Open Versus Laparoscopic Radical Prostatectomy: A Prospective Comparison of Postoperative Urinary Incontinence Rates Niels-Erik B. Jacobsen, Katherine N. Moore,* Eric Estey and Donald Voaklander From the University of Alberta, Edmonton, Canada
Purpose: We compared the 12-month postoperative urinary incontinence rates of open radical retropubic and laparoscopic radical prostatectomy. Materials and Methods: This prospective study included all men with clinically localized prostate cancer scheduled for radical prostatectomy (open retropubic or laparoscopic) at the University of Alberta between October 1999 and July 2002. Preoperative evaluation included a 24-hour pad test, fluid volume voiding diary and International Prostate Symptom Score questionnaire. Postoperative evaluation included a 24-hour pad test at 3 and 12 months, as well as a voiding diary and International Prostate Symptom Score questionnaire at 3, 6, 9 and 12 months. Results: A total of 239 patients met the eligibility criteria and consented to participate (172 open radical retropubic prostatectomy, 67 laparoscopic radical prostatectomy). Of the patients 87% (148) treated with open radical retropubic prostatectomy and 88% (57) of those treated with laparoscopic radical prostatectomy completed 12-month followup (p ⫽ 0.50). According to 24-hour pad testing 13% of those treated with open radical retropubic prostatectomy and 17% of those treated with laparoscopic radical prostatectomy remained incontinent at 1 year (p ⫽ 0.26). There was no difference in 24-hour pad weight, urinary symptom score and urinary quality of life at 1 year between the open and laparoscopic groups overall, or when stratified according to 12-month continence status. The majority of subjects in both groups described mild symptoms and a general satisfaction with urinary quality of life. Conclusions: Based on objective and subjective measures, there were no differences in urinary functional outcomes 1 year after open radical retropubic prostatectomy or laparoscopic radical prostatectomy. Urinary incontinence was found to affect a similar proportion of patients who underwent open (13%) and laparoscopic (17%) radical prostatectomy 12 months postoperatively. Key Words: prostatic neoplasms, prostatectomy, laparoscopy, urinary incontinence
RRP.6 While the continence rates of contemporary RRP and LRP series seem comparable, differences in patient selection and method and timing of evaluation make it difficult to draw conclusions. The wide range of continence rates reported after RRP (67% to 95%) and LRP (60% to 100%) underscores this point.7–10 The few studies that have directly compared the urinary functional outcome of the 2 approaches have relied on subjective measures of urinary control which may not accurately reflect absolute urine loss.8,10 In this study we prospectively compared the postoperative continence rates and urinary symptoms associated with RRP and LRP using the 24-hour pad test, voiding diary and I-PSS.
aparoscopic radical prostatectomy has emerged as a feasible minimally invasive alternative for the surgical treatment of clinically localized prostate cancer.1 Numerous studies have demonstrated that LRP provides comparative, if not improved, perioperative outcomes relative to RRP in terms of operative blood loss, transfusion, analgesic requirements, hospitalization and convalescence.1–3 Although long-term oncological data are unavailable, the laparoscopic technique would be expected to provide similar early cancer control with reported positive margin rates up to 26% and biochemical-free progression rates approaching 91% at 3 years in larger series.2,4,5 What remains less clear is the functional outcome of LRP in terms of urinary control. Proponents speculate that the improved visualization, meticulous dissection and watertight urethrovesical anastomosis that LRP provides may translate into improved postoperative continence relative to
L
MATERIALS AND METHODS Patients This prospective study evaluated 2 cohorts of men undergoing RRP or LRP at 2 University of Alberta hospital sites between October 1999 and July 2002. Inclusion criteria in-
Submitted for publication November 4, 2005. Supported by the Northern Alberta Urology Foundation and Alberta Heritage Foundation for Medical Research. Nothing to disclose. Study received ethics approval from the Health Research Ethics Board of the University of Alberta. * Correspondence: Faculty of Nursing, 3rd Floor, Clinical Sciences Building, University of Alberta, Edmonton, Alberta T6G 2G3 Canada (telephone: 780-492-1541; FAX: 780-492-2551; e-mail: katherine.
[email protected]).
0022-5347/07/1772-0615/0 THE JOURNAL OF UROLOGY® Copyright © 2007 by AMERICAN UROLOGICAL ASSOCIATION
Editor’s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 802 and 803.
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Vol. 177, 615-619, February 2007 Printed in U.S.A. DOI:10.1016/j.juro.2006.09.022
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RADICAL PROSTATECTOMY AND POSTOPERATIVE URINARY INCONTINENCE
cluded clinically localized prostate cancer and residence within a 2-hour driving distance from hospital to allow for regular followup. Exclusion criteria included prior pelvic radiotherapy, a stated subjective complaint of incontinence at baseline or a neurological impairment known to affect bladder function. Eligible men were provided written study information by the attending urologist, and interested patients contacted the clinical research nurse and were screened. All subjects underwent baseline preoperative evaluation that included a history and physical examination, 24-hour pad test, fluid and voided volume diary, and I-PSS questionnaire. Ethics approval was received from the Health Research Ethics Board of the University of Alberta. Surgical Methods Open radical retropubic prostatectomy was performed by 1 of 10 urologists, and LRP was performed by 2 of these urologists using the transperitoneal approach according to the Montsouris technique.11 As the LRP cohort represented our initial experience with this procedure, patients with risk factors for lymphatic metastases (PSA 20 ng/ml or greater, clinical stage T3 or greater, Gleason score 8-10) were offered RRP in lieu of LRP. Accordingly, pelvic lymph node dissection was not routinely performed during LRP. Urethrovesical anastomosis was performed in an interrupted manner by all surgeons, except 1 who performed a continuous anastomosis during LRP. Catheters were removed within 2 weeks. To include a suitable work-in period for LRP, the patients undergoing this procedure were divided into 2 equal groups of LRPt and LRP based on date of surgery. Followup Evaluation Postoperative evaluation included a 24-hour pad test and voiding diary performed at 3 and 12 months. The I-PSS was completed at 3, 6, 9 and 12 months with the 6 and 9-month contacts used to maintain subject awareness of the study. The primary outcome measure was gm urine loss on 24-hour pad test at 12 months. Secondary outcomes were voiding diary, and I-PSS symptom and QOL scores. Medical records were reviewed for operative, hospitalization and pathological data. Incontinence Incontinence was defined as a total pad weight gain of more than 8 gm during a 24-hour period.12 The 24-hour pad test was standardized to consist of 2 hourly pre-weighed pad changes followed by post-change weighing using a Mettler PJ 4000 balance (Mettler Instrument Corp., Hightstown, New Jersey). Pad testing is capable of detecting a 1 gm urine loss if pads are weighed within 36 hours of placement in a sealed plastic bag.13 To control for the effect of activity on pad test results, subjects were asked to record activity for the baseline pad test and to repeat this activity as closely as possible for subsequent pad tests. Fluid Volume Diary During a 24-hour period patients recorded fluid intake and voided volume using disposable measuring devices. Combined with I-PSS, a fluid volume chart provides objective information on nocturia, bladder volume, voiding frequency and the effect of voiding symptoms on QOL.14
I-PSS The I-PSS is an easily completed 7 item, subject administered, urinary symptom questionnaire. Total summary scores ranged from 0 to 35 and were broken down into 0 to 7—mildly, 8 to 19 —moderately, or 20 to 35—severely symptomatic. An additional single QOL question asks the subject how he feels about tolerating his current level of urinary symptoms for the rest of his life. Scores range from 0 (delighted) to 6 (terrible). The I-PSS is a clinically useful and valid adjunct to symptom assessment and provides some indication on the subjective impact of urinary symptoms including incontinence. Statistical Analysis The independent samples t test and chi-square analyses (SPSS® version 12.0) were used for descriptive statistical analyses. Repeated measures ANOVA controlling for surgery group was used to determine changes in pad weights, I-PSS and QOL scores. To control for the learning curve anticipated with laparoscopic surgery, 50% of the LRP was divided into an initial training period (LRPt) and later period (LRP). Statistical significance was based on p ⬍0.05. RESULTS A total of 172 of approximately 500 patients treated with RRP and 67 of 81 patients treated with LRP met the eligibility criteria, consented to participate and completed baseline evaluation. Reasons for nonparticipation included lack of time from contact with researcher to date of surgery, driving distance, lack of subject interest or clerical error. Two patients treated with LRPt in whom rectovesical fistulas developed were excluded from data analysis as was 1 patient treated with RRP who elected to undergo radical perineal prostatectomy. Full 12-month followup was available for 87.0% of patients treated with RRP (148 of 171) and 88% of those treated with LRP (57 of 67). Preoperative/Baseline Patient Characteristics There were no differences in mean age, body mass index, smoking status or biopsy Gleason score among RRP, LRPt and LRP groups with full 12-month followup (table 1). There was no significant difference between groups in preoperative PSA, and clinical stage was also similar with 49.7% of RRP and 57.9% of LRP cases presenting with nonpalpable disease
TABLE 1. Baseline demographics RRP No. pts Mean age ⫾ SD Mean kg/m2 body mass index ⫾ SD No. smokers (%) Mean ng/ml preop PSA ⫾ SD Mean biopsy Gleason sum ⫾ SD No. clinical T stage (%): T1b T1c T2a T2b T2c T3a
LRPt (1st half)
LRP (2nd half)
148 63.7 ⫾ 5.7 28.1 ⫾ 4.0
29 62.3 ⫾ 6.4 26.87 ⫾ 2.4
28 60.9 ⫾ 6.6 27.54 ⫾ 2.8
22 (14.9) 9.8 ⫾ 8.2
3 (10.3) 6.9 ⫾ 2.0
2 (7.10) 7.2 ⫾ 3.0
6.4 ⫾ 0.77
6.5 ⫾ 0.51
6.4 ⫾ 0.64
2 (1.6) 61 (48.8) 41 (32.8) 8 (6.4) 12 (9.6) 1 (0.8)
0 15 (55.6) 8 (28.6) 3 (11.1) 1 (4.26) 0
0 16 (57.1) 8 (28.6) 0 4 (14.3) 0
RADICAL PROSTATECTOMY AND POSTOPERATIVE URINARY INCONTINENCE (p ⫽ 0.29). Despite uniform subjective claims of full urinary control, 6 patients in the RRP group (4.0%) and 2 in the LRP group (3.5%) demonstrated objective evidence of incontinence at baseline (p ⫽ 0.90) (table 2). These patients met the study inclusion criteria of subjectively reporting continence and were included in the analysis. There was no statistically significant difference in baseline mean pad weight between the groups overall or when stratified according to continence status. Baseline I-PSS results were similar with both groups describing mild to moderate urinary symptoms and a general satisfaction with urinary QOL (table 3). Apart from a higher mean I-PSS at baseline (10.5 vs 7.4, p ⫽ 0.02), patients with incomplete followup did not differ statistically from those with 12-month followup. Postoperative Results Pad testing and fluid volume diary. Fewer patients treated with RRP (42.0%) and LRP (60.0%) were incontinent at 3 months compared to those treated with LRPt (70.4%) (p ⫽ 0.012) with a mean urine loss of 34.9, 49.6 and 28.0 gm, respectively (table 3). Twelve months after surgery there was no longer a significant difference in the rate of incontinence (RRP 12.8%, LRPt 19.2% and LRP 16.0%). Likewise, there was no difference in the 12-month mean pad weight between the 2 groups overall, or when stratified according to 12-month continence status. However, at 12 months pad weight was significantly greater than baseline when controlling for preoperative PSA and surgery group (p ⫽ 0.019). Fluid intake, urine output or mean number of daily voids did not differ between groups or between continent and incontinent subjects at any point (data not shown).
617
TABLE 3. Pad weights and incontinence rates according to 24-hour pad test RRP Mean gm pad wt ⫾ SD: Baseline 3.6 ⫾ 3.5 3-Mo 34.9 ⫾ 101.2 12-Mo overall 8.2 ⫾ 17.9 12-Mo incontinent 34.8 ⫾ 41.7 No. incontinent (%):* Baseline 6 (4.1) 3-Mo 58 (42.0) 12-Mo 19 (12.8)
LRPt (1st half)
LRP (2nd half)
3.6 ⫾ 1.5 28.0 ⫾ 24.4 9.6 ⫾ 9.81 24.5 ⫾ 13.19
4.0 ⫾ 2.5 49.6 ⫾ 85.7 6.0 ⫾ 3.2 12.2 ⫾ 3.5
0 19 (70.4) 6 (20.72)
2 (7.4) 15 (60.0)† 4 (14.3)
* Pad weight gain greater than 8.0 gm/24 hours. † p ⬍0.05.
continent and incontinent subjects for symptom scores or QOL. Pathology. No differences in specimen weight, pathological Gleason score or positive margin rates were noted between the 2 groups (table 4). A higher proportion of patients treated with LRP had pathologically organ confined disease (83.7% vs 66.5%, p ⫽ 0.04). Among patients treated with LRP no relationship was found between the rate of urinary incontinence at 12 months and anastomotic technique (interrupted 13.5% [5 of 37], continuous 25.0% [5 of 20], p ⫽ 0.28), apical resection margin status (positive 14.4%, negative 10.6%, p ⫽ 0.51) or nerve sparing status (nerve sparing 10.1%, nonnerve sparing 19.5%, p ⫽ 0.15). DISCUSSION
I-PSS. There were no differences in total urinary symptom scores between or within the groups at any point. Mean symptom scores were highest at baseline with RRP and LRPt/LRP groups describing mild to moderate symptoms (RRP 6.9 vs LRP 9.0), and there was a statistically significant improvement between baseline I-PSS scores and 12month followup (p ⬍0.001). Urinary QOL was poorest at 3 months in all groups and was statistically worse than at baseline (p ⬍0.001), with question 4 (urgency) most likely to be rated “more than ½ the time” as bothersome for both groups. This returned to baseline or less by 12 months. Quality of life scores were similar at all other points and returned to baseline at 1 year. At 12 months, controlling for baseline levels, there were no statistical differences between
The wide range of incontinence rates reported in the literature indicates the difficulty involved in the accurate assessment of urinary control after radical prostatectomy. Differences in timing and method of assessment, which reflect the lack of a uniform definition of postoperative continence, are central to this problem. While some studies use a strict definition of continence prohibiting the use of urinary pads altogether, others allow the use of 1 precautionary pad per day as determined by patient report. The weighted average of LRP studies using a strict definition estimates 84% continence at 1 year.1,6,10,15 This correlates well with the 80% to 95% continence rates reported by contemporary RRP series.7,16
TABLE 2. Pathology
TABLE 4. I-PSS urinary symptom and quality of life scores
No. pathological T stage (%): T0 T2a T2b T2c T3a T3b T4 N⫹ Organ confined Mean pathological Gleason sum ⫾ SD Mean gm specimen wt ⫾ SD No. pos margins (%) No. pos apical margins (%)
RRP
LRPt (1st half)
LRP (2nd half)
1 (0.7) 16 (11.0) 4 (2.7) 78 (53.4) 30 (20.5) 15 (10.3) 0 2 (1.4) 93 (67.4) 6.6 ⫾ 0.90
0 3 (10.3) 0 21 (72.4) 4 (13.8) 1 (3.4) 0 0 24 (82.8) 6.7 ⫾ 0.61
1 (3.6) 4 (14.3) 1 (3.6) 18 (64.3) 2 (7.1) 2 (7.1) 0 0 18 (81.8) 6.6 ⫾ 0.74
54.9 ⫾ 22.1 60 (42.0) 36 (23.9)
50.9 ⫾ 18.1 11 (37.96) 4 (13.8)
54.6 ⫾ 21.8 11 (39.3) 6 (21.4)
Mean (SD)
Baseline: I-PSS QOL 3-Mo I-PSS QOL 12-Mo I-PSS: Overall Continent Incontinent 12-Mo QOL: Overall Continent Incontinent
RRP
LRPt (1st half)
LRP (2nd half)
7.3 (6.6) 1.6 (1.6)
7.9 (5.4) 1.9 (1.8)
9.2 (6.7) 1.4 (1.2)
6.6 (4.9) 2.4 (1.8)
8.3 (3.8) 3.2 (1.3)
7.9 (3.5) 3.2 (1.6)
5.8 (5.0) 5.3 (4.2) 9.1 (7.4)
5.9 (2.9) 5.7 (2.8) 6.3 (3.4)
5.7 (4.4) 5.4 (3.5) 7.3 (8.4)
1.5 (1.4) 1.3 (1.3) 3.1 (1.5)
1.9 (1.4) 1.4 (0.9) 3.0 (1.7)
1.9 (1.2) 1.6 (0.9) 3.5 (2.1)
618
RADICAL PROSTATECTOMY AND POSTOPERATIVE URINARY INCONTINENCE
To our knowledge only 2 prior studies have prospectively compared urinary incontinence rates after LRP and RRP. Using the International Continence Society male questionnaire, Anastasiadis et al demonstrated less nocturnal incontinence at 1 year among patients treated with LRP (33% RRP vs 13% LRP, p ⫽ 0.008) and no difference in diurnal incontinence (33% RRP vs 28% LRP, p ⬎0.05).8 In contrast, Egawa et al found that urinary incontinence at 1 year was significantly lower after RRP (7.1% RRP vs 40% LRP, p ⫽ 0.003) based on patient reported pad usage.10 Unfortunately the outcome measures of both studies were based on subjective measures of continence and notable variations have been reported between subject reports of pad use or leakage compared with the more objective measure of the 24-hour pad test.13 Of note in our study was that 4.0% of patients treated with RRP and 3.5% of those treated with LRP at baseline were incontinent according to our definition of continence of less than 8 gm on 24-hour pad test,12 despite uniform reports to the contrary. Such discrepancy points to the inaccuracy of subjective measures alone in estimating continence, particularly for efficacy studies.14 Since we only conducted pad tests at baseline, 3 and 12 months, we did not calculate the median times to continence in our subjects. Eastham and Guillonneau et al determined this period to be 1.5 months in their open and laparoscopic series, respectively.4,7 We found that incontinence peaked at 3 months, with the LRP group demonstrating a higher rate of incontinence relative to the RRP group (66.7% vs 41.3%, p ⫽ 0.001). By 12 months continence rates, symptom scores and QOL scores were equivalent. Although these findings at 1 year differ from those of Anastasiadis8 and Egawa10 et al, the objective nature of our evaluation may protect against the potential inaccuracies associated with subjective assessment tools as used in the prior studies. Furthermore, the finding of functional equivalence at 1 year should not be unexpected since the laparoscopic approach seeks to duplicate rather than modify the key continence preserving steps of RRP. Numerous studies have sought to identify risk factors for the development of long-term incontinence after radical prostatectomy. Eastham et al found that patient age, nerve sparing status, anastomotic technique and anastomotic stricture maintained independent significance.7 A separate analysis of the present data found that increasing age, baseline incontinence and prior transurethral prostatic resection were risk factors. With regard to anastomotic technique, we compared the results of an interrupted vs continuous anastomosis among laparoscopic cases and found no difference in 12-month incontinence rates. Since anastomotic stricture was not directly addressed in the present study, we are unable to comment on its incidence or on its potential effect on continence. The influence of the neurovascular bundles on postoperative continence is controversial. Some suggest that nerve sparing provides an earlier return of continence and lower overall risk of permanent incontinence. O’Donnell and Finan found that patients who underwent a nerve sparing procedure had a longer functional urethral length, a higher peak resting urethral pressure and a lower rate of postoperative incontinence relative to patients in whom the nerves were sacrificed.17 In contrast, Catalona et al did not find an association between nerve sparing and continence status independent of established risk factors for incontinence.18 It
remains unclear whether these findings suggest a possible continence preserving role for cavernous nerve branches or rather highlight the importance of meticulous apical dissection to minimize injury to the external sphincter. Studies by Tsujimura et al and others, which found a poor correlation between potency and continence status after nerve sparing radical prostatectomy, support the latter hypothesis.19 Our results suggest that nerve sparing did not affect continence at 12 months. Likewise, the status of the apical resection margin, taken as a crude surrogate for the extent of apical dissection, did not seem to influence postoperative continence. The limitations of the present study should be noted. Although our intention was to accrue all patients undergoing radical prostatectomy between October 1999 and July 2002 at 2 centers, the fact that only 172 of approximately 500 patients undergoing RRP and 67 of 81 patients undergoing LRP consented to participate may have influenced our results. Reasons for nonparticipation included distance from study center, inconvenience, unaware of study enrollment and lack of interest due to short time between notification of study and surgery date. Likewise, the exclusion of patients with high risk clinical features from LRP, albeit with equivalent pathological Gleason sums and specimen weights, may have falsely improved the results of the laparoscopic procedure. The patients undergoing RRP comprised the radical prostatectomy experience of 10 academic urologists at 2 tertiary care hospitals including 2 who performed LRP. Although the surgeon specific rates of incontinence at 1 year did not statistically differ from the mean, we recognize that differences in surgical experience and technique are important determinants of postoperative continence, and may have had a role in this study. Moreover, the learning curve associated with LRP may have had a role in continence outcomes and positive margin rates. When we controlled for the first 30 patients, dividing the LRP sample in half, it was notable that there were no significant differences between the 2. Further research at our center will prospectively evaluate another 67 subjects with the same outcome measures to provide quality control of our outcomes. While the positive margin rate is higher than that quoted in the literature of 27%,20 our higher rate is confirmed in other recent studies. Of importance is the similarity of positive margins between the open and laparoscopic groups, even in those on the learning curve. Finally our study did not measure quality of life per se but only considered symptom related quality of life as measured by the I-PSS. Comparison across more recently published studies would be facilitated by the inclusion of a validated quality of life questionnaire such as the well-known SF-36.21,22 CONCLUSIONS Objectively and subjectively the urinary functional outcomes of RRP and LRP appear to be equivalent at 12 months. There was no difference in incontinence rates (11.6% RRP, 17.5% LRP), median pad weights, symptom scores or urinary QOL at 12 months between the 2 groups overall or when stratified according to 12-month continence status. The results offer an objective measure of the severity and the rate of postoperative incontinence which can be used to counsel patients, and describe equivalent continence outcomes between RRP and LRP using a contemporary commu-
RADICAL PROSTATECTOMY AND POSTOPERATIVE URINARY INCONTINENCE nity series. To our knowledge this is the first study to directly compare the postoperative continence rates of RRP and LRP in a prospective and objective manner. Further prospective studies should include standardized questionnaires of erectile function and a more comprehensive QOL questionnaire such as the SF-36. Such data will further assist in the evaluation of a relatively new surgical method as well as provide the urologist with comparative data for patient teaching and counseling.
8.
9.
10.
ACKNOWLEDGMENTS
11.
Gloria Harrison, Eileen Rasa and Wayne Day performed data collection and data entry.
12.
Abbreviations and Acronyms
13.
I-PSS LRP LRPt PSA QOL RRP SF-36
⫽ ⫽ ⫽ ⫽ ⫽ ⫽ ⫽
International Prostate Symptom Score laparoscopic radical prostatectomy LRP training prostate specific antigen quality of life open radical retropubic prostatectomy RAND 36-Item Health Survey
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