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Surgical results with artificial urinary sphincter
SURGICAL RESULTS WITH ARTIFICIAL URINARY SPHINCTER TERRENCE
R. MALLOY,
ALAN J. WEIN, VICTOR
M.D.
M.D.
L. CARPINIELLO,
M.D.
From the Department of Urology, Philadelphia, Pennsylvania
Pennsylvania
Hospital,
ABSTRACT - FromJune, 1974, untilJanuary, 1977, eleven AMS 721 genitourina y sphincters were installed in 9 men and 2 females. Long term success was achieved in 2 men. Failures were encountered in 9 patients (82 per cent) with urethral erosions (3 patients), infection (1 patient), and mechanical failure (5 patients) accounting for the complications necessitating prosthetic removal. From Janua y, 1979, until May, 1981,lS males had the revised AMS model AS 742 (b) or (c) sphincter installed. Long term continence was achieved in 9 patients (60 per cent). Urethral erosion in 4 patients (27 per cent) and infection of the prosthesis in 2 men (13 per cent) accounted fm failures. An improved surgical technique involving the installation of the device in a defunctionalized state with seconda y activation is anticipated to improve fitire results.
In the past decade, the perplexing problem of urinary incontinence has been treated with various surgical procedures that included surgical prostheses. la2 In 1973, Scott, Bradley, and Timm3 reported on an inflatable genitourinary sphincter that closely simulated the normal human sphincteric mechanism. Since 1974, 26 patients at the University of Pennsylvania teaching &hated hospitals have been treated with 2 models of American Medical Systems (AMS) genitourinary sphincters. Material
and Methods
From June, 1974, until January, 1977, 11AMS 721 genitourinary sphincters were implanted in 9 male and 2 female patients. The AMS GU sphincter* is a hydraulic prosthesis made of silicone elastomer. It consists of an inflatable sphincter cuff which surrounds the bladder neck in the female and either the bulbous urethra or vesical neck in the male. This cuff is connected
*American
602
by tubing to inflate and deflate valves which are placed in the labia or scrotum. These valves were further attached to a reservoir in the preperitoneal space. Fluid was pumped from the reservoir into the cuff to produce continence. To void the patient deflated the cuff by pumping the fluid back to the reservoir. The causations of incontinence in the 11 patients receiving the AMS 721 sphincter are listed in Table I. Ages range from twenty-three to seventy-seven. All the male patients had experienced previous genitourinary surgery on
Medical Systems,
Minneapolis,
Minnesota 55426.
TABLE I. Causation of incontinence in 9 males and 2 fmles receiving AMS 721 GU sphincters Causation
Males
Females
Post TUR prostate Neurogenic bladder Postradical prostatectomy Posturethral diverticulectomy
4 3
1
UROLOGY
/
JUNE 1982
2 1
/
VOLUME
XIX, NUMBER
6
FIGURE 1. (A) AMS model AS 742 (b) arti@al urinary sphincter, now marketed as AS 791; (B) AMS model AS 742 (c) artificial urinary sphincter, now marketed as AS 792.
bladder necks, or external their prostates, sphincters. The 2 female patients had previous vaginal and retropubic suspensions of their bladders and urethras in an effort to correct their incontinence. The operative technique utilized has been described previously by Scott, Bradley, and Timm. 4*5 Due to the problems with device malfunction, infections, and urethral erosion, no additional patients received the AMS 721 sphincter after 1977. From January, 1979, until May, 1981, a revised AMS model AS 742 (b) or AS 742 (c) was implanted in 15 men (Fig. 1). The AS 742 (b) or (c) consists of sphincteric occlusive cuff, a deflation pump, a delayed-fill resister (control assembly), and a balloon reservoir which regulates pressure within the cuff. The cuff in the AS 742 (b) model is implanted around the bulbous urethra (Fig. 1A). The AS 742 (c) model is implanted
TABLE II. Causation of incontinence in 15 mules receiving AMS 742 (b) or (c) GU sphincters
Causation
Males
Post TUR prostate Post open prostatectomy Neurogenic bladder Post exstrophy closure
UROLOGY
/ JUNE 1982 / VOLUMEXIX,NUMBER6
at the vesical neck (Fig. IB). The patient deflates
the sphincteric cuff to void. The sphincter is automatically filled by the balloon through the delayed-fill resister (control assembly) within ninety to one hundred twenty seconds. The causation of incontinence in the 15 males receiving the AS 742 (b) or (c) prosthesis is listed in Table II. Ages range from twenty-eight to seventy-eight. Fourteen patients received the AS 742 (b) prosthesis while 1 patient had the 742 (c) model. One patient previously had had an AMS 721 GU sphincter which had been removed two years previously. The surgical technique utilized was that described by Scott.’ The following preoperative studies were utilized to assess all patients. 1. Urographic studies IVP Voiding cystourethrogram Retrograde urethrogram (optional) 2. Urodynamics Cystometrogram Urine flowmetry Urethra pressure profile Sphincter EMG (optional) 3. Endoscopy Resection residual adenoma (if needed) External sphincterotomy Internal urethrotomy 4. Urine culture and sensitivity
603
Urographic studies should reveal normal upper urinary tracts with complete evacuation of bladder on post-voiding films. If the voiding cystourethrogram shows vesicoureteral reflux, the patients are not necessarily excluded from receiving the sphincter. Urine cultures should be negative. If infection is present, surgery should be delayed until sepsis is eradicated. Urodynamic studies are necessary to rule out sphincter dyssynergia. A good detrusor force should be present. Relative contraindications to installing the artificial GU sphincter are: (1) poor urinary flow rate (less than 7 ct./second mean flow), (2) poor compliance, (3) small (fibrotic) capacity bladder, (4) resistant urinary tract infection, (5) mental or physical retardation, and (6) poor motivation. Cystoscopy should be done on all patients to rule out strictures or residual prostatic adenoma that would impede complete evacuation of the bladder. If either are present, internal urethrotomy or a complete transurethral resection of the prostate should be completed six to eight weeks prior to installing the sphincter. Patients with paraplegia or bladder-sphincter dyssynergia should have an external sphincterotomy prior to implantation. Results Eleven patients received the AMS 721 sphincter (9 men, 2 women). Two men had excellent long term results (no incontinence and no pads). Nine patients (82 per cent) had short term success but required eventual removal of the prosthesis for the following reasons: (1) urethral erosions, 3 patients (2 females and 1 male); (2) infection, 1 patient; and (3) mechanical failure of V4 valve or cuff, 5 patients. In 15 males receiving the AS 742 (b) and (c) prosthesis, 9 patients (60 per cent) had an excellent long term result (no incontinence and no need for pads). Urethral erosion occurred in 4 patients (27 per cent) necessitating removal of the device. In 2 patients infection developed around the deflate pump or cuff necessitating removal of the prosthesis. All 6 patients are waiting for reimplantation. Comment The AMS 721 sphincter, although initially successful, had many disadvantages that eventually led to a high failure rate and eventual abandonment of its use as a prosthesis. The
604
device required two separate valves for inflation and deflation. These valves were subject to mechanical failure, as well as the cue. The device was complicated to implant and somewhat complicated for the patient to use. Its main advantage, however, was it could be implanted in the deflated state to allow time for periurethral tissue to heal prior to use. The AS 742 (b) or (c), which is now marketed as AS 791 or AS 792, has had a markedly improved success rate. However, in our small series a 40 per cent failure rate was encountered. Two thirds of these failures were due to urethral erosions. Initially the balloons utilized were higher pressure (90 to 100 mm.) than presently utilized. Experience has shown that the balloon for bulbous urethral pressure implacement probably should not exceed a pressure of 60 or 70 mm. Many of the incontinent males are elderly postoperative prostatectomy patients. The arterial perfusion pressure to the urethra and surrounding tissue often is diminished in this age group. A high pressure from the sphincter cuff is not needed as originally anticipated. Furlow in an effort to decrease the urethral erosions in his patients introduced the concept “primary deactivation.” In these patients, the cuff is installed perineally around the bulbous urethra. The pressure-regulating balloon is filled and inserted in the prevesical space. The deflation pump is inserted in the subcutaneous tissue of the scrotum or labia. However, none of the components is connected to the delayedfill resister (control assembly). Their tubings are plugged, and the incision is closed. This allows the tissue time to heal and the formation of a fibrous sheath around the silicone components. In two to four months the patient has a small inguinal incision through which the components are attached to the control assembly for activation. This technique allows the patient to activate the device immediately without pain or swelling around the deflation bulb in the scrotum or labia. The periurethral tissue has healed at this point, vastly decreasing the chance for urethral erosion. Five patients in our series had this technique of dehmctionalized installation with subsequent activation. Excellent results were obtained in all 5 cases. The method of installing the AMS model AS 742 in a defirnctionalized state with subsequent activation should be considered appropriate in patients with the following conditions: (1) All females. Most incontinent females have had numerous previous surgical procedures to their
UROLOGY
/
JUNE 1982
/
VOLUME XIX, NUMBER 6
urethras and bladder necks. These structures are thin and often scarred which makes them vulnerable to erosions. (2) Males with previous urethral erosions. (3) Males with multiple operations on the urethra or vesical neck. (4) Males who have had pelvic radiation. (5) Males with evidence of poor arterial perfusion to periurethral tissue. Further experience with the AS 742 (b) or (c) is necessary before significant claims of long term success can be made. However, it is our anticipation that with careful selection of patients, adherence to strict asepsis, and proper utilization of delayed activation the AS 742 (b) or (c) (AS 791 or AS 792) should prove to be an effective surgical means for the treatment of the incontinent patient:.
UROLOGY
/
JUNE
1982
/
VOLUME
XIX, NUMBER
6
Philadelphia, Pennsylvania 19145 (DR. MALLOW References 1. Kaufman JJ: Treatment of post-prostatectomy incontinence using a silicone jel prosthesis, Br. J. Urol. 45: 646 (1973). 2. Rosen N: The Rosen inflatable incontinence prosthesis, Urol. Clin. North Am. 5: 405 (1978). 3. Scott FB, Bradley WE, and Timm GW: Treatment ofurinary incontinence by an implantable prosthetic sphincter, Urology 1: 252 (1973). 4. Scott FB, et al: Treatment of incontinence secondary to myelodysplasia by an implantable prosthetic urinary sphincter, South. Med. J. 66: 987 (1973). 5. Scott FB, Bradley WE, and Timm GW: Treatment of urinary incontinence by the implantable prosthetic urinary sphincter, J. Urol. 112: 75 (1974). 6. Scott FB: The artificial sphincter in the management of incontinence in the male, Ural. Clin. North Am. 5: 375 (1978). 7. Furlow WL: Implantation of a new semi-automatic artificial genitourinary sphincter: experience with primary activation and deactivation in 47 patients, J. Ural. 1.26: 741 (1981).
605
R. MALLOY,
ALAN J. WEIN, VICTOR
M.D.
M.D.
L. CARPINIELLO,
M.D.
From the Department of Urology, Philadelphia, Pennsylvania
Pennsylvania
Hospital,
ABSTRACT - FromJune, 1974, untilJanuary, 1977, eleven AMS 721 genitourina y sphincters were installed in 9 men and 2 females. Long term success was achieved in 2 men. Failures were encountered in 9 patients (82 per cent) with urethral erosions (3 patients), infection (1 patient), and mechanical failure (5 patients) accounting for the complications necessitating prosthetic removal. From Janua y, 1979, until May, 1981,lS males had the revised AMS model AS 742 (b) or (c) sphincter installed. Long term continence was achieved in 9 patients (60 per cent). Urethral erosion in 4 patients (27 per cent) and infection of the prosthesis in 2 men (13 per cent) accounted fm failures. An improved surgical technique involving the installation of the device in a defunctionalized state with seconda y activation is anticipated to improve fitire results.
In the past decade, the perplexing problem of urinary incontinence has been treated with various surgical procedures that included surgical prostheses. la2 In 1973, Scott, Bradley, and Timm3 reported on an inflatable genitourinary sphincter that closely simulated the normal human sphincteric mechanism. Since 1974, 26 patients at the University of Pennsylvania teaching &hated hospitals have been treated with 2 models of American Medical Systems (AMS) genitourinary sphincters. Material
and Methods
From June, 1974, until January, 1977, 11AMS 721 genitourinary sphincters were implanted in 9 male and 2 female patients. The AMS GU sphincter* is a hydraulic prosthesis made of silicone elastomer. It consists of an inflatable sphincter cuff which surrounds the bladder neck in the female and either the bulbous urethra or vesical neck in the male. This cuff is connected
*American
602
by tubing to inflate and deflate valves which are placed in the labia or scrotum. These valves were further attached to a reservoir in the preperitoneal space. Fluid was pumped from the reservoir into the cuff to produce continence. To void the patient deflated the cuff by pumping the fluid back to the reservoir. The causations of incontinence in the 11 patients receiving the AMS 721 sphincter are listed in Table I. Ages range from twenty-three to seventy-seven. All the male patients had experienced previous genitourinary surgery on
Medical Systems,
Minneapolis,
Minnesota 55426.
TABLE I. Causation of incontinence in 9 males and 2 fmles receiving AMS 721 GU sphincters Causation
Males
Females
Post TUR prostate Neurogenic bladder Postradical prostatectomy Posturethral diverticulectomy
4 3
1
UROLOGY
/
JUNE 1982
2 1
/
VOLUME
XIX, NUMBER
6
FIGURE 1. (A) AMS model AS 742 (b) arti@al urinary sphincter, now marketed as AS 791; (B) AMS model AS 742 (c) artificial urinary sphincter, now marketed as AS 792.
bladder necks, or external their prostates, sphincters. The 2 female patients had previous vaginal and retropubic suspensions of their bladders and urethras in an effort to correct their incontinence. The operative technique utilized has been described previously by Scott, Bradley, and Timm. 4*5 Due to the problems with device malfunction, infections, and urethral erosion, no additional patients received the AMS 721 sphincter after 1977. From January, 1979, until May, 1981, a revised AMS model AS 742 (b) or AS 742 (c) was implanted in 15 men (Fig. 1). The AS 742 (b) or (c) consists of sphincteric occlusive cuff, a deflation pump, a delayed-fill resister (control assembly), and a balloon reservoir which regulates pressure within the cuff. The cuff in the AS 742 (b) model is implanted around the bulbous urethra (Fig. 1A). The AS 742 (c) model is implanted
TABLE II. Causation of incontinence in 15 mules receiving AMS 742 (b) or (c) GU sphincters
Causation
Males
Post TUR prostate Post open prostatectomy Neurogenic bladder Post exstrophy closure
UROLOGY
/ JUNE 1982 / VOLUMEXIX,NUMBER6
at the vesical neck (Fig. IB). The patient deflates
the sphincteric cuff to void. The sphincter is automatically filled by the balloon through the delayed-fill resister (control assembly) within ninety to one hundred twenty seconds. The causation of incontinence in the 15 males receiving the AS 742 (b) or (c) prosthesis is listed in Table II. Ages range from twenty-eight to seventy-eight. Fourteen patients received the AS 742 (b) prosthesis while 1 patient had the 742 (c) model. One patient previously had had an AMS 721 GU sphincter which had been removed two years previously. The surgical technique utilized was that described by Scott.’ The following preoperative studies were utilized to assess all patients. 1. Urographic studies IVP Voiding cystourethrogram Retrograde urethrogram (optional) 2. Urodynamics Cystometrogram Urine flowmetry Urethra pressure profile Sphincter EMG (optional) 3. Endoscopy Resection residual adenoma (if needed) External sphincterotomy Internal urethrotomy 4. Urine culture and sensitivity
603
Urographic studies should reveal normal upper urinary tracts with complete evacuation of bladder on post-voiding films. If the voiding cystourethrogram shows vesicoureteral reflux, the patients are not necessarily excluded from receiving the sphincter. Urine cultures should be negative. If infection is present, surgery should be delayed until sepsis is eradicated. Urodynamic studies are necessary to rule out sphincter dyssynergia. A good detrusor force should be present. Relative contraindications to installing the artificial GU sphincter are: (1) poor urinary flow rate (less than 7 ct./second mean flow), (2) poor compliance, (3) small (fibrotic) capacity bladder, (4) resistant urinary tract infection, (5) mental or physical retardation, and (6) poor motivation. Cystoscopy should be done on all patients to rule out strictures or residual prostatic adenoma that would impede complete evacuation of the bladder. If either are present, internal urethrotomy or a complete transurethral resection of the prostate should be completed six to eight weeks prior to installing the sphincter. Patients with paraplegia or bladder-sphincter dyssynergia should have an external sphincterotomy prior to implantation. Results Eleven patients received the AMS 721 sphincter (9 men, 2 women). Two men had excellent long term results (no incontinence and no pads). Nine patients (82 per cent) had short term success but required eventual removal of the prosthesis for the following reasons: (1) urethral erosions, 3 patients (2 females and 1 male); (2) infection, 1 patient; and (3) mechanical failure of V4 valve or cuff, 5 patients. In 15 males receiving the AS 742 (b) and (c) prosthesis, 9 patients (60 per cent) had an excellent long term result (no incontinence and no need for pads). Urethral erosion occurred in 4 patients (27 per cent) necessitating removal of the device. In 2 patients infection developed around the deflate pump or cuff necessitating removal of the prosthesis. All 6 patients are waiting for reimplantation. Comment The AMS 721 sphincter, although initially successful, had many disadvantages that eventually led to a high failure rate and eventual abandonment of its use as a prosthesis. The
604
device required two separate valves for inflation and deflation. These valves were subject to mechanical failure, as well as the cue. The device was complicated to implant and somewhat complicated for the patient to use. Its main advantage, however, was it could be implanted in the deflated state to allow time for periurethral tissue to heal prior to use. The AS 742 (b) or (c), which is now marketed as AS 791 or AS 792, has had a markedly improved success rate. However, in our small series a 40 per cent failure rate was encountered. Two thirds of these failures were due to urethral erosions. Initially the balloons utilized were higher pressure (90 to 100 mm.) than presently utilized. Experience has shown that the balloon for bulbous urethral pressure implacement probably should not exceed a pressure of 60 or 70 mm. Many of the incontinent males are elderly postoperative prostatectomy patients. The arterial perfusion pressure to the urethra and surrounding tissue often is diminished in this age group. A high pressure from the sphincter cuff is not needed as originally anticipated. Furlow in an effort to decrease the urethral erosions in his patients introduced the concept “primary deactivation.” In these patients, the cuff is installed perineally around the bulbous urethra. The pressure-regulating balloon is filled and inserted in the prevesical space. The deflation pump is inserted in the subcutaneous tissue of the scrotum or labia. However, none of the components is connected to the delayedfill resister (control assembly). Their tubings are plugged, and the incision is closed. This allows the tissue time to heal and the formation of a fibrous sheath around the silicone components. In two to four months the patient has a small inguinal incision through which the components are attached to the control assembly for activation. This technique allows the patient to activate the device immediately without pain or swelling around the deflation bulb in the scrotum or labia. The periurethral tissue has healed at this point, vastly decreasing the chance for urethral erosion. Five patients in our series had this technique of dehmctionalized installation with subsequent activation. Excellent results were obtained in all 5 cases. The method of installing the AMS model AS 742 in a defirnctionalized state with subsequent activation should be considered appropriate in patients with the following conditions: (1) All females. Most incontinent females have had numerous previous surgical procedures to their
UROLOGY
/
JUNE 1982
/
VOLUME XIX, NUMBER 6
urethras and bladder necks. These structures are thin and often scarred which makes them vulnerable to erosions. (2) Males with previous urethral erosions. (3) Males with multiple operations on the urethra or vesical neck. (4) Males who have had pelvic radiation. (5) Males with evidence of poor arterial perfusion to periurethral tissue. Further experience with the AS 742 (b) or (c) is necessary before significant claims of long term success can be made. However, it is our anticipation that with careful selection of patients, adherence to strict asepsis, and proper utilization of delayed activation the AS 742 (b) or (c) (AS 791 or AS 792) should prove to be an effective surgical means for the treatment of the incontinent patient:.
UROLOGY
/
JUNE
1982
/
VOLUME
XIX, NUMBER
6
Philadelphia, Pennsylvania 19145 (DR. MALLOW References 1. Kaufman JJ: Treatment of post-prostatectomy incontinence using a silicone jel prosthesis, Br. J. Urol. 45: 646 (1973). 2. Rosen N: The Rosen inflatable incontinence prosthesis, Urol. Clin. North Am. 5: 405 (1978). 3. Scott FB, Bradley WE, and Timm GW: Treatment ofurinary incontinence by an implantable prosthetic sphincter, Urology 1: 252 (1973). 4. Scott FB, et al: Treatment of incontinence secondary to myelodysplasia by an implantable prosthetic urinary sphincter, South. Med. J. 66: 987 (1973). 5. Scott FB, Bradley WE, and Timm GW: Treatment of urinary incontinence by the implantable prosthetic urinary sphincter, J. Urol. 112: 75 (1974). 6. Scott FB: The artificial sphincter in the management of incontinence in the male, Ural. Clin. North Am. 5: 375 (1978). 7. Furlow WL: Implantation of a new semi-automatic artificial genitourinary sphincter: experience with primary activation and deactivation in 47 patients, J. Ural. 1.26: 741 (1981).
605