bs_bs_banner

International Journal of Urology (2014)

doi: 10.1111/iju.12452

Original Article

Health-related quality of life after radical cystectomy and neobladder reconstruction in women: Impact of voiding and continence status Mohamed H Zahran,1 Ahmed S El-Hefnawy,1 Essam M Zidan,2 Mona A El-Bilsha,3 Diaa-Eldin Taha1 and Bedeir Ali-El-Dein1 1

Urology and Nephrology Center, 2Mental Health Department, Faculty of Education, and 3Faculty of Nursing, Mansoura University, Mansoura, Egypt

Abbreviations & Acronyms CIC = clean intermittent catheterization CUR = chronic urinary retention EORTC-QLQ-C30 = European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire FACT-Bl = Functional Assessment of Cancer Therapy bladder cancer-specific form HRQOL = health-related quality of life NI = night-time incontinence ONB = orthotopic neobladder QOL = quality of life RC = radical cystectomy SV = spontaneous voiding Correspondence: Mohamed H Zahran M.D., Urology and Nephrology Center, Mansoura University, Mansoura 35516, Egypt. Email: [email protected] Received 26 October 2013; accepted 25 February 2014.

© 2014 The Japanese Urological Association

Objectives: To assess health-related quality of life, and the impact of night-time incontinence and chronic urinary retention on health-related quality of life in women with bladder cancer after radical cystectomy and orthotopic neobladder. Methods: The study included 74 women who underwent radical cystectomy and orthotopic neobladder, and completed 1 year of follow up. Health-related quality of life was evaluated using the questionnaires of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire and the Functional Assessment of Cancer Therapy bladder cancer-specific form. Health-related quality of life was compared with an agematched control group. The impact of night-time incontinence and chronic urinary retention on health-related quality of life was assessed. Results: The study group included 18 completely continent patients with spontaneous voiding, 29 with night-time incontinence and 27 with chronic urinary retention. The study group was statistically significantly lower in all domains of health-related quality of life than the control group. In all domains of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire and Functional Assessment of Cancer Therapy bladder cancer-specific form, completely continent women were comparable with those with chronic urinary retention. Women with night-time incontinence had a significantly worse healthrelated quality of life than completely continent women, shown by the mean global health score (P = 0.038), social functioning score (P = 0.012), pain European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire score (P = 0.04), and functional well-being Functional Assessment of Cancer Therapy bladder cancer-specific form (P = 0.049) score. Conclusions: After radical cystectomy and orthotopic neobladder in women, healthrelated quality of life is lower than that of the normal population. Night-time incontinence has a negative impact on social life and most domains of health-related quality of life. Thus, night-time incontinence has a higher social impact than chronic urinary retention.

Key words: bladder neoplasm, orthotopic diversion, quality of life in women, radical cystectomy.

Introduction During the past decade, there has been an increasing focus on QOL outcomes after RC because of the potential negative impact of the surgery on patients’ satisfaction regarding body image, and urinary, sexual and social functions.1 A step towards elimination of these concerns was ONB reconstruction. Orthotopic neobladder provides an advantage of enabling volitional voiding through the urethra. In addition, the need for an external appliance is avoided.2,3 Consequently, it was likely to speculate that ONB might provide more attractive option to the patients. However, objective evidence is definitely required to support such a speculation. Currently, ONB in women has become the standard of care after radical cystectomy in select women with bladder cancer.4,5 It has been estimated that 65% of women undergoing RC are eligible for ONB.6 However, available data about HRQOL in women after RC and ONB is still lacking. Review of the literature has shown contradictory data about the ability of ONB to provide the best QOL in comparison with other types of diversion. There is no clear distinction between HRQOL in males and females in vast majority of studies.7,8 Even when sex was 1

MH ZAHRAN ET AL.

considered and evaluated, the results were biased because of the limited numbers of women involved.9,10 Data on the effect of continence status on HRQOL in these women are still lacking. Therefore, the objectives of the present study were to assess the HRQOL in women after RC and ONB in comparison with the normal population. In addition, the impact of NI and CUR on HRQOL was evaluated.

Methods The study was approved by the institutional review board. The study was carried out between August 2011 and October 2012. A total of 74 consecutive living women who underwent RC and ONB were included in the study. Inclusion criteria included women who underwent RC and ONB for invasive bladder cancer, those who were regularly attending follow-up visits at the outpatient clinic at the Urology and Nephrology Center, Mansoura, Egypt, for at least 1 year postoperative and those who had no evidence of local tumor recurrence or distant metastasis. These women were interviewed for HRQOL assessment in the study period. A control group of 72 women without bladder cancer was invited to participate in the study. All of the participants of the control group were living in the same geographical area and were age-matched to the study group.

Preoperative assessment In all cases, the tumor was organ confined without bladder neck infiltration. Diffuse carcinoma in situ, multifocal tumors and clinically evident metastatic lymphadenectomy were contraindications. All patients had a history of uncompromised continence status and intact pelvic floor anatomy.

Surgical technique The technique of RC and ONB was previously described with preservation of the urethra and the anterior vaginal wall.3,11 There was no attempt to preserve the autonomic nerve supply to the urethra.

Data collection We retrospectively reviewed data files of these patients. Detailed history was taken and a thorough physical examination was carried out. Patients were assessed regarding the HRQOL using two questionnaires: EORTC-QLQ-C3012 and FACT-Bl.13 Both questionnaires were applied after being translated into Arabic and reverse translated by an independent party. Data were gathered by face-to-face interview by a third person not involved in providing healthcare. We evaluated the impact of age (>60 years and ≤60 years), the presence of comorbidities, the time elapsed after RC and marital status on HRQOL. In addition, the impact of NI and CUR with CIC on HRQOL was assessed. According to institutional guidelines, CIC is recommended for patients with postvoid residual urine volume greater than 150 mL or more than 20% of the maximum reservoir volume, or when CUR is causing upper tract deterioration or incontinence. Patients were regarded as continent when they remained dry without protective pads and/or undue frequency. NI was considered when any amount of urinary leakage occurred during sleep hours.14 2

HRQOL Instruments The EORTC-QLQ-C30 questionnaire was designed to measure cancer-specific HRQOL in patients with a variety of malignancies.12 Its 30 items addressed domains that are common to all cancer patients. The questionnaire included five functional scales (physical, role, emotional, cognitive and social functioning), a global health scale, three symptom scales (fatigue, nausea/vomiting and pain) and six single items regarding dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties as a result of disease. It is noteworthy that the score ranges from 1 through 4, except for questions 29 and 30, which range from 1 through 7. All the scales have a score range from 0 to 100. The higher the score the higher (better) level of functioning, the higher (worse) the level of symptoms. It is measured by calculating the items that contribute to the scale, this is the raw score. Then it is standardized using a linear transformation to obtain the final score.12 The FACT-Bl was designed as a validated HRQOL tool consisting of the 27-item Functional Assessment of Cancer Therapy-general (FACT-G; with four 4 subscales: physical, social, emotional and functional well-being) plus an additional bladder cancer subscale that assessed urinary tract, intestinal and sexual symptoms.13 The five scales were scored separately, and then the sum of the scales was calculated with a higher score indicating a better outcome. The score of all items ranged from 1 to 4. The score is reversed in certain items. In order to calculate the subscales score, the sum of the item scores is multiplied by the number of items in the subscale, then divide by the number of items answered. The total score is measured by adding the subscales scores.13

Statistical analysis The continuous data were tested for normality by using the Kolmogrov–Smirnov Z test. Subsequently ANOVA, the Mann– Whitney or χ2-test was used according to the situation. All statistical tests were carried out using SPSS version 16 package (SPSS, Chicago, IL, USA), with a P-value of less than 0.05 considered significant.

Results Radical cystectomy and ONB for muscle-invasive bladder cancer was carried out for 300 women at our institutions between January 1995 and June 2012. Out of these, 50% were continent day and night with spontaneous voiding (aided by Valsalva’s maneuver), 27% were incontinent at night, 3% showed total incontinence and 20% developed chronic urinary retention. In the study cohort (74 patients), the mean age ± SD at the time of surgery was 51 ± 10 years. The mean age ± SD at the time of assessment of HRQOL was 59 ± 9 years (range 28–77 years). The mean period ± SD elapsed after RC was 8 ± 4 years. The cohort included 18 (24.4%) completely continent women with SV, 29 with NI (39.1%) and 27 (36.5%) with CUR and on CIC. The demographic criteria of the study group and the control group are shown in Table 1. When HRQOL was compared between the study group and the control group, there was a statistically significant difference in all subscales of both questionnaires used in favor of the control group (Figs 1,2). © 2014 The Japanese Urological Association

QOL after RC and orthotopic diversion

Table 1 Demographic criteria of patients treated with radical cystectomy and ONB, and the control group

Table 2 Comparison of HRQOL in completely continent patients with SV and those maintained on CIC

Parameter

ONB

Control

P-value*

QOL domains

No. eligible patients No. study cohort Age (years) Mean ± SD Above 60 60 or less Postcystectomy period (years) Mean ± SD Medical comorbidities Hypertension Diabetes mellitus Liver cirrhosis Heart disease Bronchial asthma Marital status Married Not married Continence status of the cohort Continent with SV NI CUR and on CIC

234 74

72 72

Inapplicable 0.55

59 ± 9 39 35

58 ± 7 34 38

8±4 19 8 9 2 2 1

– 21 13 11 2 1 –

32 42

70 2

18 29 27

72 – –

Inapplicable 0.76

0.001

Inapplicable

*Pearson’s χ2-test.

Among the study group, patients with CUR and on CIC were younger than completely continent patients and those with NI (P = 0.17 and 0.03, respectively). There were statistically insignificant differences in all domains of EORTC-QLQ-C30 and FACT-Bl, between completely continent patients with SV and those with CUR and on CIC (Table 2). Women with NI had a worse HRQOL than continent patients with SV (Table 3). There were significant differences between both groups in the mean global health score (P = 0.038), social functioning score (P = 0.012), pain EORTC-QLQ-C30 score (P = 0.047) and functional well-being FACT-Bl (P = 0.049) score. In addition, marginal significance was noted in favor of completely continent women with SV in physical functioning (P = 0.06) and role functioning (P = 0.055) EORTC-QLQ-C30 score, whereas the difference regarding constipation EORTC-QLQ-C30 score was not significant (P = 0.097). Also, there was no difference between the two groups regarding the total FACT-Bl score. Similarly, when the group with NI was compared with that with CUR, we obtained significant differences between both groups and in favor of the CUR group in the mean global health score (P = 0.023), social functioning score (P = 0.042) and functional well-being FACT-Bl (P = 0.031) score. However, there was no significant difference in the pain QLQ-C30 score (P = 0.612). On univariate analysis, patient age, postoperative duration, associated comorbidities, presence of diabetes mellitus and marital status had no significant impact on the HRQOL for women with ONB (Table 4).

Discussion Since the first cystectomy for treatment of bladder cancer, there have been surgical challenges not only to safely control cancer, but also to appropriately replace bladder function. There has been a trend over the past three decades to use continent urinary © 2014 The Japanese Urological Association

EORTC QLQ-C30: (0–100) Global health (QL2) Physical functioning (PF2) Role functioning (RF2) Emotional functioning (EF) Cognitive function (CF) Social function (SF) Fatigue (FA) Nausea and vomiting (NV) Pain (PA) Dyspnea (DY) Insomnia (SL) Appetite loss (AP) Constipation (CO) Diarrhea (DI) Financial difficulties (FI) FACT-Bl score Physical well-being (PWB; 0–28) Social well-being (SWB; 0–28) Emotional well-being (EWB; 0–24) Functional well-being (FWB; 0–28) Bladder cancer subscale (BICS; 0–48) FACT-Bl total score (0–156)

Patients with SV Mean (SD)

Patients on CIC Mean (SD)

P-value

52.7 (30.51) 64.07 (32.3) 59.25 (31.9) 62.5 (40.34) 63.88 (37.6) 55.5 (36.15) 44.44 (38.67) 21.29 (26) 34.25 (29.96) 25.92 (31.42) 52.94 (39.19) 37 (35.95) 18.51 (23.49) 20.37 (28.32) 33.3 (34.29)

41.35 (30.52) 53 (28.19) 44.23 (35.25) 57 (34.8) 57.2 (32.4) 41.97 (38.77) 54.7 (35.82) 19.13 (19.99) 44.44 (33.96) 20.98 (22.92) 58 (40.92) 44.4 (30.66) 19.75 (28.13) 25.92 (31.1) 45.67 (37.15)

0.205 0.29 0.14 0.62 0.44 0.18 0.47 0.99 0.3 0.77 0.59 0.43 0.93 0.55 0.26

10.77 (7.31)

11.81 (6.7)

0.63

18.49 (8.89)

15.74 (8.84)

0.34

9.55 (5.72)

9.4 (5.61)

0.96

16 (5.98)

13.66 (6.78)

0.13

21.3 (7.83)

21.1 (7.43)

0.92

76.12 (18.5)

71.74 (13.78)

0.285

AP, item 13; CF, items 20–25; CO, item 16; DI, item 17; DY, item 8; EF, items 21–24; FA, items 10, 12 and 18; FI, item 28; NV, items 14 and 15; PA, items 9 and 19; PF2, items 1–5; QL2, items 29 and 30; RF2, items 6 and 7; SF, items 26 and 27; SL, item 11.

diversions in order to improve HRQOL. However, the controversial reports on achievement of such a goal are a major limitation of the previous research.15 In the current study, patients with proven oncological failure after RC and ONB were excluded because of the possible negative impact of tumor recurrence on HRQOL. Only patients who had completed at least 1 year after surgery were included, because psychological and HRQOL measures were found to come back to the baseline level and to be stabilized 12 months after cystectomy.15 Two well-established and validated cancerspecific questionnaires were used in the present study to ensure consistency of the results. Although patient age did not have a significant impact on the HRQOL in the present study, other studies reported a better HRQOL in younger patients with ONB than older patients older than 65 years-of-age.16–18 Henningsohn et al. reported higher anxiety and depression in patients with ONB and maintained on CIC than those who can evacuate the bladder by straining.7 However, patients on CIC in the current study showed a lower, but insignificant, emotional functioning QLQ-C30 score and emotional well-being FACT-Bl score than those with SV. NI had a negative impact on the HRQOL in the present study, as well as others.19 In a multicenter study, individuals with an 3

MH ZAHRAN ET AL.

30

FI

Pa in sp ne a In so m n Ap ia pe Co tit ns e tip at io n Di ar rh ea Dy

NV

FA

SF

CF

EF

RF 2

2 PF

QL

2

100 90 80 70 60 50 40 30 20 10 0

Fig. 1 Comparison of EORTC QLQ-C30 scales score between women with RC and ONB, and the control group. , Normal control; , ONB. CF, cognitive function; EF, emotional functioning; FA, fatigue; FI, financial difficulties; NV, nausea and vomiting; PF2, physical functioning; RF2, pole functioning; QL2, global health; SF, social function.

25

Table 3 Comparison of HRQOL in completely continent patients with SV and those with NI

20

QOL domains

15

Patients with SV Mean (SD)

Patients with nocturnal incontinence Mean (SD)

P-value

52.7 (30.51) 64.07 (32.3) 59.25 (31.9) 62.5 (40.34) 63.88 (37.6) 55.5 (36.15) 44.44 (38.67) 21.29 (26) 34.25 (29.96) 25.92 (31.42) 52.94 (39.19) 37 (35.95) 18.51 (23.49) 20.37 (28.32) 33.3 (34.29)

34.48 (28.14) 42.89 (25.6) 40.22 (31.34) 44.25 (33.71) 44.44 (31.53) 29.31 (34.69) 62.06 (35.45) 20.11 (18.02) 52.87 (27.84) 27.58 (23.68) 67.81 (42.24) 50.57 (35.2) 35.63 (34.42) 17.24 (19.14) 48.27 (32.83)

0.038 0.062 0.055 0.239 0.154 0.012 0.114 0.82 0.047 0.59 0.118 0.205 0.097 0.99 0.116

10.77 (7.31)

12.55 (6.47)

0.45

18.49 (8.89)

15.7 (7.89)

0.258

9.55 (5.72)

10.62 (5.33)

0.179

16 (5.98)

13.17 (6.89)

0.05

21.3 (7.83)

22.23 (6.95)

0.538

76.12 (18.5)

74.28 (13.31)

0.648

10 5 0

PWB

SWB

EWB

FWB

BICS

Fig. 2 Comparison of FACT-Bl scales scores between women with RC and ONB, and the control group. , Normal control; , ONB. BICS, bladder cancer subscale; EWB, emotional well-being; FWB, functional well-being; PWB, physical well-being; SWB, social well-being.

ONB and NI reported negative effects on nocturnal sleep, and had a lower self-assessed HRQOL, physical health and energy level.19 In contrast, other investigators reported no significant impact of continence status on patient overall HRQOL.8,20,21 Although completely continent women with SV had a higher HRQOL than those with NI regarding role functioning (P = 0.055) and pain score (P = 0.047), the difference was of marginal or little statistical significance in the current study. In a prospective study to assess whether changes in body image has an impact on HRQOL, Somani et al. found that none of the patients who had ONB reported that body image had a significant impact on HRQOL.22 In another prospective study of a larger sample size, Hedgepeth et al. reported that patients with ONB had worse body image compared with preoperative scores.9 Although improvement of scores over time was reported, however, it did not return to the baseline. In the present study, body image changes were not fully evaluated and need to be explored in future studies. In the current study, there was a reduction in all subscales of HRQOL after RC and ONB when compared with an agematched normal population. The previously published data comparing HRQOL in patients who underwent ONB with a normal population are controversial. Some authors reported preserved HRQOL after ONB.7,8 In contrast, lower rolephysical and role-emotional functions have been reported in women with ONB than the normal population,20,23 others reported decreased overall HRQOL.21 None of the previous studies assessed the HRQOL in women, except for two recent studies.23,24 In addition, the 4

EORTC QLQ-C30 (0–100) Global health (QL2) Physical functioning (PF2) Role functioning (RF2) Emotional functioning (EF) Cognitive function (CF) Social function (SF) Fatigue (FA) Nausea and vomiting (NV) Pain (PA) Dyspnea (DY) Insomnia (SL) Appetite loss (AP) Constipation (CO) Diarrhea (DI) Financial difficulties (FI) FACT-Bl score Physical well-being (PWB; 0–28) Social well-being (SWB; 0–28) Emotional well-being (EWB; 0–24) Functional well-being (FWB; 0–28) Bladder cancer subscale (BICS; 0–48) FACT-Bl total score (0–156)

AP, item 13; CF, items 20–25; CO, item 16; DI, item 17; DY, item 8; EF, items 21–24; FA, items 10, 12 and 18; FI, item 28; NV, items 14 and 15; PA, items 9 and 19; PF2, items 1–5; QL2, items 29 and 30; RF2, items 6 and 7; SF, items 26 and 27; SL, item 11.

number of female patients included in all was small. To the best of our knowledge, the previously published studies did not assess the HRQOL in such a large number of women after RC and ONB as did our study. Thus, the results of the present study can provide an effective answer for the clinically important question “does continence status significantly affect HRQOL © 2014 The Japanese Urological Association

QOL after RC and orthotopic diversion

Table 4 Effect of patient’s age, diabetes mellitus, medical comorbidities, marital status and postoperative period on HRQOL using FACT-Bl questionnaire Mean ± SD Age at evaluation (years) ≤60 >60 Diabetes mellitus Yes No Other comorbidities Yes No Marital status Married Single Widow Divorced Postoperative duration

Health-related quality of life after radical cystectomy and neobladder reconstruction in women: impact of voiding and continence status.

To assess health-related quality of life, and the impact of night-time incontinence and chronic urinary retention on health-related quality of life in...
247KB Sizes 0 Downloads 3 Views