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Comparison of artificial urinary sphincter and collagen for the treatment of postprostatectomy incontinence
ADULT UROLOGY
COMPARISON OF ARTIFICIAL URINARY SPHINCTER AND COLLAGEN FOR THE TREATMENT OF POSTPROSTATECTOMY INCONTINENCE DIMITRI D. KUZNETSOV, HYUNG L. KIM, RAJESH V. PATEL, GARY D. STEINBERG, GREGORY T. BALES
AND
ABSTRACT Objectives. To compare how urinary symptoms affect the quality of life in groups of men with postprostatectomy incontinence treated with collagen versus artificial urinary sphincter implantation. Methods. Two cohorts of men, one which received urethral collagen injection and one artificial urinary sphincter (AUS) implantation, were surveyed with a validated quality-of-life questionnaire to assess how their urinary dysfunction impacted their daily activities. The mean impact score and bother score for the two groups were compared. In addition, the overall degree of continence between the groups was assessed. Results. At a mean follow-up of 19 months, 8 (20%) of 41 patients treated with collagen injections were at least socially continent, requiring one pad daily or less. In comparison, 27 (75%) of 36 men treated with an AUS were at least socially continent (P ⬍0.001). Both the impact score and the bother score from the quality-of-life questionnaire were significantly lower in the group treated with the AUS than in the group treated with collagen. Conclusions. Patients receiving an AUS achieved significantly higher continence rates. Also, the quality of life of men treated with an AUS was improved compared with that of the men treated with collagen injection. UROLOGY 56: 600–603, 2000. © 2000, Elsevier Science Inc.
I
ncontinence after radical prostatectomy is very prevalent, with some reports suggesting incidence rates as high as 20% to 40%.1,2 The various therapeutic options for these patients include continence pads, fluid restriction, penile clamps, sympathomimetics, urethral collagen injections, and artificial urinary sphincter (AUS) implantation. Urethral collagen injection therapy and AUS placement are two surgical modalities that have been shown to improve continence; however, to our knowledge, a direct head-to-head comparison has not been performed. A randomized, prospective trial between these two surgical options is difficult to perform, because most patients are unwilling to be randomized between two procedures that are associated with vastly different morbidity and success rates. In addition, most patients generally pre-
From the University of Chicago Hospitals, Chicago, Illinois Reprint requests: Gregory T. Bales, M.D., Section of Urology, Department of Surgery, University of Chicago Hospital, 5841 South Maryland Avenue, MC6038, Chicago, IL 60637 Submitted: April 3, 2000, accepted (with revisions): May 30, 2000
600
© 2000, ELSEVIER SCIENCE INC. ALL RIGHTS RESERVED
fer a less invasive form of treatment as first-line therapy before considering an AUS. In comparing treatments for incontinence, the effect of the treatment on urinary leakage is an important endpoint; however, the effect of the treatment on the quality of life is also a critical measure for gauging success. We used a validated quality-of-life questionnaire to compare the outcome of collagen injection therapy and AUS placement in a group of men with postprostatectomy incontinence.3 Our study compared how patients respond to each treatment modality by assessing specifically how their urinary symptoms affect their quality of life. MATERIAL AND METHODS Eighty-five men who had undergone either transurethral collagen injections (n ⫽ 44) or placement of an AUS (n ⫽ 41) for postprostatectomy incontinence between July 1997 and August 1999 comprised the study group. All men were treated at a single university hospital by the same urologist (G.T.B.). All men had had significant stress urinary incontinence for at least 1 year after radical prostatectomy and the incontinence had persisted despite conservative measures (fluid restriction, sympathomimetics, and Kegel exercises). All patients were 0090-4295/00/$20.00 PII S0090-4295(00)00723-8
TABLE I. Comparison of collagen and artificial urinary sphincter Collagen (n ⴝ 41) AUS (n ⴝ 36) Dry (0 pads) Dry, socially continent (ⱕ1 pad/day) Incontinent (⬎1 pad/day)
1 (2%) 7 (17%) 33 (81%)
12 (33%) 15 (42%) 9 (25%)
P Value ⬍0.001* 0.017† ⬍0.001†
KEY: AUS ⫽ artificial urinary sphincter. Numbers in parentheses are percentages. * Fisher’s exact test. † Chi-square analysis.
significantly bothered enough to desire surgical intervention. A complete history, physical examination, and urinalysis were obtained for all patients. All patients with urge incontinence or pre-existing voiding dysfunction were excluded from the study. For patients undergoing collagen therapy, a subcutaneous test injection was performed 1 month before the procedure to rule out immunologic reactivity to bovine collagen. A transurethral retrograde approach was used with the patient under intravenous sedation after being placed in the dorsal lithotomy position. The collagen was injected submucosally at the 3-, 6-, and 9-o’clock positions. Every attempt was made not to inject into the external sphincter itself. Coaptation of the mucosa signaled the termination of the procedure. The patients were asked to void before leaving the hospital, and any patient with urinary retention was begun on intermittent catheterization with a 12F Foley catheter. All patients, especially if the incontinence improved after the first injection, were encouraged to undergo a second injection. However, an option to undergo AUS placement was offered to patients who derived absolutely no benefit from the first procedure. The AUS group was composed of men who elected to have the AUS after the initial evaluation (n ⫽ 32) or after collagen therapy failed (n ⫽ 9). Men with any symptoms suggestive of bladder instability underwent a urodynamic study to rule out detrusor abnormalities as the cause of their incontinence. An AMS800 AUS was implanted around the proximal bulbar urethra with either a 61 to 70-cm H2O or 71 to 80-cm H2O pressure balloon. A double cuff was implanted in 7 patients using the technique of Mulcahy.4 In brief, a second cuff is placed at least 2 cm distal to the first cuff, and a Y-adaptor connects both to the same pump. No quantitative criterion was used to determine the use of a single cuff versus a double cuff. Patients with significant (continuous) leakage in the upright position received a double cuff. A urinary catheter was inserted during surgery and removed on postoperative day 1, before discharge. Patients were discharged with 10 days of oral antibiotic coverage and seen at the clinic 4 to 6 weeks postoperatively for sphincter activation. The outcome was determined retrospectively using a validated quality-of-life questionnaire designed to assess the impact and bother of any persistent voiding dysfunction. Specifically, the measured parameters included the degree of incontinence (number of pads required daily), impact of the voiding dysfunction on daily activities, and level of bother associated with the voiding dysfunction. Continence was graded as dry, socially continent (minimal leakage requiring one pad per day or less), or incontinent, with the number of pads used specified. The impact and bother scores were calculated by assigning an analog value to each answer on the questionnaire and then obtaining an overall sum for each patient. A higher score correlated with a greater degree of impact and/or bother. All comparisons were analyzed using the t test, Fisher’s exact test, and chi-square analysis. A P value of 0.05 or less was considered statistically significant. UROLOGY 56 (4), 2000
RESULTS We enrolled a total of 85 men, of whom 77 (91%) responded to the questionnaire (41 in the collagen group and 36 in the AUS group) and form the basis for this report (Table I). Of the patients lost to follow-up, three were in the collagen group and five in the AUS group. A median number of two injections (range one to four) was used in the collagen group. At a mean follow-up of 19 months, 20% of the collagen patients versus 75% of the AUS patients were either completely dry or socially continent (P ⬍0.001). Two percent of the collagen group versus 33% of the sphincter group became completely dry (Table I). The mean post-treatment impact score was 9.1 (SD 5.2) and 3.8 (SD 5.8) in the collagen and AUS group, respectively (P ⬍0.001). Likewise, the degree of bother associated with post-treatment residual urinary leakage was higher in the collagen group (mean 6.4; SD 3.0) than in the AUS group (mean 3.9; SD 3.7, P ⫽ 0.002). The crossover rate for patients who initially had undergone collagen therapy and subsequently underwent AUS placement was 20% (9 of 44). A similar rate has been previously reported.5 None of the patients knew the ultimate goal of the questionnaire to prevent any bias that they might have had toward one therapy or another. The complications encountered in the collagen group included 1 patient who required temporary intermittent catheterization for postoperative urinary retention and 2 patients who developed transient dysuria. The AUS group had no sphincterrelated infections, and no sphincters were removed because of erosion or mechanical failure at a mean follow-up of 19 months. One patient underwent a pump revision because of a high-riding pump mechanism. COMMENT Persistent incontinence after radical prostatectomy is a psychologically and socially disabling problem. Today, surgical options offer patients palliation and potentially a complete resolution of their incontinence. Several reports have evaluated 601
either collagen injection or AUS therapy for postprostatectomy incontinence; however, a head-tohead comparison has not been reported. Our results demonstrate that patients who undergo AUS placement are more likely to be completely continent and have a much higher rate of being socially continent (maximum one pad per day) compared with patients treated with collagen. However, given the vastly different morbidity associated with the two procedures, a direct comparison of the continence rates after surgery may not be valid. Litwiller et al.6 hypothesized that a patient’s perception of continence and satisfaction after AUS implantation might be the most important variable to evaluate. Several studies have assessed the quality of life after placement of an AUS; however, to our knowledge, no previous study has addressed the quality of life of patients after collagen injections. In the present study, the continued impact and bother that urinary incontinence had on the quality of daily life was significantly higher in the patients who underwent collagen injections than in those who received AUS therapy. In studies reported by Litwiller et al.6 and Gundian et al.,7 the patient satisfaction rate for men who underwent AUS implantation was approximately 90% overall. This high level of satisfaction was also noted in patients who required a revision of the sphincter. In addition, 92% of the patients stated that they would undergo AUS placement again and 14% of men noted an improvement in their sexual function. These results were confirmed by Haab et al.8 using a visual analog scale that demonstrated a high level of satisfaction, with a lengthy mean follow-up time of 7.2 years. The high patient satisfaction rate often correlates with the degree of improvement. However, it is interesting to note that patients who still have some degree of incontinence after treatment are often satisfied with their outcome; this likely reflects the realistic expectations patients have about the treatment outcome. The advantage of collagen therapy is that historically it has been well tolerated with a low complication rate.9,10 Our results also demonstrate that this procedure was well tolerated. Some investigators have reported administering as many as four to five injections to achieve maximal benefit.11,12 We found it difficult to convince patients to undergo more than two injections if they had not derived any benefit from the first one or two attempts. Furthermore, several patients, including some who initially improved but then regressed, opted to undergo AUS implantation rather than continue with collagen injections. Recently, an antegrade method of collagen instillation has been reported to provide significant improvement with only one session. Using an antegrade approach, Klutke et al.13 602
reported a 10% complete continence rate with improvement in an additional 45%. Appell et al.14 further demonstrated that some patients in whom the retrograde approach failed can be effectively treated with an antegrade approach. Perhaps our collagen patients would have scored higher if an antegrade approach had been used. Although we were able to demonstrate improved continence and quality of life in men who underwent placement of an AUS compared with those treated with collagen injections, there are several limitations in our study, which may limit the broad applicability of our findings. First, in this retrospective study, the exact quantification of the degree of pretreatment incontinence was not possible. In general, the patients who received an AUS had a greater degree of urinary leakage than the patients who received collagen injections. Since the degree of satisfaction after therapy may be influenced by the severity of incontinence before treatment, it may be difficult to directly compare quality-of-life changes in the two groups. Second, we may have achieved better results with collagen injections if all the patients had received four to five treatments, as suggested by some investigators.11,12 Finally, a comparison between patients who had achieved similar degrees of continence after placement of an AUS or collagen injections might have favored the collagen group, since this is less invasive and avoids the need for device activation. However, despite these limitations, we believe that the two treatment groups are representative of typical patients with postprostatectomy incontinence and that our results indicate the significant improvement in urinary control and quality of life that can be anticipated by most patients who undergo AUS placement. Newer surgical procedures have recently been introduced that may further improve therapy. Schaeffer et al.15 described a bulbourethral sling procedure that entails placing a hammock around the deep bulbous urethra. In addition, newer injectables are being introduced that may work better than collagen. However, as with any new modality, additional experience will allow urologists to better assess the efficacy of these new techniques. CONCLUSIONS Both the AUS and collagen can effectively treat urinary leakage after radical prostatectomy. Our results demonstrate that patients receiving an AUS have a higher quality of life and are more likely to be continent than patients treated with collagen injections; however, neither procedure is completely effective. This finding underscores the importance of preoperative counseling, which should UROLOGY 56 (4), 2000
lead to appropriate patient expectations. We hope that continued improvements in the technique of radical prostatectomy and improvements in the treatment of postprostatectomy incontinence will result in fewer men with incontinence after surgery. REFERENCES 1. Fowler FJ Jr, Barry MJ, Lu-Yao G, et al: Patient reported complications and follow-up treatment after radical prostatectomy. The National Medicare Experience: 1988 –1990. Urology 42: 622– 627, 1993. 2. Murphy GP, Mettlin C, Menck H, et al: National patterns of prostate cancer treatment by radical prostatectomy: result of a survey by the American College of Surgeons Committee on Cancer. J Urol 152: 1817–1821, 1994. 3. Uebersax JS, Wyman JF, Shumaker SA, et al: Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 14: 131–138, 1995. 4. Brito CG, Mulcahy JJ, Mitchell ME, et al: Use of a double cuff AMS800 urinary sphincter for severe stress incontinence. J Urol 149: 283–286, 1993. 5. Kreder KJ, Griebling TL, and Williams RD: Efficacy of urethral collagen injection in men with urinary incontinence (abstract). J Urol 155(suppl): 459A, 1996. 6. Litwiller SE, Kim KB, Fone PD, et al: Post-prostatectomy incontinence and the artificial urinary sphincter: a longterm study of patient satisfaction and criteria for success. J Urol 156: 1975–1980, 1996. 7. Gundian JC, Barrett DM, and Parulkar BG: Mayo Clinic
UROLOGY 56 (4), 2000
experience with use of the AMS800 artificial urinary sphincter for urinary incontinence following radical prostatectomy. J Urol 142: 1459 –1463, 1989. 8. Haab F, Trockman BA, Zimmern PE, et al: Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol 158: 435– 440, 1997. 9. Cummings JM, Boullier JA, and Parra RO: Transurethral collagen injections in the therapy of post-radical prostatectomy stress incontinence. J Urol 155: 1011–1015, 1996. 10. Appell RA, McGuire EJ, DeRidder PA, et al: Summary of effectiveness and safety in the prospective, open, multicenter investigation of Contigen implant for incontinence due to intrinsic sphincteric deficiency in males. J Urol 151(suppl): 271A, 1994. 11. Smith DN, Appell RA, Rackley RR, et al: Collagen injection therapy for post-prostatectomy incontinence. J Urol 160: 364 –368, 1998. 12. Cespedes RD, Cross CA, McGuire EJ, et al: Collagen injection therapy for the treatment of male urinary incontinence. J Urol 155(suppl): 458A, 1996. 13. Klutke JJ, Subir C, Andriole G, et al: Long-term results after antegrade collagen injection for stress urinary incontinence following radical retropubic prostatectomy. Urology 53: 975–980, 1999. 14. Appell RA, Vasavada SP, Rackley RR, et al: Percutaneous antegrade collagen injection therapy for urinary incontinence following radical prostatectomy. Urology 48: 769 –774, 1996. 15. Schaeffer AJ, Clemens JQ, Ferrari M, et al: The male bulbourethral sling procedure for post-radical prostatectomy incontinence. J Urol 159: 1510 –1514, 1998.
603
COMPARISON OF ARTIFICIAL URINARY SPHINCTER AND COLLAGEN FOR THE TREATMENT OF POSTPROSTATECTOMY INCONTINENCE DIMITRI D. KUZNETSOV, HYUNG L. KIM, RAJESH V. PATEL, GARY D. STEINBERG, GREGORY T. BALES
AND
ABSTRACT Objectives. To compare how urinary symptoms affect the quality of life in groups of men with postprostatectomy incontinence treated with collagen versus artificial urinary sphincter implantation. Methods. Two cohorts of men, one which received urethral collagen injection and one artificial urinary sphincter (AUS) implantation, were surveyed with a validated quality-of-life questionnaire to assess how their urinary dysfunction impacted their daily activities. The mean impact score and bother score for the two groups were compared. In addition, the overall degree of continence between the groups was assessed. Results. At a mean follow-up of 19 months, 8 (20%) of 41 patients treated with collagen injections were at least socially continent, requiring one pad daily or less. In comparison, 27 (75%) of 36 men treated with an AUS were at least socially continent (P ⬍0.001). Both the impact score and the bother score from the quality-of-life questionnaire were significantly lower in the group treated with the AUS than in the group treated with collagen. Conclusions. Patients receiving an AUS achieved significantly higher continence rates. Also, the quality of life of men treated with an AUS was improved compared with that of the men treated with collagen injection. UROLOGY 56: 600–603, 2000. © 2000, Elsevier Science Inc.
I
ncontinence after radical prostatectomy is very prevalent, with some reports suggesting incidence rates as high as 20% to 40%.1,2 The various therapeutic options for these patients include continence pads, fluid restriction, penile clamps, sympathomimetics, urethral collagen injections, and artificial urinary sphincter (AUS) implantation. Urethral collagen injection therapy and AUS placement are two surgical modalities that have been shown to improve continence; however, to our knowledge, a direct head-to-head comparison has not been performed. A randomized, prospective trial between these two surgical options is difficult to perform, because most patients are unwilling to be randomized between two procedures that are associated with vastly different morbidity and success rates. In addition, most patients generally pre-
From the University of Chicago Hospitals, Chicago, Illinois Reprint requests: Gregory T. Bales, M.D., Section of Urology, Department of Surgery, University of Chicago Hospital, 5841 South Maryland Avenue, MC6038, Chicago, IL 60637 Submitted: April 3, 2000, accepted (with revisions): May 30, 2000
600
© 2000, ELSEVIER SCIENCE INC. ALL RIGHTS RESERVED
fer a less invasive form of treatment as first-line therapy before considering an AUS. In comparing treatments for incontinence, the effect of the treatment on urinary leakage is an important endpoint; however, the effect of the treatment on the quality of life is also a critical measure for gauging success. We used a validated quality-of-life questionnaire to compare the outcome of collagen injection therapy and AUS placement in a group of men with postprostatectomy incontinence.3 Our study compared how patients respond to each treatment modality by assessing specifically how their urinary symptoms affect their quality of life. MATERIAL AND METHODS Eighty-five men who had undergone either transurethral collagen injections (n ⫽ 44) or placement of an AUS (n ⫽ 41) for postprostatectomy incontinence between July 1997 and August 1999 comprised the study group. All men were treated at a single university hospital by the same urologist (G.T.B.). All men had had significant stress urinary incontinence for at least 1 year after radical prostatectomy and the incontinence had persisted despite conservative measures (fluid restriction, sympathomimetics, and Kegel exercises). All patients were 0090-4295/00/$20.00 PII S0090-4295(00)00723-8
TABLE I. Comparison of collagen and artificial urinary sphincter Collagen (n ⴝ 41) AUS (n ⴝ 36) Dry (0 pads) Dry, socially continent (ⱕ1 pad/day) Incontinent (⬎1 pad/day)
1 (2%) 7 (17%) 33 (81%)
12 (33%) 15 (42%) 9 (25%)
P Value ⬍0.001* 0.017† ⬍0.001†
KEY: AUS ⫽ artificial urinary sphincter. Numbers in parentheses are percentages. * Fisher’s exact test. † Chi-square analysis.
significantly bothered enough to desire surgical intervention. A complete history, physical examination, and urinalysis were obtained for all patients. All patients with urge incontinence or pre-existing voiding dysfunction were excluded from the study. For patients undergoing collagen therapy, a subcutaneous test injection was performed 1 month before the procedure to rule out immunologic reactivity to bovine collagen. A transurethral retrograde approach was used with the patient under intravenous sedation after being placed in the dorsal lithotomy position. The collagen was injected submucosally at the 3-, 6-, and 9-o’clock positions. Every attempt was made not to inject into the external sphincter itself. Coaptation of the mucosa signaled the termination of the procedure. The patients were asked to void before leaving the hospital, and any patient with urinary retention was begun on intermittent catheterization with a 12F Foley catheter. All patients, especially if the incontinence improved after the first injection, were encouraged to undergo a second injection. However, an option to undergo AUS placement was offered to patients who derived absolutely no benefit from the first procedure. The AUS group was composed of men who elected to have the AUS after the initial evaluation (n ⫽ 32) or after collagen therapy failed (n ⫽ 9). Men with any symptoms suggestive of bladder instability underwent a urodynamic study to rule out detrusor abnormalities as the cause of their incontinence. An AMS800 AUS was implanted around the proximal bulbar urethra with either a 61 to 70-cm H2O or 71 to 80-cm H2O pressure balloon. A double cuff was implanted in 7 patients using the technique of Mulcahy.4 In brief, a second cuff is placed at least 2 cm distal to the first cuff, and a Y-adaptor connects both to the same pump. No quantitative criterion was used to determine the use of a single cuff versus a double cuff. Patients with significant (continuous) leakage in the upright position received a double cuff. A urinary catheter was inserted during surgery and removed on postoperative day 1, before discharge. Patients were discharged with 10 days of oral antibiotic coverage and seen at the clinic 4 to 6 weeks postoperatively for sphincter activation. The outcome was determined retrospectively using a validated quality-of-life questionnaire designed to assess the impact and bother of any persistent voiding dysfunction. Specifically, the measured parameters included the degree of incontinence (number of pads required daily), impact of the voiding dysfunction on daily activities, and level of bother associated with the voiding dysfunction. Continence was graded as dry, socially continent (minimal leakage requiring one pad per day or less), or incontinent, with the number of pads used specified. The impact and bother scores were calculated by assigning an analog value to each answer on the questionnaire and then obtaining an overall sum for each patient. A higher score correlated with a greater degree of impact and/or bother. All comparisons were analyzed using the t test, Fisher’s exact test, and chi-square analysis. A P value of 0.05 or less was considered statistically significant. UROLOGY 56 (4), 2000
RESULTS We enrolled a total of 85 men, of whom 77 (91%) responded to the questionnaire (41 in the collagen group and 36 in the AUS group) and form the basis for this report (Table I). Of the patients lost to follow-up, three were in the collagen group and five in the AUS group. A median number of two injections (range one to four) was used in the collagen group. At a mean follow-up of 19 months, 20% of the collagen patients versus 75% of the AUS patients were either completely dry or socially continent (P ⬍0.001). Two percent of the collagen group versus 33% of the sphincter group became completely dry (Table I). The mean post-treatment impact score was 9.1 (SD 5.2) and 3.8 (SD 5.8) in the collagen and AUS group, respectively (P ⬍0.001). Likewise, the degree of bother associated with post-treatment residual urinary leakage was higher in the collagen group (mean 6.4; SD 3.0) than in the AUS group (mean 3.9; SD 3.7, P ⫽ 0.002). The crossover rate for patients who initially had undergone collagen therapy and subsequently underwent AUS placement was 20% (9 of 44). A similar rate has been previously reported.5 None of the patients knew the ultimate goal of the questionnaire to prevent any bias that they might have had toward one therapy or another. The complications encountered in the collagen group included 1 patient who required temporary intermittent catheterization for postoperative urinary retention and 2 patients who developed transient dysuria. The AUS group had no sphincterrelated infections, and no sphincters were removed because of erosion or mechanical failure at a mean follow-up of 19 months. One patient underwent a pump revision because of a high-riding pump mechanism. COMMENT Persistent incontinence after radical prostatectomy is a psychologically and socially disabling problem. Today, surgical options offer patients palliation and potentially a complete resolution of their incontinence. Several reports have evaluated 601
either collagen injection or AUS therapy for postprostatectomy incontinence; however, a head-tohead comparison has not been reported. Our results demonstrate that patients who undergo AUS placement are more likely to be completely continent and have a much higher rate of being socially continent (maximum one pad per day) compared with patients treated with collagen. However, given the vastly different morbidity associated with the two procedures, a direct comparison of the continence rates after surgery may not be valid. Litwiller et al.6 hypothesized that a patient’s perception of continence and satisfaction after AUS implantation might be the most important variable to evaluate. Several studies have assessed the quality of life after placement of an AUS; however, to our knowledge, no previous study has addressed the quality of life of patients after collagen injections. In the present study, the continued impact and bother that urinary incontinence had on the quality of daily life was significantly higher in the patients who underwent collagen injections than in those who received AUS therapy. In studies reported by Litwiller et al.6 and Gundian et al.,7 the patient satisfaction rate for men who underwent AUS implantation was approximately 90% overall. This high level of satisfaction was also noted in patients who required a revision of the sphincter. In addition, 92% of the patients stated that they would undergo AUS placement again and 14% of men noted an improvement in their sexual function. These results were confirmed by Haab et al.8 using a visual analog scale that demonstrated a high level of satisfaction, with a lengthy mean follow-up time of 7.2 years. The high patient satisfaction rate often correlates with the degree of improvement. However, it is interesting to note that patients who still have some degree of incontinence after treatment are often satisfied with their outcome; this likely reflects the realistic expectations patients have about the treatment outcome. The advantage of collagen therapy is that historically it has been well tolerated with a low complication rate.9,10 Our results also demonstrate that this procedure was well tolerated. Some investigators have reported administering as many as four to five injections to achieve maximal benefit.11,12 We found it difficult to convince patients to undergo more than two injections if they had not derived any benefit from the first one or two attempts. Furthermore, several patients, including some who initially improved but then regressed, opted to undergo AUS implantation rather than continue with collagen injections. Recently, an antegrade method of collagen instillation has been reported to provide significant improvement with only one session. Using an antegrade approach, Klutke et al.13 602
reported a 10% complete continence rate with improvement in an additional 45%. Appell et al.14 further demonstrated that some patients in whom the retrograde approach failed can be effectively treated with an antegrade approach. Perhaps our collagen patients would have scored higher if an antegrade approach had been used. Although we were able to demonstrate improved continence and quality of life in men who underwent placement of an AUS compared with those treated with collagen injections, there are several limitations in our study, which may limit the broad applicability of our findings. First, in this retrospective study, the exact quantification of the degree of pretreatment incontinence was not possible. In general, the patients who received an AUS had a greater degree of urinary leakage than the patients who received collagen injections. Since the degree of satisfaction after therapy may be influenced by the severity of incontinence before treatment, it may be difficult to directly compare quality-of-life changes in the two groups. Second, we may have achieved better results with collagen injections if all the patients had received four to five treatments, as suggested by some investigators.11,12 Finally, a comparison between patients who had achieved similar degrees of continence after placement of an AUS or collagen injections might have favored the collagen group, since this is less invasive and avoids the need for device activation. However, despite these limitations, we believe that the two treatment groups are representative of typical patients with postprostatectomy incontinence and that our results indicate the significant improvement in urinary control and quality of life that can be anticipated by most patients who undergo AUS placement. Newer surgical procedures have recently been introduced that may further improve therapy. Schaeffer et al.15 described a bulbourethral sling procedure that entails placing a hammock around the deep bulbous urethra. In addition, newer injectables are being introduced that may work better than collagen. However, as with any new modality, additional experience will allow urologists to better assess the efficacy of these new techniques. CONCLUSIONS Both the AUS and collagen can effectively treat urinary leakage after radical prostatectomy. Our results demonstrate that patients receiving an AUS have a higher quality of life and are more likely to be continent than patients treated with collagen injections; however, neither procedure is completely effective. This finding underscores the importance of preoperative counseling, which should UROLOGY 56 (4), 2000
lead to appropriate patient expectations. We hope that continued improvements in the technique of radical prostatectomy and improvements in the treatment of postprostatectomy incontinence will result in fewer men with incontinence after surgery. REFERENCES 1. Fowler FJ Jr, Barry MJ, Lu-Yao G, et al: Patient reported complications and follow-up treatment after radical prostatectomy. The National Medicare Experience: 1988 –1990. Urology 42: 622– 627, 1993. 2. Murphy GP, Mettlin C, Menck H, et al: National patterns of prostate cancer treatment by radical prostatectomy: result of a survey by the American College of Surgeons Committee on Cancer. J Urol 152: 1817–1821, 1994. 3. Uebersax JS, Wyman JF, Shumaker SA, et al: Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 14: 131–138, 1995. 4. Brito CG, Mulcahy JJ, Mitchell ME, et al: Use of a double cuff AMS800 urinary sphincter for severe stress incontinence. J Urol 149: 283–286, 1993. 5. Kreder KJ, Griebling TL, and Williams RD: Efficacy of urethral collagen injection in men with urinary incontinence (abstract). J Urol 155(suppl): 459A, 1996. 6. Litwiller SE, Kim KB, Fone PD, et al: Post-prostatectomy incontinence and the artificial urinary sphincter: a longterm study of patient satisfaction and criteria for success. J Urol 156: 1975–1980, 1996. 7. Gundian JC, Barrett DM, and Parulkar BG: Mayo Clinic
UROLOGY 56 (4), 2000
experience with use of the AMS800 artificial urinary sphincter for urinary incontinence following radical prostatectomy. J Urol 142: 1459 –1463, 1989. 8. Haab F, Trockman BA, Zimmern PE, et al: Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol 158: 435– 440, 1997. 9. Cummings JM, Boullier JA, and Parra RO: Transurethral collagen injections in the therapy of post-radical prostatectomy stress incontinence. J Urol 155: 1011–1015, 1996. 10. Appell RA, McGuire EJ, DeRidder PA, et al: Summary of effectiveness and safety in the prospective, open, multicenter investigation of Contigen implant for incontinence due to intrinsic sphincteric deficiency in males. J Urol 151(suppl): 271A, 1994. 11. Smith DN, Appell RA, Rackley RR, et al: Collagen injection therapy for post-prostatectomy incontinence. J Urol 160: 364 –368, 1998. 12. Cespedes RD, Cross CA, McGuire EJ, et al: Collagen injection therapy for the treatment of male urinary incontinence. J Urol 155(suppl): 458A, 1996. 13. Klutke JJ, Subir C, Andriole G, et al: Long-term results after antegrade collagen injection for stress urinary incontinence following radical retropubic prostatectomy. Urology 53: 975–980, 1999. 14. Appell RA, Vasavada SP, Rackley RR, et al: Percutaneous antegrade collagen injection therapy for urinary incontinence following radical prostatectomy. Urology 48: 769 –774, 1996. 15. Schaeffer AJ, Clemens JQ, Ferrari M, et al: The male bulbourethral sling procedure for post-radical prostatectomy incontinence. J Urol 159: 1510 –1514, 1998.
603