bs_bs_banner
International Journal of Urology (2014) 21, 1220–1226
doi: 10.1111/iju.12586
Original Article: Clinical Investigation
Long-term quality of life after radical prostatectomy: 8-Year longitudinal study in Japan Shunichi Namiki, Yasuhiro Kaiho, Koji Mitsuzuka, Hideo Saito, Shigeyuki Yamada, Haruo Nakagawa, Akihiro Ito and Yoichi Arai Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan
Abbreviations & Acronyms BNS = bilateral nerve sparing HRQOL = health-related quality of life IPSS = International Prostate Symptom Score MCS = Mental Composite Summary Score PCI = Prostate Cancer Index PCS = Physical Composite Summary Score PSA = prostate-specific antigen QOL = quality of life RCS = Role Composite Summary Score RP = open radical prostatectomy SF-36 = Short Form 36-Item Health Survey SNG = contralateral sural nerve graft interposition UCLA = University of California, Los Angeles UNS = unilateral nerve sparing Correspondence: Shunichi Namiki, M.D., Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574, Japan. Email: [email protected] Received 3 April 2014; accepted 1 July 2014. Online publication 20 August 2014
Objectives: To assess long-term health-related quality of life in patients undergoing radical prostatectomy. Methods: A total of 120 patients with at least 5 years of follow up after radical prostatectomy were included in the present study. Health-related quality of life outcomes were assessed using three questionnaires, the Short Form 36-Item Health Survey, the University of California, Los Angeles Prostate Cancer Index and the International Prostate Symptom Score. Results: A total of 91 patients (73%) responded at a median follow-up time of 102 months (range 85–123 months). Among general health-related quality of life domains, mental and role composite summary score remained stable throughout the follow-up period. At the final survey, no significant differences were observed in any of the domains compared with the age-matched average score of the Japanese population. Although the slight decrease in urinary function scores and International Prostate Symptom Score beyond 5 years postoperatively compared with 5 years, the differences were not significant. The sexual function summary score showed a substantially lower score just after radical prostatectomy and remained at a deteriorated level (P < 0.001). Responders at the final survey were more likely to report favorable general, urinary and sexual outcomes at 60 months compared with non-responders. Conclusions: When taking age-related changes into account, general health-related quality of life seems to remain stable in the long term after radical prostatectomy: patients with favorable health-related quality of life outcomes during the first 5 years after radical prostatectomy maintain favorable outcomes thereafter.
Key words: prostate cancer, quality of life, questionnaires, radical prostatectomy.
Introduction RP is the recommended standard treatment for patients with localized prostate cancer, and it can provide a life expectancy of more than 10 years for those who accept the risk of treatment-related complications.1 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 HRQOL.2,3 Previously, we carried out a prospective QOL outcome study and detailed the HRQOL recovery in Japanese men with localized prostate cancer followed for 2 years and 5 years after RP.4 An extended time period beyond the 5 years of follow up would establish the durability of general, urinary and sexual HRQOL outcomes, and validate long-term results compared with other intermediate-term studies (3–5 years).5–7 As median survival after treatment for prostate cancer is approximately 14 years, elucidating the long-term impact of RP on HRQOL is important for men electing surgical treatment of localized prostate cancer.8 We therefore revisited this cohort at a time when the participating prostate cancer survivors were at a median of 8.5 years after the primary treatment, to assess the long-term, patient-reported HRQOL changes and outcomes during a later phase in prostate cancer survivors.
Methods Patient population Between January 2002 and March 2005, a total of 140 patients with newly diagnosed localized prostate cancer were treated with RP at Tohoku University Hospital. A total of 15 patients who 1220
© 2014 The Japanese Urological Association
QOL after RP
2002.1-2005.3 140 men who underwent RP were assessed for eligibility in QOL study. 2 excluded from QOL study because of unwillingness to participate 138 participants in QOL study. 18 dropped out 1 death due to prostate cancer 6 death due to other causes 11 lost follow up 120 participants during 5-year follow up. The questionnaire was sent in March 2012.
91 responders (73%) Fig. 1
29 non-responders (27%)
Study flow chart of enrolment, follow up and analyses of 140 patients.
underwent neoadjuvant hormonal therapy were observed, but all of them responded to the HRQOL questionnaire before primary treatment. The indications for a nerve-sparing procedure depended on preoperative (digital rectal examination, magnetic resonance imaging finding, the number and Gleason score of the positive biopsies, PSA level or preference of the patient) and intraoperative factors, prioritizing cancer control. The technique for nerve grafting during RP and harvesting the sural nerve has been described previously to assist plastic surgeons.9 All recruitment and research protocols were approved by the ethics committee, Tohoku University School of Medicine.
Follow up The present study was the second follow up of the original 5-year longitudinal follow up carried out since 2002.4 The questionnaires were sent to 120 men in March 2012 who completed our 5-year outcome study (Fig. 1). Non-responders to mailed questionnaires were issued a reminder call and asked to respond, if so willing.
Instruments for evaluation of HRQOL outcomes We evaluated general HRQOL with the SF-36.10 The SF-36 consolidates eight individual domains into three components including PCS, MCS and RCS, which are standardized to the general population with a normative mean of 50.11 The prostate specific HRQOL was assessed with the UCLA-PCI12 and IPSS.13 PCI encompasses urinary, bowel and sexual problems, and the extent of bother from problems in each area. PCI QOL scores for the various domains are shown as mean plus or minus one standard deviation in scales of 0 to 100, with a higher score always representing better HRQOL. IPSS is scored from 0 to 35, and QOL was investigated by the IPSS QOL index, with a higher score indicating worse outcomes. The analysis focused on comparing each HRQOL score of the post-operative groups with the baseline scores. The χ2-test was used to compare HRQOL scores, and a P-value of less than 0.05 was considered statistically significant. © 2014 The Japanese Urological Association
Results Background characteristics of the study group Table 1 lists the selected clinical characteristics of the study sample at baseline. Patients were stratified into two groups on the basis of responders (n = 91) and non-responders (n = 29) at the final survey (beyond the 5-year follow up). The response rate was 73% (n = 91). The median follow-up time was 102 months (range 85–123 months). A total of 14 patients (12%) of the population died from prostate cancer (one patient) or other causes (13 patients). Of the 120 participants, 16 (13%) patients did not undergo nerve preservation, and 85 (71%) patients underwent either unilateral (54 [64%] patients) or bilateral (31 [36%] patients) nerve-sparing surgery. A total of 19 patients underwent unilateral nerve preservation with a sural nerve graft interposition. At the final survey, 82 (90%) responders were married or lived with a partner. No patients received any types of adjuvant therapy. A total of 27 (23%) patients received salvage therapy during the study period.
HRQOL assessment Figure 2 shows the longitudinal mean score for QOL over time after RP as measured by various instruments. PCS worsened noticeably at 3 months (P = 0.002), but at 6 months it recovered to the baseline. The PCS declined marginally, but significantly, beyond 5 years after RP (P = 0.049). MCS and RCS showed no significant difference between baseline and any of the observation periods. At the final survey, no significant differences were observed in any of the eight domain scores between the prostate cancer survivors in the present study and the age-matched average score of Japanese people (Fig. 2a,b).14 At baseline, 1.7% of the participants reported frequent urinary leakage. This percent peaked 3 months after RP with 11% (13/118) of the men reporting frequent leakage or no control. By 24 months, the proportion of men reporting this much leakage had decreased to 4.5% (5/110), although it increased to 8.0% (7/87) at the follow up of more than 5 years, though the change was not significant (P = 0.307). In contrast, when continence was defined as “no pads”, overall more than 85% of men were continent after 1 year postoperatively, and this remained stable beyond 5 years (Fig. 2g,h). Summary scores in the urinary function domain attained a nadir 3 months after RP, but steadily increased through 24 months, with little change at the follow up of more than 5 years. Mean urinary function score did not change significantly beyond 5 years thereafter (P = 0.210; Fig. 2c). The mean total IPSS score showed a statistically significant improvement at 6 months after RP (P < 0.05). There was a tendency for the mean IPSS beyond 5 years postoperatively to be higher than that at 60 months, but the difference was not a statistically significant decrease (7.0 vs 8.3, P = 0.174; Fig. 2f). No significant differences were observed with regard to bowel function or bother between the baseline and any of the postoperative time groups (Fig. 2d). With regard to sexual domains, the majority of patients reported low sexual desire (60%), poor erections (48%) and less frequent erections (45%) at baseline. A total of 62 patients (52%) did not have sexual intercourse/sexual contact before 1221
S NAMIKI ET AL.
Table 1
Demographic and clinical characteristics of study population at baseline
No. patients Age (years) Mean (SD) PSA at diagnosis (ng/mL) Mean (SD) Pretreatment tumor stage T1 T2 T3 Pathological tumor stage T2 T3 Gleason score 7 or less More than 7 Nerve-sparing procedure Bilateral Unilateral None Unilateral nerve graft Comorbidity count† 0 1 2 3 or more Body mass index (kg/m2) Mean (SD) Smoking status Yes No Unknown Alcohol use Yes No Unknown Marital or relationship status Married or living with spouse or partner Unmarried or not in relationship
All
Responders at final survey
Non-responders at final survey
120
91
29
64.3 (5.6)
63.9 (6.8)
65.2 (5.6)
9.8 (7.9)
10.2 (8.9)
8.7 (3.7)
P-value (responders vs non-responders
0.210
0.324 0.319 77 34 9
59 27 5
18 7 4
91 29
69 22
22 7
89 31
70 21
19 10
31 54 16 19
24 41 11 14
7 13 5 5
32 44 28 16
29 32 22 8
3 12 6 8
24.2 (2.6)
24.2 (2.5)
24.2 (3.2)
47 69 4
26 62 3
21 7 1
77 39 4
57 31 3
20 8 1
110 10
82 9
28 1
0.711
0.221
0.925
0.018
0.961 0.642
0.516
0.274
†Comorbidity checklist includes hypertension, stomach, intestinal, and gastrointestinal diseases, heart disease, cancer (other than prostate), lung disease, diabetes, stroke and blood disease.
surgery. Beyond 5 years after RP, 85% of the patients considered their ability to have an erection as “poor” or “very poor”. Furthermore, just 18% of the patients reported having sexual intercourse beyond 5 years after RP (Fig. 2i,j). The sexual function summary score showed a substantially lower score just after RP, and it remained at a deteriorated level (P < 0.001). Similar to the sexual function score, the sexual bother scored significantly lower at each postoperative time-point in a parallel manner. Although postoperative sexual function and bother scores were lower than baseline at all postoperative time-points, they remained stable between 5 years and more than 5 years (Fig. 2e). Sexual function outcomes were stratified by the nerve-sparing status. BNS and contralateral SNG made a significant contribution to the recovery of sexual function compared with the UNS (P = 0.042 and P = 0.037, respectively). Even beyond 5 years after RP, the BNS and SNG groups were 1222
more likely to report better sexual function scores than the UNS group (20 and 32 vs 9, P = 0.047 and 0.009, respectively). The mean sexual function scores of the UNS group were low compared with those of the BNS group at each time-point. With regard to sexual bother domain, the SNG group reported lower sexual bother scores than the other two groups within the first year postoperatively. After 60 months, however, the SNG group reported better sexual bother scores than the UNS group (Fig. 3a,b).
Missing case analysis We carried out analyses between responders and nonresponders at the final survey. Most clinical factors were comparable between the responders and non-responders. The comorbidity count at baseline differed significantly between the responders and non-responders (Table 1). With regard to the © 2014 The Japanese Urological Association
QOL after RP
(b) 60
40
40
20
20
0 PF RPH BP GH VT SOF RE MH
75
QOL mean score
75
QOL mean score
(e) 100
50 25 0
25 0
20 40 60 80 100 Time after RP (months)
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
Ba
0
20 40 60 80 100 120 Time after RP (months)
8 6 4 2 0
(i) 100% 80% 60% 40% 20% 0%
3
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
Ba
20 40 60 80 100 120 Time after RP (months)
10
(h) 100% 80% 60% 40% 20% 0%
3
0
(f)
50
0
20 40 60 80 100 120 Time after RP (months)
(g) 100% 80% 60% 40% 20% 0%
25
0
(d) 100
0
50
QOL mean score
20 40 60 80 100 120 Time after RP (months)
75
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
0
Ba
0
(c) 100
QOL mean score
60
3
QOL mean score
(a)
Ba
3
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
(j) 100% 80% 60% 40% 20% 0%
Fig. 2 (a,c–f) Longitudinal mean score for QOL over time after RP as measured by various instruments. (a) SF-36. (c–e) UCLA-PCI. (f) IPSS and QOL. (b) Comparison of mean SF-36 as to eight scales between those who underwent RP beyond 5 years (n = 91) and aged-matched control (n = 136). (g–j) Longitudinal changes in urinary or sexual , PCS; , MCS; domains over time after RP. (g) How often leaked urine. (h) Quantity of daily pad use. (i) Ability to have an erection. (j) Frequency of intercourse. (a) , urinary bother; (d) , bowel bother; (e) , RCS; (b) , our cohort; , age-matched control; (c) , urinary function; , bowel function; , sexual function; , sexual bowel; (f) , IPSS; , QOL; (g) , total control; , occasional; , frequent; (h) , no pad; , one to two pads; , three or more; (i) , good; , fair; , poor; (j) , two or more; , one; , none. BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RPH, role limitations because of physical health problems; RE, role limitations because of emotional health problems; SOF, social function; VT, vitality.
responder group, at the final survey, the proportion of the number of comorbid conditions was more likely to increase compared with baseline (P = 0.018). Comparing the 5-year profile of the general HRQOL scores of the responders with those of the non-responders, the responders were more likely to report better HRQOL scores with regard to physical function, role limitations as a result of emotional problems, mental health and general health (P = 0.026, 0.008, 0.015 and
International Journal of Urology (2014) 21, 1220–1226
doi: 10.1111/iju.12586
Original Article: Clinical Investigation
Long-term quality of life after radical prostatectomy: 8-Year longitudinal study in Japan Shunichi Namiki, Yasuhiro Kaiho, Koji Mitsuzuka, Hideo Saito, Shigeyuki Yamada, Haruo Nakagawa, Akihiro Ito and Yoichi Arai Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan
Abbreviations & Acronyms BNS = bilateral nerve sparing HRQOL = health-related quality of life IPSS = International Prostate Symptom Score MCS = Mental Composite Summary Score PCI = Prostate Cancer Index PCS = Physical Composite Summary Score PSA = prostate-specific antigen QOL = quality of life RCS = Role Composite Summary Score RP = open radical prostatectomy SF-36 = Short Form 36-Item Health Survey SNG = contralateral sural nerve graft interposition UCLA = University of California, Los Angeles UNS = unilateral nerve sparing Correspondence: Shunichi Namiki, M.D., Department of Urology, Tohoku University Graduate School of Medicine, 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574, Japan. Email: [email protected] Received 3 April 2014; accepted 1 July 2014. Online publication 20 August 2014
Objectives: To assess long-term health-related quality of life in patients undergoing radical prostatectomy. Methods: A total of 120 patients with at least 5 years of follow up after radical prostatectomy were included in the present study. Health-related quality of life outcomes were assessed using three questionnaires, the Short Form 36-Item Health Survey, the University of California, Los Angeles Prostate Cancer Index and the International Prostate Symptom Score. Results: A total of 91 patients (73%) responded at a median follow-up time of 102 months (range 85–123 months). Among general health-related quality of life domains, mental and role composite summary score remained stable throughout the follow-up period. At the final survey, no significant differences were observed in any of the domains compared with the age-matched average score of the Japanese population. Although the slight decrease in urinary function scores and International Prostate Symptom Score beyond 5 years postoperatively compared with 5 years, the differences were not significant. The sexual function summary score showed a substantially lower score just after radical prostatectomy and remained at a deteriorated level (P < 0.001). Responders at the final survey were more likely to report favorable general, urinary and sexual outcomes at 60 months compared with non-responders. Conclusions: When taking age-related changes into account, general health-related quality of life seems to remain stable in the long term after radical prostatectomy: patients with favorable health-related quality of life outcomes during the first 5 years after radical prostatectomy maintain favorable outcomes thereafter.
Key words: prostate cancer, quality of life, questionnaires, radical prostatectomy.
Introduction RP is the recommended standard treatment for patients with localized prostate cancer, and it can provide a life expectancy of more than 10 years for those who accept the risk of treatment-related complications.1 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 HRQOL.2,3 Previously, we carried out a prospective QOL outcome study and detailed the HRQOL recovery in Japanese men with localized prostate cancer followed for 2 years and 5 years after RP.4 An extended time period beyond the 5 years of follow up would establish the durability of general, urinary and sexual HRQOL outcomes, and validate long-term results compared with other intermediate-term studies (3–5 years).5–7 As median survival after treatment for prostate cancer is approximately 14 years, elucidating the long-term impact of RP on HRQOL is important for men electing surgical treatment of localized prostate cancer.8 We therefore revisited this cohort at a time when the participating prostate cancer survivors were at a median of 8.5 years after the primary treatment, to assess the long-term, patient-reported HRQOL changes and outcomes during a later phase in prostate cancer survivors.
Methods Patient population Between January 2002 and March 2005, a total of 140 patients with newly diagnosed localized prostate cancer were treated with RP at Tohoku University Hospital. A total of 15 patients who 1220
© 2014 The Japanese Urological Association
QOL after RP
2002.1-2005.3 140 men who underwent RP were assessed for eligibility in QOL study. 2 excluded from QOL study because of unwillingness to participate 138 participants in QOL study. 18 dropped out 1 death due to prostate cancer 6 death due to other causes 11 lost follow up 120 participants during 5-year follow up. The questionnaire was sent in March 2012.
91 responders (73%) Fig. 1
29 non-responders (27%)
Study flow chart of enrolment, follow up and analyses of 140 patients.
underwent neoadjuvant hormonal therapy were observed, but all of them responded to the HRQOL questionnaire before primary treatment. The indications for a nerve-sparing procedure depended on preoperative (digital rectal examination, magnetic resonance imaging finding, the number and Gleason score of the positive biopsies, PSA level or preference of the patient) and intraoperative factors, prioritizing cancer control. The technique for nerve grafting during RP and harvesting the sural nerve has been described previously to assist plastic surgeons.9 All recruitment and research protocols were approved by the ethics committee, Tohoku University School of Medicine.
Follow up The present study was the second follow up of the original 5-year longitudinal follow up carried out since 2002.4 The questionnaires were sent to 120 men in March 2012 who completed our 5-year outcome study (Fig. 1). Non-responders to mailed questionnaires were issued a reminder call and asked to respond, if so willing.
Instruments for evaluation of HRQOL outcomes We evaluated general HRQOL with the SF-36.10 The SF-36 consolidates eight individual domains into three components including PCS, MCS and RCS, which are standardized to the general population with a normative mean of 50.11 The prostate specific HRQOL was assessed with the UCLA-PCI12 and IPSS.13 PCI encompasses urinary, bowel and sexual problems, and the extent of bother from problems in each area. PCI QOL scores for the various domains are shown as mean plus or minus one standard deviation in scales of 0 to 100, with a higher score always representing better HRQOL. IPSS is scored from 0 to 35, and QOL was investigated by the IPSS QOL index, with a higher score indicating worse outcomes. The analysis focused on comparing each HRQOL score of the post-operative groups with the baseline scores. The χ2-test was used to compare HRQOL scores, and a P-value of less than 0.05 was considered statistically significant. © 2014 The Japanese Urological Association
Results Background characteristics of the study group Table 1 lists the selected clinical characteristics of the study sample at baseline. Patients were stratified into two groups on the basis of responders (n = 91) and non-responders (n = 29) at the final survey (beyond the 5-year follow up). The response rate was 73% (n = 91). The median follow-up time was 102 months (range 85–123 months). A total of 14 patients (12%) of the population died from prostate cancer (one patient) or other causes (13 patients). Of the 120 participants, 16 (13%) patients did not undergo nerve preservation, and 85 (71%) patients underwent either unilateral (54 [64%] patients) or bilateral (31 [36%] patients) nerve-sparing surgery. A total of 19 patients underwent unilateral nerve preservation with a sural nerve graft interposition. At the final survey, 82 (90%) responders were married or lived with a partner. No patients received any types of adjuvant therapy. A total of 27 (23%) patients received salvage therapy during the study period.
HRQOL assessment Figure 2 shows the longitudinal mean score for QOL over time after RP as measured by various instruments. PCS worsened noticeably at 3 months (P = 0.002), but at 6 months it recovered to the baseline. The PCS declined marginally, but significantly, beyond 5 years after RP (P = 0.049). MCS and RCS showed no significant difference between baseline and any of the observation periods. At the final survey, no significant differences were observed in any of the eight domain scores between the prostate cancer survivors in the present study and the age-matched average score of Japanese people (Fig. 2a,b).14 At baseline, 1.7% of the participants reported frequent urinary leakage. This percent peaked 3 months after RP with 11% (13/118) of the men reporting frequent leakage or no control. By 24 months, the proportion of men reporting this much leakage had decreased to 4.5% (5/110), although it increased to 8.0% (7/87) at the follow up of more than 5 years, though the change was not significant (P = 0.307). In contrast, when continence was defined as “no pads”, overall more than 85% of men were continent after 1 year postoperatively, and this remained stable beyond 5 years (Fig. 2g,h). Summary scores in the urinary function domain attained a nadir 3 months after RP, but steadily increased through 24 months, with little change at the follow up of more than 5 years. Mean urinary function score did not change significantly beyond 5 years thereafter (P = 0.210; Fig. 2c). The mean total IPSS score showed a statistically significant improvement at 6 months after RP (P < 0.05). There was a tendency for the mean IPSS beyond 5 years postoperatively to be higher than that at 60 months, but the difference was not a statistically significant decrease (7.0 vs 8.3, P = 0.174; Fig. 2f). No significant differences were observed with regard to bowel function or bother between the baseline and any of the postoperative time groups (Fig. 2d). With regard to sexual domains, the majority of patients reported low sexual desire (60%), poor erections (48%) and less frequent erections (45%) at baseline. A total of 62 patients (52%) did not have sexual intercourse/sexual contact before 1221
S NAMIKI ET AL.
Table 1
Demographic and clinical characteristics of study population at baseline
No. patients Age (years) Mean (SD) PSA at diagnosis (ng/mL) Mean (SD) Pretreatment tumor stage T1 T2 T3 Pathological tumor stage T2 T3 Gleason score 7 or less More than 7 Nerve-sparing procedure Bilateral Unilateral None Unilateral nerve graft Comorbidity count† 0 1 2 3 or more Body mass index (kg/m2) Mean (SD) Smoking status Yes No Unknown Alcohol use Yes No Unknown Marital or relationship status Married or living with spouse or partner Unmarried or not in relationship
All
Responders at final survey
Non-responders at final survey
120
91
29
64.3 (5.6)
63.9 (6.8)
65.2 (5.6)
9.8 (7.9)
10.2 (8.9)
8.7 (3.7)
P-value (responders vs non-responders
0.210
0.324 0.319 77 34 9
59 27 5
18 7 4
91 29
69 22
22 7
89 31
70 21
19 10
31 54 16 19
24 41 11 14
7 13 5 5
32 44 28 16
29 32 22 8
3 12 6 8
24.2 (2.6)
24.2 (2.5)
24.2 (3.2)
47 69 4
26 62 3
21 7 1
77 39 4
57 31 3
20 8 1
110 10
82 9
28 1
0.711
0.221
0.925
0.018
0.961 0.642
0.516
0.274
†Comorbidity checklist includes hypertension, stomach, intestinal, and gastrointestinal diseases, heart disease, cancer (other than prostate), lung disease, diabetes, stroke and blood disease.
surgery. Beyond 5 years after RP, 85% of the patients considered their ability to have an erection as “poor” or “very poor”. Furthermore, just 18% of the patients reported having sexual intercourse beyond 5 years after RP (Fig. 2i,j). The sexual function summary score showed a substantially lower score just after RP, and it remained at a deteriorated level (P < 0.001). Similar to the sexual function score, the sexual bother scored significantly lower at each postoperative time-point in a parallel manner. Although postoperative sexual function and bother scores were lower than baseline at all postoperative time-points, they remained stable between 5 years and more than 5 years (Fig. 2e). Sexual function outcomes were stratified by the nerve-sparing status. BNS and contralateral SNG made a significant contribution to the recovery of sexual function compared with the UNS (P = 0.042 and P = 0.037, respectively). Even beyond 5 years after RP, the BNS and SNG groups were 1222
more likely to report better sexual function scores than the UNS group (20 and 32 vs 9, P = 0.047 and 0.009, respectively). The mean sexual function scores of the UNS group were low compared with those of the BNS group at each time-point. With regard to sexual bother domain, the SNG group reported lower sexual bother scores than the other two groups within the first year postoperatively. After 60 months, however, the SNG group reported better sexual bother scores than the UNS group (Fig. 3a,b).
Missing case analysis We carried out analyses between responders and nonresponders at the final survey. Most clinical factors were comparable between the responders and non-responders. The comorbidity count at baseline differed significantly between the responders and non-responders (Table 1). With regard to the © 2014 The Japanese Urological Association
QOL after RP
(b) 60
40
40
20
20
0 PF RPH BP GH VT SOF RE MH
75
QOL mean score
75
QOL mean score
(e) 100
50 25 0
25 0
20 40 60 80 100 Time after RP (months)
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
Ba
0
20 40 60 80 100 120 Time after RP (months)
8 6 4 2 0
(i) 100% 80% 60% 40% 20% 0%
3
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
Ba
20 40 60 80 100 120 Time after RP (months)
10
(h) 100% 80% 60% 40% 20% 0%
3
0
(f)
50
0
20 40 60 80 100 120 Time after RP (months)
(g) 100% 80% 60% 40% 20% 0%
25
0
(d) 100
0
50
QOL mean score
20 40 60 80 100 120 Time after RP (months)
75
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
0
Ba
0
(c) 100
QOL mean score
60
3
QOL mean score
(a)
Ba
3
se li m ne on 6 th m s 12 on m ths 24 ont m hs 36 ont m hs 48 ont m hs 60 ont m hs on t 5+ hs ye ar s
(j) 100% 80% 60% 40% 20% 0%
Fig. 2 (a,c–f) Longitudinal mean score for QOL over time after RP as measured by various instruments. (a) SF-36. (c–e) UCLA-PCI. (f) IPSS and QOL. (b) Comparison of mean SF-36 as to eight scales between those who underwent RP beyond 5 years (n = 91) and aged-matched control (n = 136). (g–j) Longitudinal changes in urinary or sexual , PCS; , MCS; domains over time after RP. (g) How often leaked urine. (h) Quantity of daily pad use. (i) Ability to have an erection. (j) Frequency of intercourse. (a) , urinary bother; (d) , bowel bother; (e) , RCS; (b) , our cohort; , age-matched control; (c) , urinary function; , bowel function; , sexual function; , sexual bowel; (f) , IPSS; , QOL; (g) , total control; , occasional; , frequent; (h) , no pad; , one to two pads; , three or more; (i) , good; , fair; , poor; (j) , two or more; , one; , none. BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RPH, role limitations because of physical health problems; RE, role limitations because of emotional health problems; SOF, social function; VT, vitality.
responder group, at the final survey, the proportion of the number of comorbid conditions was more likely to increase compared with baseline (P = 0.018). Comparing the 5-year profile of the general HRQOL scores of the responders with those of the non-responders, the responders were more likely to report better HRQOL scores with regard to physical function, role limitations as a result of emotional problems, mental health and general health (P = 0.026, 0.008, 0.015 and
