Eiji Kikuchi, Yutaka Horiguchi, Jun Nakashima, Takashi Ohigashi, Mototsugu Oya, Ken Nakagawa, Akira Miyajima and Masaru Murai

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1 Assessment of Long-Term Quality of Life Using the FACT-BL Questionnaire in Patients with an Ileal Conduit, Continent Reservoir, or Orthotopic Neobladder Eiji Kikuchi, Yutaka Horiguchi, Jun Nakashima, Takashi Ohigashi, Mototsugu Oya, Ken Nakagawa, Akira Miyajima and Masaru Murai Department of Urology, Keio University School of Medicine, Tokyo, Japan Received May 16, 2006; accepted July 9, 2006; published online October 3, 2006 Objective: To assess and compare quality of life (QOL) of patients followed for a long time who underwent an ileal conduit (IC), continent reservoir (CR) or ileal neobladder (NB) using FACT-BL, a bladder-cancer-specific questionnaire. Methods: One hundred and forty-seven patients underwent radical cystectomy and urinary diversion for bladder cancer from 1987 to 2002 at our institution. Of them, 79 (54%) patients were asked to participate in this study. Forty-nine patients (20 IC, 14 CR and 15 NB) returned the answered questionnaire for a survey response rate of 62%. Mean follow-up was 83.0 months. Results: Four categories (physical, social/familial, emotional and functional well-being) in FACT-G were equally favorable in these groups. Patients with IC had less trouble controlling urine but had a worse image on altered body appearance compared with NB patients. Interest in sex was extremely low in all patients and capability of maintaining an erection was also low in 39 male patients. The mean total value of FACT-BL in IC, CR and NB patients was , , and , respectively, showing no significant difference. Ten (77%) of 13 IC, seven (78%) of nine CR and six (86%) of seven NB patients answered that they would choose the same type of diversion if they had the choice again. Conclusions: The type of urinary diversion does not appear to be associated with a different QOL by general cancer-related assessment. Urinary function and body image are affected and related to the method used to reconstruct the urinary system. Key words: quality of life total cystectomy urinary diversion Jpn J Clin Oncol 2006;36(11) doi: /jjco/hyl094 INTRODUCTION With the development of numerous techniques for continent reconstruction of the lower urinary tract, the trend has markedlychangedinthewayinwhichurologistsselectameans of urinary reconstruction as the most appropriate urinary diversion after radical cystectomy (1). During the 1980s the main urinary diversions were ileal conduits and continent cutaneous reservoirs, respectively. Since the early 1990s, orthotopic urinary reservoirs have been replacing those urinary diversions with acceptable morbidity rates (2). Meanwhile, it is of great importance to assess patients quality of life (QOL) to understand the psychological, physical and social consequences of urinary reconstruction. For reprints and all correspondence: Eiji Kikuchi, Department of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo , Japan; eiji-k@kb3.so-net.ne.jp However, the comparative impact of different types of urinary diversions on health related QOL has not been well studied. The re-evaluation of the patients QOL seems long overdue. Patients with bladder cancer have common problems as seen among any cancer patients. Once they undergo urinary reconstruction after cystectomy, they also have specific problems related to the surgery, such as urine leakage, change of body image and loss of sexual interest. Most previous studies, however, assessed QOL of bladder-cancer patients using the instruments available for general cancer patients (3, 4). As these questionnaires are sometimes with untested validity and reliability, it is difficult to assess the difference among the studies. FACT-BL, a bladder-cancer-specific module has recently become available for use in conjunction with FACT-G (5), which is intended for general cancer patients. Although these validated instruments are assumed # 2006 Foundation for Promotion of Cancer Research

2 Jpn J Clin Oncol 2006;36(11) 713 to be useful, few studies have compared the QOL of patients with an ileal conduit (IC), a continent cutaneous reservoir (CR), or an orthotopic neobladder (NB), using the FACT-BL questionnaire (6). In the present study, we assessed the QOL of patients followed for a long time who underwent different forms of urinary diversions, using Japanese version of the FACT-BL questionnaire. We examined differences in urinary diversionrelated symptoms, such as trouble controlling urine, body image dissatisfaction, and sexual dysfunction and dissatisfaction. PATIENTS AND METHODS 147 patients underwent radical cystectomy and urinary diversion for invasive bladder cancer from 1987 to 2002 at our institution. Potency-preserving surgery was not performed routinely. Of them, 42 (29%) patients were dead at the time of the present study, 24 (16%) were inaccessible by mail, one (0.6%) was too old to answer the questionnaire and one (0.6%) had undergone conversion from a cutaneous Kock pouch to an IC. Consequently, 79 (54%) patients were available for the assessment. Each patient was mailed a questionnaire packet, informed consent form, personal cover letter and a stamped return envelope. A total of 49 (62%) answered questionnaires were returned to us. These patients included 20 with an IC, 14 with a CR (Indiana pouch in five, Kock pouch in eight, and Mainz pouch in one), and 15 with a NB. Mean follow-up was 83.0 months (20 202). QOL was assessed using FACT-BL. The following scores were calculated from the FACT-BL questionnaire and list: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), total FACT-G, overall bladder-specific subscale and total FACT-BL score. A high FACT score indicated a high level of QOL. The questionnaire was translated into Japanese using an iterative forward back method (7). As for the bladder-specific subscale, because one question is only for men, and two questions are only for patients with an ostomy appliance, we did not include these results and the overall bladder-specific subscale score was calculated from the remaining nine questions of the 12 bladder-specific ones. The medical records of each patient were reviewed. Clinical parameters, including age, type of diversion, final pathological status and current disease status, were recorded. Statistical analyses were performed using the Mann Whitney U-test or one-way analysis of variance followed by Bonferroni s correction for continuous variables and Fisher s exact test or chi-square test for categorical variables. A P value less than 0.05 was considered to indicate statistical significance. RESULTS The comparison between respondents and non-respondents revealed no significant differences in the percent of males, or of patients with pathological stage T3 or greater (Table 1). Respondents were significantly younger than nonrespondents both at the time of surgery and survey. Respondents underwent IC less frequently than nonrespondents (41 versus 80%). Furthermore, the rate of no evidence of disease was higher and the follow-up period was longer in respondents. When respondents were stratified by type of diversion, no differences were found in the number of patients with pathological stage T3 or greater, number of patients administered chemotherapy, number of patients subjected to radiotherapy, number of disease-free patients and age at the time of the survey (Table 2). There were 13, 11 and 15 male patients with an IC, CR and NB, respectively (P ¼ 0.039). Patients Table 1. Comparison between survey respondents and non-respondents Respondents No. Pts (%) Non-respondents No. Pts (%) P value No. Pts Mean age at surgery + SD (years) No. men 39 (79.6%) 26 (86.7%) Mean follow-up + SD (months) No. pathological stage T3 or greater 13 (26.5%) 10 (33.3%) Type of diversion Ileal conduit 20 (40.8%) 24 (80.0%) Continent cutaneous reservoir 14 (28.6%) 4 (13.3%) Orthotopic neobladder 15 (30.6%) 2 (6.7%) No. disease-free 45 (91.8%) 20 (66.7%) Mean age at the survey + SD (years) Pts, patients; SD, standard deviation.

3 714 Long-term QOL after urinary diversion Table 2. Medical and demographic data of respondents distributed Ileal conduit Continent cutaneous reservoir Orthotopic neobladder No. Pts Mean age at surgery + SD (years) * No. men 13 (65%) 11 (78.6%) 15 (100%) Mean follow-up + SD (months) * No. pathological stage T3 or greater 5 (25.0%) 5 (35.7%) 3 (20%) No. systemic chemotherapy Neoadjuvant 1 (5%) 1 (7.1%) 0 (0%) Adjuvant 3 (15.0%) 3 (21.4%) 4 (26.7%) No. post-operative radiotherapy 1 (5%) 0 (0%) 1 (6.7%) No. disease-free 18 (90.0%) 14 (100%) 13 (86.7%) Mean age at the survey + SD (years) Pts, patients; SD, standard deviation. *P, 0.05 versus continent cutaneous diversion reservoir. P, 0.05 versus continent cutaneous reservoir and orthotopic neobladder. Table 3. Summary of FACT-BL in the diversion groups Function (maximum) Overall (mean + SD) Ileal conduit (mean + SD) Continent cutaneous reservoir (mean + SD) Orthotopic neobladder (mean + SD) PWB (28) SWB (28) EWB (24) FWB (28) FACT-G (108) Bladder-specific subscale (36) FACT-BL (144) SD, standard deviation; PWB, physical well-being; SWB, social/family well-being; EWB, emotional well-being; FWB, functional well-being; FACT-G, functional assessment of cancer therapy general; FACT-BL, functional assessment of cancer therapy bladder. with a CR were significantly younger than those with an IC (P ¼ 0.003). Patients with a CR were followed up significantly longer than those with an IC (P ¼ 0.023). FACT-BL scores are shown in Table 3. The overall mean + SD of FACT-G was of a total of 108 points. The patients had high scores for PWB. However, SWB scores were approximately half the maximum obtainable scores. The mean + SD of FACT-G in patients with an IC, CR, and NB was , and , respectively, showing no significant differences. Total scores of bladder-cancer subscale and FACT-BL were similar among the urinary diversion groups. The results of the bladder-cancer subscale questionnaire are shown in Table 4. Seventeen (85%) of 20 patients with an IC answered no trouble at all in controlling urine, compared to eight (57%) of 14 patients with a CR and three (20%) of 15 patients with a NB. Patients with an IC had significantly less trouble controlling urine than those with a NB (mean + SD of versus , P ¼ 0.018). However, half of the patients with an IC reported that they did not like the appearance of their bodies at all, compared with only one (7%) patient with a CR and two (13%) with a NB. Patients with an IC had a significantly worse QOL score regarding their body image than those with a NB (mean + SD of versus , P ¼ 0.036). There were no significant differences regarding the control of bowel function among the three diversion groups. Fifteen (75%) of 20, eight (57%) of 14, and eight (53%) of 15 patients with an IC, CR and NB, respectively, had interest in sex not at all. Twelve (92%) of 13, 11 (100%) of 11 and 11 (73%) of 15 patients with an IC, CR and NB respectively, reported inability to maintain an erection. The questions I am embarrassed by my ostomy appliance and Caring for my ostomy appliance is difficult were answered by some of the patients with an IC or a CR, while these two statements were only for patients with an ostomy appliance. There were no significant differences in QOL score for these two questions between the IC and CR groups.

4 Jpn J Clin Oncol 2006;36(11) 715 Table 4. Answer to each bladder-cancer subscale question Not at all A little bit Somewhat Quite a bit Very much I have trouble controlling my urine IC CR NB I like the appearance of my body IC CR NB I am interested in sex IC CR NB I am able to have and maintain an erection IC CR NB I am embarrassed by my ostomy appliance IC CR Caring for my ostomy is difficult IC CR IC, ileal conduit; CR, continent cutaneous reservoir; NB, orthotopic neobladder. Patients were also asked whether they would choose the same type of diversion if they had the choice again; 10 (77%) of 13 IC, seven (78%) of nine CR and six (86%) of seven NB patients answered they would choose the same diversion. DISCUSSION In the present study, we used the Japanese version of the FACT-BL, an accepted and well-known questionnaire to assess differences in QOL among patients with bladder cancer subjected to different types of urinary diversion. Dutta et al. used FACT-G in 72 patients with an IC or a NB and found no significant differences in total FACT-G score between the two groups (8). However, they noted that patients with a NB had a significantly better QOL than those with an IC in the areas of EWB and FWB. In contrast, we did not find any difference between the two groups in any of four domains of FACT-G. Mansson et al. compared the QOL of 64 patients with a CR or NB using FACT-BL and observed no differences in any domain of FACT-G between the two groups (6). In their study, patients with a CR had significantly less trouble controlling urine and patients with a NB had a significantly better appreciation of their body appearance. In our series, patients with a CR tended to have less trouble controlling urine (mean + SD of in CR group versus in NB group) and patients with a NB tended to have a better appreciation of their body appearance (mean + SD of inCRgroupversus in NB group). We found that our patients with an IC had significantly less trouble controlling urine than those with a NB, as reported by other authors (9, 10). Better stoma appliances and post-operative care by a skilled stoma therapist might have reduced the stoma related problems. Some degree of urinary leakage, especially at night, is a constant finding in NB patients (11). However, it is considered that patients in our population were adapted to and accepted their urinary diversion. Patients with an IC may come to manage their diversion well over time and this situation may make urine control more easily manageable and their QOL may then be comparable to that of those with a CR and a NB. In our study the score for external body image in patients with an IC was the poorest among the three groups and patients with a CR had a slightly poorer body image than those with a NB, as reported in other studies (9, 12). Although patients with a CR do not need an external appliance, they still have a stoma, which may affect the perception of their body image. The effect of surgery on sexual function depends largely on the extent of the operation. Radical cystectomy without nerve sparing surgery almost inevitably results in impotence. Furthermore, loss of interest in sex was thought to be based on having a stoma and older age. However, we found a reduced sexual capacity in the great majority of patients without nerve sparing surgery, with no difference being noted among the IC, CR and NB groups. Hart et al. reported that patients had a low QOL score in sexual function regardless of the type of urinary diversion and recipients who had a penile prosthesis placed had a significantly better sexual function and satisfaction (13). It might be necessary for

5 716 Long-term QOL after urinary diversion physicians to counsel and discuss the availability of erectile aids and phosphodiesterase-5 inhibitor therapy to improve the sexual life of patients who undergo radical cystectomy. The present study has some limitations. First of all, it was retrospective and non-randomized. The decision to perform any type of urinary diversion depends upon many considerations, including patient and surgeon preferences, co-morbidity and patient s age and body build. In most series, patients receiving an IC tend to be older. In our series of 147 patients, the mean age + SD of 86 patients who underwent IC was years old, which was significantly older compared to the 36 who underwent CR ( ) or the 24 subjected to NB ( ). In some situations, the surgeon might have tended to select IC for patients with more co-morbidities to perform urinary diversion in a shorter operative time. However, as there were no differences in pathological stage, grade of bladder cancer, lymph node status in radical cystectomy specimens and cause-specific survival rate among the three diversion groups (data not shown), there seemed to be no selection bias as IC was performed on patients with more advanced disease. Comparison between respondents and non-respondents demonstrated that 45% of the 44 patients with an IC responded our questionnaire, compared to 78% of the 18 patients with a CR and 88% of the 17 patients with a NB. It is possible that patients with an IC who did not participate might have been more dissatisfied with the outcome of surgery than participants or might have felt more uncomfortable. There were no differences in the number of patients with pathological stage T3 or greater and G3. However, respondents were younger at surgery and at the time of the survey and had been followed up for longer periods than non-respondents. Furthermore, there were significant differences in the number of disease-free patients. These differences might have influenced our QOL results. Further large and prospective longitudinal research will be needed to clarify the real differences among these three diversion groups. CONCLUSION Despite the limitations as a result of the small sample size and type of survey, our study demonstrates that the type of urinary diversion does not appear to be associated with differential post-operative QOL. In contrast, urinary function and body image are affected and related to the method used to reconstruct the urinary system. Reduced sexual satisfaction and capacity was frequently encountered in our study population. Acknowledgments This study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology, Japan. References 1. Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol 2001;19: Yossepowitch O, Dalbagni G, Golijanin D, Donat SM, Bochner BH, Herr HW, et al. Orthotopic urinary diversion after cystectomy for bladder cancer: implications for cancer control and patterns of disease recurrence. JUrol2003;169: Kitamura H, Miyao N, Yanase M, Masumori N, Matsukawa M, Takahashi A, et al. Quality of life in patients having an ileal conduit, continent reservoir or orthotopic neobladder after cystectomy for bladder carcinoma. Int J Urol 1999;6: Hobisch A, Tosun K, Kinzl J, Kemmler G, Bartsch G, Holtl L, et al. Life after cystectomy and orthotopic neobladder versus ileal conduit urinary diversio. Semin Urol Oncol 2001;19: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11: Mansson A, Davidsson T, Hunt S, Mansson W. The quality of life in men after radical cystectomy with a continent cutaneous diversion or orthotopic bladder substitution: is there a difference? BJU Int 2002;90: Hinotsu A, Niimi M, Akaza H, Miyanaga N, Takeshima H, Eremenco S, et al. Development of Japanese version of QOL questionnaire for bladder and prostate cancer patients using FACT-Bl and P: pilot study (in Japanese). Gan To Kagaku Ryoho 1999;26: Dutta SC, Chang SC, Coffey CS, Smith JA, Jr., Jack G, Cookson MS. Health related quality of life assessment after radical cystectomy: comparison of ileal conduit with continent orthotopic neobladder. JUrol2002;168: Bjerre BD, Johansen C, Steven K. Health-related quality of life after cystectomy: bladder substitution compared with ileal conduit diversion. A questionnaire survey. Br J Urol 1995;75: Sullivan LD, Chow VD, Ko DS, Wright JE, McLoughlin MG. An evaluation of quality of life in patients with continent urinary diversions after cystectomy. Br J Urol 1998;81: Steers WD. Voiding dysfunction in the orthotopic neobladder. World J Urol 2000;18: Bjerre BD, Johansen C, Steven K. Health-related quality of life after urinary diversion: continent diversion with the Kock pouch compared with ileal conduit. A questionnaire study. Scand J Urol Nephrol 1994;157(Suppl): Hart S, Skinner EC, Meyerowitz BE, Boyd S, Lieskovsky G, Skinner DG. Quality of life after radical cystectomy for bladder cancer in patients with an ileal conduit, cutaneous or urethral kock pouch. J Urol 1999;162:77 81.