Health-Related Quality-of-Life Following Modified Ureterosigmoidostomy (Mainz Pouch II) as Continent Urinary Diversion

Transcription

1 European Urology European Urology 46 (2004) Health-Related Quality-of-Life Following Modified Ureterosigmoidostomy (Mainz Pouch II) as Continent Urinary Diversion Patrick J. Bastian a,*, Peter Albers a, Herbert Hanitzsch b, Giancarlo Fabrizi b, Romano Casadei b, Axel Haferkamp a, Stefan Schumacher a, Stefan C. Müller a a Klinik und Poliklinik für Urologie, Universitätsklinikum Bonn, Rheinische Friedrich-Wilhelms Universität, Sigmund-Freud-Str. 25, Bonn, Germany b Divisione di Urologia Ospedale San Salvadore, Pesaro, Italy Accepted 6 June 2004 Available online 26 June 2004 Abstract Introduction and objectives: The purpose of this study was to estimate the health-related quality of life (HRQoL) following modified ureterosigmoidostomy (Mainz Pouch II) urinary diversion. Materials and methods: Between March 1995 and February 2003 the procedure was performed in 83 patients (67 male and 16 female, median age 62 years, range 2 78 years) at the Departments of Urology in Bonn, Germany, and Pesaro, Italy. Patients were asked during follow-up to complete a validated, cancer-specific quality of life questionnaire, namely the EORTC QLQ C-30 Version 3. Forty-one patients (29 male, 12 female) completed the QLQ C-30. Twenty-eight patients were dead at the time of the study and 14 patients were lost to follow-up. A nonvalidated questionnaire was answered by 31 patients (75%) of the Bonn series to determine specific urinary diversion items. Mean follow-up time was 24.4 months (6 to 84 months). Results: No statistically significant differences (p < 0.05) in functional and symptom scales or global health status were detected between males and females. All scales but diarrhea showed good results and the outcome was comparable to health-related quality of life in a reference population of Germany. Continence rate was 100% at daytime; all but one patient had to get up for urination at night. About one third of the patients have to urinate more than six times during the day and more than three times during the night. Sixty-three percent of the patients in the Bonn series were able to distinguish between stool and urine. Conclusion: The Mainz Pouch II serves as a satisfying continent urinary diversion for both sexes in selected patients in terms of quality of life. Patients seem to adapt to their individual form of urinary diversion. In terms of continence modified ureterosigmoidostomy can lead to daytime continence rate of 100%. The relatively high voiding frequency during night-time was not felt to be disturbing by the patients and demonstrates the adaptability of the patients. # 2004 Elsevier B.V. All rights reserved. Keywords: Mainz Pouch II; Ureterosigmoidostomy; Urinary diversion; Quality of life; EORTC QLQ C-30; Urinary continence; Modified ureterosigmoidostomy 1. Introduction The impact of disease and treatment on the patient s overall well-being and functioning is a topic of rising * Corresponding author. Tel. þ ; Fax: þ address: patrick.bastian@gmx.de (P.J. Bastian). interest in clinical research. Long-term outcome healthrelated quality of life (HRQoL) combined with continence after cystectomy are important considerations aside from cancer cure and control in decision making regarding the type of urinary diversion. Researches have found that the type of urinary diversion does not seem to be associated with differences in the quality /$ see front matter # 2004 Elsevier B.V. All rights reserved. doi: /j.eururo

2 592 P.J. Bastian et al. / European Urology 46 (2004) of life [1,2]. Others have shown that continent diversion is advantageous over incontinent diversion [3 6]. Ureterosigmoidostomy as a continent urinary diversion was first introduced in 1852 and gained a broad popularity during the first half of the 20th century. Due to many problems such as electrolyte imbalance, pyelonephritis, renal function deterioration, incontinence and renal stone formation many modifications were described. Until recently the major unsolved problem of ureterosigmoidostomy was the high rate of incontinence. A modification [7] using detubularization (Mainz Pouch II) demonstrated that this technique is a safe and accepted technique of urinary diversion after cystectomy with low complication rate and morbidity [7 9,20]. Multiple studies have compared the HRQoL of different forms of continent and incontinent urinary diversions. Only one report on the HRQoL supported the use of ileocecal rectal bladder compared to ileal conduit diversion for selected patients [19]. However, no data is available on quality of life in patients following modified ureterosigmoidostomy (Mainz Pouch II, sigma rectum pouch) as a continent diversion. The aim of this study was to estimate the HRQoL after modified ureterosigmoidostomy as one form of continent urinary diversion. 2. Material and methods Between March 1995 and December patients (67 male and 16 female, 2 children, mean age 62.1 years, range 2 75) underwent modified ureterosigmoidostomy (Mainz Pouch II) for urinary diversion at the Department of Urology of the University of Bonn (n ¼ 41), Germany, and at the Department of Urology in Pesaro (n ¼ 42), Italy (14.5% of all urinary diversions in the centers). All patient data was reviewed retrospectively and informed consent was obtained from all patients prior to surgery. The Mainz Pouch II urinary diversion was performed after radical cystecomy for malignant bladder carcinoma (n ¼ 79), for morphological or functional bladder loss (bladder extrophy and epispadia) (n ¼ 3) and for gynaecological carcinoma infiltrating the urinary bladder (n ¼ 1). Ureterosigmoidostomy was performed in cases when other forms of continent diversion, e.g. ileal neobladder or Mainz Pouch I diversion, were not possible because of oncological reasons, lacking patient compliance or other co-morbidities. Contraindications for the procedure were an incontinent anal sphincter, sigma diverticulosis, intestinal polyps, prior or planned radiotherapy and insufficient renal function (serum kreatinine above 1.5 mg/ml). Preoperative preparations were performed according to the description by Fisch et al. [7]. The anal sphincter competence was judged as normal when patients could hold a ml water enema for at least 4 5 hours during daytime and at night. Sphincter monometry of the rectum were neither done pre- or postoperatively. Follow-up was available for 69 of the 83 patients (83%). The mean follow-up of the study group was 24.4 months (range 6 84 months, median 19 months). At the time of the study 28 patients Table 1 Study population Age <65 years (mean age) 17 (42) >65 years (mean age) 24 (58) Sex ratio (M:F) 28:13 Disease Benign 1 (2.4) Malignant 40 (97.6) QLQ C of 83 (49) Questionnaire reply (Bonn series) 31 of 41 (75) Mean follow-up (range) (in months) 24.4 (6 84) Median follow-up (in months) 19 Number of patients (n ¼ 41) (%) were dead. Twenty two patients have died of metastatic disease, two patients of unrelated malignant disease, two of septic disease and two of heart disease. Fourteen patients were lost to followup. These patients could not be located. None of the patients contacted and asked to participate in the study refused to do so. None of the children were available for follow-up. During followup 8.5% of the patients developed pyelonephritis and 1.5% of the patients stenosis at the uretero-intestinal implantation site [20]. Forty-five percent needed oral medication to prevent hyperchloremic, metabolic acidosis [20]. Of the 83 patients with modified ureterosigmoidostomy, 41 patients (49%, 29 male and 12 female, age 27 to 78 years) completed the QLQ C-30 during outpatient, follow-up visit (Table 1). The validated cancer-specific EORTC QLQ C-30 Version 3 was used [10,11]. The QLQ C-30 consists of 30 items. These include a global health status/qol scale, five functional scales (physical, emotional, cognitive, social and role functioning), three symptom scales (pain, fatigue, nausea and vomiting), and six single items (dyspnoea, sleep disturbances/insomnia, loss of appetite, diarrhoea, constipation and financial impact of the disease). Each of the multi-item scales include a different set of items, no item occurs in more than one scale. For functional and global quality of life scales, higher scores demonstrate a higher level of functioning, whereas high scores in the symptom scales represent more problems and mean a reduced quality of life. The QLQ C-30 was evaluated according to the EORTC guidelines [10,11]. For statistical analysis the Mann Whitney Rank Sum Test was performed with a p-value <0.05 being of statistical significance. A non-validated questionnaire to ask for diversion-related problems was used at the University of Bonn and answered by 31 of 41 patients (75.6%). The development of an own, non-validated questionnaire was indicated, because no validated questionnaire to assess quality of life after cystectomy and urinary diversion exists and the validated EORTC bladder/urinary diversion modul is not available yet. The items studied were chosen after careful study of the literature with the intention to improve patient counseling before urinary diversion. The questionnaire included the following: urinary frequency and continence (day and night), change of eating, dressing or sexual habits, impact on social life, daily activities or work, martial status and the question whether the patient would undergo the type of diversion again (see Table 2). Tumor stage according to the TMN classification of 1997 was T1/T2/Cis in 67% (53 of 80 patients with malignant disease) and T3/T4 in 33% (27 of 80 patients with malignant disease). Seven patients had pn1 and 10 patients pn2 disease. In nineteen (28%)

3 P.J. Bastian et al. / European Urology 46 (2004) Table 2 Results of the self-developed questionnaire used in 31 of the 41 evaluated patients (%) Voiding frequency Day time Night time (3) (23) 19 (61) (45) 9 (29) >6 11 (35) 2 (7) Continence 31 (100) 31 (100) Changes in habits Eating habits 9 (29) Dressing habits 3 (10) Sexual habits 29 (93.5) Sexual activity after diversion 6 (19.4) Impacts on Daily activities 27 (87) Social life 27 (87) Work life 27 (87) Martial status Married/partner 30 (97) Widow 1 (3) Employment Active 9 (29) Retired 22 (71) Grade of education Higher 27 (87) Lower 4 (13) Patients, who would undergo 30 (97) Mainz Pouch II diversion again out of 67 male patients unexpected organ-confined prostatic carcinoma was detected. 3. Results Mean operating time of 8 different surgeons for standard cystectomy and modified ureterosigmoidostomy (Mainz Pouch II) was 4 hours and 54 min (3 h and 45 min 8 h and 30 min). Patients were hospitalised for a mean of 16.6 days (10 47 days) Functional scales and global health/quality of life Tables 3a and b show the subscales of the EORTC QLQ C-30 Version 3 according to the various functional scales and global health/quality of life (QL2). The functional subscales contain physical (PF2), role (RF2), emotional (EF), cognitive (CF) and social functioning (SF). Higher scores demonstrate a higher level of functioning. A high score (maximum score 100) represents a high level of quality of life Symptom scales/items Tables 4a and b show the subscales of the EORTC QLQ C-30 Version 3 according to the various symptom scales/items. The subscales contain fatigue (FA), nausea and vomiting (NV), pain (PA), dyspnoe (DY), insomnia (SL), appetite loss (AP), constipation Table 3 (a) Global health/quality of life and functional scales according to functional domains and sex (EORTC QLQ C-30) Total (n ¼ 41) Male (n ¼ 29) Female (n ¼ 12) Global health status/quality of life Functional scales Physical functioning Role functioning Emotional functioning Cognitive functioning Social functioning (b) Global health/quality of life and functional scales according to functional domains and center of surgery (EORTC QLQ C-30) Total (n ¼ 41) Bonn (n ¼ 29) Pesaro (n ¼ 12) Global health status/quality of life Functional scales Physical functioning Role functioning Emotional functioning Cognitive functioning Social functioning S.D.: standard deviation.

4 594 P.J. Bastian et al. / European Urology 46 (2004) Table 4 (a) Symptom scales/items according to various symptoms and sex (EORTC QLQ C-30) Total (n ¼ 41) Male (n ¼ 29) Female (n ¼ 12) Symptom scales/items Fatigue Nausea and vomiting Pain Dyspnoe Insomnia Appetite loss Constipation Financial difficulties Diarrhea (b) Symptom scales/items according to various symptoms and center of surgery (EORTC QLQ C-30) Total (n ¼ 41) Bonn (n ¼ 29) Pesaro (n ¼ 12) Symptom scales/items Fatigue Nausea and vomiting Pain Dyspnoe Insomnia Appetite loss Constipation Financial difficulties Diarrhea S.D.: standard deviation. (CO), diarrhea (DI) and financial difficulties (FI). A high score (maximum score 100) represents a reduced quality of life with more problems. No significant difference (p < 0,05) between male and female was detected for global health/quality of life and functional or symptom scales. The women did score lower than men on most functional scales and higher on most symptoms scales. Also, there was no statistical difference between the age groups (older and younger than 65 years of age). No statistical significant difference between the study population from Bonn and Pesaro for global health/quality of life and functional or symptom scales was revealed. However, the Pesaro group did have a much lower value for diarrhea than the Bonn group Specific urinary diversion items 31 patients (75.6%) answered our questionnaire about urinary specific items. The results are listed in Table 2. All patients (100%) were completely continent during daytime. Eight patients (25.8%) sometimes leaked urine at night but that was not felt to be disturbing. In all, five patients (16%) used pads (one pad per night) prophylactically during the night and three patients (9.7%) used pads (one to two pads per day) during the day without becoming wet. All patients with nocturia felt the pressure and need to urinate. One patient (3%) did not have to void at night. Of the patients with urinary leakage at night all get up for urination between one and three times at night. Sixty three pecent of the patients were able to distinguish between stool and urine. Negative changes or alterations in sexuality compared to the time before surgery occurred in 29 patients (93.5%). One 27 yearold female (follow-up 84 months) was now able to experience sexuality after modified ureterosigmoidostomy for incontinent epispadia. Twenty five patients (80.6%) do not report to enjoy sexuality postoperatively at all. 4. Discussion During the past century various techniques of urinary diversion have been developed and proposed to be advantageous regarding postoperative morbidity and complications. Today, cancer treatment no longer implies only the cure and control of the disease. The effect on psychological, functional, social and economic life of the patient plays a more important role during decision in respect to the type of urinary

5 P.J. Bastian et al. / European Urology 46 (2004) diversion. However, once a method of urinary diversion is selected, the patient has a strong tendency to want to believe that he has made the correct choice. It is almost impossible to compare the studies of postoperative HRQoL since there is no consensus on what should be measured and many different test instruments are used. To minimize the differences in HRQol after urinary diversion the patient should be part of the decision making and all options of diversion should be discussed. We choose to use the EORTC QLQ C-30 as a validated tool for cancer patients and combined it with an own questionnaire. Several studies have demonstrated no difference in the overall HRQoL between neobladder or ileal conduit [1,2]. Others have shown that orthotopic neobladder/continent diversions are superior in aspects of HRQoL after the patients return to their normal activities or professions compared to ileal conduit [3 5,12]. Interestingly, Henningsohn et al. observed the same self-assessed quality of life in patients with orthotopic neobladder diversion compared to a randomly assigned control group without bladder cancer [25]. Apart from the medical indication, the psychological and social status combined with the employment status should also influence the selection of the type of urinary diversion [13]. It has been reported that patients developed their own coping mechanism and the patient s HRQoL measures almost in all aspects returned to the pre-operative values one year after surgery [14,15]. All patients in our study were questioned a least 6 months after undergoing urinary diversion. Two studies presented reference values for the EORTC QLQ C-30 questionnaire randomly selecting a sample of German or Norwegian adults [16,17]. The comparison to the general population was chosen because of the high patient s expectations in the treatment outcome and unavailability of own reference material or values of other types of diversions. Schwarz et al. observed that men reported fewer symptoms than female and younger people reported fewer symptoms and better functioning. The data showed that age and sex differences should not be neglected [17]. In contrast to that, our study did not show age or sex related differences. Compared to our study, there is no difference in the mean functional scales and the global quality of life. Comparing our male group to the German males, higher scores for social functioning are found, maybe due to the problems of adjusting life after urinary diversion and a diagnosis of cancer. Looking at the symptom scale, the general population reports higher numbers for pain and sleep disturbances, but lower numbers for diarrhea and constipation. Having undergone radical cystectomy and urinary diversion patients may learn to cope with pain more easily and may not be disturbed by pain as much as the general population. The excretion of a stool and urine mixture may lead to alterated sensation for diarrhea. Cognitive and social functioning was reduced after Mainz Pouch II procedure (Table 5). Hjermstad presented reference data from general Norwegian population in 1998 [16]. Again, functioning scales and global health status showed no difference to our study group. Differences were observed in the symptom scales for pain, fatigue, dyspnoe, insomnia and nausea/vomiting, all in favor of our series of patients after ureterosigmoidostomy. No gender related difference between the functioning scale, the global health status and the symptom scale for nausea and vomiting was detected. Gender-related differences included fatigue, pain and dyspnoe for our group. Financial disturbance in both sexes had less impact in the Norwegian population than in our study group [16]. Compared to the reference values, the patients after ureterosigmoidostomy experience an almost equally high score compared to the general Norwegian population HRQoL (Table 5). Only the score for diarrhea was significantly higher in our study population. Although cultural or sexual differences may be important in adapting to treatment outcome and HRQol study, we did not detect significant differences between the groups from Germany and Italy. Hobisch et al. described a significant difference in the functioning score and global QoL for orthotopic neobladder (NB) diversion compared to ileal conduit (IC) using the EORTC QLQ C-30 (Table 5) [5]. There has been an ongoing discussion about the selection criteria for the IC diversion in that study. Since it is the only report that also used the QLQ C-30 we compared the results to our findings. Functioning scale and global status of health was superior in NB compared to IC. Symptoms scores demonstrated lower scores in all categories, with the scores for fatigue and insomnia being statistically significant (Table 5) [5]. Comparing their findings for IC to our series with Mainz Pouch II diversion, a difference for social functioning in favor for the IC group was observed. A reason may be, that the IC group did not have to worry about urgency and the need to find a restroom in public. The relatively high voiding frequency may have added in lowering the social functioning score. The remaining functioning scales showed no difference between IC and Mainz Pouch II. A trend towards higher scores for physical and cognitive functioning was seen in NB. Role, emotional and social functioning reveal higher scores indicating a better quality of life. The relatively low score for social functioning in our series may have been due to the fact,

6 596 P.J. Bastian et al. / European Urology 46 (2004) Table 5 Quality of life using the EORTC QLQ C-30 after Mainz Pouch II urinary diversion compared to orthotopic neobladder and ileal conduit [5] and to the general German and Norwegian populations [16,17] Global health status/ quality of life Mainz Pouch II (n ¼ 41) Bonn, Germany Mainz Pouch II (n ¼ 29) Pesaro, Italy Mainz Pouch II (n ¼ 12) Orthotopic Neobladder (n ¼ 69) Ileal Conduit (n ¼ 33) Germany (n ¼ 2028) Norway (n ¼ 1965) Mean Mean Mean Mean Mean Mean Mean Functional scales Physical functioning Role functioning Emotional functioning Cognitive functioning Social functioning Symptom scales/items Fatigue Nausea and vomiting Pain Dyspnoe Insomnia Appetite loss Financial difficulties Constipation Diarrhoea that the mean follow-up only was 24.4 months and that the patients may need a longer period to adapt and go back to daily life as before. All symptoms scores excluding dyspnoe were lower compared to Mainz Pouch II diversion. Taken together, orhotopic neobladder is advantageous and ileal conduit is inferior compared to Mainz Pouch II diversion in that study. A long-term quality of life study by Hart [2] compared three different types of urinary diversion; regardless of the type of urinary diversion, most patients reported good overall HRQoL with little emotional distress and only few problems in social, physical or functional activities. No difference between ileal conduit, cutaneous Kock pouch and urethral Kock pouch was detected. Penile prothesis placement had a positive impact on sexual function. It is encouraging to see the patients adapt to the difficulties caused by urinary diversion during a relatively short period as in our study and in the long-term as described by Hart. The results by Satoh et al. supported the use of a ilealcecal rectal bladder for selected patients in a HRQoL study compared to IC diversion. One major advantage for the patients was that they were able to freely turn over during sleep, whereas 42% of the IC patients where worried about turning [19]. Postoperative incontinence after ureterosigmoidostomy is devastating. The continence rate of 100% during daytime shows that the anal sphincter can be used as a continence mechanism in urinary diversion. Eight patients (25.8%) sometimes leak urine at night but that was not felt to be disturbing. In all, 5 patients (16%) use pads (one pad per night) prophylactically during the night and three patients (9.7%) use pads (one to two pads per day) during the day without becoming wet. That means that none of the patients is incontinent in terms of an uncontrolled loss of a mixture of stool and urine during the day and night. Additionally, no incontinence of any kind was detectable in during flatulence periods. The relatively high voiding frequency during night time is a quality of life limiting factor, but since urination could be controlled, the patients did not feel disturbed. However, oral intake of oxybutinin may reduce the frequency [23]. The relatively high voiding frequency was accepted and a change of social life was not necessary in 87.1% of the patients. An estimation whether patients with increased night time voiding frequencies slept in a separate bedroom has not been addressed, but would indicate social isolation. Voiding in a seating position did not affect the overall satisfaction in male patients of our study. Patients learned to adopt and continue life as normal as possible. Due to decreasing anal sphincter compliance with age it has been suggested not to perform modified ureterosigmoidostomy in elderly patients [8]; studies have not proved a decreasing anal sphincter function or reduced anal compliance with age [21,22]. Despite the small cohort and relatively short follow-up, our experience suggested that modified ureterosigmoidostomy is possible in elderly patients without increased risk for incontinence [20].

7 P.J. Bastian et al. / European Urology 46 (2004) After urinary diversion pregnancy may still be possible and women undergoing ureterosigmoidostomy for morphological or functional bladder loss were still able to give birth to healthy children [18]. This is an important issue for young females having to undergo urinary diversion. Although no female in our series became pregnant during the follow-up period, having the chance of becoming pregnant may also add to the good global health status. However, one female with benign disease is now able to be sexually active. Notably, Henningsohn et al. described symptoms of sexual dysfunctioning the most distressing ones regardless to the type of urinary diversion [24]. Although our study did not rank symptoms in patients after diversions, negative alterations in sexual functioning was found in 93.5% of the patients. This data supports the importance of this particular issue after reconstructive surgery. This was a retrospective, non-randomized study without baseline data for the HRQoL. Nevertheless, it reveals the high degree of patient s adaptability after urinary diversion. A prospective, randomised longitudinal study of HRQoL after adjusting for differences in age and sex among patients undergoing different types of urinary diversion is needed to corroborate these findings. 5. Conclusion The Mainz Pouch II procedures serves as a satisfying alternative to other forms of continent urinary diversion in selected patients in terms of HRQoL. No differences between the two study groups, or between sexes and compared to general German or Norwegian population was revealed, indicating that people do adopt to their individual form of urinary diversion and try to continue life as similar as before. In terms of continence modified ureterosigmoidostomy can lead to daytime continence rate of 100%. The relatively high voiding frequency during night time was not felt to be disturbing by the patients and demonstrates the adaptability of the patients. References [1] Hara I, Miyake H, Hara S, et al. Health-related quality of life after radical cystectomy for bladder cancer: a comparison of ileal conduit and orthotopic bladder replacement. BJU Int 2002;89:10. [2] Hart S, Skinner EC, Meyerowitz BE, et al. 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. [3] Dutta SC, Chang SC, Coffey CS, et al. Health related quality of life assessment after radical cystectomy: comparison of ileal conduit with continent orthotopic neobladder. J Urol 2002;168:164. [4] Gerharz EW, Weingartner K, Dopatka T, et al. Quality of life after cystectomy and urinary diversion: results of a retrospective interdisciplinary study. J Urol 1997;158:778. [5] Hobisch A, Tosun K, Kinzl J, et al. Quality of life after cystectomy and orthotopic neobladder versus ileal conduit urinary diversion. World J Urol 2000;18:338. [6] Mansson A, Davidsson T, Hunt S, et al. 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: 386. [7] Fisch M, Wammack R, Muller SC, et al. The Mainz pouch II (sigma rectum pouch). J Urol 1993;149:258. [8] Gerharz EW, Kohl UN, Weingartner K, et al. Experience with the Mainz modification of ureterosigmoidostomy. Br J Surg 1998;85: [9] Woodhouse CR, Christofides M. Modified ureterosigmoidostomy (Mainz II) technique and early results. Br J Urol 1998;81:247. [10] Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365. [11] Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC QLQ-C30. Eur J Cancer 2001;37: [12] 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;75:200. [13] Filipas D, Egle UT, Budenbender C, et al. Quality of life and health in patients with urinary diversion: a comparison of incontinent versus continent urinary diversion. Eur Urol 1997;32:23. [14] Hardt J, Filipas D, Hohenfellner R, et al. Quality of life in patients with bladder carcinoma after cystectomy: first results of a prospective study. Qual Life Res 2000;9:1. [15] Kulaksizoglu H, Toktas G, Kulaksizoglu IB, et al. When should quality of life be measured after radical cystectomy? Eur Urol 2002;42:350. [16] Hjermstad MJ, Fayers PM, Bjordal K, et al. Using reference data on quality of life the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (þ3). Eur J Cancer 1998;34:1381. [17] Schwarz R, Hinz A. Reference data for the quality of life questionnaire EORTC QLQ-C30 in the general German population. Eur J Cancer 2001;37:1345. [18] Volkmer BG, Seidl EM, Gschwend JE, et al. Pregnancy in women with ureterosigmoidostomy. Urology 2002;60:979. [19] Satoh et al. Health related quality of life of ilealcecal rectal bladder compared with ileal conduit diversion: a questionnaire survey. Int J Urol 2002;9:385. [20] Bastian PJ, Albers P, Hanitzsch H, et al. Die modifizierte Ureterosigmoidostomie (Mainz Pouch II) als kontinente Form der Harnableitung. Urologe A, in press. [21] Krogh P, Christiansen J. A study of the physiological variation in anal manometry. Br J Surg 1989;76:69. [22] Devroede G, Vobecky S, Mase A. Ischaemic fecal incontinence and rectal angina. Gastroenterology 1982;83:970. [23] Gilja I, Kovacic M, Mazuran B, Deban R. Sigma-Rektum-Pouch: klinische, rektodynamische und radiologische Untersuchung. Aktuel Urol 2000;31:169. [24] Henningsohn L, Wijkstrom H, Steven K, et al. Relative importance of sources of symptoms-induced distress in urinary bladder cancer survivors. Eur Urol 2003;43:651. [25] Henningsohn L, Steven K, Kallestrup EB, et al. Distressful symptoms and well-being after radical cystectomy and orthotopic bladder substitution compared with a matched control group. J Urol 2002;168:168.