Impact of radical perineal prostatectomy on urinary continence and quality of life: A longitudinal study of Japanese patients

Blackwell Science, LtdOxford, UKIJUInternational Journal of Urology919-81725 Blackwell Publishing Asia Pty LtdNovember 51211953958Original ArticleQuality of life after radical perineal prostatectomya Matsubara et al. International Journal of Urology (5) 12, 953 958 Original Article Impact of radical perineal prostatectomy on urinary continence and quality of life: A longitudinal study of Japanese patients AKIO MATSUBARA, HIROAKI YASUMOTO, KAZUAKI MUTAGUCHI, KOJI MITA, JUN TEISHIMA, MITSUHIRO SEKI, MITSURU KAJIWARA, MASAO KATO, MASANOBU SHIGETA AND TSUGURU USUI Department of Urology, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan Aim: We used self-completed questionnaires to obtain a longitudinal assessment of urinary continence and urinary, bowel, and sexual domain-related quality of life (QOL) in Japanese patients undergoing radical perineal prostatectomy (RPP). Methods: A total of 41 Japanese patients with a median age of 69 years who underwent RPP between February 2 and February 4 were included in the study. We measured QOL by the University of California, Los Angeles, Prostate Cancer Index (UCLA- PCI) and assessed urinary continence on the basis of three different definitions of continence. The International Prostate Symptom Score (I-PSS) was also included to evaluate lower urinary tract symptoms (LUTS). Results: When urinary continence was defined as none, one, or two protective pads per day, 1%, 73%, 94%, 97%, or 1% of the patients were continent before, and 1, 3, 6, and 12 months after, RPP, respectively. When it was defined as total control or occasional dribbling, the corresponding values were 97%, 7%, 84%, 94%, and 97%. Urinary function returned to the preoperative baseline level by 6 months postoperatively and scores for urinary bother had significantly surpassed the baseline by 12 months (P =.43). The I-PSS was significantly improved (P =.14), with a mean 4.7-unit decrease. Sexual function worsened significantly after surgery, and its recovery was less favorable. No significant change was observed in scores for bowel function or bowel bother. Conclusions: The majority of patients who undergo RPP rapidly regain urinary continence and QOL within 3 6 months. RPP has a favorable impact on LUTS. Key words incontinence, prostate cancer, quality of life, radical perineal prostatectomy. Introduction Radical perineal prostatectomy (RPP) is a minimally invasive surgical technique for treating localized prostate cancer. By this procedure, the prostate gland, which lies only 5 or 6 cm beneath the perineal skin, can be removed through only a small perineal incision. 1 3 Indeed, the fact that RPP is minimally invasive is reflected in the shorter operating time compared with that of traditional, more invasive procedures, together with less blood loss, and faster postoperative return of appetite and resumption of normal activity. These advantages, in turn, result in a shorter hospital stay. 1 4 However, because the literature on patient-reported outcomes after RPP is limited, it is not clear how RPP affects the health-related quality of life (HRQOL) of patients, and especially how RPP affects urinary continence, one of patients greatest concerns. 5 In addition, to date there has Correspondence: Akio Matsubara MD PhD, Department of Urology, Graduate School of Biomedical Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan. Email: matsua@hiroshima-u.ac.jp Received 4 November 4; accepted May 5. been no report of sequential assessment of HRQOL in Japanese patients following RPP, despite the fact that prospective longitudinal studies using patient pretreatment scores as controls are the most desirable because baseline QOL is already impaired in most prostate cancer patients owing to their advanced age. It remains to be established how many, and how quickly, Japanese patients return to their preoperative state. We therefore performed a longitudinal evaluation of the influence of RPP on HRQOL, with special reference to urinary continence and lower urinary tract symptoms (LUTS) in Japanese patients with localized prostate cancer. Methods Patients Between February 2 and February 4, four attending surgeons (A.M., H.Y., K.M., and M.S.) treated 47 consecutive patients by RPP without neoadjuvant hormonal therapy for clinically organ-confined prostate cancer at Hiroshima University Hospital. The patients were asked to complete the following HRQOL questionnaires before, and 1, 3, 6, and 12 months after the surgery, and to mail them to the Department of Urology, Graduate School of

954 A Matsubara et al. Biomedical Sciences, Hiroshima University. Although all of the 47 eligible patients agreed to participate and signed an informed consent form, 6 (13%) of them were excluded from the analysis because their preoperative baseline scores were unavailable due to a clerical mistake. Therefore, our present analysis was based on the remaining 41 patients who provided longitudinal follow up with HRQOL surveys. Of the 41 RPP procedures, 27 were performed by an experienced surgeon (A.M.) according to the techniques described by Weldon, 2 and the remaining 14 by other 3 less experienced surgeons (H.Y., K.M., and M.S.) under the supervision of A.M. The patients were followed without additional therapy for up to 6 months after RPP. At 12 months following surgery, however, five patients had undergone salvage radioand/or hormonal therapy, and therefore were excluded from the assessment at 12 months after RPP. Anticholinergic drugs were not administered in principle within 3 months after RPP, but thereafter they were used by a doctor in attendance at his discretion according to the symptoms. Survey instruments Quality of life was assessed with a validated instrument, the University of California, Los Angeles, prostate cancer index (UCLA-PCI 6 ). This is a self-administered -item questionnaire that quantifies prostate cancer-specific HRQOL in six separate domains: urinary function and the distress caused by urinary dysfunction (termed urinary bother in the UCLA-PCI), bowel function and bowel bother, and sexual function and sexual bother. Each scale is scored separately from to 1, with a higher score representing a better outcome. The UCLA-PCI has been used in numerous prostate cancer HRQOL studies, and its reliability and validity have already been demonstrated in Japanese patients with prostate cancer, by Kakehi et al. in 2. 7 Further, the International Prostate Symptom Score (I- PSS) was included to assess urinary obstructive and irritative symptoms, because the UCLA-PCI urinary function domains assess only incontinence. The I-PSS is scored from to 35, with higher scores indicating a worse outcome. Statistical methods The Wilcoxon signed-rank test was used to compare HRQOL before and after surgery. The t test was used to compare HRQOL between patients aged less than 69 years and those aged 69 years or older. The level of statistical significance was set at P <.5. Results Clinical characteristics of the study patients are listed in Table 1. The median age of the patients was 69 years. Of the 41 patients in the study, 4 and 1 underwent unilateral and bilateral nerve-sparing surgery, respectively. The HRQOL scores are shown in Table 2, and the proportions of patients whose scores returned to preoperative baseline levels are shown Table 3. Patients scores were considered to have returned to the baseline when they had recovered to within 1 points of the presurgical scores, in accordance with the results of previous studies, 8 which reported that.3.5 SD represented a clinically meaningful change. Although scores for the urinary function domain were significantly disturbed by RPP, they improved with time, and average scores reached baseline levels by 6 months after surgery. Scores for urinary bother were also reduced by RPP. However, they recovered rapidly and had surpassed the baseline levels by 6 months Table 1 Patients clinical characteristics Median age (years) 69 (57 75) Median PSA at diagnosis (ng/ml) 7 (2 38) Number of patients American Society of Anesthesiology class 1 2 2 39 Clinical tumor classification T1c 29 T2 12 Surgery type Non-nerve sparing 36 Unilateral nerve sparing 4 Bilateral nerve sparing 1 PSA, prostate-specific antigen. Table 2 HRQOL scores before and after radical perineal prostatectomy Baseline (41 Patients) 1 month (33 Patients) Assessment point 3 months 6 months (36 Patients) 12 months HRQOL score (mean ± SD) Urinary function 87 ± 16 59 ± 29* 72 ± 27* 87 ± 89 ± 17 Urinary bother 84 ± 28 71 ± 33 79 ± 31 91 ± 16 97 ± 1* Bowel function 9 ± 9 85 ± 17 89 ± 13 94 ± 12 93 ± 11 Bowel bother 97 ± 9 9 ± 18 94 ± 13 94 ± 19 98 ± 1 Sexual function 36 ± 23 7 ± 17* 6 ± 11* 5 ± 1* 9 ± 17* Sexual bother 71 ± 25 58 ± 39 59 ± 39* 67 ± 33 67 ± 35 *P <.5 versus baseline. HRQOL, health-related quality of life.

Quality of life after radical perineal prostatectomy 955 Table 3 Proportion of patients whose HRQOL scores returned to preoperative baseline Assessment Point 1 month 3 months 6 months 12 months % Patients reaching baseline Urinary function 24 59 78 84 Urinary bother 61 75 83 91 Bowel function 79 84 94 9 Bowel bother 73 88 94 97 Sexual function 16 29 17 26 Sexual bother 59 55 69 77 Actual HRQOL Scores 1 8 6 1 8 6 A B * B 1 3 6 * 12 C D B 1 3 69 yrs. < 69 yrs. Time after Surgery (Months) * p<.5 69 yr vs. <69 yr Fig. 1 Comparison of the health-related quality of life scores for urinary function (a), urinary bother (b), bowel function (c), bowel bother (d), sexual function (e) and sexual bother (f) between patients aged less than 69 years ( ) and those aged 69 years or older ( ). There was not much difference in the scores for sexual function after radical perineal prostatectomy (RPP) between younger (<69 years) and older ( 69 years) patients. However, contrary to the scores for sexual bother in younger patients, for whom such deterioration paralleled the sexual function scores, those of older patients scarcely changed postoperatively. In the bowel-related domain, no significant difference was noted between younger and older patients throughout the study period. No significant differences were observed in the urinary domain between younger and older patients, except that scores for urinary bother at the preoperative baseline and 6 months after RPP were significantly higher in younger patients than in older ones. 6 12 E F B 1 * * * * 3 6 12 1 8 6 1 8 6 postoperatively. About 6%, 75%, and 85% of patients regained their preoperative baselines for urinary function by 3, 6 and 12 months, respectively, after RPP, and for bother by 1, 3, and 6 months. The proportion of patients who regained baseline levels of urinary bother was higher than that for urinary function at all postoperative measurement points. No significant change was observed in scores for either bowel function or bowel bother. The scores for sexual function were significantly reduced at all measurement points after surgery, and recovery of the scores was less favorable, reaching less than half of the baseline level by 12 months postoperatively. The decline in the scores for sexual bother, however, was minimal and regained the baseline levels only 6 months postoperatively. The HRQOL scores were compared between patients aged less than 69 years (younger group) and those aged 69 years or older (older group), and are shown in Figure 1. No significant differences in the urinary function domain were observed between the younger and older groups. Although the decline of the score for urinary bother was significant in younger patients (P =.16), they regained the preoperative baseline level by 6 months after surgery. Scores for urinary bother in the older group were significantly lower than those in the younger group at the baseline (P =.32), but they were restored rapidly and

956 A Matsubara et al. Table 4 Urinary continence after radical perineal prostatectomy Baseline (41 Patients) 1 month (33 Patients) Assessment point 3 months 6 months (36 Patients) 12 months Continence assessment criterion Continence rate (%) Pad use per day 1 43 65 83 87 1 or 2 3 29 14 13 3 or more 27 6 3 Urinary control Total control 75 28 53 72 69 Occasional dribbling 22 42 31 22 28 Frequent dribbling or no control 3 3 16 6 3 Incontinence problems No or very small 76 43 56 81 88 Small 5 21 9 8 3 Moderate or big 19 36 35 11 9 Each value represents proportion of patients who were continent based on the definitions as listed in leftmost column. had significantly surpassed the baseline level by 12 months postoperatively (P =.16). With respect to the bowel domain, there was no significant difference between the younger and older groups at any of the assessment points. Baseline scores for sexual function were significantly better in the younger group than in the older group (P =.6), but declined markedly after surgery in both groups, with no significant intergroup difference. While the scores for sexual bother in the younger group were significantly reduced by RPP (P =.16), those in the older group scarcely changed. Table 4 shows the chronological assessment of urinary continence. Responses to questions phrased according to two of the four items used in the UCLA-PCI urinary function domain (pad requirement and urinary control) and one of the two items in the urinary bother domain (incontinence problems) were as follows. When urinary continence was defined as either none, one or two protective pads per day, 1%, 73%, 94%, 97%, and 1% of the patients were continent before, and 1, 3, 6, and 12 months after, surgery, respectively. When it was defined as total control or occasional dribbling, the corresponding values were 97%, 7%, 84%, 94%, and 97%. When it was defined as no, or only small, problems, the values were 81%, 64%, 65%, 89%, and 91%. Table 5 shows the changes in I-PSS from before, and 6 months after, RPP. Mean I-PSS scores decreased significantly (P =.14) from 9.3 to 4.6 points (a 5% decrease), and this reduction was especially marked in patients with baseline I-PSS of 8 or greater (P =.17; from 18.8 to 7.4 points, a 6% decrease). Likewise, in patients with baseline I-PSS of less than 8, mean I-PSS scores decreased from 3.2 to 2.7 points (a 16% decrease), but the difference was not significant. Discussion Table 5 Changes in international prostate symptom score (I-PSS) before and after radical perineal prostatectomy Baseline I-PSS I-PSS score (mean ± SD) % Baseline 6 months after RPP decrease Less than 8 3.2 ± 2. 2.7 ± 1.8 16 8 or Greater 18.8 ± 6.3 7.4 ± 5.1* 6 Overall 9.3 ± 8.8 4.6 ± 4.1* 5 *P <.5 versus baseline. RPP, radical perineal prostatectomy. Because there is no consensus on the definition of urinary continence following radical prostatectomy, and continence rates differ significantly depending on definition, it is still considered reasonable and proper to evaluate patients by using a broad range of continence definitions. 5,9 11 In this context, Lepor 11 et al. found that three definitions of continence derived from responses to the UCLA-PCI requirement for no, or one, pad per day; no, or slight, problems due to incontinence; and total control or occasional dribbling had excellent agreement with patients global self-assessment of continence. Also, Kielb 1 et al. reported that the number of pads used daily corresponded well to the level of impairment. Therefore, our assessment was based on these three definitions. Our investigation, which involved elderly Japanese patients with localized prostate cancer, revealed that the overwhelming majority of patients regained their continence by 3 months, and thereafter continence continued to improve. The continence rates at different intervals after surgery, as described in Table 4, were much the same as those in Young s RPP series, 9 which researched urinary QOL following RPP using a validated self-reported questionnaire. However, Young s study involved younger American patients (mean age 6 years) and the preoperative continence rate (based on self-reported problems due to incontinence) was relatively low in our series (76% vs 93% in Young s report). The lower baseline value in our

Quality of life after radical perineal prostatectomy 957 series may be attributable to the greater age of our study patients. An analysis of urinary-domain-related HRQOL scores also revealed that although RPP resulted in a significant deterioration of urinary function, the average scores swiftly returned to preoperative baseline levels postoperatively, and the distress caused by urinary dysfunction tended to be relieved rather than exacerbated. This was again consistent with the results from other RPP series. 9 Therefore, we consider that recovery of urinary continence and QOL in our patients followed a typical course after RPP, even though the patients were relatively old. We found that I-PSS improved significantly after RPP, and that higher preoperative I-PSS scores tended to decline more dramatically than lower ones. This may have been because the study patients were relatively old, and so not a few of them may have had benign prostatic hyperplasia (BPH). Nevertheless, this observation indicates that RPP has another advantage in relieving LUTS, although it may cause incontinence. In our study, the proportion of patients who regained their preoperative scores for urinary bother was higher than that for urinary function at all measurement points after RPP (Table 3). Similar observations have been made in other RPP 9 or RRP 6 series, suggesting that this is a universal trend in patients undergoing prostatectomy, regardless of the surgical approach. Because the item for the urinary bother domain in UCLA-PCI comprehensively assesses not only incontinence but also overall distress, it would be expected that improvement of obstructive and irritative symptoms after RPP would favorably affect the scores for the urinary bother domain. Therefore, the difference in recovery between the urinary function and bother domains may be due to the relief of LUTS, in addition to recovery from the distress caused by incontinence. To evaluate the relative impacts of RPP and RRP (which is widely accepted as the standard approach for radical prostatectomy) on urinary QOL and continence, we compared the results of RPP series, 9,12 including ours, with those of RRP. 5,8,13 15 It appeared that recovery of urinary function and recovery from urinary bother in RPP patients were not only rapid, but also favorable in comparison with RRP patients. In addition, when recovery of continence was strictly defined as no pad wearing, total urinary control, or no incontinence problems, continence rates in the RPP series appeared to be more favorable than in the RRP series. From a national survey using a self-reported questionnaire, Bishoff et al. 16 also reported that RPP patients had lower rates of urinary incontinence immediately after RPP than immediately after RRP (79% vs 85%; P =.43), and that a higher proportion of RPP patients regained full continence (RPP 7%, RRP 53%; P =.1), although this was a cross-sectional comparative study. A large-scale prospective longitudinal test is needed to elucidate any such advantage of RPP over RRP. With respect to bowel QOL, no significant change was noted in either bowel function or bowel bother before and after RPP. Bishoff et al. 16 have reported higher fecal incontinence rates in RPP patients than in RRP patients. However, RPP surgeons have not reported this, although they have noted fecal soiling very occasionally. 17 Thus, the bowel QOL in RPP patients is currently being reevaluated. 17 Most recently, Dahm et al. 18 have reported that fecal incontinence and bowel-related symptoms are more prevalent following RPP compared to preoperative, baseline levels, but resolve within the early postoperative period in the majority of patients. Although the UCLA-PCI used in this study is not necessarily appropriate for evaluation of fecal incontinence, our results suggest that the RPP procedure does not impair the sense of well-being on defecation. With regard to sexual QOL, poor sexual outcomes were expected given the very small proportion of patients undergoing a nerve-sparing procedure. However, contrary to a significant reduction of sexual function for up to 12 months postoperatively, the decline in scores for sexual bother was minimal. One possible reason for this discrepancy is that since the study patients were elderly and most did not undergo a nerve-sparing procedure, they might have had no preoperative expectations regarding recovery of sexual function. As shown in Figure 1, while the scores for sexual bother in patients younger than 69 years were significantly reduced by RPP, those in patients aged 69 years or older scarcely changed postoperatively. Unfortunately, in this study, the effect of nerve preservation on sexual QOL could not be evaluated due to the very small number of patients who underwent the procedure. Future studies should address the benefit of nervesparing RPP on recovery of sexual QOL. Conclusions Our longitudinal assessment was conducted on a small number of patients treated at a single institution. However, it is the first study to have used a validated self-reported instrument to rigorously investigate the course of recovery of urinary continence and QOL in Japanese men in the year following RPP. This study provides important, detailed information about the degree to which RPP affects the urinary continence and urinary, bowel, and sexual domainrelated QOL of elderly Japanese patients and the speed with which they are likely to return to their preoperative states in the early postoperative period. Discussing these data with patients preoperatively may help to relieve their anxiety. In addition, these data may prove useful for surgeons by encouraging them to try RPP. References 1 Gibbons RP. Radical perineal prostatectomy. In: Walsh PC, Retik AB, Vaughan ED Jr et al. (eds). Campbell s Urology, 8th edn, chapter 91. Saunders, Philadelphia, 2; 3131 46. 2 Weldon VE. Radical perineal prostatectomy. In: Carroll PR, Grossfeld GD (eds). Prostate Cancer, American Cancer Society Atlas of Clinical Oncology, chapter 13. BC Decker, London, 2; 184 6. 3 Gillitzer R, Thuroff JW. Relative advantages and disadvantages of radical perineal prostatectomy versus radical retropubic prostatectomy. Crit. Rev. Oncol. Hematol. 2; 43: 167 9.

958 A Matsubara et al. 4 Ruiz-Deya G, Davis R, Srivastav SKM, Wise A, Thomas R. Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome. J. Urol. 1; 166: 581 6. 5 Lepor H, Kaci L. The impact of open radical retropubic prostatectomy on continence and lower urinary tract symptoms: a prospective assessment using validated selfadministered outcome instruments. J. Urol. 4; 171: 1216 19. 6 Litwin MS, Hays RD, Fink A, Ganz PA, Leake B, Brook RH. The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure. Med. Care. 1998; 36: 12 12. 7 Kakehi Y, Kamoto T, Ogawa O et al. Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study. Int. J. Clin. Oncol. 2; 7: 36 11. 8 Litwin MS, Melmed GY, Nakazon T. Life after radical prostatectomy: a longitudinal study. J. Urol. 1; 166: 587 92. 9 Young MD, Weizer AZ, Silverstein AD et al. Urinary continence and quality of life in the first year after radical perineal prostatectomy. J. Urol. 3; 17: 2374 8. 1 Kielb S, Dunn RL, Rashid MG et al. Assessment of early continence recovery after radical prostatectomy: patient reported symptoms and impairment. J. Urol. 1; 166: 958 61. 11 Lepor H, Kaci L, Xue X. Continence following radical retropubic prostatectomy using self-reporting instruments. J. Urol. 4; 171: 1212 15. 12 Harris MJ. Radical perineal prostatectomy: cost efficient, outcome effective, minimally invasive prostate cancer management. Eur. Urol. 3; 44: 33 38. 13 Lubeck DP, Litwin MS, Henning JM, Stoddard ML, Flanders SC, Carroll PR. Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE. Urology 1999; 53: 18 6. 14 Walsh PC, Marschke P, Ricker D, Burnett AL. Patientreported urinary continence and sexual function after anatomic radical prostatectomy. Urology ; 55: 58 61. 15 Namiki S, Tochigi T, Kuwahara M et al. Recovery of health related quality of life after radical prostatectomy in Japanese men: a longitudinal study. Int. J. Urol. 4; 11: 742 9. 16 Bishoff JT, Motley G, Optenberg SA et al. Incidence of fecal and urinary incontinence following radical perineal and retropubic prostatectomy in a national population. J. Urol. 1998; 16: 454 8. 17 Thrasher JB, Robinson JJ, Lance R. Comparison of radical perineal prostatectomy to radical retropubic prostatectomy for localized prostate cancer. AUA update series Lesson 2, Volume, pp. 1 7, 1. 18 Dahm P, Silverstein AD, Weizer AZ et al. A longitudinal assessment of bowel related symptoms and fecal incontinence following radical perineal prostatectomy. J. Urol. 3; 169: 22 4.