Long-Term Followup of Incontinence and Obstruction After Salvage Cryosurgical Ablation of the Prostate: Results in 143 Patients

Long-Term Followup of Incontinence and Obstruction After Salvage Cryosurgical Ablation of the Prostate: Results in 143 Patients

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~022-5347/97/1571-0237$03.00/0 TtIt .IOURNAL OF UROLCGY Cophright 0 1997 by AMERICAN UROLOGICAL ASSOCIATION, INC.

Vol. 157, 237-240,January 1997 Printed i n U S A .

LONG-TERM FOLLOWUP OF INCONTINENCE AND OBSTRUCTION AFTER SALVAGE CRYOSURGICAL ABLATION OF THE PROSTATE: RESULTS IN 143 PATIENTS R. DUANE CESPEDES, LOUIS L. PETERS, ANDREW C. EDWARD J. McGUIRE

VON

ESCHENBACH

AND

From the Division of Urology, University of Texas Houston and Department of Urology, University of Texas, M.D. Anderson Cancer

Center, Houston, Texas

ABSTRACT

Purpose: We report long-term followup of patients with incontinence and obstruction after salvage cryosurgical ablation of the prostate. Materials and Methods: We reviewed the records of 143 patients who underwent cryosurgical ablation of the prostate for treatment failure after radiation therapy. Data were collected by telephone interview with each patient and chart review. Median followup was 27 months (range 12 to 42). Results: Of 107 patients who underwent cryosurgical ablation of the prostate using a commercially available urethral warmer 15 (14%) had significant obstruction or retention that required transurethral resection of the prostate in 10,of whom 6 became incontinent. Urinary incontinence occurred in 45 patients (42%) and resolved in 21 (47%), for an overall 28% long-term incontinence rate. Of 28 patients who underwent cryosurgical ablation of the prostate using an alternative urethral warmer 13 (46%)had incontinence and 15 (54%)had significant obstruction or retention. Resolution was rare and 89% of the patients are currently incontinent. Eight patients underwent 2 separate cryosurgical ablations with an 88% incontinence rate (43% overall). The double freezing technique did not increase postoperative obstruction or incontinence. Conclusions: Incontinence and urinary retention rates are increased in patients undergoing cryosurgical ablation of the prostate after failure of radiation therapy but spontaneous resolution occurs in half of the patients within 1 year if an effective urethral warmer is used. Incontinence treatments should be delayed until after this period. Postoperative incontinence and obstruction rates are significantly greater when an effective urethral warmer is not used and spontaneous resolution is rare. KEYWORDS: urinary incontinence, cryosurgery, prostate, prostatectomy MATERIALS AND METHODS

Radiation therapy has been used successfully to treat localized prostate cancer. However, approximately 25% of tumors may recur locally.1 Currently, definitive treatment is salvage prostatectomy but positive surgical margins occur in as many as 50% of patients and significant postoperative morbidity is common.2.3 Other frequently used alternatives include observation and hormonal therapy but these options are not curative. A renewed enthusiasm for cryosurgical ablation of the prostate, a potentially curative treatment, has developed due to improvements in transrectal ultrasonography and cryosurgical instrumentation. Two recent reports citing short-term data suggest that complications after cryosurgical ablation of the prostate are common and appear to be increased in patients in whom radiation therapy failed.4.5 We retrospectively investigated the long-term complications of urinary incontinence and obstruction after salvage cryosurgical ablation of the prostate performed after failure of radiation therapy to cure localized prostatic carcinoma.

The records of 143 men with recurrent prostatic carcinoma after radiation therapy who underwent salvage cryosurgical ablation of the prostate between July 1992 and February 1995 were reviewed for specific information on postoperative urinary obstruction and incontinence. Additional data were collected by telephone interview with each patient by a physician uninvolved in patient care (R.D. C.). The 7 patients who could not be contacted were not included in the study. All patients had locally recurrent prostate cancer documented by increasing prostate specific antigen, a positive prostate biopsy and no metastatic disease on radiographic evaluation. Some patients had received chemotherapy and/or hormonal therapy before cryosurgical ablation of the prostate. No patient had stress incontinence preoperatively but 12 complained of severe urinary urgency and rare urge incontinence. The cryosurgical ablation technique used was that reported by Onik et al,6 and Pisters and von Eschenbach.' In the first 107 patients a commercial urethral warming device was used during the procedure. In the last 28 patients this Accepted for publication July 5, 1996. urethral warmer was unavailable and an alternative ureEditor's Note: This article is the fifth of 5 published in this thral warmer was used, consisting of a moditkd 24F 3-way issue for which category 1 CME credits can be earned. InStructions for obtaining credits are given with the questions hematuria catheter that cycled warm irrigation fluid (4W) through the proetatic urethra. In an attempt to increase the on pages 596 and 337. 237

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INCONTINENCE AND OBSTRUCTION AFTER SALVAGE CRYOSURGICAL ABLATION OF PROSTATE

tumor cell kill rate the technique of double freezing, that is freezing with complete thawing and immediate refreezing of the entire prostate, was routinely performed after April 1993.8 Eight patients underwent 2 separate cryosurgical ablations because of a positive biopsy or increasing prostate specific antigen after the initial operation. A commercial warmer was used for both freezing procedures in all 8 patients. Most patients were discharged home within 48 hours of the procedure with a small indwelling suprapubic catheter, which was removed when post-void residuals were consistently less than 100 ml. Patients were followed a t routine intervals, including prostate biopsy at 6 months. Median followup was 27 months (range 12 to 42). Patients were specifically questioned whether urine leaked with activities or they were wet due to severe urgency. Incontinent patients were asked to quantitate the amount of urine leakage in terms of pads changed per day. Only postoperative obstruction or retention requiring catheterization or suprapubic tube placement was tabulated. Additionally, only the operations needed to relieve the obstruction that was directly related to cryosurgical ablation of the prostate were tabulated. Statistical analysis was performed using a chi-square test with significance defined as p <0.05. RESULTS

A total of 107 patients underwent cryosurgical ablation of the prostate with a commercially available urethral warmer in place. Significant obstruction or retention occurred in 15 patients (14%)with transurethral resection of the prostate required in 10,6 of whom became incontinent thereafter (see table). The interval for onset of retention after suprapubic tube removal was variable. Approximately half of the patients had abrupt onset within l to 2 weeks and half had slow progression to retention within 3 months aRer catheter removal. Retention slowly resolved spontaneously without surgical intervention in 5 patients. A total of 45 patients (42%) had stress urinary incontinence with varying degrees of coincident urgency and urge incontinence. Generally the incontinence developed within 1 to 3 weeks after cryosurgical ablation of the prostate, and in many cases it was associated with passage of tissue per urethra. The degree of incontinence varied: 18 patients used fewer than 2,25 used 2 to 4 and 8 used 5 to 8 pads, while 13 required a clamp for severe leakage. During followup of longer than 1 year incontinence resolved in 21 of 45 patients (47%)for a 22%incontinence rate. The interval for recovery of continence was slowly progressive in most cases but extremely variable and no pattern could be determined. The overall incontinence rate, including patients incontinent after transurethral resection of the prostate, was 28%. No patient who became incontinent aRer transurethral resection of the prostate later regained continence. Of the patients 28 underwent cryosurgical ablation of the prostate with an alternative urethral warmer and 15 (54%) had significant obstruction or progression to urinary reten-

tion, with 13 incontinent after transurethral resection of the, prostate or spontaneous passage of tissue. Overall, 13 patients (46%)were incontinent within l to 2 weeks postoperatively. One patient became dry and 3 showed mild improvement. Of the patients undergoing cryosurgical ablation of the prostate with a n alternative warmer 25 (89%) remain incontinent, which represents a significant increase (p <0.001) compared to use of the commercial urethral warmer. Eight patients underwent 2 cryosurgical ablations for local tumor recurrence after the initial procedure, with 6 incontinent postoperatively. One patient had retention and underwent transurethral resection of the prostate with subsequent incontinence. No patient became continent during followup, for an overall incontinence rate of 88% in this subgroup. Of 2 patients with an obliterative membranous urethral stricture, 1 currently is on intermittent catheterization after multiple endoscopic procedures and 1 received a continent appendicovesicostomy. Overall, 22%of the patients reported spontaneous passage of tissue after cryosurgical ablation of the prostate with subsequent urinary obstruction andor incontinence in many cases. The double freezing technique waa associated with a 26%long-term incontinence rate, whereas 25%of patients remained incontinent after the single freeze technique. The difference was not statistically significant (p = 0.85). Postoperative obstruction and retention rates were also comparable. Relatively few patients have undergone treatment for incontinence to date. One patient received an artificial sphincter, which subsequently eroded and was removed. Collagen injection therapy was begun in 17 patients, of whom 5 have completed treatment to date with 3 (60%)using fewer than 2 pads daily. One patient underwent ileal diversion elsewhere. DISCUSSION

The reported rates of incontinence and urinary retention vary widely depending on whether cryosurgical ablation of the prostate is performed as a primary or salvage procedure. Miller et a1 performed cryosurgical ablation as primary therapy in 62 patients with stage C prostate cancer and reported urinary incontinence in 2.7%,prolonged urinary retention in 1.3%, sloughed urethral tissue in 1.3% and urethral strictures in 1.3%.9The resolution rate of urinary incontinence and sequelae of treatment for urinary retention were not noted during the 12-month mean followup. In a more recent series, in which 11 a€ 63 patients received prior radiation therapy, Cox and Crawford noted that 9 (82%)experienced significant complications but incontinence, retention and resolution rates were not reported in this subgroup.4 The overall incidence of urinary incontinence was 27% at 3 months with spontaneous resolution in 3 patients by 10 months. Urinary retention occurred in 29% of the patients and 3% had a urethral stricture. Bales et a1 reported on 23 patients who underwent cryosurgical ablation of the prostate after failure of radiation therapy for localized prostate cancer.5 Initially, 95% of patients were incontinent but resolution was noted in 5, for an overall 73%incontinence rate. A total of 12 patients

lncrdence of incontinence and urinary retention after salvage cryosurgical ablation of the prostate in 143 patients No. Pts. 1%) Total

No Obstmctiofitention

ObstmctiodRetention

NO.

~

Postop. Resolved Transurethral Residual Incidence Spontaneously Resection of Prostate Incontinence Urethral warmer: Commercial Alternative Repeat cryosurgical ablation of

107 28 8

15114) 15(54J l(13)

5 2 0

10 8 1

6 13 I

Postop. Incontinence

Long-Term Incontinence

45 (42 I 13 (46)

24 122, 12 192,

6(75$

611001

Overall Incontinence

301281*

251891” 7 !881

INCONTINENCE AND OBSTRUCTION AFTER SALVAGE CRYOSURGICAL ABLATION OF PROSTATE

239

*ateof reversible but prolonged retention occurs after colla(54%) had urinary retention and at least 3 of them remain ;en injection because not only does the urethra not close incontinent after surgical intervention. It is clear from these reports and our data that the inci- :ompletely, resulting in incontinence, but it also does not dence of urinary retention and incontinence is much greater )pen easily due to tissue fibrosis. When the bladder neck is when cryosurgical ablation of the prostate is performed after )bstructed with collagen many patients have difficulty voidradiation therapy, the reasons for which are speculative. ing. Of the 17 patients who began collagen injection therapy Prior radiation therapy probably causes microvascular ~ n l y5 have completed therapy to date, with 3 (60%) having changes that exaggerate periprostatic tissue damage, leading significant improvement. Unfortunately, a n artificial sphincto increased tissue slough and urinary retention. Similarly, a ter is probably not a better choice, since further transurecompromised vascular supply to the sphincteric unit may thral procedures may be required as in 1 case with erosion in increase initial damage and undermine the healing process our series. Also, in a recent report only 63% of postprostatectomy patients who received radiation therapy and, with resulting incontinence. An effective urethral warmer is crucial in minimizing post- subsequently, a n artificial urinary sphincter became contioperative urinary retention and long-term incontinence. Our nent (fewer than 2 pads used daily), and 55%required revidata show a significant difference in short-term and long- sion within 3.7 years." In a few cases the obliterated memterm complications using an alternative urethral warmer, branous urethra may not be salvageable and an alternative although these procedures were done at the end of the study urinary conduit may be necessary. The patient should be when the learning curve should be minimized. Additionally, aware of this unusual but serious complication. Regardless of the method chosen to treat incontinence, we few patients had spontaneous resolution once incontinence or retention occurred. Cox and Crawford reported a 48% reten- recommend waiting at least 12 months because spontaneous tion rate and 48% short-term incontinence rate in patients resolution often is protracted and, occasionally, there may be undergoing primary cryosurgical ablation of the prostate us- a need for transurethral procedures to treat obstruction at a late date. Additionally, collagen injection is much easier and ing an alternative urethral warmer.4 It is well known that the incidence of reported incontinence more successful the longer one waits after surgery. varies depending on the method of data acquisition, such as patient report via a quality of life instrument or by chart CONCLUSIONS review and direct patient interview. Additionally, differences Salvage cryosurgical ablation of the prostate is currently in the definition used for incontinence may lead to significant variation in reported continence rates in the same patients.1° an investigational treatment option after failure of radiation Reviewer bias may also lead to inaccurate data but in our therapy for localized prostate cancer. The rate of incontiseries the interviewerkhart reviewer was uninvolved in pa- nence and retention appears rather high. However, symptient care, which should decrease this effect. The additional toms will resolve in approximately 50% of patients in whom information gained by a quality of life instrument can be an effective urethral warming device is used. We recommend invaluable and studies are in progress to ascertain those use of the commercial urethral warmer (available soon) in all patients undergoing cryosurgical ablation of the prostate. data. The technique of double freezing was not associated with a Treatment of post-ablation incontinence remains difficult significantly increased rate of incontinence or retention, with and further study is needed in this area. When comparing post-radiation cryosurgical ablation of preliminary evaluation suggesting improved tumor cell kiK7 the prostate to salvage prostatectomy, it appears that the Within each subgroup the rate of incontinence did not change significantly as surgical experience increased, and inconti- initial promises of greatly decreased morbidity and equivanence rates did not vary significantly among surgeons who lent cure rate have not yet been realized.12 The other quesperformed the procedures, suggesting that a steep learning tion, not addressed in our study, is that of long-term tumor control. Longer followup is necessary to demonstrate curve does not exist. Transurethral resection of the prostate performed for re- whether cryosurgical ablation of the prostate improves surfractory urinary retention resulted in a high percentage of vival. Once these data are known the optimal role of cryosurpostoperative incontinence. Whether incontinence would gical ablation of the prostate in salvage situations can be have ultimately occurred due to necrosis and slough of further defined. However, transurethral resecsphincteric tissue is &own. REFERENCES tion of the prostate after cryosurgical ablation of the prostate is difficult to perform because of indistinct landmarks lead1. Hanks, G. E. and Dawson, A. K.: The role of external beam ing to possible over resection. In some cases we performed a radiation therapy after prostatectomy for prostate cancer. Cancer, 58: 2406,1986. mini transurethral prostatectomy. Unfortunately, multiple 2. Neerhut, G. J., Wheeler, T., Cantini, M. and Scardino, P. T.: procedures were sometimes necessary without clear benefit Salvage radical prostatectomy for radiorecurrent adenocarciln t e r n s of incontinence. A definitive interval for performing noma of the prostate. J. Urol., 140 544,1988. transurethral resection of the prostate cannot be determined. 3. Rainwater, L. M. and Zincke, H.:Radical prostatectomy after However, a few patients improve spontaneously after passing radiation therapy for cancer of the prostate: feasibility and tissue, and waiting at least 3 months after cryosurgical abprognosis. J. Urol., 140 1455,1988. lation of the prostate should result in better landmarks 4. Cox, R. L. and Crawford, E. D.: Complications of cryosurgical and possibly better characterization of what must be reablation of the prostate to treat localized adenocarcinoma of sected. the prostate. Urology, 46: 932,1995. 5. Bales, G. T., Williams, M. J., Sinner, M., Thisted, R. A. and Treatment of incontinence &er cryosurgical ablation of Chodak, G. W.: Short-term outcomes after cryosurgical ablaProstate remains problematic. We have extensive expetion of the prostate in men with recurrent prostate carcinoma nence with injection of collagen in patients who undergo following radiation therapy. Urology, 46 676,1995. cVosurgical ablation after radiation failure, and without 6. Onik, G. M., Cohen, J. K., Reyes, G. D., Rubinsky, B., Chang, Z. doubt they are the most difficult group in which to perform and Baust, J.: Transrectal ultrasound-guided percutaneous Injection. The tissue is extremely friable, allowing the collaradical cryosurgical ablation of the prostate. Cancer, 72: 1291, gen to rupture easily through the mucosa, and necessitating 1993. of injection volumes smaller than 7.5 ml. and longer 7. Pisters, L. L. and von Eschenbach, A. C.: Cryoablation for prosw n d s (at least 6 weeks) between injections to allow healing. tate cancer, In: Advances in Urology. Edited by E. J. McGuim, The tissues begin to improve after 12 to 15 months and W.Catalona, L. Lipshultz and D. Bloom. St. Louis: MosbyYear Book,vol. 8,pp. 97-116, 1995. QJections should not be& then. Additionally, a high

the

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INCONTINENCE AND OBSTRUCTION AFTER SALVAGE CRYOSURGICAL ABLATION OF PROSTATE

8. von Eschenbach, A. C., Babaian, R. J. and Evans, R. B.: Technique of cryosurgery of the prostate. Atlas Urol. Clin. N. h e r . , 2: 127,1994. 9. Miller, R. J., Cohen, J. K and Merlotti, L. A.: Percutaneous transperineal cryosurgical ablation of the prostate for the primary treatment of clinical stage C adenocarcinoma of the prostate. Urology, 44: 170,1994. 10. Korman, H.J., Sirls, L. T. and Kirkemo, A. K.: Success rate of modified Pereyra bladder neck suspension determined by out-

comes analysis. J. Urol., 152: 1453,1994. 11. Perez, L. M.and Webster, G . D.: Successful outcome of artificial urinary sphincters in men with post-prostatectomy urinam incontinence despite adverse implantation features. J. Urol:, 148 1166,1992. 12. Rogers, E., Ohori, M., Kassabian, V. S., Wheeler, T. M. and Scardino, P. T.: Salvage radical prostatectomy: outcome measured by serum prostate specific antigen levels. J. Urol., 153: 104,1995.