Ann Surg Oncol (2014) 21:1398–1404 DOI 10.1245/s10434-013-3458-8
ORIGINAL ARTICLE – UROLOGIC ONCOLOGY
Long-Term Women-Reported Quality of Life After Radical Cystectomy and Orthotopic Ileal Neobladder Reconstruction Mathieu Rouanne, MD1,2, Guillaume Legrand, MD1, Yann Neuzillet, MD, PhD1,2, Tarek Ghoneim, MD1,2, Florence Cour, MD1, Nicolas Letang, MD1, Laurent Yonneau, MD1, Jean-Marie Herve´, MD1, Henry Botto, MD1, and Thierry Lebret, MD, PhD1,2 Department of Urology, Hoˆpital Foch, Suresnes, France; 2UFR des Sciences de la Sante´, Universite´ Versailles-SaintQuentin-en-Yvelines, Versailles, France
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ABSTRACT Background. The purpose of this study was to determine health-related quality of life (HRQoL) among long-term disease-free survivors in women who underwent radical cystectomy (RC) for urothelial carcinoma and orthotopic ileal neobladder (ONB) reconstruction, using validated patient-reported outcome instruments. Methods. From 2000 to 2011, a total of 46 women with urothelial bladder carcinoma had RC and ONB at our institution; 31 (67 %) eligible women completed 3 validated questionnaires: the medical outcome study short form 12 (SF-12), the urinary symptom profile, and the Contilife, respectively evaluating general HRQoL, voiding function, and urinary incontinence specific HRQoL. Unadjusted analyses were performed to analyze standardized measures of HRQoL and voiding symptoms; p \ 0.05 was considered significant. Results. The mean follow-up was 5.7 years; 24 women (77 %) considered their health as good, very good, or excellent. The SF-12 physical and mental scores were not significantly different between the population study and the general population (p [ 0.05). A total of 20 women (65 %) declared to be fully continent. Daytime incontinence, nighttime incontinence, and hypercontinence were reported by 26, 29, and 31 % of women, respectively. On
Mathieu Rouanne and Guillaume Legrand contributed equally to this article and share first authorship. Society of Surgical Oncology 2013 First Received: 30 June 2013; Published Online: 1 January 2014 M. Rouanne, MD e-mail: [email protected]; [email protected]
unadjusted analysis, incontinence was associated with age [ 65 years at the time of surgery (p \ 0.001). Hypercontinence was not associated with any variable. Conclusions. This study suggests that in the setting of radical cystectomy in women, ileal neobladder reconstruction provides long-term satisfaction with maintained HRQoL. For properly selected women, orthotopic neobladder can be considered an appropriate diversion choice. The path to improved management of localized muscle invasive bladder cancer involves the tackling of 2 major challenges: first and foremost, the complete surgical resection of the cancer and, second, the preservation of patient’s quality of life. In line with these objectives, anterior pelvectomy with subsequent urinary diversion is the gold standard treatment for localized high-risk bladder cancer in women.1 Indeed, this surgical procedure includes radical cystectomy (RC), hysterectomy, bilateral salpingo-oophorectomy, anterior vaginal wall resection, and either urethrectomy with ileal conduit, or continent urinary diversion.2 Over the last 20 years, the orthotopic low-pressure detubularized ileal neobladder appears to be a reliable and reproducible method of urinary diversion in men.3,4 However, orthotopic neobladder (ONB) has been less frequently applied to women compared with ileal conduit urinary diversion. Obviously, since female urethral anatomy has become more clearly described and ONB has been shown to have good oncologic outcomes in selected cases, development and propagation of this technique for female patients was facilitated.5,6 Nevertheless, the long-term quality of life (HRQoL) and functional results of ONB in women are poorly described. Consequently, this study aimed to describe the HRQoL and the outcome of diversion-specific voiding complications, specifically daytime and nighttime urinary incontinence and hypercontinence in this population.
Long-Term Quality of Life in Women with Neobladder
METHODS
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Patient Population From June 1995 to December 2011, 46 women underwent RC and ONB diversion for localized muscle invasive bladder cancer in a single tertiary department of urology. The indications for RC included only cancers, in accordance with the contemporary guidelines.1 Criteria for performing ONB included the woman’s request for orthotopic bladder substitution and her acceptance of the voiding pattern required by the reservoir on one hand and, on the other hand, the absence of cancer invasion of the bladder neck, the vaginal wall, or the urethra, of impaired renal function (estimated creatinine clearance\40 ml/min), or of significant comorbidity. The final decision to perform the ONB was taken in accordance with the analysis of the frozen section of the urethra. Surgical Technique All women underwent first a pelvic lymphadenectomy; then RC was performed. The anterior vaginal wall was routinely preserved if deemed oncologically safe. In addition, among women without a previous hysterectomy, the uterus was routinely spared if they were determined to be candidates for a vaginal-sparing cystectomy. With regard to ONB, all women underwent reconstruction of the neobladder using the Z-shaped technique as previously described.7 Postoperative Follow-Up A minimum follow-up period of 6 months was required for eligible patients to account for early postoperative voiding changes. During the first 2 postoperative years, women were evaluated quarterly in our institution by physical examination, basic laboratory tests, and computed tomography (CT) scan. During the 3rd and 4th year, patients were evaluated biannually and annually thereafter.
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The Short Form-12 Health Survey, SF-12, is a generic HRQoL instrument. This 12-item version of the widely used SF-36 questionnaire provides mental health (MCS) and physical health (PCS) component summary scores that measure self-perceived HRQoL. Higher scores reflected better functioning. The French version has been validated, and normative data for French people have been published.8,9 The USP is a self-report instrument including 11 items assessing 3 symptom scores: stress urinary incontinence (/9), urge incontinence (/12), and dysuria (/9). Each question can provide a score varying from 0 to 3.10 The Contilife is a French questionnaire originally designed for women suffering from urinary incontinence. The Contilife contains 28 items scored from 1 to 5–6 evaluating the quality of life. Scores ranged from 0 (high HRQoL) to 140 (low HRQoL). One global score, and 7 dimension scores are generated: daily activities (/35), effort activities (/20), self-image (/35), emotional consequences (/30), sexuality (/15), and well-being (/5). European psychometric validation of the Contilife has been validated in 505 women.11
Statistic Analysis Continuous, normally distributed variables were reported as the mean value with range. Continuous non-normal variables were presented as the median values with interquartile range. Univariate statistical analyses were performed with t test for quantitative variables and Chi square test for qualitative variables. Linear regression was used to test the liaison between quantitative variables. For all statistical analyses, a 2-sided p value \ 0.05 was considered statistically significant. All data were analyzed using the Statistical Package for the Social Sciences v.16.0 (SPSS, Chicago, IL, USA). RESULTS Patients Characteristics
Questionnaires In June 2012, first, all women were offered a personal interview by the same male interviewer regarding healthrelated quality of life (HRQoL) and continence status. The following parameters were assessed during the interview: urine leakage, pad usage, and need of self-catheterization. Women with any reported daytime urinary incontinence were classified as having stress urinary incontinence (SUI). Then, all women filled out the 3 self-questionnaires assessing HRQoL, urinary symptom profile (USP), and urinary quality of life:
A total of 46 consecutive women who underwent RC and ONB for bladder cancer were identified. Of these, 31 women (67 %) fulfilled the questionnaires (others had died n = 9; were lost to follow-up, n = 3; or had declined participation, n = 3). At the time of analysis, mean age was 64.8 years (range, 43–86 years) and mean duration of postoperative follow-up was 68 months (6–204 months). The 5-year disease-free and overall survivals were 59 and 79 %, respectively. Clinical and pathological characteristics of patients at the time of surgery are reported in Table 1. Early postoperative complications included 1 case
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TABLE 1 Clinical and pathologic characteristics of patients at the time of surgery (n = 31)
TABLE 2 Predictive factor of daytime stress urinary incontinence (SUI)
No. (%) Mean age (year, range) Age [ 65 years
64.8 (43–86) 6 (19)
2
Mean BMI (kg/m , range)
23.2 (18–31)
ASA score I
8 (26)
II
21 (68)
III Clinical T stage
Daytime SUI Others (n = 23) p value (n = 8)
2 (6)
cT1/Cis
11 (36)
cT2
17 (54)
cT3
3 (10)
Hydronephrosis
3 (10)
Type of surgery
Age [ 65 years at surgery (%)
6 (75 %)
2 (8.5 %)
0.001
BMI (kg/m2)
23.7
22.8
0.5
Hysterectomy (%)
4 (50 %)
3 (26 %)
0.28
5.2
0.45
Time of follow-up (years) 6.7 Pathological tumor stage
0.2
\pT2
4
8
pT2
0
6
pT3
4
9
1
2
6
2
5
16
3
1
1
ASA score
0.8
Vaginal-sparing radical cystectomy
21 (68)
Prior or simultaneous hysterectomy
10 (32)
Daytime SUI was evaluated during the personal interview
12 (39)
and performed self-intermittent catheterization (SIC) 4–6 times a day. Also, 1 patient (3 %) had a persistent vesicovaginal fistula with severe daytime incontinence requiring 5 or more pads per day. Statistically significant association was found with age [ 65 years at the time of surgery and postoperative daytime SUI (p = 0.001). None of the other preoperative and postoperative variables turned out to be predictive of urinary incontinence at follow-up in univariate analysis (Table 2). Moreover, there was no significant predictor of hypercontinence in univariate analysis.
Pathologic T stage Ta/T1, Cis T2
6 (19)
T3
13 (42)
T4
0 (0)
Pathologic N stage N0 N?
28 (90) 3 (10)
of ileo-bladder fistula requiring conversion to incontinent diversion, 1 severe sepsis due to urinary infection, and 1 pyelonephritis due to ureteroenteric anastomotic stricture. Late surgical complications were reported in 6 patients. There were 2 patients who had small bowel obstruction medically treated and 2 patients who had abdominal hernia surgically repaired. Two patients had vaginal fistula. The fistula was successfully repaired transvaginally for 1 woman; in the other case, vaginal fistula was persistent despite a transvaginal Martius flap. Continence Status Provided from the Personal Interview Of 31 patients, 20 (64.5 %) stated not to have any urine leakage during the clinical interview and were classified as fully continent. Also, 23 (74 %) and 25 (80 %) of them declared using no pad or a safety pad for occasional leakage during daytime and nighttime, respectively. There were 8 women (26 %) who reported daytime SUI and 9 women (29 %) who had nighttime incontinence. Of the 8 women with daytime SUI, 6 (75 %) had nighttime incontinence. There were 9 women (29 %) were hypercontinent
Urinary Symptom Profile The mean USP score was 12.4/40 ± 7.2 (Table 3). According to question 5 of the USP, 26 women (84 %) could spend 2 h or more between 2 voidings. According to question 6, 11 (35.5 %), 14 (45.5 %), and 6 (19 %) women woke up, respectively, never or once, twice, or 3 or more times during the night. According to question 7, 16 women (51.5 %) never had urine leak while asleep nor woke up wet. Health-Related Quality of Life Results for SF-12 subscales in the study population and normative French data are presented in Table 4. Both physical and mental health component scores were lower in this study population than in the normative French patients. However, no statistically significant difference was found between our study population and normative French assessments for physical (p = 0.07) and mental (p = 0.20)
Long-Term Quality of Life in Women with Neobladder
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TABLE 3 Results of USP score USP
TABLE 3 continued No. patients (%)
Q1: Over the past 4 weeks, please specify the number of times a week you have had leaks during physical effort: No urine leaks Strenuous effort Moderate effort
13 (42) 18 (58)
Light effort
22 (71)
Less than 1 urine leak a week
USP
No. patients (%)
Never or once
11 (35.5)
Twice
14 (45.5)
3 or 4 times
5 (16)
More than 4 times
1 (3)
Q7: How many times a week have you had a urine leak while asleep or have you woken up wet? Never
16 (51.5)
Strenuous effort
6 (19.5)
Less than once a week
3 (9.5)
Moderate effort
6 (19.5)
Several times a week
6 (19)
Light effort
2 (6.5)
Several times a day
6 (19)
Several urine leaks a week
Q8: How would you describe your usual urination over these past 4 weeks?
Strenuous effort
4 (13)
Moderate effort
2 (6.5)
Normal
Light effort
2 (6.5)
Needed to push with abdominal (stomach) muscles or 11 (35.5) lean forward (or required a change of position) to urinate
Several urine leaks a day Strenuous effort
8 (25.5)
Moderate effort
5 (16)
Light effort
5 (16)
Q2: How many times a week have you had to rush to the toilet to urinate because you urgently needed to go? Never Less than once a week Several times a week Several times a day
18 (58) 7 (22.5) 4 (13) 2 (6.5)
Q3: When you have had an urgent need to urinate, for how many minutes on average have you been able to hold on? More than 15 min
20 (65)
From 6 to 15 min From 1 to 5 min
1 (3) 6 (19)
Less than 1 min
4 (13)
Q4: How many times a week have you experienced a urine leak preceded by an urgent need to urinate that you were unable to control? Never
21 (68)
Less than once a week
9 (29)
Several times a week
1 (3)
Several times a day 0 (0) Q4a: In the above case, what kind of leaks did you have? No leaks in this case
18 (58)
A few drops
5 (16.5)
Light leaks
6 (19.5)
Heavy leaks
2 (6)
Q5: During the day, in general, how long elapsed between urinating? 2 h or more
26 (84)
Between 1 and 2 h
4 (13)
Between 30 min and 1 h
1 (3)
Less than 30 min
0 (0)
Q6: How many times on average have you been woken up during the night by a need to urinate?
5 (16)
Needed to press on the lower stomach with my hands
6 (19.5)
Used a catheter
9 (29)
Q9: In general, how would you describe your urine flow? Normal
16 (52)
Weak
6 (19)
Drop by drop
0 (0)
Used a catheter
9 (29)
Q10: In general, how has your urination been? Normal and quick
10 (32)
Difficult to start, then normal or easy at first but slow to finish
8 (26)
Very slow from start to finish
4 (13)
Used a catheter
9 (29)
S strenuous, M moderate, L light
health component. A total of 24 patients (77 %) considered their health was good, very good, or excellent, and 25 patients (80.6 %) were a little or not at all embarrassed in their social life or their relationships by their health. Moreover, no statistically significant association was found with preoperative and postoperative variables and reduction of the SF-12 physical and mental health scores (p [ 0.05). Impact of Urinary Symptoms on Quality of Life The mean Contilife score was 59.8/140 ± 21. The mean scores of daily activities, effort activities, self-image, emotional consequences, and overall well-being were, respectively, 13.8/35 ± 7, 5.8/20 ± 3, 15.9/35 ± 7, 15.3/ 30 ± 6, and 3.4/5 ± 1. A total of 18 women (58 %) had sexual intercourse at the time of analysis, and 16 of them (89 %) had vaginal wall sparing procedure. The mean
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TABLE 4 SF-12 subscales in the study population and normative French data (mean value ± SD)
Physical
Neobladder (n = 31)
General population (n = 2,743)
p value
44.24 ± 10.0
51.2 ± 7.4
0.07
48.4 ± 9.4
0.20
Mental and social 43.55 ± 9.3
TABLE 5 Results of Contilife Variable
Mean score ± SD
Median score (range)
Daily activities (7 items/35)
13.8 ± 7
12.5 (6–32)
Effort activities (4 items/20)
5.8 ± 3
5 (3–11)
Self-image (7 items/35)
16.0 ± 7
14 (6–37)
Emotional consequences (6 items/30)
15.3 ± 6
14 (6–26)
Sexuality (3 items/15)
4.8 ± 5
3 (1–15)
Well-being (1 item/5)
3.4 ± 1
3 (1–5)
Total (28 items/140)
59.8 ± 21
56 (23–99)
score of sexual activity was 54.8/15 ± 5. Results for each component are reported in Table 5. According to questions 17 and 28, 22 patients (71 %) reported feeling good about themselves despite their urinary symptoms and considered their health was good, very good, or excellent. According to question 18, 19 patients (61 %) reported being a little or not at all bothered by wearing pads. DISCUSSION This study constitutes the first-ever reported analysis regarding long-term HRQoL and functional outcomes in women following ONB. Among 34 patients disease-free with regular follow-up, 31 accepted the interview and agreed to fill out all the questionnaires. This high response rate confirms that urinary continence recovery and overall HRQoL are major issues for bladder cancer survivors. The Z-shaped ileal neobladder is an original technique for bladder substitution following RC developed in our center in the late 1990s. At a mean follow-up of 5.7 years, day and night continence rate was reported by women as 74 and 71 %, respectively. Moreover, 74 and 80 % of them declared not to require more than 1 pad a day and 1 pad a night, respectively. The prevalence of daytime SUI in women with ONB has been reported in other series between 10 and 27 %.12–23 In line with these numbers, 8 of 31 patients (26 %) declared to the interviewer to have daytime urine leakage. Currently, limited treatment options have been described in case of post-ONB SUI, with poor results of periurethral bulking agents and pubovaginal slings.24,25 Recently, Anderson et al. showed that the only
predictor of daytime leakage was having a prior or concurrent hysterectomy.12 Arguably, this is a known risk factor for urinary incontinence in the general population, suggesting the importance of posterior vaginal and periurethral support to maintain urinary continence.12,26 Interestingly, we identified that age \ 65 years at time of surgery was predictive of achieving continence. Therefore, this prognosis factor for urinary continence recovery seems very important to us when informing and selecting the women for neobladder. Nocturnal incontinence prevalence was as high as 29 %, consistent with other findings with rates typically ranging from 20 to 40 %.6,13,22,23,27,28 Women were recommended to void several times a night to attempt to minimize involuntary leakage. However, the etiology of nocturnal incontinence is multifactorial and may be caused by overdistension of the ONB and pathophysiological impairments to the neurological system, as well as physiological diuresis. In general, approximately 25 % of women may become dependent on intermittent catheterization to manage the ONB, although higher rates have been reported.12 Similarly, we found 9 of 31 patients (29 %) with urinary hypercontinence. Chronic urinary retention after RC and ONB remains a significant issue for female patients. A regular intermittent catheterization was recommended to prevent neobladder overdistension and upper urinary tract deterioration. In this study, we did not find any preoperative or postoperative factor significantly associated with hypercontinence. Although some have suggested that chronic retention is secondary to hypocontractility of the neobladder wall, Ali-El-Dein et al.18 demonstrated that there is strong evidence that urinary retention is caused by anatomical, rather than functional or neurogenic reasons. Videourodynamics had demonstrated a falling back of the pouch into the pelvic cavity that results in an acute angulation of the neobladder-urethral junction. Further ongoing studies with 3-dimensional and dynamic pelvic MRI will provide more details of the mechanisms underlying chronic retention in women with ONB. According to HRQoL, the women scored decrease in both physical and mental health component with the SF-12. However, despite the lower scores, no statistically significant difference was found between our study population and normative French assessments on the SF-12. In addition, the mean scores of the 5 domains evaluated with the Contilife were high, particularly those concerning wellbeing, effort-activities, and self-image. These results highlight that long-term ONB is safe and preserves the mental and physical well-being. Furthermore, when we compared Contilife scores according to the presence of self-intermittent catheterization (SIC), the scores for HRQoL were significantly lower in patients who required
Long-Term Quality of Life in Women with Neobladder
SIC. These results are similar to other findings that show a relative trade-off of chronic retention versus total incontinence.6 Despite a major pelvic surgery, the majority of women (18 of 31) were sexually active and were interested in preserving a good quality of sexual life. This response rate confirmed that overall HRQoL and sexual function in particular continue to be major issues for cancer patients and cancer survivors. In addition to cancer survival and urinary control, identification of other chronic treatmentassociated conditions is important.27 Although poorly identified, impaired sexual function has been recognized as the primary source of self-assessed distress among patients undergoing radical cystectomy.28,29 Therefore, several anatomic factors have been identified to decrease postoperative sexual dysfunction: nerve-sparing cystectomy with conservation of the neurovascular bundles on the lateral walls of the vagina, preservation of the anterior vaginal wall, and vascularization of the clitoris. Our study suffers from several limitations. Firstly, we conducted a retrospective study with no baseline data on voiding function and physical and mental health. Indeed, we could not evaluate any preoperative factor that may impact variation in postoperative HRQoL and voiding function. Secondly, despite its capacity to evaluate urinary disorders including stress, frequency, or urinary obstructive symptoms with a reliable and standardized method, the use of a USP questionnaire has not been specifically validated in this population study. Then, the number of patients evaluated was not particularly large, mainly because of cancer-related mortality. Consequently, some of our statistical analyses were underpowered with limited possibilities to realize cross-sectional analyses. Furthermore, the population study was relatively young compared with other series with a high percentage of patients (90 %) with organ-confined disease. Both parameters may have a positive impact on the functional outcomes and HRQoL. Finally, sexual function was not specifically evaluated with validated questionnaires; in addition, preoperative sexuality was not reported. Therefore, our study provides limited data concerning sexual impairment after RC and ONB. Nevertheless, we presented for the first time the long-term HRQoL and functional results in a cohort of women who underwent RC and ONB at a high-volume, specialized cancer center. One of the major strengths of the present study was measure of HRQoL and impact on quality of life secondary to postoperative voiding dysfunction. In summary, the standardized self-report questionnaires enabled us to capture essential information regarding the impact of ONB on women’s satisfaction. These data suggest that in the setting of RC in women, ONB reconstruction provides long-term satisfaction with maintained HRQoL. However, we identified a significant
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prevalence of incontinence in women with ONB who were [65 years. In the context of shared medical decision making, it is crucial for patients to be informed with meaningful data with which to make informed choices regarding the urinary diversion options.
REFERENCES 1. Stein JP, Penson DF, Wu SD, Skinner DG. Pathological guidelines for orthotopic urinary diversion in women with bladder cancer: a review of the literature. J Urol. 2007;178:756–60. 2. Marshall FF, Treiger BF: Radical cystectomy (anterior exenteration) in the female patient. Urol Clin North Am. 1991;18:765– 75. 3. Fujisawa M, Isotani S, Gotoh A, Okada H, Arakawa S, Kamidono S. Health-related quality of life with orthotopic neobladder versus ileal conduit according to the SF-36 survey. Urology. 2000;55: 862–5. 4. Hobisch A, Tosun K, Kinzl J, Kemmler G, Bartsch G, Ho¨ltl L, et al. Quality of life after cystectomy and orthotopic neobladder versus ileal conduit urinary diversion. World J Urol. 2000;18: 338–44. 5. Colleselli K, Stenzl A, Eder R, Strasser H, Poisel S, Bartsch G. The female urethral sphincter: a morphological and topographical study. J Urol. 1998;160:49–54. 6. Stein JP, Penson DF, Lee C, Cai J, Miranda G, Skinner DG. Long-term oncological outcomes in women undergoing radical cystectomy and orthotopic diversion for bladder cancer. J Urol. 2009;181:2052–8. 7. Neuzillet Y, Yonneau L, Lebret T, Herve JM, Butreau M, Botto H. The Z-shaped ileal neobladder after radical cystectomy: an 18 years experience with 329 patients. BJU Int. 2011;108:596– 602. 8. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1171–8. 9. Rouanne M, Massard C, Hollebecque A, Rousseau V, Varga A, Gazzah A, et al. Evaluation of sexuality, health-related qualityof-life and depression in advanced cancer patients: A prospective study in a Phase I clinical trial unit of predominantly targeted anticancer drugs. Eur J Cancer. 2013;49:431–8. 10. Haab F, Richard F, Amarenco G, Coloby P, Arnould B, Benmedjahed K, et al. Comprehensive evaluation of bladder and urethral dysfunction symptoms: development and psychometric validation of the Urinary Symptom Profile (USP) questionnaire. Urology. 2008;71:646–56. 11. Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European urology European psychometric validation of the CONTILIFE 1: a quality of life questionnaire for urinary incontinence. Eur Urol. 2003;43:391–404. 12. Anderson CB, Cookson MS, Chang SS, Clark PE, Smith JA Jr, Kaufman MR. Voiding function in women with orthotopic neobladder urinary diversion. J Urol. 2012;188:200–4. 13. Granberg CF, Boorjian S, Crispen PL, Tollefson MK, Farmer SA, Frank I, et al. Functional and oncological outcomes after orthotopic neobladder reconstruction in women. BJU Int. 2008;102: 1551–5. 14. Nesrallah LJ, Almeida FG, Dall’oglio MF, Nesrallah AJ, Srougi M. Experience with the orthotopic ileal neobladder in women: a mid-term follow-up. BJU Int. 2005;95:1045–7.
1404 15. Puppo P, Introini C, Calvi P, Naselli A. Prevention of chronic urinary retention in orthotopic bladder replacement in the female. Eur Urol. 2005;47:674–8. 16. Lee CT, Hafez KS, Sheffield JH, Joshi DP, Montie JE. Orthotopic bladder substitution in women: nontraditional applications. J Urol. 2004;171:1585–8. 17. Chang SS, Cole E, Cookson MS, Peterson M, Smith JA Jr. Preservation of the anterior vaginal wall during female radical cystectomy with orthotopic urinary diversion: technique and results. J Urol. 2002;168:1442–5. 18. 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;168:587–92. 19. Stenzl A, Jarolim L, Coloby P, Golia S, Bartsch G, Babjuk M, et al. Urethra-sparing cystectomy and orthotopic urinary diversion in women with malignant pelvic tumors. Cancer. 2001;92: 1864–71. 20. Hautmann RE, Petriconi R De, Kleinschmidt K, Gottfried HW, Gschwend JE. Orthotopic ileal neobladder in females: impact of the urethral resection on functional results. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:224–9. 21. Jarolı´m L, Babjuk M, Pecher SM Grim M, Nanka O, Tichy´ M, et al. Causes and treatment of residual urine volume after orthotopic bladder replacement in women. Eur Urol. 2000;38: 748–52. 22. Steers WD. Voiding dysfunction in the orthotopic neobladder. World J Urol. 2000;18:330–7.
M. Rouanne et al. 23. Ali-El-Dein B, Shaaban AA, Abu-Eideh RH, el-Azab M, Ashamallah A, Ghoneim MA. Surgical complications following radical cystectomy and orthotopic neobladders in women. J Urol. 2008;180:206–10. 24. Quek ML, Ginsberg DA, Wilson S, Skinner EC, Stein JP, Skinner DG. Pubovaginal slings for stress urinary incontinence following radical cystectomy and orthotopic neobladder reconstruction in women. J Urol. 2004;172:219–21. 25. Wilson S, Quek ML, Ginsberg DA. Transurethral injection of bulking agents for stress urinary incontinence following orthotopic neobladder reconstruction in women. J Urol. 2004;172: 244–6. 26. Brown JS, Sawaya G, Thom DH, Grady D. Hysterectomy and urinary incontinence: a systematic review. Lancet. 2000;356: 535–9. 27. Clifton MM, Tollefson MK: Anatomic basis of radical cystectomy and orthotopic urinary diversion in female patients. Clin Anat. 2013;26:105–9. 28. Henningsohn L, Wijkstro¨m H, Steven K, Pedersen J, Ahlstrand C, Aus G, et al. Relative importance of sources of symptom-induced distress in urinary bladder cancer survivors. Eur Urol. 2003;43: 651–62. 29. Henningsohn L, Steven K, Kallestrup EB, Steineck G. Distressful symptoms and well-being after radical cystectomy and orthotopic bladder substitution compared with a matched control population. J Urol. 2002;168:168–74.
ORIGINAL ARTICLE – UROLOGIC ONCOLOGY
Long-Term Women-Reported Quality of Life After Radical Cystectomy and Orthotopic Ileal Neobladder Reconstruction Mathieu Rouanne, MD1,2, Guillaume Legrand, MD1, Yann Neuzillet, MD, PhD1,2, Tarek Ghoneim, MD1,2, Florence Cour, MD1, Nicolas Letang, MD1, Laurent Yonneau, MD1, Jean-Marie Herve´, MD1, Henry Botto, MD1, and Thierry Lebret, MD, PhD1,2 Department of Urology, Hoˆpital Foch, Suresnes, France; 2UFR des Sciences de la Sante´, Universite´ Versailles-SaintQuentin-en-Yvelines, Versailles, France
1
ABSTRACT Background. The purpose of this study was to determine health-related quality of life (HRQoL) among long-term disease-free survivors in women who underwent radical cystectomy (RC) for urothelial carcinoma and orthotopic ileal neobladder (ONB) reconstruction, using validated patient-reported outcome instruments. Methods. From 2000 to 2011, a total of 46 women with urothelial bladder carcinoma had RC and ONB at our institution; 31 (67 %) eligible women completed 3 validated questionnaires: the medical outcome study short form 12 (SF-12), the urinary symptom profile, and the Contilife, respectively evaluating general HRQoL, voiding function, and urinary incontinence specific HRQoL. Unadjusted analyses were performed to analyze standardized measures of HRQoL and voiding symptoms; p \ 0.05 was considered significant. Results. The mean follow-up was 5.7 years; 24 women (77 %) considered their health as good, very good, or excellent. The SF-12 physical and mental scores were not significantly different between the population study and the general population (p [ 0.05). A total of 20 women (65 %) declared to be fully continent. Daytime incontinence, nighttime incontinence, and hypercontinence were reported by 26, 29, and 31 % of women, respectively. On
Mathieu Rouanne and Guillaume Legrand contributed equally to this article and share first authorship. Society of Surgical Oncology 2013 First Received: 30 June 2013; Published Online: 1 January 2014 M. Rouanne, MD e-mail: [email protected]; [email protected]
unadjusted analysis, incontinence was associated with age [ 65 years at the time of surgery (p \ 0.001). Hypercontinence was not associated with any variable. Conclusions. This study suggests that in the setting of radical cystectomy in women, ileal neobladder reconstruction provides long-term satisfaction with maintained HRQoL. For properly selected women, orthotopic neobladder can be considered an appropriate diversion choice. The path to improved management of localized muscle invasive bladder cancer involves the tackling of 2 major challenges: first and foremost, the complete surgical resection of the cancer and, second, the preservation of patient’s quality of life. In line with these objectives, anterior pelvectomy with subsequent urinary diversion is the gold standard treatment for localized high-risk bladder cancer in women.1 Indeed, this surgical procedure includes radical cystectomy (RC), hysterectomy, bilateral salpingo-oophorectomy, anterior vaginal wall resection, and either urethrectomy with ileal conduit, or continent urinary diversion.2 Over the last 20 years, the orthotopic low-pressure detubularized ileal neobladder appears to be a reliable and reproducible method of urinary diversion in men.3,4 However, orthotopic neobladder (ONB) has been less frequently applied to women compared with ileal conduit urinary diversion. Obviously, since female urethral anatomy has become more clearly described and ONB has been shown to have good oncologic outcomes in selected cases, development and propagation of this technique for female patients was facilitated.5,6 Nevertheless, the long-term quality of life (HRQoL) and functional results of ONB in women are poorly described. Consequently, this study aimed to describe the HRQoL and the outcome of diversion-specific voiding complications, specifically daytime and nighttime urinary incontinence and hypercontinence in this population.
Long-Term Quality of Life in Women with Neobladder
METHODS
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Patient Population From June 1995 to December 2011, 46 women underwent RC and ONB diversion for localized muscle invasive bladder cancer in a single tertiary department of urology. The indications for RC included only cancers, in accordance with the contemporary guidelines.1 Criteria for performing ONB included the woman’s request for orthotopic bladder substitution and her acceptance of the voiding pattern required by the reservoir on one hand and, on the other hand, the absence of cancer invasion of the bladder neck, the vaginal wall, or the urethra, of impaired renal function (estimated creatinine clearance\40 ml/min), or of significant comorbidity. The final decision to perform the ONB was taken in accordance with the analysis of the frozen section of the urethra. Surgical Technique All women underwent first a pelvic lymphadenectomy; then RC was performed. The anterior vaginal wall was routinely preserved if deemed oncologically safe. In addition, among women without a previous hysterectomy, the uterus was routinely spared if they were determined to be candidates for a vaginal-sparing cystectomy. With regard to ONB, all women underwent reconstruction of the neobladder using the Z-shaped technique as previously described.7 Postoperative Follow-Up A minimum follow-up period of 6 months was required for eligible patients to account for early postoperative voiding changes. During the first 2 postoperative years, women were evaluated quarterly in our institution by physical examination, basic laboratory tests, and computed tomography (CT) scan. During the 3rd and 4th year, patients were evaluated biannually and annually thereafter.
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The Short Form-12 Health Survey, SF-12, is a generic HRQoL instrument. This 12-item version of the widely used SF-36 questionnaire provides mental health (MCS) and physical health (PCS) component summary scores that measure self-perceived HRQoL. Higher scores reflected better functioning. The French version has been validated, and normative data for French people have been published.8,9 The USP is a self-report instrument including 11 items assessing 3 symptom scores: stress urinary incontinence (/9), urge incontinence (/12), and dysuria (/9). Each question can provide a score varying from 0 to 3.10 The Contilife is a French questionnaire originally designed for women suffering from urinary incontinence. The Contilife contains 28 items scored from 1 to 5–6 evaluating the quality of life. Scores ranged from 0 (high HRQoL) to 140 (low HRQoL). One global score, and 7 dimension scores are generated: daily activities (/35), effort activities (/20), self-image (/35), emotional consequences (/30), sexuality (/15), and well-being (/5). European psychometric validation of the Contilife has been validated in 505 women.11
Statistic Analysis Continuous, normally distributed variables were reported as the mean value with range. Continuous non-normal variables were presented as the median values with interquartile range. Univariate statistical analyses were performed with t test for quantitative variables and Chi square test for qualitative variables. Linear regression was used to test the liaison between quantitative variables. For all statistical analyses, a 2-sided p value \ 0.05 was considered statistically significant. All data were analyzed using the Statistical Package for the Social Sciences v.16.0 (SPSS, Chicago, IL, USA). RESULTS Patients Characteristics
Questionnaires In June 2012, first, all women were offered a personal interview by the same male interviewer regarding healthrelated quality of life (HRQoL) and continence status. The following parameters were assessed during the interview: urine leakage, pad usage, and need of self-catheterization. Women with any reported daytime urinary incontinence were classified as having stress urinary incontinence (SUI). Then, all women filled out the 3 self-questionnaires assessing HRQoL, urinary symptom profile (USP), and urinary quality of life:
A total of 46 consecutive women who underwent RC and ONB for bladder cancer were identified. Of these, 31 women (67 %) fulfilled the questionnaires (others had died n = 9; were lost to follow-up, n = 3; or had declined participation, n = 3). At the time of analysis, mean age was 64.8 years (range, 43–86 years) and mean duration of postoperative follow-up was 68 months (6–204 months). The 5-year disease-free and overall survivals were 59 and 79 %, respectively. Clinical and pathological characteristics of patients at the time of surgery are reported in Table 1. Early postoperative complications included 1 case
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TABLE 1 Clinical and pathologic characteristics of patients at the time of surgery (n = 31)
TABLE 2 Predictive factor of daytime stress urinary incontinence (SUI)
No. (%) Mean age (year, range) Age [ 65 years
64.8 (43–86) 6 (19)
2
Mean BMI (kg/m , range)
23.2 (18–31)
ASA score I
8 (26)
II
21 (68)
III Clinical T stage
Daytime SUI Others (n = 23) p value (n = 8)
2 (6)
cT1/Cis
11 (36)
cT2
17 (54)
cT3
3 (10)
Hydronephrosis
3 (10)
Type of surgery
Age [ 65 years at surgery (%)
6 (75 %)
2 (8.5 %)
0.001
BMI (kg/m2)
23.7
22.8
0.5
Hysterectomy (%)
4 (50 %)
3 (26 %)
0.28
5.2
0.45
Time of follow-up (years) 6.7 Pathological tumor stage
0.2
\pT2
4
8
pT2
0
6
pT3
4
9
1
2
6
2
5
16
3
1
1
ASA score
0.8
Vaginal-sparing radical cystectomy
21 (68)
Prior or simultaneous hysterectomy
10 (32)
Daytime SUI was evaluated during the personal interview
12 (39)
and performed self-intermittent catheterization (SIC) 4–6 times a day. Also, 1 patient (3 %) had a persistent vesicovaginal fistula with severe daytime incontinence requiring 5 or more pads per day. Statistically significant association was found with age [ 65 years at the time of surgery and postoperative daytime SUI (p = 0.001). None of the other preoperative and postoperative variables turned out to be predictive of urinary incontinence at follow-up in univariate analysis (Table 2). Moreover, there was no significant predictor of hypercontinence in univariate analysis.
Pathologic T stage Ta/T1, Cis T2
6 (19)
T3
13 (42)
T4
0 (0)
Pathologic N stage N0 N?
28 (90) 3 (10)
of ileo-bladder fistula requiring conversion to incontinent diversion, 1 severe sepsis due to urinary infection, and 1 pyelonephritis due to ureteroenteric anastomotic stricture. Late surgical complications were reported in 6 patients. There were 2 patients who had small bowel obstruction medically treated and 2 patients who had abdominal hernia surgically repaired. Two patients had vaginal fistula. The fistula was successfully repaired transvaginally for 1 woman; in the other case, vaginal fistula was persistent despite a transvaginal Martius flap. Continence Status Provided from the Personal Interview Of 31 patients, 20 (64.5 %) stated not to have any urine leakage during the clinical interview and were classified as fully continent. Also, 23 (74 %) and 25 (80 %) of them declared using no pad or a safety pad for occasional leakage during daytime and nighttime, respectively. There were 8 women (26 %) who reported daytime SUI and 9 women (29 %) who had nighttime incontinence. Of the 8 women with daytime SUI, 6 (75 %) had nighttime incontinence. There were 9 women (29 %) were hypercontinent
Urinary Symptom Profile The mean USP score was 12.4/40 ± 7.2 (Table 3). According to question 5 of the USP, 26 women (84 %) could spend 2 h or more between 2 voidings. According to question 6, 11 (35.5 %), 14 (45.5 %), and 6 (19 %) women woke up, respectively, never or once, twice, or 3 or more times during the night. According to question 7, 16 women (51.5 %) never had urine leak while asleep nor woke up wet. Health-Related Quality of Life Results for SF-12 subscales in the study population and normative French data are presented in Table 4. Both physical and mental health component scores were lower in this study population than in the normative French patients. However, no statistically significant difference was found between our study population and normative French assessments for physical (p = 0.07) and mental (p = 0.20)
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TABLE 3 Results of USP score USP
TABLE 3 continued No. patients (%)
Q1: Over the past 4 weeks, please specify the number of times a week you have had leaks during physical effort: No urine leaks Strenuous effort Moderate effort
13 (42) 18 (58)
Light effort
22 (71)
Less than 1 urine leak a week
USP
No. patients (%)
Never or once
11 (35.5)
Twice
14 (45.5)
3 or 4 times
5 (16)
More than 4 times
1 (3)
Q7: How many times a week have you had a urine leak while asleep or have you woken up wet? Never
16 (51.5)
Strenuous effort
6 (19.5)
Less than once a week
3 (9.5)
Moderate effort
6 (19.5)
Several times a week
6 (19)
Light effort
2 (6.5)
Several times a day
6 (19)
Several urine leaks a week
Q8: How would you describe your usual urination over these past 4 weeks?
Strenuous effort
4 (13)
Moderate effort
2 (6.5)
Normal
Light effort
2 (6.5)
Needed to push with abdominal (stomach) muscles or 11 (35.5) lean forward (or required a change of position) to urinate
Several urine leaks a day Strenuous effort
8 (25.5)
Moderate effort
5 (16)
Light effort
5 (16)
Q2: How many times a week have you had to rush to the toilet to urinate because you urgently needed to go? Never Less than once a week Several times a week Several times a day
18 (58) 7 (22.5) 4 (13) 2 (6.5)
Q3: When you have had an urgent need to urinate, for how many minutes on average have you been able to hold on? More than 15 min
20 (65)
From 6 to 15 min From 1 to 5 min
1 (3) 6 (19)
Less than 1 min
4 (13)
Q4: How many times a week have you experienced a urine leak preceded by an urgent need to urinate that you were unable to control? Never
21 (68)
Less than once a week
9 (29)
Several times a week
1 (3)
Several times a day 0 (0) Q4a: In the above case, what kind of leaks did you have? No leaks in this case
18 (58)
A few drops
5 (16.5)
Light leaks
6 (19.5)
Heavy leaks
2 (6)
Q5: During the day, in general, how long elapsed between urinating? 2 h or more
26 (84)
Between 1 and 2 h
4 (13)
Between 30 min and 1 h
1 (3)
Less than 30 min
0 (0)
Q6: How many times on average have you been woken up during the night by a need to urinate?
5 (16)
Needed to press on the lower stomach with my hands
6 (19.5)
Used a catheter
9 (29)
Q9: In general, how would you describe your urine flow? Normal
16 (52)
Weak
6 (19)
Drop by drop
0 (0)
Used a catheter
9 (29)
Q10: In general, how has your urination been? Normal and quick
10 (32)
Difficult to start, then normal or easy at first but slow to finish
8 (26)
Very slow from start to finish
4 (13)
Used a catheter
9 (29)
S strenuous, M moderate, L light
health component. A total of 24 patients (77 %) considered their health was good, very good, or excellent, and 25 patients (80.6 %) were a little or not at all embarrassed in their social life or their relationships by their health. Moreover, no statistically significant association was found with preoperative and postoperative variables and reduction of the SF-12 physical and mental health scores (p [ 0.05). Impact of Urinary Symptoms on Quality of Life The mean Contilife score was 59.8/140 ± 21. The mean scores of daily activities, effort activities, self-image, emotional consequences, and overall well-being were, respectively, 13.8/35 ± 7, 5.8/20 ± 3, 15.9/35 ± 7, 15.3/ 30 ± 6, and 3.4/5 ± 1. A total of 18 women (58 %) had sexual intercourse at the time of analysis, and 16 of them (89 %) had vaginal wall sparing procedure. The mean
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TABLE 4 SF-12 subscales in the study population and normative French data (mean value ± SD)
Physical
Neobladder (n = 31)
General population (n = 2,743)
p value
44.24 ± 10.0
51.2 ± 7.4
0.07
48.4 ± 9.4
0.20
Mental and social 43.55 ± 9.3
TABLE 5 Results of Contilife Variable
Mean score ± SD
Median score (range)
Daily activities (7 items/35)
13.8 ± 7
12.5 (6–32)
Effort activities (4 items/20)
5.8 ± 3
5 (3–11)
Self-image (7 items/35)
16.0 ± 7
14 (6–37)
Emotional consequences (6 items/30)
15.3 ± 6
14 (6–26)
Sexuality (3 items/15)
4.8 ± 5
3 (1–15)
Well-being (1 item/5)
3.4 ± 1
3 (1–5)
Total (28 items/140)
59.8 ± 21
56 (23–99)
score of sexual activity was 54.8/15 ± 5. Results for each component are reported in Table 5. According to questions 17 and 28, 22 patients (71 %) reported feeling good about themselves despite their urinary symptoms and considered their health was good, very good, or excellent. According to question 18, 19 patients (61 %) reported being a little or not at all bothered by wearing pads. DISCUSSION This study constitutes the first-ever reported analysis regarding long-term HRQoL and functional outcomes in women following ONB. Among 34 patients disease-free with regular follow-up, 31 accepted the interview and agreed to fill out all the questionnaires. This high response rate confirms that urinary continence recovery and overall HRQoL are major issues for bladder cancer survivors. The Z-shaped ileal neobladder is an original technique for bladder substitution following RC developed in our center in the late 1990s. At a mean follow-up of 5.7 years, day and night continence rate was reported by women as 74 and 71 %, respectively. Moreover, 74 and 80 % of them declared not to require more than 1 pad a day and 1 pad a night, respectively. The prevalence of daytime SUI in women with ONB has been reported in other series between 10 and 27 %.12–23 In line with these numbers, 8 of 31 patients (26 %) declared to the interviewer to have daytime urine leakage. Currently, limited treatment options have been described in case of post-ONB SUI, with poor results of periurethral bulking agents and pubovaginal slings.24,25 Recently, Anderson et al. showed that the only
predictor of daytime leakage was having a prior or concurrent hysterectomy.12 Arguably, this is a known risk factor for urinary incontinence in the general population, suggesting the importance of posterior vaginal and periurethral support to maintain urinary continence.12,26 Interestingly, we identified that age \ 65 years at time of surgery was predictive of achieving continence. Therefore, this prognosis factor for urinary continence recovery seems very important to us when informing and selecting the women for neobladder. Nocturnal incontinence prevalence was as high as 29 %, consistent with other findings with rates typically ranging from 20 to 40 %.6,13,22,23,27,28 Women were recommended to void several times a night to attempt to minimize involuntary leakage. However, the etiology of nocturnal incontinence is multifactorial and may be caused by overdistension of the ONB and pathophysiological impairments to the neurological system, as well as physiological diuresis. In general, approximately 25 % of women may become dependent on intermittent catheterization to manage the ONB, although higher rates have been reported.12 Similarly, we found 9 of 31 patients (29 %) with urinary hypercontinence. Chronic urinary retention after RC and ONB remains a significant issue for female patients. A regular intermittent catheterization was recommended to prevent neobladder overdistension and upper urinary tract deterioration. In this study, we did not find any preoperative or postoperative factor significantly associated with hypercontinence. Although some have suggested that chronic retention is secondary to hypocontractility of the neobladder wall, Ali-El-Dein et al.18 demonstrated that there is strong evidence that urinary retention is caused by anatomical, rather than functional or neurogenic reasons. Videourodynamics had demonstrated a falling back of the pouch into the pelvic cavity that results in an acute angulation of the neobladder-urethral junction. Further ongoing studies with 3-dimensional and dynamic pelvic MRI will provide more details of the mechanisms underlying chronic retention in women with ONB. According to HRQoL, the women scored decrease in both physical and mental health component with the SF-12. However, despite the lower scores, no statistically significant difference was found between our study population and normative French assessments on the SF-12. In addition, the mean scores of the 5 domains evaluated with the Contilife were high, particularly those concerning wellbeing, effort-activities, and self-image. These results highlight that long-term ONB is safe and preserves the mental and physical well-being. Furthermore, when we compared Contilife scores according to the presence of self-intermittent catheterization (SIC), the scores for HRQoL were significantly lower in patients who required
Long-Term Quality of Life in Women with Neobladder
SIC. These results are similar to other findings that show a relative trade-off of chronic retention versus total incontinence.6 Despite a major pelvic surgery, the majority of women (18 of 31) were sexually active and were interested in preserving a good quality of sexual life. This response rate confirmed that overall HRQoL and sexual function in particular continue to be major issues for cancer patients and cancer survivors. In addition to cancer survival and urinary control, identification of other chronic treatmentassociated conditions is important.27 Although poorly identified, impaired sexual function has been recognized as the primary source of self-assessed distress among patients undergoing radical cystectomy.28,29 Therefore, several anatomic factors have been identified to decrease postoperative sexual dysfunction: nerve-sparing cystectomy with conservation of the neurovascular bundles on the lateral walls of the vagina, preservation of the anterior vaginal wall, and vascularization of the clitoris. Our study suffers from several limitations. Firstly, we conducted a retrospective study with no baseline data on voiding function and physical and mental health. Indeed, we could not evaluate any preoperative factor that may impact variation in postoperative HRQoL and voiding function. Secondly, despite its capacity to evaluate urinary disorders including stress, frequency, or urinary obstructive symptoms with a reliable and standardized method, the use of a USP questionnaire has not been specifically validated in this population study. Then, the number of patients evaluated was not particularly large, mainly because of cancer-related mortality. Consequently, some of our statistical analyses were underpowered with limited possibilities to realize cross-sectional analyses. Furthermore, the population study was relatively young compared with other series with a high percentage of patients (90 %) with organ-confined disease. Both parameters may have a positive impact on the functional outcomes and HRQoL. Finally, sexual function was not specifically evaluated with validated questionnaires; in addition, preoperative sexuality was not reported. Therefore, our study provides limited data concerning sexual impairment after RC and ONB. Nevertheless, we presented for the first time the long-term HRQoL and functional results in a cohort of women who underwent RC and ONB at a high-volume, specialized cancer center. One of the major strengths of the present study was measure of HRQoL and impact on quality of life secondary to postoperative voiding dysfunction. In summary, the standardized self-report questionnaires enabled us to capture essential information regarding the impact of ONB on women’s satisfaction. These data suggest that in the setting of RC in women, ONB reconstruction provides long-term satisfaction with maintained HRQoL. However, we identified a significant
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prevalence of incontinence in women with ONB who were [65 years. In the context of shared medical decision making, it is crucial for patients to be informed with meaningful data with which to make informed choices regarding the urinary diversion options.
REFERENCES 1. Stein JP, Penson DF, Wu SD, Skinner DG. Pathological guidelines for orthotopic urinary diversion in women with bladder cancer: a review of the literature. J Urol. 2007;178:756–60. 2. Marshall FF, Treiger BF: Radical cystectomy (anterior exenteration) in the female patient. Urol Clin North Am. 1991;18:765– 75. 3. Fujisawa M, Isotani S, Gotoh A, Okada H, Arakawa S, Kamidono S. Health-related quality of life with orthotopic neobladder versus ileal conduit according to the SF-36 survey. Urology. 2000;55: 862–5. 4. Hobisch A, Tosun K, Kinzl J, Kemmler G, Bartsch G, Ho¨ltl L, et al. Quality of life after cystectomy and orthotopic neobladder versus ileal conduit urinary diversion. World J Urol. 2000;18: 338–44. 5. Colleselli K, Stenzl A, Eder R, Strasser H, Poisel S, Bartsch G. The female urethral sphincter: a morphological and topographical study. J Urol. 1998;160:49–54. 6. Stein JP, Penson DF, Lee C, Cai J, Miranda G, Skinner DG. Long-term oncological outcomes in women undergoing radical cystectomy and orthotopic diversion for bladder cancer. J Urol. 2009;181:2052–8. 7. Neuzillet Y, Yonneau L, Lebret T, Herve JM, Butreau M, Botto H. The Z-shaped ileal neobladder after radical cystectomy: an 18 years experience with 329 patients. BJU Int. 2011;108:596– 602. 8. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51:1171–8. 9. Rouanne M, Massard C, Hollebecque A, Rousseau V, Varga A, Gazzah A, et al. Evaluation of sexuality, health-related qualityof-life and depression in advanced cancer patients: A prospective study in a Phase I clinical trial unit of predominantly targeted anticancer drugs. Eur J Cancer. 2013;49:431–8. 10. Haab F, Richard F, Amarenco G, Coloby P, Arnould B, Benmedjahed K, et al. Comprehensive evaluation of bladder and urethral dysfunction symptoms: development and psychometric validation of the Urinary Symptom Profile (USP) questionnaire. Urology. 2008;71:646–56. 11. Amarenco G, Arnould B, Carita P, Haab F, Labat JJ, Richard F. European urology European psychometric validation of the CONTILIFE 1: a quality of life questionnaire for urinary incontinence. Eur Urol. 2003;43:391–404. 12. Anderson CB, Cookson MS, Chang SS, Clark PE, Smith JA Jr, Kaufman MR. Voiding function in women with orthotopic neobladder urinary diversion. J Urol. 2012;188:200–4. 13. Granberg CF, Boorjian S, Crispen PL, Tollefson MK, Farmer SA, Frank I, et al. Functional and oncological outcomes after orthotopic neobladder reconstruction in women. BJU Int. 2008;102: 1551–5. 14. Nesrallah LJ, Almeida FG, Dall’oglio MF, Nesrallah AJ, Srougi M. Experience with the orthotopic ileal neobladder in women: a mid-term follow-up. BJU Int. 2005;95:1045–7.
1404 15. Puppo P, Introini C, Calvi P, Naselli A. Prevention of chronic urinary retention in orthotopic bladder replacement in the female. Eur Urol. 2005;47:674–8. 16. Lee CT, Hafez KS, Sheffield JH, Joshi DP, Montie JE. Orthotopic bladder substitution in women: nontraditional applications. J Urol. 2004;171:1585–8. 17. Chang SS, Cole E, Cookson MS, Peterson M, Smith JA Jr. Preservation of the anterior vaginal wall during female radical cystectomy with orthotopic urinary diversion: technique and results. J Urol. 2002;168:1442–5. 18. 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;168:587–92. 19. Stenzl A, Jarolim L, Coloby P, Golia S, Bartsch G, Babjuk M, et al. Urethra-sparing cystectomy and orthotopic urinary diversion in women with malignant pelvic tumors. Cancer. 2001;92: 1864–71. 20. Hautmann RE, Petriconi R De, Kleinschmidt K, Gottfried HW, Gschwend JE. Orthotopic ileal neobladder in females: impact of the urethral resection on functional results. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:224–9. 21. Jarolı´m L, Babjuk M, Pecher SM Grim M, Nanka O, Tichy´ M, et al. Causes and treatment of residual urine volume after orthotopic bladder replacement in women. Eur Urol. 2000;38: 748–52. 22. Steers WD. Voiding dysfunction in the orthotopic neobladder. World J Urol. 2000;18:330–7.
M. Rouanne et al. 23. Ali-El-Dein B, Shaaban AA, Abu-Eideh RH, el-Azab M, Ashamallah A, Ghoneim MA. Surgical complications following radical cystectomy and orthotopic neobladders in women. J Urol. 2008;180:206–10. 24. Quek ML, Ginsberg DA, Wilson S, Skinner EC, Stein JP, Skinner DG. Pubovaginal slings for stress urinary incontinence following radical cystectomy and orthotopic neobladder reconstruction in women. J Urol. 2004;172:219–21. 25. Wilson S, Quek ML, Ginsberg DA. Transurethral injection of bulking agents for stress urinary incontinence following orthotopic neobladder reconstruction in women. J Urol. 2004;172: 244–6. 26. Brown JS, Sawaya G, Thom DH, Grady D. Hysterectomy and urinary incontinence: a systematic review. Lancet. 2000;356: 535–9. 27. Clifton MM, Tollefson MK: Anatomic basis of radical cystectomy and orthotopic urinary diversion in female patients. Clin Anat. 2013;26:105–9. 28. Henningsohn L, Wijkstro¨m H, Steven K, Pedersen J, Ahlstrand C, Aus G, et al. Relative importance of sources of symptom-induced distress in urinary bladder cancer survivors. Eur Urol. 2003;43: 651–62. 29. Henningsohn L, Steven K, Kallestrup EB, Steineck G. Distressful symptoms and well-being after radical cystectomy and orthotopic bladder substitution compared with a matched control population. J Urol. 2002;168:168–74.
