R, Perrotti M, Weiss RE, Cummings KB. Ureteroenteric anastomosis in continent urinary diversion: long-term results and complications of direct versus non-refluxing techniques. J Urol 2000;163: [12] Hohenfellner R, Black P, Leissner J, Allhoff EP. Refluxing ureterointestinal anastomosis for continent cutaneous urinary diversion. J Urol 2002;168: [13] El Bahnasawy M, Osman Y, Gomha M, Shaaban A, Ashamallah A, Ghoneim M. Nocturnal enuresis in men with an orthotopic ileal reservoir: urodynamic evaluation. J Urol 2000;164:10 3. [14] Ali-El-Dein B, Gomha M, Ghoneim MA. Critical evaluation of the problem of chronic urinary retention after orthotopic bladder substitution in women. J Urol 2002;168: [15] Kristjansson A, Abol-Enein H, Alm P, Mokhtar AA, Ghoneim MA. Long term renal morphology and function following enterocystoplasty (refluxing or anti-reflux anastomosis): an experimental study. Br J Urol 1996;78: [16] Gotoh M, Yoshikawa Y, Sahashi M, et al. Urodynamic study of storage and evacuation of urine in patients with a urethral Kock pouch. J Urol 1995;154: [17] Roth S, Ahlen HV, Semjonow A, Oberpenning F, Hertle L. Does the success of ureterointestinal implantation in orthotopic bladder substitution depend more on surgeon level of experience or choice of technique? J Urol 1997;157: [18] Abol-Enein H, El-Baz M, Ghoneim MA. Optimization of ureterointestinal anastomosis in urinary diversion: an experimental study in dogs. I. Evaluation of the Le Duc technique. Urol Res 1993;21: [19] Thoeny HC, Sonnenschein MJ, Madersbacher S, Vock P, Studer UE. Is ileal orthotopic bladder substitution with an afferent tubular segment detrimental to the upper urinary tract in the long term? J Urol 2002;168: [20] Ghoneim MA. Ureterointestinal anastomosis in continent urinary diversion: an antirefluxing procedure Is it necessary? Tech Urol 2001;7(3): [21] Sagalowsky AI. Further experience with split-cuff nipple ureteral reimplantation in urinary diversion. J Urol 1998;159: [22] Steven K, Poulsen AL. The orthotopic Kock ileal neobladder: functional results, urodynamic features, complications and survival in 166 men. J Urol 2000;164: [23] Elmajian DA, Stein JP, Esrig D, Freeman JA, Skinner EC, Boyd SD, et al. The Kock ileal neobladder: updated experience in 295 male patients. J Urol 1996;156: [24] Abol-Enein H, Ghoneim MA. Functional results of orthotopic ileal neobladder with serous-lined extramural ureteral reimplantation: experience with 450 patients. J Urol 2001;165: [25] Stein JP, Skinner DG. T-mechanism applied to urinary diversion: the orthotopic T-pouch ileal neobladder and cutaneous double-t-pouch ileal reservoir. Tech Urol 2001;7(3):