RADICAL RETROPUBIC PROSTATECTOMY: MORBIDITY AND URINARY CONTINENCE IN 418 CONSECUTIVE CASES R. E. HAUTMANN, M.D. T. W. SAUTER, M.D. U. K. WENDEROTH, M.D. From the Department of Urology, Faculty ot Medicine, University of Ulm, Ulm, German)
ABSTRACT-Objective. To evaluate morbidity and mortality after standard retropubic radical prostatectomy with special attention to postoperative urinary continence. Methods. Four hundred eighteen consecutive patients undergoing radical prostatectomy for treatment of localized prostatic cancer were reviewed. Both clinical and pathologic staging was assessed retrospectively according to the new TNM classification (International Union Against Cancer, 1992). Postoperative urinary continence was assessed according to the criteria of the International Continence Society. Results. There were no operative deaths. Perioperative mortality was 1 .2 percent, with 3 patients dying of myocardial infarction and 2 of pulmonary embolism after uneventful operations. Rectal injury, which was primarily closed, occurred in 2.9 percent. In 1 case (0.2%), reimplantation of the left ureter had to be performed. A total of 20 patients (4.7%) required reoperation: abscess 1.7 percent; postoperative hemorrhage, 1.7 percent; anastomotic urinary leakage, 1 .2 percent; massive lymphocele, 0.2 percent. Corn plications that were treated conservatively occurred in 73 patients (17.4%): lymphocele, 6.4 percent; hemorrhage, 5.7 percent; thromboembolism, 2.6 percent; secondary wound healing, 2.6 percent. Of all patients who were followed for one year or longer, 80 percent achieved complete urinary control or reported occasional spotting only; 15 percent experienced stress incontinence grade II; and 3 percent were totally incontinent. Conclusions. Despite extensive surgical experience, our continence rates are far from the optimistic l-3 percent incontinence rates reported in the literature. In our experience, radical retropubic prostatectomy can be performed with acceptable morbidity and without significantly affecting the quality of life in the majority of patients.
In the last decade radical retropubic prostatectomy has gained increasing popularity as treatment of choice for localized carcinoma of the prostate. As a result of improvements in surgical technique, mortality and morbidity of this procedure have been significantly reduced. In comparison to previous techniques, radical prostatectomy, as proposed by Walsh,’ is said to have improved continence rates considerably. Consequently, an increasing number of patients with locally advanced disease have been subjected to radical prostatectomy.‘,’ Since 1984, we have treated patients with clinical stages Tl-T3 prostatic cancer without evidence of metastatic disease, provided their anes-
thesiologic risk status did not exceed grade 111 of the American Society of Anesthesiologists (ASA). We report on our experience with 4 18 consecutive patients regarding complications and longterm results. PATIENTS AND METHODS Between January 1984 and February 1993, 418 consecutive patients underwent radical retropubic prostatectomy for prostatic carcinoma at our institution. Mean patient age was sixty-four years, ranging from forty-two to seventy--nine years. Patients were considered suitable for radical prostatectomy when prostatic carcinoma was proven by biopsy without evidence of metasratic disease. In
addition, general health conditions in terms of the anesthesiologic risk status was assessed and graded according to the ASA. Patients with a risk status greater than ASA grade III were treated by androgen ablation alone. Of all patients considered to be suitable for radical prostatectomy, 10.1 percent were ASA grade I, 62.1 percent were ASA grade II, and 27.8 percent were ASA grade III risk status. Preoperative evaluation included digital rectal examination (DRE), ultrasound of the upper and lower abdomen, chest radiograph, radioisotopic bone scan, and computed tomography (CT) scan. Standard laboratory tests, including alkaline phosphatase and prostatic acid phosphatase, were carried out. In addition to the renal ultrasound the upper urinary tract was evaluated by intravenous urography. Since 1988, serum prostate-specific antigen (PSA) was added using the Hybritech assay, and transrectal ultrasound (TRUS) of the prostate was performed in the majority of patients. Preoperative CT of the pelvis has no longer been carried out routinely since 1989, because of its poor sensitivity and specificity. Patients with evidence of extension of the tumor beyond the capsule or into the seminal vesicles, either by DRE or TRUS, were also considered as candidates for radical prostatectomy. If tumor extension beyond the prostate was confirmed pathologically, adjuvant treatment using bilateral orchiectomy or gonadotropin-releasing hormone (GRH) analogues was carried out as standard treatment. Prior to radical prostatectomy, a total of 60 patients (14.4%) had undergone either simple prostatectomy (1.4%) or transurethral resection of the prostate (13.0%) for benign prostatic hyperplasia. Four patients (0.9%) had received full-dose radiation therapy for prostatic carcinoma. Both clinical and pathologic staging were assessed retrospectively according to the new TNM classification (International Union Against Cancer, 1992). Of all 388 patients, in whom clinical staging was available, 18.0 percent had a clinical Tl tumor, 75.0 percent a T2 tumor, and 7.0 percent a T3 tumor (Table I). Following standard pelvic lymph node dissection, all patients underwent radical prostatectomy as described by Walsh.’ During the first two years after operation, all patients were followed at three-month intervals, and every six months thereafter for another two years. From the fifth year on, follow-up was performed annually. Follow-up included patient history, general physical examination, abdominal ultrasound, TRUS of the vesicourethral junction and adjacent tissue, chest radiograph, alkaline phosphatase,
TABLE I. Clinical Stage
Comparison between clinical and pathologic tumor stages Pathologic Tumor Stage PTO PT~ pT3 51 7 30 1 118 161 0 5 17
No. Patients
71 72 73
70 291 27
TOTAL
388
153 8 161 (41 5”0]
309
pT4a 2 11 5 18
227 (58 Soo)
and PSA measurements. Bone scan and CT of the pelvis were performed routinely at 6-month intervals during the first two years of follow-up, and annually thereafter. Postoperative urinary continence was assessed according to the criteria of the International Continence Society (ICS) and was divided into four categories. Patients were considered to be continent if no involuntary urine loss occurred during normal or strenuous activities and no pads or appliances were needed at any time. Patients with occasional spotting of urine in the underwear on coughing or sneezing or strenuous activities were considered to have a stress incontinence grade I. Stress incontinence grade II included frequent loss of urine during normal activities, such as walking or climbing stairs, and wearing sanitary pads for protection. No urinary control, neither in an upright nor in a supine position, was considered to be a stress incontinence grade 111. Continence data were obtained by questionnaires, which were mailed to the referring urologist or to the house physician, and all questionnaires were filled out by the patients’ physicians. RESULTS MORBIDITI,
AND
MORTALJ~
Y
Mean operation time was 2.8 hours, ranging from 1.8 to 4.1 hours. The average blood loss was 900 mL (range, 300-2,000 mL) and mean number of blood units required was 1.7 (range, O-6). There were no operative deaths. Table II lists early and late complications. The perioperative mortality was 1.2 percent, with 3 patients (0.7%) dying from myocardial infarction and 2 (0.5%) from pulmonary embolism. In all cases, death occurred between days 3 and 11 after an uneventful operation. In 11 patients (2.6%) the rectum was injured during the operation. All of them were primarily closed and healed completely without the need of a colostomy. In 1 patient (0.2%) with tumor invasion into the bladder neck, the left ureter was injured and reimplantation of
TABLE II.
Complications after radical prostatectomy in 4 18 patients No.
?h
the ureter had to be performed at the time of primar)! surgery. The rate‘ of early complications requiring reopcration was 4.8 percent (20 cases). In 7 cases ( I .7X) rtoperation was carried out for postoperati\,e hemorrhage; in another 7 cases (1.7%), abxcss lormation required surgical treatment, 5 cases ( I .2(X,) needed open repair of complete dehiscence of the vcsicourethral anastomosis, and 1 patient (0 2%) required reoperation for a massive lymphocck. In a total of 96 cases (23%) early postoperative complications could be managed either by conservative means or by percutaneous drainage. In 23 patients (5.5(X)), urinary leakage of the vcsicourethral .junction was diagnosed by cystogram, which is routinely done before removal of the catheter. Consequently. the urethral catheter was Left in place for another one or two weeks, and the leakage resolved without sequelac in all patients. Seven patients (I .7(K) were treated conservatively for deep vein thrombosis, and 4 (1%) for pulmonary cmholi. Of 27 cases (6.5%) with postoperative lymphoccle formation, 9 (2.2%) required no specific therapy, whereas in 18 cases (4.3%) treatment was successfully carried out by ultra-
sound-guided application oI ‘I p~‘lcl~tant‘ous drainage. In 24 patients (5.7’)ii,) po~topcrativc hemorrhage resolved spontaneously. and sccondary wound healing, rnostl)’ due to \ubc,utaneous bleeding, was obscrvcd in I 1 cams i 2.0% ). The late complication rate, excluding postopcrative incontinence. was 12.7 pcrccnt. Anastomotic strictures requiring transurcthral inc isiorl occurred in 37 patients (8.%). and 17 patients (4.1%) developed a stricture of 111~.urethra, rcquiring dilation or careful transurrrtllral int ision of the anastomosis or urethrotonl)., rc>pectivcl>’ (Table II).
Data on the patients‘ postopcratt\‘t’ txjntincncc were available for a total of 351 patient-;, and 191 patients have been followed one !rc,tr OI- Iongcr. Mean follow-up was twenty-eight mollths, ranging from three to ninety-eight months,. Iwo thirds of inquiries on continence wcrc’ made hj, ttie patient’s physician or urologist in pri\atc practict. The remaining vnc third of the continence data was collected from patients who uerc folloued up on a regular basis at our o~+n institution. The data were then analyzed for three, SIX, t\sclvc, t\\zcnt)‘four, and thirty-six months’ lollou -up and arc listed in Table III. At one year postoperativclj,, KU.7 percent of the patients were either completely ccjntinent or rcported occasional spotting. causing no considerable discomfort (grade 1). Further improvement of the continence rate from 40.9 ( 12 months’ followup) to 54.5 percent (36 months’ I’oIlow-up) was observed, which was predominantl), due to the fact that patients with a stress incontincncc grade I regained complete urinary controt The rates for stress incontinence grade I1 decrca>ed from 29.~1 percent at three months after the operation to 15.9 percent at one year’s follow-up ~lowevcr, ~10 further improvement could hc achieved In this group thereafter. In patients with 5trcss incontinence grade II, the mean number (.)I’pads necdcd for protection was 3.4 (range, I- I’5 ). Finally, one year after radical prostatcctom): 5 ( I.-F%; of 2-I patients (1 1.7%) at the three months‘ follow-up remained totally incontinent (Table III 1. PATHOIeOGK
Flhl)lN(,5
Of 418 patients who undcrwcnt radical prostatectomy before Februar) 19c)3? clinical staging was available in 388 patients. Based on this figure, clinical and pathologic findings were compared (Table 1). Of 361 patients (93%), who prcscnttd preoperatively with an organ-comfi ncd tumor (70
TABLE III. Follow-up*
TABLE
3 Months
IV.
Lymph Node Stage
Postoperative 6 Months
Comparison
between pathologic
PTO
pT2b
pT2c
pN0
8
.5
0 0 0
20 2 0 0
17 3 I 0
80 8 2 0
Suhlotal
0
3
4
Total
8
2%
41
Tumor
pT3b
pT3c
35
34
5 ii
6 3 I
5I 51 0
10
9
82
90
28
43
I38
COMMENT Regarding the intraoperative and postoperative complications, our results resemble those of previous reports. +mhIn 2.6 percent (11 patients) of all operations, an in-jury of the rectum occurred, which was closed primarily and healed without further complications. No colostomy was required. As previously published,“,“,’ the rate for rectal lesions during radical prostatectomy varies between 1 and 6 percent, with 1 percent requiring a colostomy.H In our experience, rectal lesions almost always occur in patients with tumor extension beyond the prostatic capsule and in those who had had preoperative therapy in the small pelvis, such as radiation therapy for prostatic cancer or surgery for benign prostatic hyperplasia. Leakage of the anastomosis was observed in 27 cases (6.7%) of our series. Four of the 5 cases, which required open surgical repair of the anastomosis (J.Z%), had experienced significant postop-
SUPPLEMENT
36 Months
Stage
pT3a
3 0 0 5
patients as Tl, 291 patients as TZ), 205 patients (56.8%) had histologic evidence of tumor extension beyond the prostatic capsule (pT3, 192 patients; pT4a, 13 patients). This includes 33 of 70 patients (47.1%) with a Tl tumor, and 172 of 291 patients (59.1%) with a T2 tumor (Table I). Jn 138 (35.6%) of 388 patients, tumor infiltration into the seminal vesicles (pT3c) was found. This group also constitutes the majority of patients (82 patients [67.80/l) with positive lymph nodes (121 patients; Table 1V).
50
24 Months
tumor and lymph node stages
Pathologic pT2a
continence
12 Months
PNl [IN2 pN
urinary
pT4a
Total
7 5 5 I 1I
121
18
388
erative hemorrhage, rupturing the anastomosis. As a late complication of radical prostatectomy, anastomotic strictures occurred in 8.9 percent (37 patients) of all patients. This Iigure is similar to those reported in the literature,i,h ranging between 1.3 and 27.0 percent. In a review, Steiner et ul.” reported on urinary continence rates in the literature following anatomic radical prostatectomy, as described by Walsh.’ Accordingly, 63-96 percent of all patients regain complete urinary control, O-35 percent complain of stress incontinence, and O-1 7 percent have total urinary incontinence.” In our series, postoperative urinary continence has been followed in 191 patients for one year or longer. In this group of patients, 80.7 percent have been considered either to be completely continent (47.1%), or to experience occasional urine spotting (33.5%). These patients with a stress incontinence grade I, however, have not been affected by this in their everyday activities. Stress incontinence grade 11 was found in 30 patients (15.7%), and 5 (3.1%) were completely incontinent. We did not find that urinary continence was influenced by pathologic stage or by the patient’s age. In our series, 88 of 351 patients (25.1%) were older than 70 years. This ratio remained constant, irrespective of the length of follow-up. Of 119 patients with stress incontinence grade II, 23 (19.3%) were older than 70 years, indicating that age does not have a negative impact on urinary control. In our subjective experience, younger patients achieve
TO
UROLOGY
/ F,.ria~‘\m
I W-t
/ L’OI I’.\II 4.5. NI .\fii/ FZ2
urinar),
controt more rapidly than men over se\‘ent)’ years. after the indwelling catheter has been removed. But three months after surgery no significant differcncc belween both age groups was found regarding urinary control. Again, these results are similar to those in the literature.’ The comparison of clinical and histologic tumor stages rcvcals that 47. I percent of all patients with a clinical 7-l tumor- and 59.1 percent with a clinical TZ tumor had histologic evidence of tumor extension beyond the capsule (pT3-pTSa). These data arc confirmed by a previous report.” Had these patients been left untreated, their risk for tumor progression would have been high. Our rcsuits, therefore, strongly support the opinion that clinical PI tulnors must be treated definitively by radical prostatectomy As far as adjuvant therap) with androgcn ablation in prostate cancer greater than grade pT2 is concerned, no definitijze answer can he given Lyith respect to any curative benefit for these patients at the present time. In conclusion, our eight-year experience with radical retropubic prostatectomy demonstrates that this procedure provides excellent tumor control for localized carcinoma of the prostate and largely preserves quality of life. Further follow-up will he necessar)’ to assess the impact of this operation on progression-free and crude survival for patients with localized and locally advanced prost,ltic c3ncc1-. ‘ ‘
51