Japanese Journal of Clinical Oncology Advance Access originally published online on September 1, 2005
Japanese Journal of Clinical Oncology 2005 35(9):551-558; doi:10.1093/jjco/hyi145
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© 2005 Foundation for Promotion of Cancer Research
Quality of Life after Radical Prostatectomy in Japanese Men: 2 year Longitudinal Study
1 Department of Urology, Tohoku University Graduate School of Medicine, Sendai, 2 Department of Urology, Miyagi Cancer Center, Natori, Miyagi, 3 Department of Urology, Sendai Shakaihoken Hospital, Sendai and 4 Department of Urology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan
For reprints and all correspondence: Shunichi Namiki, Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574, Japan. E-mail: namikin{at}uro.med.tohoku.ac.jp
Received June 6, 2005; accepted July 10, 2005
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Abstract |
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 TOP Abstract INTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONReferences |
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Objective: We performed a 2 year longitudinal survey of health-related quality of life (HRQOL) after radical retropubic prostatectomy (RP) in Japanese men with localized prostate cancer.
Patients and methods: We measured 112 patients who underwent RP with SF-36 and University of California, Los Angeles Prostate Cancer Index before and 3, 6, 12, 18 and 24 months after surgery.
Results: Patients who underwent RP showed problems in some domains of general HRQOL, but these problems diminished over time. Mental health significantly improved throughout the follow-up period. The urinary function substantially declined at 3 months and continued to recover gradually but never returned to the baseline. Urinary bother at 3 months showed a significant decrease, but at 6 months it returned to baseline. The data of sexual function and bother showed a substantially lower score after RP. Patients lost their sexual desire significantly throughout the post-operative period. After 12 months, the nerve sparing group had significantly better improvement in sexual function than the non-nerve sparing group and this improvement continued up to 2 years after operation.
Conclusion: Despite reports of problems with sexuality and urinary continence, general HRQOL was mostly unaffected by RP after 6 months. RP had a favorable impact on mental health. Although urinary function did not completely return to the baseline level even at 2 years after RP, recovery from urinary bother was rapid. RP had serious consequences on libido, erectile function and sexual activity. In the second year, the sexual function of those who underwent RP with bilateral nerve sparing procedure continued to improve.
Key Words: prostate cancer • radical retropubic prostatectomy • longitudinal study • quality of life
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INTRODUCTION |
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TOPAbstractINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONReferences |
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Prostate cancer has recently received considerable attention because its incidence and mortality rates in developed countries have significantly increased, which may reflect the widespread use of serum prostate-specific antigen (PSA) screening (1).
Some management options are available for patients with localized prostate cancer, including radical surgery, external-beam irradiation, brachytherapy and expectant management for selected patients. Especially radical retropubic prostatectomy (RP) is considered a safe and effective treatment for localized prostate cancer and has gained popularity among Japanese urologists over the last decade (2). As prostate cancer is increasingly diagnosed at early stages and, therefore, with more favorable survival outcomes, the basis on which patients select primary therapy has shifted toward considerations of health-related quality of life (HRQOL) (3,4). Therefore, HRQOL assessment has become an important form of outcomes-based research that may weigh heavily on the justification for health care expenditures and the treatment selection by patients.
Longitudinal HRQOL data collection facilitates the assessment of changes with time by comparing each patient to his own individual baseline. Previously, we detailed HRQOL recovery in 72 Japanese men with localized prostate cancer followed for 1 year after RP (5). We now report how HRQOL changed in Japanese men undergoing RP followed for the first 2 years.
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PATIENTS AND METHODS |
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PATIENT POPULATION AND DATA COLLECTION
Between June 2001 and December 2002, a total of 154 patients with newly diagnosed localized prostate cancer (T1-T3N0M0) were treated with radical prostatectomy at Tohoku University Hospital and two affiliated hospitals, and Kurashiki Central Hospital. The RP was performed using essentially the same technique as originally described by Walsh (6); all procedures were carried out by staff urologists in each institute. The indications for nerve sparing procedure depended on preoperative (the number and Gleason score of the positive biopsies, PSA level or preference of the patient) and intraoperative factors, prioritizing cancer control.
All patients were informed of their cancer diagnosis before being asked to fill out the HRQOL questionnaires. Every patient who agreed to participate in this study received from his urologist a questionnaire, an informed consent form, and a prepaid envelope for returning the questionnaire. The baseline interview was conducted after the diagnosis. Follow-up interviews were conducted in person at scheduled study visits of 3, 6, 12, 18 and 24 months after RP.
QOL METHODOLOGY AND STATISTICAL ANALYSIS
We measured the general and prostate-specific HRQOL using two types of instruments. The general HRQOL was assessed with the RAND 36-Item Health Survey (SF-36) (7,8). The general scales cover eight domains, four physical and four emotional. The prostate-specific HRQOL was assessed with University of California, Los Angeles Prostate Cancer Index (UCLA PCI), developed by Litwin and co-workers (9). The disease-specific items encompass urinary, bowel and sexual problems, and the extent of bother from problems in each area. Both questionnaires have already been translated into Japanese and the validity and reliability were previously tested (10,11).
For SF-36 and UCLA PCI quality of life scores for the various domains are shown as mean plus or minus standard deviation (SD) in scales of 0–100, with a higher score always representing better HRQOL. The analysis focused on comparing each HRQOL score of the post-operative groups with the baseline scores. Statistical analysis made P < 0.05 significance by using Mann–Whitney U-test or 
2-test.
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RESULTS |
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BACKGROUND CHARACTERISTICS OF THE STUDY GROUP
Among these patients who underwent RP, 31 patients who received neoadjuvant therapy were excluded because neoadjuvant therapy might affect the recovery of HRQOL (12). Only patients with preoperative HRQOL data and data from at least two later times (3, 6, 12, 18 or 24 months after surgery) were included in the analysis, resulting in a final study cohort of 112 patients.
Table 1 lists the distributions of patients with prostate cancer according to selected demographic and clinical characteristics. The mean patient age was 66.1 ± 5.8 years (median 67, range from 55 to 79). At the time of the survey, 95% of the men were married or lived with a partner and 48.6% were employed.
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The respondents showed a median preoperative PSA of 8.3 ng/ml (range from 3.3 to 54.0). Histopathologically, organ-confined disease was found in 86% (n = 96) of the surgical specimens. Most patients (83%) experienced co-morbidities, the most common of which were hypertension (33%), diabetes (20%), gastrointestinal (24%), cardiovascular (15%) disease and other kinds of carcinoma (7%), but these co-morbidities were well controlled. Among the 112 patients, 16 (14%) patients did not undergo nerve preservation, and 96 (86%) patients underwent either unilateral [75 (67%) patients] or bilateral [21 (19%) patients] nerve sparing surgery. Nineteen (17%) patients received salvage therapy during the study period. In detail, 12 men underwent radiotherapy, 5 patients received hormonal therapy and 2 patients received both radio and hormonal therapy.
SF-36 ASSESSMENT
The questionnaire submission rates among these patients were 87% (n = 97), 86% (n = 96), 94% (n = 105), 70% (n = 78) and 93% (n = 104) at 3, 6, 12, 18 and 24 months after baseline, respectively. The mean HRQOL scores are shown in Table 2 (general scales) and Table 3 (disease-specific scales). Among the eight SF-36 domains, role limitations due to physical problems and bodily pain significantly decreased at 3 months (P = 0.002 and P = 0.033, respectively), but at 6 months these domains recovered to the baseline. Mental health scored statistically higher throughout the post-operative period (P < 0.05). Other domains including physical function, vitality, social function and general health perception showed no significant difference between baseline and any of the observation periods. There were no significant differences in any of the general HRQOL domains between the patients who received post-operative salvage therapy and those who underwent RP alone (data not shown).
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UCLA PCI ASSESSMENT
According to UCLA PCI scores that represent disease-specific HRQOL, the urinary function that reflects leakage substantially declined at 3 months and continued to recover at 6, 12, 18 and 24 months but scored lower than the baseline (P < 0.001, respectively). Urinary bother had a significantly worse score at 3 months than that at baseline (P = 0.036). However, at 6 months after surgery it returned to the baseline. On the one hand, when continence was defined as ‘leaked urine not at all’, only 46% of the patients were continent at 24 months after RP (Fig. 1A). On the other hand, when continence was defined as ‘no pads’, overall 50.5, 84.4, 87.6, 88.5 and 90.5% of men were continent at the 3, 6, 12, 18 and 24 month follow-up points, respectively (Fig. 1B). No significant difference was observed in bowel function and bother between the baseline and any of the post-operative time groups. The mean urinary function score stratified by age is shown in Fig. 2. At baseline, there was no difference between younger patients (65 years old or younger, n = 49) and older patients (older than 65 years, n = 63). Both groups after RP reported significant lower score than baseline (P < 0.05 for all time points). Younger men tended to show more rapid recovery than older men within 12 months after RP (75.1 versus 65.8, 89.5 versus 78.6 at 3 and 6 months, respectively, P < 0.05) (Fig. 2). However, after 18 months there were no significant differences among the post-operative groups.
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The data of sexual function showed a substantially lower score just after RP and remained at a deteriorated level (Table 3). Similarly, sexual bother scored significantly lower at each post-operative time point in a parallel way. Even if the analysis was limited to those who underwent RP alone, sexual function and bother were significantly worse than baseline (both P < 0.001 for all times versus baseline). As shown in Fig. 3A, the proportion of patients with ‘poor’ or ‘very poor’ sexual desire significantly increased throughout the post-operative period (P < 0.001, respectively,
2-test). Thirty-eight percent of patients stated at baseline that they had sexual intercourse once or more often during the last 4 weeks. However, this reduced to only 15% at 24 months after RP (Fig. 3B). In addition, 25 and 65% of the patients considered their ability to have erection as ‘poor’ and ‘very poor’, respectively, at 24 months (Fig. 3C). Among the 23 patients who had intercourse preoperatively and underwent nerve preservation, however, 69% (n = 16) remained sexually active 2 years after RP. Figure 4 shows sexual function scores stratified by the bilateral nerve sparing (n = 16), unilateral nerve sparing (n = 64) and non-nerve sparing (n = 13) group, who underwent RP alone. Before RP, the non-nerve sparing group scored lower than the bilateral and unilateral nerve sparing group. All groups had low scores of sexual function in the 2 years after RP compare to baseline (P < 0.05). Sexual function was equivalent in the nerve sparing and the non-nerve sparing group at 3 and 6 months. However, after 12 months the nerve sparing groups had significantly better improvement than the non-nerve sparing group (both P < 0.05 for all time points). The bilateral and unilateral nerve sparing groups showed similar recovery profiles of sexual function in the first year, but the former group continued to improve even in the second year (25.4 versus 14.9 at 24 months, P < 0.05).
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Among the 80 patients who underwent RP with nerve sparing procedure, the younger men (n = 43) had significantly better sexual function score than the older men (n = 37) at baseline (P < 0.001). Post-operative sexual domains were worse than baseline (P < 0.01) (Fig. 5A and B). Although both groups continued to show improvement in post-operative sexual function over the 2 years, the younger men had significantly improved sexual function compared to the older men (21.2 versus 9.1, 24.4 versus 11.1 and 29.2 versus 14.0 at 12, 18 and 24 months, respectively, P < 0.05). In contrast to sexual function, the scores of sexual bother of the older men were considerably better than those of the younger men after RP (44.0 versus 51.7, 41.1 versus 58.9 and 46.8 versus 60.0 at 3, 12 and 24 months, respectively, P < 0.05).
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DISCUSSION |
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TOPAbstractINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONReferences |
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Longitudinal studies of HRQOL allow clinicians and patients to determine the impact of treatment on HRQOL over time, and to make reasonable comparisons of various treatments (13). Our study using the SF-36 and UCLA PCI, which are instruments used worldwide, could provide various kinds of useful information for patient-centered outcome evaluations. The tendencies we observed indicated that, in several domains of SF-36, patients undergoing RP had significant declines in physical domains such as role limitations due to physical problems and bodily pain, but had significant improvements in these scores during 6 months, with values returning almost to the pretreatment levels. Furthermore, mental health, classified as the mental domain of SF-36, revealed that some post-operative groups had higher scores than the preoperative group. Previous studies found that, following surgery, with the relief accompanying the perceived cure, the tension level was reduced and that a reduction in tension was correlated with a reduction in feelings of confusion, depression and anger (14,15).
Urinary incontinence is a concern particularly relevant to men undergoing RP because surgery often negatively affects on continence than do other treatment modalities, and because patients rate urinary status as one of their greatest concerns regarding HRQOL. Hoffman and co-workers (16) showed that 75% of those who developed daily urinary incontinence still reported that the poor function was at most only a small problem. In the 3 year longitudinal study by Litwin et al. (17), 61% of men treated with RP had reportedly recovered pretreatment urinary function at 1 year post-treatment. According to our survey based on UCLA PCI, it appears to be difficult for patients treated with RP to return completely to the baseline urinary function. This is supported by the fact that only 46% of the patients claimed ‘no leakage at all’ even at 2 years after RP. However, about 90% wore no pads after 6 months or later. Consequently, the recovery from urinary bother was observed early at 6 months and in the remaining post-operative periods, showing that post-operative incontinence was, if any, minimal in most patients and their problems were not so severe. Another explanation for the observed discrepancy between the functional and bother status may be the overriding conviction that the disease has been cured. Urinary function score returned gradually during the first 12 months after surgery. There was no difference in urinary function between 12 and 24 months after treatment. Our findings confirm the longitudinal trends in urinary function observed by Walsh et al. (18). Recently, Cooperberg et al. (19) stated that there was a significant difference in urinary HRQOL between patients using no pad and those using one pad. Furthermore, we previously revealed that ‘not urine leakage at all’ was a stricter definition and that continence defined as ‘not using pads’ allowed various degrees of incontinence status (20). To date, there is no consensus regarding the optimal definition of continence. Thus, we believe that multiple outcomes should be measured and discussed while counseling patients.
Although most post-operative patients reported good general HRQOL, significant deteriorations of sexual function and sexual bother were observed and most patients reported diminished sexual desire (libido) throughout the post-operation period. Especially, only 15% of our patients stated they had intercourse during the last 4 weeks at 2 years after RP. Koeman et al. (21) stated that RP had serious consequences both on libido and erectile function but sometimes other important factors, such as the absence of prostate and seminal vesicle contractions, the loss of ejaculation and involuntary loss of urine might also compromise the orgasm. However, it has been reported that RP increased the serum testosterone levels, suggesting that the sexual dysfunction associated with RP could not be explained by androgen deficiency (22). Elderly Japanese men, unlike their American counterparts, do not report dissatisfaction with their sexual life, even when reporting erectile dysfunction and decreased libido (23). The ages in the present study groups were higher than those reported in the American literature, suggesting a possible influence of age on sexual domains. In addition, male erectile rigidity contributed to the frequency of sexual intercourse, but not to a satisfactory sexual life for the partner (24). In recent years, an anatomical approach to preserving neurovascular bundles that control continence and erection has been used in certain men. We found that there were much higher levels of potency and continence after nerve sparing RP, similar to other studies (25–27). Actually, 69% of the patients who underwent nerve preservation reported to be sexually active 2 years after RP when the group was limited to those who had sexual intercourse before RP. However, in our study, the younger patients were more likely to have had nerve sparing operation, which might have affected the recovery.
Although the small number of patients might limit the reliability of our results, those who underwent surgery with nerve sparing procedure reported a promising rate of potency during the first year after treatment. Moreover, in the second year they continued to improve, which was similar to other groups (28). Based on these results, we recommend that such comparative studies should have at least 24 months of follow-up.
The sexual function score of the younger patients was better than that of older men 2 years after surgery. However, it would appear that erectile dysfunction was more of a burden to the younger patients. Younger men who underwent RP with nerve sparing procedure were potentially more interested or motivated to maintain or resume sexual function post-operatively. Therefore, they reported lower sexual bother scores because of post-operative sexual dysfunction.
We acknowledge several limitations in this prospective observational study. Firstly, our study had relatively few patients, consistent with its design as a feasibility study of longitudinal collection. Secondly, the treatment was not in a randomized fashion but selected by the patient and his urologist. Finally, trends in HRQOL might differ for these individuals. A selection bias may have occurred with regard to patients who agreed to participate in this study.
Despite these limitations, our findings must be confirmed or refuted by the longitudinal data of others. A richer understanding of the changes in HRQOL after RP will enable physicians to provide clinically relevant information that allows patients who elect surgery to be comfortable with their choices. Cross-cultural comparative studies of the changes in HRQOL over time, using common instruments, will certainly contribute to the global advancement of outcomes assessment following treatment for localized prostate cancer.
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Acknowledgments |
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This study was supported in part by a grant from the Ministry of Health and Welfare of Japan.
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References |
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