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Treatment of urinary incontinence by an implantable prosthetic urinary sphincter
0022-5347/02/1672-1125/0 TItEJoum<,~OF UROLOGY~
Vol. 167, 1125-1129,February 2002 Printed in U.S.A.
Copyright © 2002 by A.MERICA,~ ' UROLOGIC,kLASSOCIATION,INC.®
TREATMENT OF URINARY INCONTINENCE BY AN IMPLANTABLE PROSTHETIC URINARY SPHINCTER F. B R A N T L E Y SCOTT, W I L L I A M E. B R A D L E Y AND G E R A L D W. T I M M
From the Roy and Lillie Cullen Department of Urologic Research, Division of Urology, Baylor College of Medicine and the Urology Service, St. Luke's Episcopal Hospital, Houston, Texas, and the Departments of Neurology and Electrical Engineering, University of Minnesota Hospitals, Minneapolis, Minnesota (Reprinted from J Urol, 112: 75-80, 1974) Our concern with urinary incontinence and our certainty that control of sphincteric function is essential to achieve electromechanical take-over of micturition in patients with neurologic bladder dysfunction, led us to the development of an artificial prosthetic urinary sphincter. Animal studies convinced us of its effectiveness and safety. 1 In June 1972 the first prosthetic urinary sphincter was implanted in a human. Since that time this prosthesis has been implanted in more than 34 patients for the treatment of urinary incontinence of various causes. The goals of this new method of treatment in patients were many: 1) to determine whether the concept of an occlusive cuff around the urethra as first advocated by Foley2 was sound in rendering the patient continent, 2) to determine whether total implantation of such a prosthesis in a human was safe, as it had been in animals, 3) to determine the reliability of a mechanical device totally implanted and under external control, 4) to prove that the device would not interfere with normal function of the lower urinary tract and 5) to prove that the device would not cause obstruction during voiding. Our goals included an attempt to rehabilitate selected patients with neurologic bladder dysfunction and to offer patients who underwent an unsuccessful operation for stress incontinence or whose atonic bladders contraindicated an operation for stress incontinence a new alternative to achieve continence. We also sought to determine the occlusive pressure about the urethra that would be safe yet effective in bringing about volitional control of voiding. The surgical technical problems of implantation, the most effective and simplest technique of implantation and the most effective preoperative and postoperative regimen of care all required determination. Last, but perhaps most important, we needed to delineate those neurourological testing criteria which would allow us to appropriately select patient~=who would benefit by this new method of treatment. The results of implantation of an artificial prosthetic urinary sphincter in 34 patients are reported herein. MATERIALS AND METHODS
The prosthetic urinary sphincter. The silicone rubber prosthetic urinary sphincter consisted of 4 main parts: 1) a reservoir, 2) an inflatable occlusive cuff, 3) an inflating pumping mechanism and 4) a deflating pumping mechanism. The reservoir contained a fluid which served to inflate the cuff. The cuff encircled the urethra in such a manner that once completely inflated the urethra was occluded. The pumping
mechanism was activated by squeezing a bulb which was placed subcutaneously. The pumping mechanism contained valves which controlled the direction of flow of fluid within the system and also determined the maximum pressure which could be exerted inside the cuff, obviating the possibility of overinflation. Activation of the deflating pumping mechanism by squeezing the other subcutaneous bulb opened the urethral cuff by returning fluid from the prosthetic occlusive urethral cuff to the reservoir (fig. 1). Surgical method. The prosthetic system was implanted by attaching the reservoir to the posterior rectus sheath behind the rectus muscle. This placed the reservoir in a protected position where it was unlikely to be punctured accidentally. The tubing passed through the inguinal canal into the scrotum or labium. The valves were in a protected position inside the inguinal canal. The bulb which inflated the cuff was placed on the right side of the scrotum or in the right labium. The bulb used to deflate the cuffor open the artificial sphincter was placed in the left side of the scrotum or labium. The cuff which encircled the urethra was placed at the bladder neck, at the membranous urethra or around the bulbous urethra. The surgical technique continued to evolve but the design of the device required at least a portion of the prosthesis be assembled at the operating table and the length of the tubing was often shortened to suit the patient situation. Since many patients had had previous vesical or prevesical operations the placement of the occlusive cuff around the bladder neck demanded meticulously careful dissection. The reservoir was placed beneath abdominal muscles where it was not only protected but where increased abdominal pressure against the reservoir offset pressure increases in the cuff caused by coughing or straining, which otherwise would cause leakage beyond the cuff. Since many patients had had reflex and overflow incontinence with the inability to void satisfactorily, some were rendered totally incontinent by means of a 12 o'clock sphincterotomy in male patients 3 or a bladder flap urethroplasty in female patients. 4 These techniques and the results obtained are the subjects of separate papers. Briefly, the 12 o'clock sphincterotomy consisted of transurethral resection of the urethral sphincter in the anterior 12 o'clock position, taking care to preserve the bladder neck. In the bladder flap urethroplasty, a pedicle flap on the anterior surface of the bladder was advanced and reconstructed into the anterior wall of the urethra, extending the flap throughout the entire length of the urethra, including the meatus. Preoperative evaluation. Preoperative evaluation included a history and physical examination, neurological examination, uroflowmetry, cystometry, voiding fluorocystography, excretory urography (IVP), eystoscopy, micturition study (combined simultaneous recording of cystometry, uroflow-
Accepted for publication December 14, 1973. Supported in part by the National Institutes of Health and the generous contributions of Mr. Albert B. Alkek of Victoria, Texas. 1 Timm, G. W., Bradley, W. E. and Scott, F. B.: Experimental 3 Scott, F. B. and Madersbacher, H.: The twelve o'clock sphincterevaluation of an implantable externally controllable urinary sphincotomy: technique, indications, results. Unpublished data ter. Invest Urol., 2: 326, 1974 4 Scott, F. B. and Kenessey, G.: The bladder flap urethroplasty: a 2 Foley, F. E. B.: An artificial sphincter: a new device and operation for control ofenuresis and urinary incontinence. J Urol., 58: 250, technique to produce total incontinence to improve bladder emptying. Unpublished data 1947 1125
1126
TREATMENT OF URINARY INCONTINENCE
\
FIG. 1. P r o s t h e t i c u r i n a r y s p h i n c t e r c o n s i s t s o f 4 m a i n p a r t s : reservoir, i n f l a t a b l e c u f f a n d 2 p u m p i n g m e c h a n i s m s .
metry and electromyography during voiding) and, in selected cases, electromyelography 5 and sphincterometry. These studies were repeated postoperatively to assess results, particularly fluorocystography and uroflowmetry. In each case, before the patient was discharged from the hospital, the bladder was filled to capacity With radiopaque medium, the patient was placed in the vertical position and asked to cough and strain, while the prosthetic sphincter was closed. This maneuver was repeated with the prosthetic sphincter open, before finally asking the patient to simply void. Patient population. The ages of the patients varied from 3 to 76 years (fig. 2). Sex distribution indicated a predominance of female patients, with 20 female and 14 male. The causes of incontinence are listed in table 1-19 patients had neurological disease, 8 had stress incontinence and 5 had postprostatectomy incontinence. One patient was incontinent because of congenital epispadias and another patient had extensive urethral t r a u m a and required bladder flap reconstruction to create a new urethra and then received an artificial sphincter for control. The majority of patients with neurological causes h~t~l spina bifida with myelomeningocele (table 2). The first patient received the implantation on J u n e 9, 1972 and all patients have had at least I month of followup (fig. 3). More than half of the patients have received the implantation since J a n u a r y 1, 1973. Between June 1972 and J a n u a r y 1973 there were fewer patients operated on, mainly because of the unavailability of the prosthetic sphincter, which at the time of this writing is commercially available.
der dysfunction, with the poorest success rate among pe tients with spinal cord injuries. In looking at the causes ofth 7 failures one will note t h a t 4 of the patients had detrusc hyperreflexia and, thus, detrusor contractions caused ur~ nary leakage beyond the artificial sphincter. Subsequent t this experience the authors have concluded that selectiv differential sacral rhizotomy should be done prior to sphinc ter implantation in patients with detrusor hyperreflexia. One of the patients who had hyperreflexia also had a woun infection, which required removal of the prosthesis. Ther were only 2 wound infections in the entire series and 1 c these 2 patients will undergo reimplantation of the artificie sphincter at a future time. Two of the failures were the resu] of a dehiscence of the wound with exposure of the prosthesfi At this point the prosthesis was removed, since it was be lieved that the chances of healing without infection unde those circumstances were unlikely. However, there was other dehiscence but the patient was immediately close with thorough irrigation of antibiotic solution and he subsc quently healed and had a successful result. Surgical compli cations included dehiscence of the wound in 3 cases (1 c which was repaired with success), deep wound infection re quiring removal of the artificial sphincter in 2 cases, a su perficial wound infection which subsequently healed saris factorily in 1 case and thrombophlebitis of the leg in 2 case (table 3). N
AGE DISTRIBUTION
lOI-
ARTIFICIAL SPHINCTER
5
5 4
gg
4 3
10
20
30
40 AGE
50
60
3
70
80
Fro. 2
TABLE 1.
Neurologic Stress Post-prostatectomy Epispadias Urethral trauma (reconstructed)
Etiology of incontinence No.
Failure
Success Rate
19 8 5 1 1
7 0 0 0 0
12 8 5 1 1
RESULTS
The objective success determined by filling the bladder to capacity with radiopaque medium and having the patient cough or strain while standing in the vertical position was encouraging. All 34 patients were successfully rendered continent. However, clinical success over a longer period of time revealed no urinary leakage at any time under all conditions in 27 of 34 patients. The greatest success rates were obtained in patients with stress and post-prostatectomy incontinence. The 7 failures occurred among patients with neurologic blad5 Bradley, W. E.: Urethral electromyelography. J Urol., 108: 563, 1972
TABLE 2. Neurologic condition Spina bifida with myelomeningocele Spinal cord injury Multiple sclerosis Atonic bladder (unknown cause) Surgical denervation (abdominal perineal) Sacral agenesis
No.
Failure
Success
9
4
5
4 2 2
3 0 0
1 2 2
1
0
1
1
0
1
1127
TREATMENT OF URINARY INCONTINENCE TREATMENT OF URINARY INCONTINENCE N
DAIE OF SURGERY
I0
ARIIFICIAL SPHINClER
8
6 4
1
IFHH nH JUNE 72
JULY AUG SEP1
OCl
NOV DEC
JAN 73
FEB
II
MAR APRIL
FIG. 3
Mechanical complications were noted 8 times in 7 cases (table 4). One patient underwent 2 operative procedures to remove kinks in the tubing at each operative setting. This particular patient was the first young patient in the series (6 years old) and the kinking was attributed to the small prevesical area crowding the artificial sphincter. Before the last operative procedure the prosthesis had been miniaturized and smaller parts were implanted with subsequent excellent results. All 8 mechanical complications were corrected surgically but 2 cases are failures at the present time, one because of detrusor hyperreflexia 6 which contraindicates any future attempt at repair and the other because of dehiscence of the wound which required removal of the prosthesis for healing. In the latter patient a repeat attempt to implant the prosthesis has been requested by the patient and is planned for the future. The serious mechanical problems of splitting of the tube, leaking of the reservoir and leaking of the bulb, all occurred within the first 6 patients. Subsequent prostheses were prepared under more stringent quality control conditions. One patient was continent except when he sat on the occlusive cuff, which had been placed around the bulbous urethra. This condition was corrected by moving the occlusive cuff to a more suitable position around the more distal bulbous urethra. Therefore, if the occlusive cuff is placed too far posteriorly in the bulbous urethra adjacent to the perineal body, there is likely to be compression of the cuff with sitting, which then results in deflation and subsequent leakage. ~,~ Repeat cystoscopic evaluations have shown excellent tissue acceptance with good normal color of the urethral mucosa and there has been no evidence of sloughing of the urethral mucosa, nor has there been any sign of fecal or urinary fistula formation. In order to improve bladder emptying prior to implantation of the artificial sphincter, 8 female patients underwent bladder flap urethroplasty, whereas 4 male patients underwent transurethral sphincterotomy. Since all patients have been kept on suppressive medication for a period of time postoperatively insufficient time has elapsed to take them off their suppressive medication and to determine whether they will have recurrent cystitis. How: ever, there have been no apparent cases in which infection became a problem postoperatively and several of the patients who were operated on several months ago are now off all antibiotics and maintaining a sterile urinary tract. Therefore, the indications are encouraging at this time. A case is reported to illustrate the success that has been 6 Rockswold, G. L., Bradley, W. E. and Chou, S. N.: Differential sacral rhizotomy in the treatment ofneurogenic bladder dysfunction. Preliminary report of six cases. J Neurosurg., 38: 748, 1973
TABLE 3. Surgical complications No. Dehiscence Deep wound infection Superficial wound infection Leg thrombophlebitis
3 2 1 2
TABLE 4. Mechanical complications No.
No. Pts. Reservoir leak Kink Tubing split Bulb leak Sitting on cuff
1 3 1 1 1
Complications 1 4 1 1 1
All corrected but 2 patients are failures at present owing to hyperreflexia and dehiscence.
achieved in rehabilitating patients with neurologic bladder dysfunction. CASE REPORT
G. B., a 27-year-old man, had a myelomeningocele repaired at birth. The neurological deficit included partial sacral anesthesia and neurological bladder dysfunction leading to bilateral hydronephrosis. The patient was ambulatory and did not need crutches. Because of advancing hydronephrosis he was referred to another doctor for ileal urinary diversion. However, he was advised to lose weight before undergoing ileal diversion. The patient was able to reduce from 450 to 308 pounds but an ileal diversion was still out of the question because of marked obesity. Instead, a suprapubic cystostomy was done. Subsequent to this procedure the patient was bothered with frequent recurrent bladder calculi, recurrent sepsis and progression of the hydronephrosis. He was referred to our hospital for evaluation and possible treatment using the artificial prosthetic urinary sphincter. Urodynamic studies revealed an intravesical pressure in excess of 100 ram. Hg but the man was unable to produce any urinary flow. The urethral sphincter was clearly obstructing the flow of urine by inappropriate spasms and this was apparent on micturition studies as well as fluorocystography. Therefore, a 12 o'clock transurethral sphincterotomy and excision of the suprapubic sinus tract were done on February 8, 1973. After a suitable healing period the voiding flow rate peak was measured at 36 cc per second. On March 8 the prosthetic
TREATMENT OF URINARY INCONTINENCE
1128
urinary sphincter was implanted, with the occlusive cuff being placed around the bulbous urethra r a t h e r than the bladder neck. This particular site was chosen to avoid the technical problems and hazards of dissecting around the bladder neck in such an obese patient who had had a previous vesical operation. Convalescence was uneventful and the catheter was removed 5 days postoperatively. This patient was allowed to activate the artificial sphincter 6 days postoperatively, at which time he had volitional control over urination. This man was quite continent under all conditions, including sleep. The last IVP on April 24 showed improvement in the hydronephrosis and good emptying of the bladder on the post-voiding film (fig. 4). The voiding flow rates were 49 cc per second and the urine remained sterile without use of antibiotics (fig. 5). DISCUSSION
An implantable occlusive cuff under external control will serve to help rehabilitate neurologic bladder dysfunction. Success in 27 of 34 patients is certainly acceptable, especially in a group of patients for whom no other satisfactory method of treatment existed. Absence of urethral necrosis, fistulas or restrictive fibrosis but instead good tissue acceptance, pliable normal-appearing mucosa observed cystoscopically, certainly indicates that this new operative procedure can be done successfully with gratifying results. Although there were disturbing mechanical problems early in the series subsequent studies indicate that the device is reliable. This improved reliability is attributable to improved changes in design as well as the rigid quality controlled commercial production methods used since about October 1972. Malfunctions caused by acute angulation and kinking of tubing indicated the need for successful interfacing of surgical technique and engineering design. This has resulted in t h e use of smaller reservoirs, shorter tubing connectors and the judicious placement of angled connectors at the time of the operation at those points where kinking might occur (fig. 6).
The use of this prosthesis in younger patients presente problems relating to the small space that is available in tll prevesical area. Kinking of the tubing became a most impo~ tant problem but has been resolved. The length of the cu that has been used in even the 3-year-old patient is the sam as has been used in some adults. Therefore, no urethr~ constriction with growth would be expected. The subcutam ous bulbs are smaller in the small children and could difficult to squeeze in later years as the scrotum or labi increase in size but this is not thought to be likely since th child will have had practice. Should the smallness of th bulbs be a problem in the teenage years, they could be r~ placed easily with the adult size by a minor operation in th scrotum or labium. Whether growth of the child will result i problems of shorter tubing in relation to larger body propo~ tions remains to be seen. Hopefully, migration of the tubin within the tissues in response to slowly changing tension caused by growth will obviate the need to insert longer tubin as the child grows. The senior author was concerned that although the bladdc flap urethroplasty, designed to produce total incontinenc~ improved the effectiveness of antibiotics in treating cystitis, large patent urethra might also facilitate the re-entering c bacteria from the perineum. However, none of the patienl who have undergone bladder flap urethroplasty has had problem in controlling urinary tract infections. A longer pc riod of followup and subsequent removal of the patient froi all suppressive medications will provide information whic might allow us to determine whether effective occlusion c the urethra is one of the primary defense mechanism against urethral reinfections. Only 2 patients had infections around the prosthesis whic required its removal. In both cases the infecting organis~ was the same as that cultured from the urinary tract. Thi endogenous infection was considered to be caused by contarf ination during the operation since cultures taken on the da prior to the operation subsequently proved to be positive. Fc
FIG. 4. A, IVP reveals improvement in collecting system. B, occlusive cuff can be seen around bulbous urethra and post-voiding residu~ is acceptable.
TREATMENT OF URINARY INCONTINENCE
1129
TREATMENT OF URINARY INCONTINENCE
POST If'~LANT GU PROSTHESIS
G.B, 27 YRS, I
I
!:..!IIUIIFL,;IH~m~'I!!!'!.:
,
,
li~t!!t!Hititl,ltiit!titttl ~fill!itd!iiil!!iil,~ fll!ll!l!t!itilNIliiiti~!]~t~t ~i!!l!l~ill !!lh!!l~lll t tl!ii!liliil!!iit!]il~fll i i, I i ;' I i ' i' t tt • I"~tt't ,~] !!.~,.,th'~tl~,~!,lmitttdtfll,h..hl,lll,hlh.,I,,,,ltli~rl lii iil',~iit~!~ii!]lllll Ifl!lttl!l!!th.tI!hl,,~.P~'t~ .{i I i i ' i ' 'Pi ilqi' " I I~tltll!l~ilil~,Jt,~iN~tll!l lttt!llt!ll!tt!!it!i~ll~!t~ ~.,iL,l,l~,~titdtfflWt~tl!hll:fhl,,,,hlht~fhl!tltt iiHtli!ti~iiililiil!~it!lilt I]ll!ltlili!li!!!liliili!hl~ !~lL~ititil~it~L~i~t!tiillil!liiillt!tit!ttftl]!t~ IF
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v
'..."
Flo. 5. Voiding peak flow rate of 49 cc per second is outstanding following transurethral sphincterotomy, then implantation of artificial sphincter in 27-year-old man whose myelomeningocele caused neurologic bladder dysfunction. this reason, operations are postponed until several daily urine cultures prove sterile urine. A number of measures are followed in an effort to prevent infection of the prosthesis: 1) the urine is proved sterile by culture, 2) infection is treated with the antibiotic of choice for a minimum of 5 days, 3) traffic in the operating room is restricted to the surgical team, 4) antiseptic solution is sprayed onto the surgeon's hands prior to donning gloves, 5) the skin is scrubbed with an antiseptic soap for 15 rather than 5 minutes, 6) resifilm spray is applied to the skin before applying adhesive skin drapes, 7) skin towels are also used and 8) touching urine or opening the urinary tract is avoided whenever possible. Urodynamic and neurourological testing results have shown that marked detrusor hyperreflexia contraindicates the artificial sphincter since increased bladder pressure caused by detrusor contraction will cause the cuff to deflate and urinary leakage will occur. Indeed, the healthy patient can void through the artificial sphincter by this means without squeezing the deflationary bulb. Increased bladder pressure caused by abdominal straining, on the other hand, will not cause the cuff to deflate, because such straining also increases the pressure in the reservoir and, thus, prevents a pressure differential between the cuff and the reservoir. Patients with detrusor hyperreflexia require careful neurourological testing and then selective partial rhizotomy prior to implantation of the prosthetic sphincter. Surgical repairs of the prosthesis, such as removing kinks and replacing a leaking reservoir bulb, have presented interesting problems requiring~pecial techniques. Utmost care is required, for example in preventing the entry of blood into the prosthetic system. One drop of blood inside the system can foul the valves of the pumping mechanisms. Care must be exercised for the same reason at the time of assembly at the original operation. Thus, a new prosthetic surgical methodology seems to be evolving, requiring the development of new instrumentation to facilitate surgical techniques. For these reasons, other surgeons desiring to do this type of operation are advised to visit surgical centers where the operation is done before performing the procedures. SUMMARY
I m p l a n t a t i o n of a prosthetic urinary sphincter represents the first of a series of developments which will ulti-
FIG. 6. Monitoring of function of prosthetic sphincter is possible because of radiopaque medium used as its fluid. Angled stainless steel connectors placed at strategic points will avoid angulation and obstruction of tubing as shown in this pediatric patient.
mately lead to complete electromechanical control of micturition in the patient with neurologic bladder dysfunction. This prosthesis has been implanted successfully to restore continence in 27 of 34 patients with various types of urinary incontinence, including neurologic bladder dysfunction, stress incontinence, post-prostatectomy incontinence and epispadias.
Vol. 167, 1125-1129,February 2002 Printed in U.S.A.
Copyright © 2002 by A.MERICA,~ ' UROLOGIC,kLASSOCIATION,INC.®
TREATMENT OF URINARY INCONTINENCE BY AN IMPLANTABLE PROSTHETIC URINARY SPHINCTER F. B R A N T L E Y SCOTT, W I L L I A M E. B R A D L E Y AND G E R A L D W. T I M M
From the Roy and Lillie Cullen Department of Urologic Research, Division of Urology, Baylor College of Medicine and the Urology Service, St. Luke's Episcopal Hospital, Houston, Texas, and the Departments of Neurology and Electrical Engineering, University of Minnesota Hospitals, Minneapolis, Minnesota (Reprinted from J Urol, 112: 75-80, 1974) Our concern with urinary incontinence and our certainty that control of sphincteric function is essential to achieve electromechanical take-over of micturition in patients with neurologic bladder dysfunction, led us to the development of an artificial prosthetic urinary sphincter. Animal studies convinced us of its effectiveness and safety. 1 In June 1972 the first prosthetic urinary sphincter was implanted in a human. Since that time this prosthesis has been implanted in more than 34 patients for the treatment of urinary incontinence of various causes. The goals of this new method of treatment in patients were many: 1) to determine whether the concept of an occlusive cuff around the urethra as first advocated by Foley2 was sound in rendering the patient continent, 2) to determine whether total implantation of such a prosthesis in a human was safe, as it had been in animals, 3) to determine the reliability of a mechanical device totally implanted and under external control, 4) to prove that the device would not interfere with normal function of the lower urinary tract and 5) to prove that the device would not cause obstruction during voiding. Our goals included an attempt to rehabilitate selected patients with neurologic bladder dysfunction and to offer patients who underwent an unsuccessful operation for stress incontinence or whose atonic bladders contraindicated an operation for stress incontinence a new alternative to achieve continence. We also sought to determine the occlusive pressure about the urethra that would be safe yet effective in bringing about volitional control of voiding. The surgical technical problems of implantation, the most effective and simplest technique of implantation and the most effective preoperative and postoperative regimen of care all required determination. Last, but perhaps most important, we needed to delineate those neurourological testing criteria which would allow us to appropriately select patient~=who would benefit by this new method of treatment. The results of implantation of an artificial prosthetic urinary sphincter in 34 patients are reported herein. MATERIALS AND METHODS
The prosthetic urinary sphincter. The silicone rubber prosthetic urinary sphincter consisted of 4 main parts: 1) a reservoir, 2) an inflatable occlusive cuff, 3) an inflating pumping mechanism and 4) a deflating pumping mechanism. The reservoir contained a fluid which served to inflate the cuff. The cuff encircled the urethra in such a manner that once completely inflated the urethra was occluded. The pumping
mechanism was activated by squeezing a bulb which was placed subcutaneously. The pumping mechanism contained valves which controlled the direction of flow of fluid within the system and also determined the maximum pressure which could be exerted inside the cuff, obviating the possibility of overinflation. Activation of the deflating pumping mechanism by squeezing the other subcutaneous bulb opened the urethral cuff by returning fluid from the prosthetic occlusive urethral cuff to the reservoir (fig. 1). Surgical method. The prosthetic system was implanted by attaching the reservoir to the posterior rectus sheath behind the rectus muscle. This placed the reservoir in a protected position where it was unlikely to be punctured accidentally. The tubing passed through the inguinal canal into the scrotum or labium. The valves were in a protected position inside the inguinal canal. The bulb which inflated the cuff was placed on the right side of the scrotum or in the right labium. The bulb used to deflate the cuffor open the artificial sphincter was placed in the left side of the scrotum or labium. The cuff which encircled the urethra was placed at the bladder neck, at the membranous urethra or around the bulbous urethra. The surgical technique continued to evolve but the design of the device required at least a portion of the prosthesis be assembled at the operating table and the length of the tubing was often shortened to suit the patient situation. Since many patients had had previous vesical or prevesical operations the placement of the occlusive cuff around the bladder neck demanded meticulously careful dissection. The reservoir was placed beneath abdominal muscles where it was not only protected but where increased abdominal pressure against the reservoir offset pressure increases in the cuff caused by coughing or straining, which otherwise would cause leakage beyond the cuff. Since many patients had had reflex and overflow incontinence with the inability to void satisfactorily, some were rendered totally incontinent by means of a 12 o'clock sphincterotomy in male patients 3 or a bladder flap urethroplasty in female patients. 4 These techniques and the results obtained are the subjects of separate papers. Briefly, the 12 o'clock sphincterotomy consisted of transurethral resection of the urethral sphincter in the anterior 12 o'clock position, taking care to preserve the bladder neck. In the bladder flap urethroplasty, a pedicle flap on the anterior surface of the bladder was advanced and reconstructed into the anterior wall of the urethra, extending the flap throughout the entire length of the urethra, including the meatus. Preoperative evaluation. Preoperative evaluation included a history and physical examination, neurological examination, uroflowmetry, cystometry, voiding fluorocystography, excretory urography (IVP), eystoscopy, micturition study (combined simultaneous recording of cystometry, uroflow-
Accepted for publication December 14, 1973. Supported in part by the National Institutes of Health and the generous contributions of Mr. Albert B. Alkek of Victoria, Texas. 1 Timm, G. W., Bradley, W. E. and Scott, F. B.: Experimental 3 Scott, F. B. and Madersbacher, H.: The twelve o'clock sphincterevaluation of an implantable externally controllable urinary sphincotomy: technique, indications, results. Unpublished data ter. Invest Urol., 2: 326, 1974 4 Scott, F. B. and Kenessey, G.: The bladder flap urethroplasty: a 2 Foley, F. E. B.: An artificial sphincter: a new device and operation for control ofenuresis and urinary incontinence. J Urol., 58: 250, technique to produce total incontinence to improve bladder emptying. Unpublished data 1947 1125
1126
TREATMENT OF URINARY INCONTINENCE
\
FIG. 1. P r o s t h e t i c u r i n a r y s p h i n c t e r c o n s i s t s o f 4 m a i n p a r t s : reservoir, i n f l a t a b l e c u f f a n d 2 p u m p i n g m e c h a n i s m s .
metry and electromyography during voiding) and, in selected cases, electromyelography 5 and sphincterometry. These studies were repeated postoperatively to assess results, particularly fluorocystography and uroflowmetry. In each case, before the patient was discharged from the hospital, the bladder was filled to capacity With radiopaque medium, the patient was placed in the vertical position and asked to cough and strain, while the prosthetic sphincter was closed. This maneuver was repeated with the prosthetic sphincter open, before finally asking the patient to simply void. Patient population. The ages of the patients varied from 3 to 76 years (fig. 2). Sex distribution indicated a predominance of female patients, with 20 female and 14 male. The causes of incontinence are listed in table 1-19 patients had neurological disease, 8 had stress incontinence and 5 had postprostatectomy incontinence. One patient was incontinent because of congenital epispadias and another patient had extensive urethral t r a u m a and required bladder flap reconstruction to create a new urethra and then received an artificial sphincter for control. The majority of patients with neurological causes h~t~l spina bifida with myelomeningocele (table 2). The first patient received the implantation on J u n e 9, 1972 and all patients have had at least I month of followup (fig. 3). More than half of the patients have received the implantation since J a n u a r y 1, 1973. Between June 1972 and J a n u a r y 1973 there were fewer patients operated on, mainly because of the unavailability of the prosthetic sphincter, which at the time of this writing is commercially available.
der dysfunction, with the poorest success rate among pe tients with spinal cord injuries. In looking at the causes ofth 7 failures one will note t h a t 4 of the patients had detrusc hyperreflexia and, thus, detrusor contractions caused ur~ nary leakage beyond the artificial sphincter. Subsequent t this experience the authors have concluded that selectiv differential sacral rhizotomy should be done prior to sphinc ter implantation in patients with detrusor hyperreflexia. One of the patients who had hyperreflexia also had a woun infection, which required removal of the prosthesis. Ther were only 2 wound infections in the entire series and 1 c these 2 patients will undergo reimplantation of the artificie sphincter at a future time. Two of the failures were the resu] of a dehiscence of the wound with exposure of the prosthesfi At this point the prosthesis was removed, since it was be lieved that the chances of healing without infection unde those circumstances were unlikely. However, there was other dehiscence but the patient was immediately close with thorough irrigation of antibiotic solution and he subsc quently healed and had a successful result. Surgical compli cations included dehiscence of the wound in 3 cases (1 c which was repaired with success), deep wound infection re quiring removal of the artificial sphincter in 2 cases, a su perficial wound infection which subsequently healed saris factorily in 1 case and thrombophlebitis of the leg in 2 case (table 3). N
AGE DISTRIBUTION
lOI-
ARTIFICIAL SPHINCTER
5
5 4
gg
4 3
10
20
30
40 AGE
50
60
3
70
80
Fro. 2
TABLE 1.
Neurologic Stress Post-prostatectomy Epispadias Urethral trauma (reconstructed)
Etiology of incontinence No.
Failure
Success Rate
19 8 5 1 1
7 0 0 0 0
12 8 5 1 1
RESULTS
The objective success determined by filling the bladder to capacity with radiopaque medium and having the patient cough or strain while standing in the vertical position was encouraging. All 34 patients were successfully rendered continent. However, clinical success over a longer period of time revealed no urinary leakage at any time under all conditions in 27 of 34 patients. The greatest success rates were obtained in patients with stress and post-prostatectomy incontinence. The 7 failures occurred among patients with neurologic blad5 Bradley, W. E.: Urethral electromyelography. J Urol., 108: 563, 1972
TABLE 2. Neurologic condition Spina bifida with myelomeningocele Spinal cord injury Multiple sclerosis Atonic bladder (unknown cause) Surgical denervation (abdominal perineal) Sacral agenesis
No.
Failure
Success
9
4
5
4 2 2
3 0 0
1 2 2
1
0
1
1
0
1
1127
TREATMENT OF URINARY INCONTINENCE TREATMENT OF URINARY INCONTINENCE N
DAIE OF SURGERY
I0
ARIIFICIAL SPHINClER
8
6 4
1
IFHH nH JUNE 72
JULY AUG SEP1
OCl
NOV DEC
JAN 73
FEB
II
MAR APRIL
FIG. 3
Mechanical complications were noted 8 times in 7 cases (table 4). One patient underwent 2 operative procedures to remove kinks in the tubing at each operative setting. This particular patient was the first young patient in the series (6 years old) and the kinking was attributed to the small prevesical area crowding the artificial sphincter. Before the last operative procedure the prosthesis had been miniaturized and smaller parts were implanted with subsequent excellent results. All 8 mechanical complications were corrected surgically but 2 cases are failures at the present time, one because of detrusor hyperreflexia 6 which contraindicates any future attempt at repair and the other because of dehiscence of the wound which required removal of the prosthesis for healing. In the latter patient a repeat attempt to implant the prosthesis has been requested by the patient and is planned for the future. The serious mechanical problems of splitting of the tube, leaking of the reservoir and leaking of the bulb, all occurred within the first 6 patients. Subsequent prostheses were prepared under more stringent quality control conditions. One patient was continent except when he sat on the occlusive cuff, which had been placed around the bulbous urethra. This condition was corrected by moving the occlusive cuff to a more suitable position around the more distal bulbous urethra. Therefore, if the occlusive cuff is placed too far posteriorly in the bulbous urethra adjacent to the perineal body, there is likely to be compression of the cuff with sitting, which then results in deflation and subsequent leakage. ~,~ Repeat cystoscopic evaluations have shown excellent tissue acceptance with good normal color of the urethral mucosa and there has been no evidence of sloughing of the urethral mucosa, nor has there been any sign of fecal or urinary fistula formation. In order to improve bladder emptying prior to implantation of the artificial sphincter, 8 female patients underwent bladder flap urethroplasty, whereas 4 male patients underwent transurethral sphincterotomy. Since all patients have been kept on suppressive medication for a period of time postoperatively insufficient time has elapsed to take them off their suppressive medication and to determine whether they will have recurrent cystitis. How: ever, there have been no apparent cases in which infection became a problem postoperatively and several of the patients who were operated on several months ago are now off all antibiotics and maintaining a sterile urinary tract. Therefore, the indications are encouraging at this time. A case is reported to illustrate the success that has been 6 Rockswold, G. L., Bradley, W. E. and Chou, S. N.: Differential sacral rhizotomy in the treatment ofneurogenic bladder dysfunction. Preliminary report of six cases. J Neurosurg., 38: 748, 1973
TABLE 3. Surgical complications No. Dehiscence Deep wound infection Superficial wound infection Leg thrombophlebitis
3 2 1 2
TABLE 4. Mechanical complications No.
No. Pts. Reservoir leak Kink Tubing split Bulb leak Sitting on cuff
1 3 1 1 1
Complications 1 4 1 1 1
All corrected but 2 patients are failures at present owing to hyperreflexia and dehiscence.
achieved in rehabilitating patients with neurologic bladder dysfunction. CASE REPORT
G. B., a 27-year-old man, had a myelomeningocele repaired at birth. The neurological deficit included partial sacral anesthesia and neurological bladder dysfunction leading to bilateral hydronephrosis. The patient was ambulatory and did not need crutches. Because of advancing hydronephrosis he was referred to another doctor for ileal urinary diversion. However, he was advised to lose weight before undergoing ileal diversion. The patient was able to reduce from 450 to 308 pounds but an ileal diversion was still out of the question because of marked obesity. Instead, a suprapubic cystostomy was done. Subsequent to this procedure the patient was bothered with frequent recurrent bladder calculi, recurrent sepsis and progression of the hydronephrosis. He was referred to our hospital for evaluation and possible treatment using the artificial prosthetic urinary sphincter. Urodynamic studies revealed an intravesical pressure in excess of 100 ram. Hg but the man was unable to produce any urinary flow. The urethral sphincter was clearly obstructing the flow of urine by inappropriate spasms and this was apparent on micturition studies as well as fluorocystography. Therefore, a 12 o'clock transurethral sphincterotomy and excision of the suprapubic sinus tract were done on February 8, 1973. After a suitable healing period the voiding flow rate peak was measured at 36 cc per second. On March 8 the prosthetic
TREATMENT OF URINARY INCONTINENCE
1128
urinary sphincter was implanted, with the occlusive cuff being placed around the bulbous urethra r a t h e r than the bladder neck. This particular site was chosen to avoid the technical problems and hazards of dissecting around the bladder neck in such an obese patient who had had a previous vesical operation. Convalescence was uneventful and the catheter was removed 5 days postoperatively. This patient was allowed to activate the artificial sphincter 6 days postoperatively, at which time he had volitional control over urination. This man was quite continent under all conditions, including sleep. The last IVP on April 24 showed improvement in the hydronephrosis and good emptying of the bladder on the post-voiding film (fig. 4). The voiding flow rates were 49 cc per second and the urine remained sterile without use of antibiotics (fig. 5). DISCUSSION
An implantable occlusive cuff under external control will serve to help rehabilitate neurologic bladder dysfunction. Success in 27 of 34 patients is certainly acceptable, especially in a group of patients for whom no other satisfactory method of treatment existed. Absence of urethral necrosis, fistulas or restrictive fibrosis but instead good tissue acceptance, pliable normal-appearing mucosa observed cystoscopically, certainly indicates that this new operative procedure can be done successfully with gratifying results. Although there were disturbing mechanical problems early in the series subsequent studies indicate that the device is reliable. This improved reliability is attributable to improved changes in design as well as the rigid quality controlled commercial production methods used since about October 1972. Malfunctions caused by acute angulation and kinking of tubing indicated the need for successful interfacing of surgical technique and engineering design. This has resulted in t h e use of smaller reservoirs, shorter tubing connectors and the judicious placement of angled connectors at the time of the operation at those points where kinking might occur (fig. 6).
The use of this prosthesis in younger patients presente problems relating to the small space that is available in tll prevesical area. Kinking of the tubing became a most impo~ tant problem but has been resolved. The length of the cu that has been used in even the 3-year-old patient is the sam as has been used in some adults. Therefore, no urethr~ constriction with growth would be expected. The subcutam ous bulbs are smaller in the small children and could difficult to squeeze in later years as the scrotum or labi increase in size but this is not thought to be likely since th child will have had practice. Should the smallness of th bulbs be a problem in the teenage years, they could be r~ placed easily with the adult size by a minor operation in th scrotum or labium. Whether growth of the child will result i problems of shorter tubing in relation to larger body propo~ tions remains to be seen. Hopefully, migration of the tubin within the tissues in response to slowly changing tension caused by growth will obviate the need to insert longer tubin as the child grows. The senior author was concerned that although the bladdc flap urethroplasty, designed to produce total incontinenc~ improved the effectiveness of antibiotics in treating cystitis, large patent urethra might also facilitate the re-entering c bacteria from the perineum. However, none of the patienl who have undergone bladder flap urethroplasty has had problem in controlling urinary tract infections. A longer pc riod of followup and subsequent removal of the patient froi all suppressive medications will provide information whic might allow us to determine whether effective occlusion c the urethra is one of the primary defense mechanism against urethral reinfections. Only 2 patients had infections around the prosthesis whic required its removal. In both cases the infecting organis~ was the same as that cultured from the urinary tract. Thi endogenous infection was considered to be caused by contarf ination during the operation since cultures taken on the da prior to the operation subsequently proved to be positive. Fc
FIG. 4. A, IVP reveals improvement in collecting system. B, occlusive cuff can be seen around bulbous urethra and post-voiding residu~ is acceptable.
TREATMENT OF URINARY INCONTINENCE
1129
TREATMENT OF URINARY INCONTINENCE
POST If'~LANT GU PROSTHESIS
G.B, 27 YRS, I
I
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,
,
li~t!!t!Hititl,ltiit!titttl ~fill!itd!iiil!!iil,~ fll!ll!l!t!itilNIliiiti~!]~t~t ~i!!l!l~ill !!lh!!l~lll t tl!ii!liliil!!iit!]il~fll i i, I i ;' I i ' i' t tt • I"~tt't ,~] !!.~,.,th'~tl~,~!,lmitttdtfll,h..hl,lll,hlh.,I,,,,ltli~rl lii iil',~iit~!~ii!]lllll Ifl!lttl!l!!th.tI!hl,,~.P~'t~ .{i I i i ' i ' 'Pi ilqi' " I I~tltll!l~ilil~,Jt,~iN~tll!l lttt!llt!ll!tt!!it!i~ll~!t~ ~.,iL,l,l~,~titdtfflWt~tl!hll:fhl,,,,hlht~fhl!tltt iiHtli!ti~iiililiil!~it!lilt I]ll!ltlili!li!!!liliili!hl~ !~lL~ititil~it~L~i~t!tiillil!liiillt!tit!ttftl]!t~ IF
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Flo. 5. Voiding peak flow rate of 49 cc per second is outstanding following transurethral sphincterotomy, then implantation of artificial sphincter in 27-year-old man whose myelomeningocele caused neurologic bladder dysfunction. this reason, operations are postponed until several daily urine cultures prove sterile urine. A number of measures are followed in an effort to prevent infection of the prosthesis: 1) the urine is proved sterile by culture, 2) infection is treated with the antibiotic of choice for a minimum of 5 days, 3) traffic in the operating room is restricted to the surgical team, 4) antiseptic solution is sprayed onto the surgeon's hands prior to donning gloves, 5) the skin is scrubbed with an antiseptic soap for 15 rather than 5 minutes, 6) resifilm spray is applied to the skin before applying adhesive skin drapes, 7) skin towels are also used and 8) touching urine or opening the urinary tract is avoided whenever possible. Urodynamic and neurourological testing results have shown that marked detrusor hyperreflexia contraindicates the artificial sphincter since increased bladder pressure caused by detrusor contraction will cause the cuff to deflate and urinary leakage will occur. Indeed, the healthy patient can void through the artificial sphincter by this means without squeezing the deflationary bulb. Increased bladder pressure caused by abdominal straining, on the other hand, will not cause the cuff to deflate, because such straining also increases the pressure in the reservoir and, thus, prevents a pressure differential between the cuff and the reservoir. Patients with detrusor hyperreflexia require careful neurourological testing and then selective partial rhizotomy prior to implantation of the prosthetic sphincter. Surgical repairs of the prosthesis, such as removing kinks and replacing a leaking reservoir bulb, have presented interesting problems requiring~pecial techniques. Utmost care is required, for example in preventing the entry of blood into the prosthetic system. One drop of blood inside the system can foul the valves of the pumping mechanisms. Care must be exercised for the same reason at the time of assembly at the original operation. Thus, a new prosthetic surgical methodology seems to be evolving, requiring the development of new instrumentation to facilitate surgical techniques. For these reasons, other surgeons desiring to do this type of operation are advised to visit surgical centers where the operation is done before performing the procedures. SUMMARY
I m p l a n t a t i o n of a prosthetic urinary sphincter represents the first of a series of developments which will ulti-
FIG. 6. Monitoring of function of prosthetic sphincter is possible because of radiopaque medium used as its fluid. Angled stainless steel connectors placed at strategic points will avoid angulation and obstruction of tubing as shown in this pediatric patient.
mately lead to complete electromechanical control of micturition in the patient with neurologic bladder dysfunction. This prosthesis has been implanted successfully to restore continence in 27 of 34 patients with various types of urinary incontinence, including neurologic bladder dysfunction, stress incontinence, post-prostatectomy incontinence and epispadias.