REPEAT URETHROTOMY AND DILATION FOR THE TREATMENT OF URETHRAL STRICTURE ARE NEITHER CLINICALLY EFFECTIVE NOR COST-EFFECTIVE

REPEAT URETHROTOMY AND DILATION FOR THE TREATMENT OF URETHRAL STRICTURE ARE NEITHER CLINICALLY EFFECTIVE NOR COST-EFFECTIVE

0022-5347/04/1721-0275/0 THE JOURNAL OF UROLOGY® Copyright © 2004 by AMERICAN UROLOGICAL ASSOCIATION Vol. 172, 275–277, July 2004 Printed in U.S.A. ...

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0022-5347/04/1721-0275/0 THE JOURNAL OF UROLOGY® Copyright © 2004 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 172, 275–277, July 2004 Printed in U.S.A.

DOI: 10.1097/01.ju.0000132156.76403.8f

REPEAT URETHROTOMY AND DILATION FOR THE TREATMENT OF URETHRAL STRICTURE ARE NEITHER CLINICALLY EFFECTIVE NOR COST-EFFECTIVE T. J. GREENWELL,* C. CASTLE, D. E. ANDRICH, J. T. MACDONALD, D. L. NICOL AND A. R. MUNDY From the Institute of Urology, London, United Kingdom, and Princess Alexandra Hospital (CC, DLN), Brisbane, Australia

ABSTRACT

Purpose: We developed an algorithm for the management of urethral stricture based on cost-effectiveness. Materials and Methods: United Kingdom medical and hospital costs associated with the current management of urethral stricture were calculated using private medical insurance schedules of reimbursement and clean intermittent self-catheterization supply costs. These costs were applied to 126 new patients treated endoscopically for urethral stricture in a general urological setting between January 1, 1991 and December 31, 1999. Treatment failure was defined as recurrent symptomatic stricture requiring further operative intervention following initial intervention. Mean followup available was 25 months (range 1 to 132). Results: The costs were urethrotomy/urethral dilation £2,250.00 ($3,375.00, ratio 1.00), simple 1-stage urethroplasty £5,015.00 ($7,522.50, ratio 2.23), complex 1-stage urethroplasty £5,335.00 ($8,002.50, ratio 2.37) and 2-stage urethroplasty £10,370 ($15,555.00, ratio 4.61). Of the 126 patients assessed 60 (47.6%) required more than 1 endoscopic retreatments (mean 3.13 each), 50 performed biweekly clean intermittent self-catheterization and 7 underwent urethroplasty during followup. The total cost per patient for all 126 patients for stricture treatment during followup was £6,113 ($9,170). This cost was calculated by multiplying procedure cost by the number of procedures performed. A strategy of urethrotomy or urethral dilation as first line treatment, followed by urethroplasty for recurrence yielded a total cost per patient of £5,866 ($8,799). Conclusions: A strategy of initial urethrotomy or urethral dilation followed by urethroplasty in patients with recurrent stricture proves to be the most cost-effective strategy. This financially based strategy concurs with evidence based best practice for urethral stricture management. KEY WORDS: urethra, urethral stricture, urinary catheterization, cost-benefit analysis, balloon dilatation

Optical urethrotomy and urethral dilation are simple endoscopic procedures that are currently the most commonly performed treatments for new and recurrent urethral stricture.1 Each has a reported success rate of 50%.2 It was recently suggested that endoscopic stricture management is being excessively and inappropriately used because of its simplicity and ease of repetition, and also because of a lack of familiarity with more major urethral reconstruction techniques.3, 4 To assess the cost-effectiveness and clinical appropriateness of stricture management we reviewed the results in all new patients treated for urethral stricture disease within a general urological practice. The cost of this treatment was then calculated using United Kingdom (UK) private medical insurance reimbursement schedules and an algorithm developed for the cost-effective management of urethral stricture. PATIENTS AND METHODS

All new patients undergoing endoscopic and open treatment for urethral stricture disease between January 1, 1991 and December 31, 1999 were identified from the hospital computerized database using International Classification of Disease-9 and 10 codes for urethral dilation, urethrotomy, urethral realignment and urethroplasty. The case notes on all patients identified by this search were reviewed and 186

male patients were verified as having undergone endoscopic or open treatment for urethral stricture disease during this period. Excluded from further analysis were patients with treatment for recurrent stricture who were first treated prior to the study period (49), those with prophylactic urethrotomy prior to transurethral prostate resection (TURP) (6), those with primary urethroplasty (2) and those with primary open (2) or endoscopic (1) realignment for pelvic fracture related urethral trauma within the study period. Data on patient age (current and at urethral stricture disease diagnosis), stricture etiology and anatomical site, primary treatment mode, outcome in terms of recurrence and side effects, and the number and mode of treatment of recurrences were obtained from a formal review of the case notes. Treatment failure was defined as recurrent symptomatic stricture requiring further operative intervention. Mean followup available on all patients was 25 months (range 1 to 132). UK private insurance schedules of reimbursement and costs for urethral stricture treatment were obtained along with supply costs for clean intermittent self-catheterization (CISC) catheters. They formed the basis for the calculation of treatment cost. The frequency of 1 vs 2-stage urethroplasty and the need for revision surgery were calculated using the Institute of Urology urethroplasty database.

Accepted for publication February 27, 2004. RESULTS * Correspondence: Institute of Urology, 48, Riding House St., LonA complete data set was obtained on all 126 patients with a don W1P 7PN, United Kingdom (telephone: 00 11 44 201 7504 9381; mean age of 57.7 years (range 17 to 93). The main causes of FAX: 00 11 44 201 76377076; e-mail: [email protected]). 275

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VALUE OF URETHRAL STRICTURE DISEASE TREATMENT

urethral stricture disease were iatrogenic and traumatic (table 1). The most common anatomical sites of stricture were bulbar (48.47% of cases), penile (25.4%) and mixed (16.6%). A total of 25 patients had posterior and 101 had anterior urethral strictures. Strictures recurred in 36% of posterior and 54% of anterior urethral stricture cases. This difference was not statistically significant (chi-square analysis p ⬎0.05). Of bulbar and penile urethral strictures 56% and 47% recurred, respectively. Bulbar strictures recurring following endoscopic treatment had the same mean length (1.1 cm) as those not recurring, while penile strictures recurring following endoscopic treatment were significantly longer than those not recurring (3.9 vs 1.5 cm, Student’s t test p ⬍0.05). Urethrotomy, urethral dilation and the 2 procedures were the primary treatment in 91 (72.2%), 32 (25.46%) and 3 (2.4%) cases, respectively. A total of 32 unselected patients (25%) then proceeded to perform twice weekly CISC using a 16Fr or the largest possible catheter. Overall endoscopic treatment was successful in 66 patients (52.4%), although 19 (28.8%) of them performed CISC and mean followup was 25 months only. The 60 patients with recurrent urethral stricture required a total of 194 further operations during the study period (mean 3.23 per patient) (table 1). Mean time to recurrence was 16 months (range 0.5 to 132). There were no significant complications and minor complications were not specifically recorded. Table 2 lists urethral stricture treatment costings in the study. All costs were calculated from UK private reimbursement schedules, including surgeon, anesthetic and hospital inpatient, and initial and followup outpatient fees. A fee for a routine postoperative urethrogram was also included. Twostage urethroplasty costs presumed a routine postoperative urethrogram after stage 2 and 2 outpatient visits. Inpatient stays were presumed to be 24 hours for urethrotomy or urethral dilation, 3 days for simple 1-stage or second stage urethroplasty and 5 days for complex 1-stage or first stage urethroplasty. The cost of twice weekly CISC was £11.31 ($16.97) monthly. Table 3 lists the total costs accrued for patients performing CISC in the study period. The cost per patient for endoscopic only stricture treatment and all (open and endoscopic) stricture treatments during the study period was then calculated. The cost of an evidence based management strategy of initial urethrotomy or urethral dilation for all strictures followed by urethroplasty was also calculated. The ratio of 1-to-2-stage urethroplasties performed at our tertiary referral urethral reconstruction center was assessed for 522 consecutive urethroplasties performed from January 1, 1997 to August 31, 2002 and it was found to be 1.9:1. This ratio of 1 to 2-stage urethroplasties is lower than in some practices. Any increase in this ratio would further decrease the total costs of urethroplasty and increase the costeffectiveness of evidence based practice. An adjusted urethro-

TABLE 1. Etiology of urethral stricture and operations after stricture recurrence No. (%) Etiology: TURP Indwelling catheter Idiopathic cause Straddle injury Radiotherapy Infection Pelvic fracture Miscellaneous Operation: Urethral dilation Urethrotomy 1-Stage urethroplasty 2-Stage urethroplasty CISC

45 (33.7) 30 (23.9) 22 (17.5) 9 (7.1) 7 (5.6) 5 (4.0) 4 (3.2) 4 (3.2) 108 (55.7) 79 (40.7) 6 (3.1) 1 (0.5) 32 (17.0)

TABLE 2. Urethral stricture treatment costing Treatment

No.

Cost/Procedure (£/$)

Cost Ratio

Total Cost (£/$)

Urethrotomy Urethral dilation 1-Stage simple urethroplasty 1-Stage complex urethroplasty 2-Stage Urethroplasty

173 143 0

2,250/3,375 2,250/3,375 5,015/7,522.5

1.0 1.0 2.23

389,250/583,875 321,750/482,625 0

6

5,335/8,002.5

2.37

32,010/48,015

1

10,370/15,555

4.61

All treatments

323

10,370/15,555 753,380/1,130,070

TABLE 3. CISC costs No. Pts 32 18

Mean Followup on CISC (mos)

Total Cost (£/$)

15.55 55.05

5,628/8,442 11,207/16,810.5



16,835/25,252.5

Total

plasty cost of £7,067 ($10,600.50) per urethroplasty was used to calculate the costs of evidence based management. All 1-stage urethroplasties were presumed to be complex. In addition, a revision surgery rate of 10.5% (re-graft of stage 1, fistula repair or repeat urethroplasty for recurrent stricture) was factored into the calculated costs of evidence based practice. This revision surgery value of 10.5% was calculated from our tertiary referral center database and it was the revision surgery requirement in the 522 consecutive urethroplasties entered onto the database at a mean followup of 29.8 months. Factoring these revision procedures as simple 1 stage in terms of additional costs yielded an additional cost of £250.75 ($376.13) per patient (table 4). DISCUSSION

Urethral stricture disease is common in current clinical practice, accounting for around 14 new cases yearly at the general urological institution studied, which serves a population of approximately 500,000 individuals. Endoscopic treatment was performed in the majority of stricture cases with only 10 urethroplasties performed during the study period (3 for primary and 7 for recurrent urethral stricture). Visual urethrotomy is the most common initial treatment modality, used in 72.2% of patients. Failure rates for all forms of endoscopic management are high at 47.6% despite CISC in 25% of patients. Each stricture recurrence required a further 3.13 endoscopic operations during the relatively short mean followup of 25 months, although CISC was commenced or continued in 39.7% of cases. Seven urethroplasties were performed for salvage during followup with no stricture recurrence. The total cost per patient for urethral stricture treatment during the study period was £6,113 ($9,169.50). The total cost per patient in all patients in whom stricture was managed only endoscopically was £6,116 ($9,174). The total cost per patient of pursuing an evidence based strategy of initial urethrotomy or urethral dilation followed by urethroplasty for stricture recurrence was £5,866 ($8,799). Costing is a difficult issue. In this study the concrete and quantifiable costs of inpatient and outpatient assessment, TABLE 4. Cost per patient of urethral stricture treatment All Treatments No. pts (£/$) Total cost (£/$) Cost/pt (£/$)

126 770,215/ 1,155,322.50 6,113/ 9,169.50

Endoscopy With ⫹ Without CISC Repeated as Needed

1 Endoscopy ⫹ Urethroplasty at Recurrence

119 727,835/ 1,091,752.50 6,116/9,174

126 739,115/ 1,108,672 5,866/8,799

VALUE OF URETHRAL STRICTURE DISEASE TREATMENT

investigation and treatment were calculated and compared. Other, far less easily quantifiable costs are the economic burden of time off work during and while recovering from treatment, and consequent to the complications of recurrent urethral stricture disease and to the treatment of complications. The burden of repeat hospital admissions is perhaps greatest in the young patient in terms of lost work time and the associated possibility of job loss. There may also be a financial burden involved in travel to a specialist urethroplasty center, although this is more likely to be significant in nontaxation funded health care systems. The costs of repeat urethroplasty in the 10% to 30% of patients (depending on stricture etiology and site, and urethroplasty type) with recurrent or new urethral stricture disease at 10 years were not factored into this discussion. To achieve a meaningful comparison 10-year data on the frequency of endoscopic intervention in the endoscopically treated group would also be required. To our knowledge no study to date has achieved this followup. In our current study we evaluated costs to a mean of 25 months for endoscopic treatment and a mean of 29.8 months for urethroplasty. Extrapolating further from our conclusions at this time would introduce an unacceptable degree of inaccuracy. Urethrotomy and urethral dilation have been shown to be of equal efficacy in the treatment of urethral stricture, producing cure in 50% of cases after 1 procedure, in an additional 20% after 2 and in 0% after 3.2, 5, 6 This was verified in our study with an overall success rate for endoscopic treatment of 52.4%. That neither therapy is effective for stricture recurrence is underlined by the large number of reinterventions required during the study period in patients in whom initial endoscopic therapy failed. Urethroplasty should be considered primary therapy in younger individuals with strictures following straddle injury and pelvic fracture who in general have strictures suitable for anastomotic urethroplasty or as second line therapy in patients younger than 55 years in whom 1 attempt at endoscopic management has failed. The 5 and 10-year success rates of anastomotic urethroplasty are greater than 88% with relatively few side effects, although a 2% to 5% impotence rate consequent to the procedure has been reported,7–9 while patch urethroplasties have a reported 5 and 10-year success rate of 80% and 69%, respectively, with few side effects.10 In the older than 55 years age group, which included the majority of patients with TURP, transurethral bladder tumor resection and open prostatectomy related strictures, urethroplasty has been found to be less effective.6, 9, 10 However, limited data are available and it may be that urethroplasty is justified in older men with good vascularity, as indicated by erectile function, penile artery Doppler flow measurement and urethral laser Doppler blood flow measurement. A randomized trial of endoscopic management vs urethroplasty for recurrent stricture following failed initial endoscopic management in older men may well be indicated to help answer this question. In those with poor vascularity or in all patients older than 55 years starting intermittent self-catheterization as palliation immediately following second urethrotomy or dilation may decrease the number of re-interventions required in this aging group.11 In the short term this does not appear to be the case.12 Urethral stents may provide an alternative to intermittent self-catheterization for long-term management of stricture disease in the older than 55 years age group but they are currently expensive and have been associated with problematic post-micturition dribble, dysuria and urethral pain.13, 14 The persistent use of endoscopic management for recurrent urethral strictures may be the result of unfamiliarity with the literature and inexperience with urethroplasty surgery.

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This may be compounded by a perception that, however ineffective, repeat urethrotomy or urethral dilation are safe and simple, and by the desire not to refer for further care. A recent survey of anterior urethral stricture management involving 424 urologists confirmed this with only 21% to 29% indicating that they would refer a patient with a long or recurrent bulbar stricture to another urologist for urethroplasty, while 33% to 34% elected to continue endoscopic management despite predictable failure. Of the urologists surveyed 74% believed that the literature supports the use of urethroplasty only after repeat endoscopic failure.3 Urethroplasty is not an occasional operation. It demands skill and experience to achieve the excellent long-term results that justify the evidence based, cost-effective management advocated. A lack of available specialist skills should prompt specialist referral for urethroplasty. CONCLUSIONS

While primary endoscopic management of urethral stricture is simple and safe, it yields a high failure rate with recurrence in 47.6% of patients. A strategy of initial urethrotomy or urethral dilation followed by urethroplasty for stricture recurrence is cost-effective and clinically effective. In light of this finding repeat endoscopic management for recurrent urethral stricture can no longer be justified. REFERENCES

1. Andrich, D. E. and Mundy, A. R.: Urethral strictures and their surgical treatment. BJU Int, 86: 571, 2000 2. Steenkamp, J. W., Heyns, C. F. and de Kock, M. S.: Internal urethrotomy versus dilation as treatment for male urethral strictures: a prospective, randomized comparison. J Urol, 157: 98, 1997 3. Brandes, S. B., Smith, J., Virgo, K. and Johnson, F. E.: Adult anterior urethral strictures: a national practice patterns survey. J Urol, suppl., 165: 13, abstract 53, 2001 4. Andrich, D. E., MacDonald, J., Greenwell, T. J. and Mundy, A. R.: Treatment of pelvic fracture related urethral trauma: a survey of current practice in the UK. Unpublished data 5. Heyns, C. F., Steenkamp, J. W., De Kock, M. S. L. and Whitaker, P.: Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol, 160: 356, 1998 6. Holm-Nielsen, A., Schultz, A. and Moller-Pedersen, V.: Direct vision internal urethrotomy. A critical review of 365 operations. Br J Urol, 56: 308, 1984 7. Mundy, A. R.: Urethroplasty for posterior urethral strictures. Br J Urol, 78: 243, 1996 8. Webster, G. D. and Ramon, J.: Repair of pelvic fracture posterior urethral defects using an elaborated perineal approach: experience with 74 cases. J Urol, 145: 744, 1991 9. Martinez-Pineiro, J. A., Carcamo, P., Garcia Matres, M. J., Martinez-Pine, L., Iglesias, J. R. and Rodriguez Ledesma, J. M.: Excision and anastomotic repair for urethral stricture disease: experience with 150 cases. Eur Urol, 32: 433, 1997 10. Roehrborn, C. G. and McConnell, J. D.: Analysis of factors contributing to success or failure of 1-stage urethroplasty for urethral stricture disease. J Urol, 151: 869, 1994 11. Hariss, D. R., Beckingham, I. J., Lemberger, R. J. and Lawrence, W. T.: Long-term results of intermittent low-friction selfcatheterization in patients with recurrent urethral strictures. Br J Urol, 74: 790, 1994 12. Matanhelia, S. S., Salaman, R., John, A. and Matthews, P. N.: A prospective randomized study of self-dilatation in the management of urethral strictures. J R Coll Surg Edinb, 40: 295, 1995 13. Sertcelik, N., Sagnak, L., Imamoglu, A., Temel, M. and Tuygun, C.: The use of self-expanding metallic stents in the treatment of recurrent bulbar urethral strictures: long-term results. BJU Int, 86: 686, 2000 14. Baert, L., Verhamme, L., Van Peppel, H., Vandeursen, H. and Baert, J.: Long-term consequences of urethral stents. J Urol, 150: 853, 1993