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Clean Intermittent Catheterization in Spinal Cord Injury Patients: A Followup Study
0022-5347/93/1495-1068$03 .00/0 THE JOURNAL OF UROLOGY Copyright © 1993 by AMERICAN UROLOGICAL ASSOCIATION, INC.
Vol. 149, 1068- 1071, May 1993
Printed in U.S.A.
CLEAN INTERMITTENT CATHETERIZATION IN SPINAL CORD INJURY PATIENTS: A FOLLOWUP STUDY INDER PERKASH AND JAN GIROUX From the Spinal Cord Injury Service, Department of Veterans Affairs, Stanford University Medical Center, Palo Alto, California
ABSTRACT
A followup study on nonhospitalized spinal cord injury patients using clean intermittent catheterization was conducted to evaluate long-term clean intermittent catheterization for any genitourinary complications, and to institute and evaluate prompt management. A total of 50 patients (36 paraplegics and 14 quadriplegics) was followed for 3 months to 6.5 years (average followup 22 months). All patients had a baseline urodynamic study and renal scan before they were discharged from the hospital. Patients with a reflex bladder and sustained, high intravesical pressures (greater than 40 cm. water) were placed on anticholinergic medication to lower voiding pressures and maintain continence_ Those on clean intermittent catheterization and condom drainage were also given a-blockers to achieve low pressure voiding and to control autonomic dysreflexia. Of 50 patients 43 (86%) acquired a total of 364 events of significant bacteriuria (104 or more colony-forming units per ml.) at a rate of 13.63 infections per 1,000 patient-days on clean intermittent catheterization. Subclinical symptoms for urinary tract infection were noted in 22 of the 43 patients (51%), whereas clinical symptoms for urinary tract infection were recorded in 16 of 43 (37%). These symptoms included fever in 8 patients, chills in 3, hematuria in 3 and flank pain in 2. There were 31 genitourinary complications in 21 patients noted during periodic diagnostic evaluations, with 6 classified as upper tract. Of 50 patients 4 (8%) required rehospitalization for urological problems. One patient died of questionable sepsis. Transurethral sphincterotomy was performed in 15 of the 50 patients (30%) and transurethral prostatectomy was done in 1 for multiple reasons, for example high intravesical voiding pressures, difficult catheterization, repeated symptomatic urinary tract infections or per patient request to discontinue clean intermittent catheterization. Of 7 patients who were catheterized by others 4 elected to discontinue long-term clean intermittent catheterization after an average of 13 months. Overall, 33 patients (66%) discontinued clean intermittent catheterization and 17 are still being followed on a long-term basis. Clean intermittent catheterization is a successful long-term option to drain bladders in spinal cord injury patients who can perform catheterization independently. KEY WORDS: urinary catheterization; bladder, neurogenic; spinal cord injuries
Intermittent catheterization is an accepted method of bladder drainage in spinal cord injury individuals with a neurogenic bladder. We previously reported on our experience with sterile technique intermittent catheterization on spinal cord injury inpatients during the initial rehabilitation. 1 In a community setting where a patient may be usefully employed, however, sterile intermittent catheterization is cumbersome, time-consuming and costly. Therefore, the clean intermittent catheterization technique has been recommended as a more practical procedure. 2- 4 However, overall risk of urinary tract infection has been reported to be higher with clean intermittent catheterization.3 ,5 We report a followup study in nonhospitalized spinal cord injury patients who perform clean intermittent catheterization for bladder drainage. Evaluation of long-term clean intermittent catheterization, any genitourinary complications and the prompt management is presented. METHODS AND MATERIALS
From February 1983 to February 1992 we followed 50 male spinal cord injury patients on clean intermittent catheterization (36 paraplegics and 14 quadriplegics) after they were discharged from the hospital. The mean length of followup was 22 months (range 3 months to 6.5 years). Of these patients 43 performed self-catheterization and 7 were catheterized by others. The 37 patients (74%) who were continent on clean intermittent cathAccepted for publication October 16, 1992. Read at annual meeting of American Urological Association, Washington, D. C., May 10-14, 1992.
eterization did not wear any external collecting devices, while 13 (26%) had some degree of incontinence and required external collecting devices. Mean patient age was 46 years (range 19 to 70). Of the patients 19 had complete motor and sensory lesions (Frankel class A and B) and 31 had incomplete motor and sensory lesions (Frankel class C and D). All patients discharged from the hospital on clean intermittent catheterization were invited to participate in the study provided they were willing to mail in urine specimens every month or they were living in geographic proximity so they could attend followup ambulatory care at the medical center monthly. All patients underwent a baseline urodynamic study and renal scan before they were discharged on clean intermittent catheterization. Patients with a reflex bladder and sustained, high intravesical pressures of greater than 40 cm. water were placed on anticholinergics to maintain continence. Those on condom drainage and clean intermittent catheterization were given ablockers alone or in combination with anticholinergics to achieve low pressure voiding and to control autonomic dysreflexia. Doses of these drugs were individualized. Of 50 patients 13 (26%) were given anticholinergics alone, 5 (10%) were given a-blockers and anticholinergics, and 9 (18%) were on a-blockers alone. Followup criteria included monthly urine culture and monthly telephone contact to document any symptoms, such as febrile episode, dysreflexia or difficulty in catheterization. Periodic urological evaluation included urodynamics every 6 to 12 months as required and renal scan every 1 to 2 years. Bacteriuria was monitored with either a mail-in dip slide cul-
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CLEAN INTERMITTENT CATHETERIZATION IN SPINAL CORD INJURY PATIENTS
ture or clinic visit urine specimen. Patients were provided the dip slides as well as sterile urine containers and packaging equipment for mailing. Antibiotic prophylaxis at hospital discharge was the prerogative of the ward physician. The criteria for significant bacteriuria (10 4 or more colony-forming units per ml.) and its management included any of the following: white blood count greater than 104jml. urine, clinical symptoms and a urease-splitting organism. Rate of urinary tract infection was calculated as number of infections per 1,000 patient-days on clean intermittant catheterization. RESULTS
1. Organisms causing bacteriuria No. Species
Gram-neg.: Klebsiella Pseudomonas Escherichia coli Acinetobacter Serratia Citrobacter Acromobacter Enterobacter Herellea Xanthomonas maltophilia Proteus mirabilis Enteric CDC group 17 Alcalingenes Providencia rettgeri Gram-pos.: Enterococcus Staphylococcus, coagulase neg. Staph., coagulase pos. Candida species Diphtheroids Streptococcus
2. Genitourinary complications in 31 patients No. Pts. (mos.)
Bladder neck ledge Epididymo-orchitis Diverticula Calculi Hydronephrosis Reflux False passage
13 5 4 3 3 2 1
(7-24) (4-9) (3-12) (9-14)* (3-6) (3-18) (7)
* Bladder stones in 2 patients and renal calculi in 1. Indications for transurethral sphincterotomy and transurethral prostatectomy in 16 patients
TABLE 3.
The 50 outpatients underwent a total of 33,566 patient-days on clean intermittent catheterization. Of the 50 patients 43 (86%) experienced 364 events of significant bacteriuria (104 or more colony-forming units per ml.) at a rate of 13.63 infections per 1,000 patient-days on clean intermittent catheterization overall (17.32 per 1,000 patient-days with and 12.49 per 1,000 patient-days without an external collecting device). For patients without an external collecting device analysis of individual collections per days with a pooled t test revealed no significant difference. On the other hand, when total infections were analyzed for total days chi-square analysis was 10.43 (p <0.001). Of the 50 patients 7 (14%) did not have any documented bacteriuria (less than 104 colony-forming units per ml.) during followup with 1 patient continuing to maintain sterile urine for 6 years. Microorganisms cultured are classified in table 1. Periodic significant bacteriuria was documented in 43 of 50 patients (86%) and symptoms were reported in all of these patients. Of the 43 patients 22 (51 %) had subclinical symptoms, that is cloudy urine, malaise, mild dysreflexia and increased spasms, and 16 (37%) reported clinical symptoms that included fever (8), chills (3), hematuria (3) and flank pain (2), while 5 (12%) were asymptomatic despite significant bacteriuria. Overall, there were 21 patients (42%) with 31 documented genitourinary complications (some patients had greater than 1 complication, table 2). No significant decrease in total renal function per renal scan was noted in any of these patients. A bladder neck ledge was demonstrated by use of trans rectal sonography.6 Ofthe 13 bladder neck ledges documented 1 (7%) was less than 0.5 cm., 2 (15%) were 0.5 to 1.0 cm., 2 (15%) were greater than 1.0 cm. and 8 (62%) were of indeterminate size. Transurethral resection of the sphincter was performed in 15 patients (30%) and transurethral prostatectomy in 1 for multiple reasons, including a reflex bladder with sustained high TABLE
TABLE
82 63 53 30 13 12 9 9
5 5 4 2 2 2
60 16 4 3 2 2
There were 30 episodes of bacteriuria caused by multiple organisms.
No. Urological complications Retractile penis with incontinence (before implantation) Inconvenience
12* 3
Of 10 patients 6 also cited inconvenience as a factor.
bladder pressure (54 to 100 cm. water) in 7, difficult catheterization in 1 and vesicourethral reflux in 1, while 7 wished to stop clean intermittent catheterization due to inconvenience (table 3). Of the 7 patients being catheterized by others 4 elected to discontinue catheterization after an average of 17 months. A total of 13 post-transurethral sphincterotomy patients was followed for a mean of 46 months (range 6 to 78 months). Symptomatic urinary tract infection was recorded in 25% of these patients with stable or no upper tract change. Indications for discontinuing clean intermittent catheterization were transurethral sphincterotomy jtransurethral prostatectomy in 16 patients, initiation of voiding in 9, loss to followup in 4, other bladder management in 3 and death in 1. Of the 7 quadriplegic patients who were being catheterized by others 4 elected to discontinue clean intermittent catheterization, 1 died of possible septicemia, 1 began to void spontaneously and 1 was lost to followup. All 17 patients on long-term clean intermittent catheterization who are still being actively followed (13 paraplegic and 4 quadriplegic) perform clean intermittent catheterization independently. DISCUSSION
Clean intermittent catheterization has been used successfully as a long-term bladder drainage option in spinal cord injury patients and the long-term efficacy and safety have been described. 7- n However, the reported followup has generally been by sporadic urine cultures. Our followup was directed to screen periodically for asymptomatic significant bacteriuria and high intravesical pressure. Their effects on the genitourinary tract were documented to prevent and manage serious urological complications. The overall rate of urinary tract infection in our outpatient population was 13.63 infections per 1,000 patient-days on intermittent catheterization versus our previously reported incidence of 10.3 per 1,000 catheterizations for inpatients using sterile technique. 1 Other studies analyzing clean intermittent catheterization showed an incidence of bacteriuria ranging from 41 to 90% but in only 1 study were routine urine cultures taken at regular intervals (every 3 months).l1 The overall incidence of bacteriuria was 86% (greater than 104 colony-forming units per ml.). This high incidence may have been influenced by some of our patients who were using external catheters and leg bags. Our previous studies have shown that exogenous sources, such as external catheters and urinary leg bags, are crucial factors in the development of spinal cord injury bacteriuria. 12, 13 However, symptomatic urinary tract infections, when managed expeditiously and appropriately, do not seem to have predisposed our patients to genitourinary complications. This is true for patients on clean intermittent catheterization and also after
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PERKASH AND GIROUX
transurethral surgery, since kidney function was well maintained on nuclear scanning in all of these patients. We noted 31 genitourinary complications in 21 patients during our followup, the majority confined to the lower tract. Vesicoureteral reflux developed in only 2 patients (4%) and only 3 (6 %) had minimal hydronephrosis. Vesicoureteral reflux has resolved in 1 patient while on clean intermittent catheterization, and 1 with grade II reflux and asymptomatic urinary tract infection is being followed on clean intermittent catheterization. Both of these patients wanted transurethral sphincterotomy. Followup on the 3 patients with hydronephrosis shows 1 with no progression, 1 whose hydronephrosis resolved after he possibly passed a stone and 1 who is being followed. The incidence of vesicoureteral reflux and/or hydronephrosis in another study was 33%.10 These authors attributed these findings to increased intravesical pressure or to marked detrusor hyperreflexia with sphincter dyssynergia and obstruction. Therefore, in patients with a high intravesical pressure and who may be noncompliant with anticholinergics, expeditious transurethral sphincterotomy may be appropriate to decrease the incidence of vesicoureteral reflux and renal stone disease. Kuhn et al reported a lower tract complication rate of 4.3% with no deterioration of the upper tract observed. 14 However, they did not define any parameters or criteria for measurement of upper tract function. Others have reported no upper tract changes on urography.9,1l Maynard et al documented several lower tract complications during 3.7 to 5 years in 34 patients, including urethral stricture in 2 (6%), false passage in 1 (3%), epididymitis in 3 (9%), bladder stones in 6 (18%) and renal stones in 2 (6%).7,8 Their method of monitoring entailed a single telephone interview with the patients and medical record review. They also reported that 15 of the 34 patients (44%) were hospitalized at least once during the 5 years for urological complications. In comparison, of our 50 patients 5 (10%) had epididymitis,4 (8%) had diverticula, 2 (4%) had bladder stones, 1 (2%) had a renal stone and 1 (2%) had a false passage. Of the 50 patients 4 (8%) were hospitalized (epididymo-orchitis in 2, urosepsis in 1 and bladder stones in 1). Development of bladder neck ledges in 13 patients (26%) was diagnosed on trans rectal sonography. As we reported previously, secondary bladder neck obstruction can result from development of a posterior ledge at the bladder neck, which has been postulated to be caused by repeated trauma from intermittent catheterization. 6 Only 1 patient experienced difficulty with catheterization and subsequently underwent transurethral sphincterotomy for this reason. The role of antibiotics as a suppressive therapy for asymptomatic bacteriuria is still controversial. Anderson reported an infection rate of 9.6% with sterile technique and no suppressive antibiotics. 5 In the same study, when sterile technique was accompanied by oral suppressive therapy along with intravesical antibiotic irrigation, the infection rate decreased to 2.8%. However, with nonsterile technique with prophylactic therapy and bladder irrigation, the infection rate was 8.3%. Maynard and Diokno reported a significant decrease in the incidence of asymptomatic bacteriuria but no significant decrease in clinical urinary tract infection when prophylactic trimethoprim-sulfamethoxazole was used. 15 In another study when antibiotic treatment was given for asymptomatic bacteriura no difference was noted when compared with placebo. 16 Therefore, we did not discharge our patients from the hospital on controlled antibiotic regimens, and we managed urinary tract infection on an individual case basis. Urodynamic evaluation to determine the intravesical voiding pressure, particularly in the reflex bladder, is a key to prevent upper tract changes, since the higher incidence of upper tract changes has been reported with increased intravesical pressure. 10 Therefore, use of anticholinergics to control a sustained increase in intravesical pressure is mandatory in such patients on external drainage. Patients on clean intermittent catheter-
ization and external drainage leg bags can also benefit from the use of a-blockers for controlling autonomic dysreflexia and low pressure voiding. Use of a-blockers will ease spontaneous and/ or triggered voiding, and therefore the frequency of catheterization can be decreased. Monitoring of renal status has historically been accomplished through routine excretory urography, serum creatinine, blood urea nitrogen and creatinine clearance determinations. While these methods provide useful clinical information, recent studies indicate that radioisotope renography is a more sensitive screening indicator for evaluating renal function. 17-19 Excretory ability of the kidneys and lower tract is calculated through effective renal plasma flow and peak time denoting renal blood flow/renal tubular function. Thus, analysis of individual kidney function is possible, and any evidence of delayed excretion can be further evaluated and appropriately managed. Clean intermittent catheterization can be a successful longterm management option for spinal cord injury patients. However, this method of bladder management is not without risk and may be fraught with secondary complications. Maintenance of acceptable intravesical pressures and compliance in anticholinergic therapy, when indicated, are key elements of trouble-free intermittent catheterization. Monitoring of significant bacteriuria, its effect on renal function and the efficacy of suppressive antibiotic therapy still warrant further investigation. While genitourinary complications were reported in our study, few were upper tract changes and no overall decrease in renal function was demonstrated. We believe that this is due partly to our routine followup, and also to prompt medical and/ or surgical intervention whenever it was considered necessary. Therefore, close monitoring is required in spinal cord injury patients on clean intermittent catheterization to prevent urological complications leading to urological sequelae and renal damage. Clean intermittent catheterization is a successful longterm option to drain bladders in spinal cord injury patients who can independently perform catheterization. REFERENCES 1. Rhame, F. S. and Perkash, 1.: Urinary tract infections occurring in recent spinal cord injury patients on intermittent catheterization. J. Urol., 122: 669, 1979. 2. Lapides, J., Diokno, A. C., Silber, S. J. and Lowe, B. S.: Clean, intermittent self-catheterization in the treatment of urinary tract disease. J. Urol., 107: 458, 1972. 3. Lapides, J., Diokno, A. C., Gould, F. R. and Lowe, B. S.: Further observations on self-catheterization. J. Urol., 116: 169, 1976. 4. Maynard, F. M. and Diokno, A. C.: Urinary infection and complications during clean intermittent catheterization following spinal cord injury. J. Urol., 132: 943, 1984. 5. Anderson, R. u.: Non-sterile intermittent catheterization with antibiotic prophylaxis in the acute spinal cord injured male patient. J. Urol., 124: 392, 1980. ' 6. Perkash, I. and Friedland, G. W.: Posterior ledge at the bladder neck: crucial diagnostic role of ultrasonography. Urol. Rad., 8: 175, 1986. 7. Maynard, F. M. and Diokno, A. C.: Clean intermittent catheterization for spinal cord injury patients. J. Urol., 128: 477, 1982. 8. Maynard, F. M. and Glass, J.: Management of the neuropathic bladder by clean intermittent catheterization: 5 year outcomes. Paraplegia, 25: 106, 1987. 9. Diokno, A. C., Sonda, L. P., Hollander, J. B. and Lapides, J.: Fate of patients started on clean intermittent self-catheterization therapy 10 years ago. J. Urol., 129: 1120, 1983. 10. Nanninga, J. B., Wu, Y. and Hamilton, B.: Long-term intermittent catheterization in the spinal cord injury patient. J. Urol., 128: 760,1982. 11. McGuire, E. J. and Savastano, J. A.: Long-term followup of spinal cord injury patients managed by intermittent catheterization. J. Urol., 129: 775, 1983. 12. Giroux, J. and Perkash, I.: Limited use of the Fairley test in urologic infections in patients with neuropathic bladders. J. Amer. Parapleg. Soc., 8: 10, 1985.
CLEAr,\} INTERlvXITTEI"'JT CATHETERIZAT!CN E'>J SPlr..JAL COHD Ir-IJURY
13. Giroux, J. and Perk ash, L: In vitro evaluation of current disinfectants for leg bags. J. Arner. Parapleg. Soc., 8: 13, 1985. 14. Kuhn, W., Rist, M. and Zaech, G. A.: Intermittent urethral selfcatheterisation: long term results (bacteriological evolution, continence, acceptance, complications). Paraplegia, 29: 222, 1991. 15. Maynard, F., Jr. and Diokno, A.: Clean intermittent catheterization as initial management for spinal cord injured patients. Read at 9th annual meeting of American Spinal Injury Association, April 11-l3, 1983. 16. Mohler, J. L., Cowen, D. L. and Flanigan, R C.: Suppression and treatment of urinary tract infection in patients with an inter-
PATIEr~>1TS
1071
mittently catheterized neurogenic bladder. J. Uro!., 138: 336, 1987. 17. Tempkin, A., Sullivan, G., Paldi, J. and Perkash, 1.: Radioisotope renography in spinal cord injury. J. UroL, 133: 228, 1985. 18. Lloyd, L. K, Dubovsky, E. V., Bueschen, A. J., Witten, D. M., Scott, J. W., Kuhlemeier, K. and Stover, S. L.: Comprehensive renal scintillation procedures in spinal cord injury: Comparison with excretory urography. J. Ural., 126: 10, 1981. 19. Kuhlemeier, K V., McEachran, A. B., Lloyd, L. K., Stover, S. L. and Fine, P. R.: Serum creatinine as an indicator of renal function after spinal cord injury. Arch. Phys. Med. Rehabi!., 65: 694,1984.
Vol. 149, 1068- 1071, May 1993
Printed in U.S.A.
CLEAN INTERMITTENT CATHETERIZATION IN SPINAL CORD INJURY PATIENTS: A FOLLOWUP STUDY INDER PERKASH AND JAN GIROUX From the Spinal Cord Injury Service, Department of Veterans Affairs, Stanford University Medical Center, Palo Alto, California
ABSTRACT
A followup study on nonhospitalized spinal cord injury patients using clean intermittent catheterization was conducted to evaluate long-term clean intermittent catheterization for any genitourinary complications, and to institute and evaluate prompt management. A total of 50 patients (36 paraplegics and 14 quadriplegics) was followed for 3 months to 6.5 years (average followup 22 months). All patients had a baseline urodynamic study and renal scan before they were discharged from the hospital. Patients with a reflex bladder and sustained, high intravesical pressures (greater than 40 cm. water) were placed on anticholinergic medication to lower voiding pressures and maintain continence_ Those on clean intermittent catheterization and condom drainage were also given a-blockers to achieve low pressure voiding and to control autonomic dysreflexia. Of 50 patients 43 (86%) acquired a total of 364 events of significant bacteriuria (104 or more colony-forming units per ml.) at a rate of 13.63 infections per 1,000 patient-days on clean intermittent catheterization. Subclinical symptoms for urinary tract infection were noted in 22 of the 43 patients (51%), whereas clinical symptoms for urinary tract infection were recorded in 16 of 43 (37%). These symptoms included fever in 8 patients, chills in 3, hematuria in 3 and flank pain in 2. There were 31 genitourinary complications in 21 patients noted during periodic diagnostic evaluations, with 6 classified as upper tract. Of 50 patients 4 (8%) required rehospitalization for urological problems. One patient died of questionable sepsis. Transurethral sphincterotomy was performed in 15 of the 50 patients (30%) and transurethral prostatectomy was done in 1 for multiple reasons, for example high intravesical voiding pressures, difficult catheterization, repeated symptomatic urinary tract infections or per patient request to discontinue clean intermittent catheterization. Of 7 patients who were catheterized by others 4 elected to discontinue long-term clean intermittent catheterization after an average of 13 months. Overall, 33 patients (66%) discontinued clean intermittent catheterization and 17 are still being followed on a long-term basis. Clean intermittent catheterization is a successful long-term option to drain bladders in spinal cord injury patients who can perform catheterization independently. KEY WORDS: urinary catheterization; bladder, neurogenic; spinal cord injuries
Intermittent catheterization is an accepted method of bladder drainage in spinal cord injury individuals with a neurogenic bladder. We previously reported on our experience with sterile technique intermittent catheterization on spinal cord injury inpatients during the initial rehabilitation. 1 In a community setting where a patient may be usefully employed, however, sterile intermittent catheterization is cumbersome, time-consuming and costly. Therefore, the clean intermittent catheterization technique has been recommended as a more practical procedure. 2- 4 However, overall risk of urinary tract infection has been reported to be higher with clean intermittent catheterization.3 ,5 We report a followup study in nonhospitalized spinal cord injury patients who perform clean intermittent catheterization for bladder drainage. Evaluation of long-term clean intermittent catheterization, any genitourinary complications and the prompt management is presented. METHODS AND MATERIALS
From February 1983 to February 1992 we followed 50 male spinal cord injury patients on clean intermittent catheterization (36 paraplegics and 14 quadriplegics) after they were discharged from the hospital. The mean length of followup was 22 months (range 3 months to 6.5 years). Of these patients 43 performed self-catheterization and 7 were catheterized by others. The 37 patients (74%) who were continent on clean intermittent cathAccepted for publication October 16, 1992. Read at annual meeting of American Urological Association, Washington, D. C., May 10-14, 1992.
eterization did not wear any external collecting devices, while 13 (26%) had some degree of incontinence and required external collecting devices. Mean patient age was 46 years (range 19 to 70). Of the patients 19 had complete motor and sensory lesions (Frankel class A and B) and 31 had incomplete motor and sensory lesions (Frankel class C and D). All patients discharged from the hospital on clean intermittent catheterization were invited to participate in the study provided they were willing to mail in urine specimens every month or they were living in geographic proximity so they could attend followup ambulatory care at the medical center monthly. All patients underwent a baseline urodynamic study and renal scan before they were discharged on clean intermittent catheterization. Patients with a reflex bladder and sustained, high intravesical pressures of greater than 40 cm. water were placed on anticholinergics to maintain continence. Those on condom drainage and clean intermittent catheterization were given ablockers alone or in combination with anticholinergics to achieve low pressure voiding and to control autonomic dysreflexia. Doses of these drugs were individualized. Of 50 patients 13 (26%) were given anticholinergics alone, 5 (10%) were given a-blockers and anticholinergics, and 9 (18%) were on a-blockers alone. Followup criteria included monthly urine culture and monthly telephone contact to document any symptoms, such as febrile episode, dysreflexia or difficulty in catheterization. Periodic urological evaluation included urodynamics every 6 to 12 months as required and renal scan every 1 to 2 years. Bacteriuria was monitored with either a mail-in dip slide cul-
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CLEAN INTERMITTENT CATHETERIZATION IN SPINAL CORD INJURY PATIENTS
ture or clinic visit urine specimen. Patients were provided the dip slides as well as sterile urine containers and packaging equipment for mailing. Antibiotic prophylaxis at hospital discharge was the prerogative of the ward physician. The criteria for significant bacteriuria (10 4 or more colony-forming units per ml.) and its management included any of the following: white blood count greater than 104jml. urine, clinical symptoms and a urease-splitting organism. Rate of urinary tract infection was calculated as number of infections per 1,000 patient-days on clean intermittant catheterization. RESULTS
1. Organisms causing bacteriuria No. Species
Gram-neg.: Klebsiella Pseudomonas Escherichia coli Acinetobacter Serratia Citrobacter Acromobacter Enterobacter Herellea Xanthomonas maltophilia Proteus mirabilis Enteric CDC group 17 Alcalingenes Providencia rettgeri Gram-pos.: Enterococcus Staphylococcus, coagulase neg. Staph., coagulase pos. Candida species Diphtheroids Streptococcus
2. Genitourinary complications in 31 patients No. Pts. (mos.)
Bladder neck ledge Epididymo-orchitis Diverticula Calculi Hydronephrosis Reflux False passage
13 5 4 3 3 2 1
(7-24) (4-9) (3-12) (9-14)* (3-6) (3-18) (7)
* Bladder stones in 2 patients and renal calculi in 1. Indications for transurethral sphincterotomy and transurethral prostatectomy in 16 patients
TABLE 3.
The 50 outpatients underwent a total of 33,566 patient-days on clean intermittent catheterization. Of the 50 patients 43 (86%) experienced 364 events of significant bacteriuria (104 or more colony-forming units per ml.) at a rate of 13.63 infections per 1,000 patient-days on clean intermittent catheterization overall (17.32 per 1,000 patient-days with and 12.49 per 1,000 patient-days without an external collecting device). For patients without an external collecting device analysis of individual collections per days with a pooled t test revealed no significant difference. On the other hand, when total infections were analyzed for total days chi-square analysis was 10.43 (p <0.001). Of the 50 patients 7 (14%) did not have any documented bacteriuria (less than 104 colony-forming units per ml.) during followup with 1 patient continuing to maintain sterile urine for 6 years. Microorganisms cultured are classified in table 1. Periodic significant bacteriuria was documented in 43 of 50 patients (86%) and symptoms were reported in all of these patients. Of the 43 patients 22 (51 %) had subclinical symptoms, that is cloudy urine, malaise, mild dysreflexia and increased spasms, and 16 (37%) reported clinical symptoms that included fever (8), chills (3), hematuria (3) and flank pain (2), while 5 (12%) were asymptomatic despite significant bacteriuria. Overall, there were 21 patients (42%) with 31 documented genitourinary complications (some patients had greater than 1 complication, table 2). No significant decrease in total renal function per renal scan was noted in any of these patients. A bladder neck ledge was demonstrated by use of trans rectal sonography.6 Ofthe 13 bladder neck ledges documented 1 (7%) was less than 0.5 cm., 2 (15%) were 0.5 to 1.0 cm., 2 (15%) were greater than 1.0 cm. and 8 (62%) were of indeterminate size. Transurethral resection of the sphincter was performed in 15 patients (30%) and transurethral prostatectomy in 1 for multiple reasons, including a reflex bladder with sustained high TABLE
TABLE
82 63 53 30 13 12 9 9
5 5 4 2 2 2
60 16 4 3 2 2
There were 30 episodes of bacteriuria caused by multiple organisms.
No. Urological complications Retractile penis with incontinence (before implantation) Inconvenience
12* 3
Of 10 patients 6 also cited inconvenience as a factor.
bladder pressure (54 to 100 cm. water) in 7, difficult catheterization in 1 and vesicourethral reflux in 1, while 7 wished to stop clean intermittent catheterization due to inconvenience (table 3). Of the 7 patients being catheterized by others 4 elected to discontinue catheterization after an average of 17 months. A total of 13 post-transurethral sphincterotomy patients was followed for a mean of 46 months (range 6 to 78 months). Symptomatic urinary tract infection was recorded in 25% of these patients with stable or no upper tract change. Indications for discontinuing clean intermittent catheterization were transurethral sphincterotomy jtransurethral prostatectomy in 16 patients, initiation of voiding in 9, loss to followup in 4, other bladder management in 3 and death in 1. Of the 7 quadriplegic patients who were being catheterized by others 4 elected to discontinue clean intermittent catheterization, 1 died of possible septicemia, 1 began to void spontaneously and 1 was lost to followup. All 17 patients on long-term clean intermittent catheterization who are still being actively followed (13 paraplegic and 4 quadriplegic) perform clean intermittent catheterization independently. DISCUSSION
Clean intermittent catheterization has been used successfully as a long-term bladder drainage option in spinal cord injury patients and the long-term efficacy and safety have been described. 7- n However, the reported followup has generally been by sporadic urine cultures. Our followup was directed to screen periodically for asymptomatic significant bacteriuria and high intravesical pressure. Their effects on the genitourinary tract were documented to prevent and manage serious urological complications. The overall rate of urinary tract infection in our outpatient population was 13.63 infections per 1,000 patient-days on intermittent catheterization versus our previously reported incidence of 10.3 per 1,000 catheterizations for inpatients using sterile technique. 1 Other studies analyzing clean intermittent catheterization showed an incidence of bacteriuria ranging from 41 to 90% but in only 1 study were routine urine cultures taken at regular intervals (every 3 months).l1 The overall incidence of bacteriuria was 86% (greater than 104 colony-forming units per ml.). This high incidence may have been influenced by some of our patients who were using external catheters and leg bags. Our previous studies have shown that exogenous sources, such as external catheters and urinary leg bags, are crucial factors in the development of spinal cord injury bacteriuria. 12, 13 However, symptomatic urinary tract infections, when managed expeditiously and appropriately, do not seem to have predisposed our patients to genitourinary complications. This is true for patients on clean intermittent catheterization and also after
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transurethral surgery, since kidney function was well maintained on nuclear scanning in all of these patients. We noted 31 genitourinary complications in 21 patients during our followup, the majority confined to the lower tract. Vesicoureteral reflux developed in only 2 patients (4%) and only 3 (6 %) had minimal hydronephrosis. Vesicoureteral reflux has resolved in 1 patient while on clean intermittent catheterization, and 1 with grade II reflux and asymptomatic urinary tract infection is being followed on clean intermittent catheterization. Both of these patients wanted transurethral sphincterotomy. Followup on the 3 patients with hydronephrosis shows 1 with no progression, 1 whose hydronephrosis resolved after he possibly passed a stone and 1 who is being followed. The incidence of vesicoureteral reflux and/or hydronephrosis in another study was 33%.10 These authors attributed these findings to increased intravesical pressure or to marked detrusor hyperreflexia with sphincter dyssynergia and obstruction. Therefore, in patients with a high intravesical pressure and who may be noncompliant with anticholinergics, expeditious transurethral sphincterotomy may be appropriate to decrease the incidence of vesicoureteral reflux and renal stone disease. Kuhn et al reported a lower tract complication rate of 4.3% with no deterioration of the upper tract observed. 14 However, they did not define any parameters or criteria for measurement of upper tract function. Others have reported no upper tract changes on urography.9,1l Maynard et al documented several lower tract complications during 3.7 to 5 years in 34 patients, including urethral stricture in 2 (6%), false passage in 1 (3%), epididymitis in 3 (9%), bladder stones in 6 (18%) and renal stones in 2 (6%).7,8 Their method of monitoring entailed a single telephone interview with the patients and medical record review. They also reported that 15 of the 34 patients (44%) were hospitalized at least once during the 5 years for urological complications. In comparison, of our 50 patients 5 (10%) had epididymitis,4 (8%) had diverticula, 2 (4%) had bladder stones, 1 (2%) had a renal stone and 1 (2%) had a false passage. Of the 50 patients 4 (8%) were hospitalized (epididymo-orchitis in 2, urosepsis in 1 and bladder stones in 1). Development of bladder neck ledges in 13 patients (26%) was diagnosed on trans rectal sonography. As we reported previously, secondary bladder neck obstruction can result from development of a posterior ledge at the bladder neck, which has been postulated to be caused by repeated trauma from intermittent catheterization. 6 Only 1 patient experienced difficulty with catheterization and subsequently underwent transurethral sphincterotomy for this reason. The role of antibiotics as a suppressive therapy for asymptomatic bacteriuria is still controversial. Anderson reported an infection rate of 9.6% with sterile technique and no suppressive antibiotics. 5 In the same study, when sterile technique was accompanied by oral suppressive therapy along with intravesical antibiotic irrigation, the infection rate decreased to 2.8%. However, with nonsterile technique with prophylactic therapy and bladder irrigation, the infection rate was 8.3%. Maynard and Diokno reported a significant decrease in the incidence of asymptomatic bacteriuria but no significant decrease in clinical urinary tract infection when prophylactic trimethoprim-sulfamethoxazole was used. 15 In another study when antibiotic treatment was given for asymptomatic bacteriura no difference was noted when compared with placebo. 16 Therefore, we did not discharge our patients from the hospital on controlled antibiotic regimens, and we managed urinary tract infection on an individual case basis. Urodynamic evaluation to determine the intravesical voiding pressure, particularly in the reflex bladder, is a key to prevent upper tract changes, since the higher incidence of upper tract changes has been reported with increased intravesical pressure. 10 Therefore, use of anticholinergics to control a sustained increase in intravesical pressure is mandatory in such patients on external drainage. Patients on clean intermittent catheter-
ization and external drainage leg bags can also benefit from the use of a-blockers for controlling autonomic dysreflexia and low pressure voiding. Use of a-blockers will ease spontaneous and/ or triggered voiding, and therefore the frequency of catheterization can be decreased. Monitoring of renal status has historically been accomplished through routine excretory urography, serum creatinine, blood urea nitrogen and creatinine clearance determinations. While these methods provide useful clinical information, recent studies indicate that radioisotope renography is a more sensitive screening indicator for evaluating renal function. 17-19 Excretory ability of the kidneys and lower tract is calculated through effective renal plasma flow and peak time denoting renal blood flow/renal tubular function. Thus, analysis of individual kidney function is possible, and any evidence of delayed excretion can be further evaluated and appropriately managed. Clean intermittent catheterization can be a successful longterm management option for spinal cord injury patients. However, this method of bladder management is not without risk and may be fraught with secondary complications. Maintenance of acceptable intravesical pressures and compliance in anticholinergic therapy, when indicated, are key elements of trouble-free intermittent catheterization. Monitoring of significant bacteriuria, its effect on renal function and the efficacy of suppressive antibiotic therapy still warrant further investigation. While genitourinary complications were reported in our study, few were upper tract changes and no overall decrease in renal function was demonstrated. We believe that this is due partly to our routine followup, and also to prompt medical and/ or surgical intervention whenever it was considered necessary. Therefore, close monitoring is required in spinal cord injury patients on clean intermittent catheterization to prevent urological complications leading to urological sequelae and renal damage. Clean intermittent catheterization is a successful longterm option to drain bladders in spinal cord injury patients who can independently perform catheterization. REFERENCES 1. Rhame, F. S. and Perkash, 1.: Urinary tract infections occurring in recent spinal cord injury patients on intermittent catheterization. J. Urol., 122: 669, 1979. 2. Lapides, J., Diokno, A. C., Silber, S. J. and Lowe, B. S.: Clean, intermittent self-catheterization in the treatment of urinary tract disease. J. Urol., 107: 458, 1972. 3. Lapides, J., Diokno, A. C., Gould, F. R. and Lowe, B. S.: Further observations on self-catheterization. J. Urol., 116: 169, 1976. 4. Maynard, F. M. and Diokno, A. C.: Urinary infection and complications during clean intermittent catheterization following spinal cord injury. J. Urol., 132: 943, 1984. 5. Anderson, R. u.: Non-sterile intermittent catheterization with antibiotic prophylaxis in the acute spinal cord injured male patient. J. Urol., 124: 392, 1980. ' 6. Perkash, I. and Friedland, G. W.: Posterior ledge at the bladder neck: crucial diagnostic role of ultrasonography. Urol. Rad., 8: 175, 1986. 7. Maynard, F. M. and Diokno, A. C.: Clean intermittent catheterization for spinal cord injury patients. J. Urol., 128: 477, 1982. 8. Maynard, F. M. and Glass, J.: Management of the neuropathic bladder by clean intermittent catheterization: 5 year outcomes. Paraplegia, 25: 106, 1987. 9. Diokno, A. C., Sonda, L. P., Hollander, J. B. and Lapides, J.: Fate of patients started on clean intermittent self-catheterization therapy 10 years ago. J. Urol., 129: 1120, 1983. 10. Nanninga, J. B., Wu, Y. and Hamilton, B.: Long-term intermittent catheterization in the spinal cord injury patient. J. Urol., 128: 760,1982. 11. McGuire, E. J. and Savastano, J. A.: Long-term followup of spinal cord injury patients managed by intermittent catheterization. J. Urol., 129: 775, 1983. 12. Giroux, J. and Perkash, I.: Limited use of the Fairley test in urologic infections in patients with neuropathic bladders. J. Amer. Parapleg. Soc., 8: 10, 1985.
CLEAr,\} INTERlvXITTEI"'JT CATHETERIZAT!CN E'>J SPlr..JAL COHD Ir-IJURY
13. Giroux, J. and Perk ash, L: In vitro evaluation of current disinfectants for leg bags. J. Arner. Parapleg. Soc., 8: 13, 1985. 14. Kuhn, W., Rist, M. and Zaech, G. A.: Intermittent urethral selfcatheterisation: long term results (bacteriological evolution, continence, acceptance, complications). Paraplegia, 29: 222, 1991. 15. Maynard, F., Jr. and Diokno, A.: Clean intermittent catheterization as initial management for spinal cord injured patients. Read at 9th annual meeting of American Spinal Injury Association, April 11-l3, 1983. 16. Mohler, J. L., Cowen, D. L. and Flanigan, R C.: Suppression and treatment of urinary tract infection in patients with an inter-
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mittently catheterized neurogenic bladder. J. Uro!., 138: 336, 1987. 17. Tempkin, A., Sullivan, G., Paldi, J. and Perkash, 1.: Radioisotope renography in spinal cord injury. J. UroL, 133: 228, 1985. 18. Lloyd, L. K, Dubovsky, E. V., Bueschen, A. J., Witten, D. M., Scott, J. W., Kuhlemeier, K. and Stover, S. L.: Comprehensive renal scintillation procedures in spinal cord injury: Comparison with excretory urography. J. Ural., 126: 10, 1981. 19. Kuhlemeier, K V., McEachran, A. B., Lloyd, L. K., Stover, S. L. and Fine, P. R.: Serum creatinine as an indicator of renal function after spinal cord injury. Arch. Phys. Med. Rehabi!., 65: 694,1984.