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Keywords:

  • stress urinary incontinence;
  • urodynamics;
  • cost-effectiveness analysis

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

Objective To compare the cost-effectiveness of preoperative testing strategies in women with stress incontinence symptoms, as although urodynamic testing is used to improve the diagnostic accuracy in women with incontinence, the clinical and economic consequences of different levels of testing have not been evaluated.

Materials and methods Decision analysis was used to evaluate basic office assessment (BOA) and urodynamic testing for women with stress incontinence symptoms who were candidates for primary surgical treatment. Costs were calculated using the Federal Register. Parameter estimates for the effectiveness of treatment for different diagnoses of incontinence were based on published reports. Incremental cost-effectiveness was defined as the cost in dollars per additional patient cured of incontinence.

Results Urodynamics did not improve the effectiveness of treatment; both strategies of a BOA and urodynamic testing resulted in a cure rate of 96% after initial and secondary treatments. The mean cost of care (including initial and secondary treatments and outcomes) was similar for the two strategies ($5042 for BOA, $5046 for urodynamic testing). With BOA reduced testing costs were balanced by increased costs for patients who failed the initial treatment. Under baseline assumptions, one additional cure of incontinence (incremental cost-effectiveness) using the urodynamic strategy cost $3847, compared with BOA. By sensitivity analyses, BOA was less costly than urodynamics when the prevalence of genuine stress incontinence was geqslant R: gt-or-equal, slanted 80%.

Conclusion These findings do not support the routine use of urodynamics before surgery in women likely to have genuine stress incontinence, and provide the justification for randomized trials of preoperative testing strategies.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

The Agency for Health Care Policy and Research (AHCPR) developed guidelines for managing urinary incontinence in adults, to improve care and to reduce variation in care [1]. Recommendations for evaluating uncomplicated stress incontinence in women include a detailed history and physical examination, urine analysis, a provocative cough-stress test, and measurement of postvoid residual urine volume (PVR). Urodynamic testing was not recommended routinely but was reserved for cases with complicating factors and comorbidities. However, concern has been expressed that inaccurate diagnoses made without urodynamics may lead to inappropriate treatment for up to a third of women with stress incontinence symptoms [2].

With the annual societal cost of incontinence of > $26 billion, with an estimated $393.5 million attributed to costs of diagnostic testing, the cost-effectiveness of urodynamic testing must be critically evaluated [3]. The objective of the present study was to compare different strategies of preoperative diagnostic testing in the predicted success and cost-effectiveness of treatment for uncomplicated stress urinary incontinence (SUI) in women. Using a decision-analysis approach and published data to predict the probability of outcomes (cure of incontinence and need for re-treatment), the success of treatment and costs were calculated to assess the cost-effectiveness. Sensitivity analyses were used to determine the effect of parameter estimates on outcomes.

Materials and methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

Decision-analysis models were developed in three stages. First, a hypothetical patient population was defined of otherwise healthy women, aged leqslant R: less-than-or-eq, slant 65 years, with predominantly stress incontinence symptoms (with or without urgency, frequency or nocturia) who were candidates for primary surgical treatment. Second, all patients had a basic office assessment (BOA) including a detailed history, physical examination, urine analysis, provocative cough-stress test, and measurement of PVR. Table 1 lists the characteristics defining the patient population based on the BOA. Women then had either no further testing or urodynamics to assign a presumed or confirmed diagnosis of incontinence (Fig. 1a). Finally, treatment was instituted and the outcomes of treatment (cure of incontinence, need for re-treatment and cost) estimated. The model included initial treatment (Fig. 1a) and a second series of evaluation and treatment for patients not cured initially (Fig. 1b).

Table 1.  The defining characteristics of the hypothetical patient population
CharacteristicDetail
GeneralAdult women, aged leqslant R: less-than-or-eq, slant 65 years, with the predominant symptom  of SUI, with or with no urgency,  frequency or nocturia.
HistoryNo previous surgical treatment for  urinary incontinence.
No history of neurological conditions.
No causes of acute or reversible  incontinence (e.g. UTI or drug side-effects).
No history of pelvic radiation or surgery for pelvic cancer.
Physical examinationNo symptomatic pelvic organ  prolapse or prolapse extending  beyond the hymen.
 Normal screening neurological examination.
 Urethral hypermobility.
Office testingNormal urine analysis.
 Direct observation of urine loss  through the urethra instantaneously with cough. Normal PVR.
imageimage

Figure 1. The format of: a , the proximal part of the decision analysis model. After the BOA, two groups of patients were formed, i.e. ‘no further testing’ and ‘urodynamics’. Treatment was instituted based on presumed or confirmed diagnoses of incontinence. Baseline variable estimates are provided, with ranges used for sensitivity analyses in parentheses. b , the distal part of the model. Three outcomes of surgery were included, as well as subsequent evaluation and treatment for patients with failed initial treatment. Baseline variable estimates are provided for the diagnosis of GSI, with ranges used for sensitivity analyses in parentheses.

Estimates of the variables were obtained from articles identified through a Medline search of English-language peer-reviewed journals from 1966 to 1998, supplemented by references in the articles recovered through Medline (Table 2) [1,2,4–43]. The quality of evidence was rated using the following system [1]: (A) properly designed and implemented controlled trials; (B) properly designed and implemented clinical series; and (C) expert opinion. The literature review identified the range of reported outcomes rather than all publications on each variable; the highest and lowest values were used as ranges for sensitivity analyses. Variables for which no data could be found were estimated by consensus of the authors and were varied by at least ±10% for sensitivity analyses.

Table 2.  Parameter estimates of variables in the cost-effectiveness analyses of preoperative testing for SUI in women
Variable: Value (range)%Definition [reference] (quality grade)
Prevalence of diagnoses in defined population
80 (58–89)Urodynamically confirmed GSI in women with stress symptoms and positive cough stress test [2,5–9] (B)
18 (9–37)Urodynamically confirmed mixed incontinence in women with stress symptoms and positive cough stress  test [2,5–9] (B)
2 (0–5)Urodynamically confirmed DI in women with stress symptoms and positive cough stress test [2,5–9] (B)
Test characteristics for urodynamics
86 (78–94)Urodynamic test positive for GSI when GSI is true condition (sensitivity or true-positive for GSI) [10,11] (B)
14 (7–18)Urodynamic test positive for mixed incontinence when GSI is true condition (false-positive for DI) [12–14] (B)
75 (67–83)Urodynamic test positive for mixed incontinence when mixed is true condition (true-positive for mixed) (C)
25 (22–28)Urodynamic test positive for GSI when mixed incontinence is true condition (false-negative for DI) [15–17] (B)
86 (76–92)Urodynamic test positive for DI when DI is true condition (true-positive for DI) (C)
0.05 (0.04–0.06)Urodynamic test positive for GSI when DI is true condition (false-positive for GSI)(C)
13.95 (13.94–13.96)Urodynamic test positive for mixed incontinence when DI is true condition (false-positive for mixed) (C)
Cure Rates of Incontinence
86 (76–92)Cure rate after initial retropubic bladder suspension for GSI [1,18] (B)
86 (82–97)Cure rate after repeat retropubic bladder suspension for urethral hypermobility and GSI [19–22] (B)
31 (25–35)Cure rate after initial retropubic bladder suspension for DI [28] (B)
78 (30–92)Cure rate after initial retropubic bladder suspension for mixed incontinence [19,23–27] (B)
82 (81–90)Cure rate after collagen injection for ISD [35–38] (B)
72 (65–78)Cure rate after urethrolysis for retention [29–34] (B)
68 (59–80)Cure rate for medical treatment for DI [25,26] (B); [39–41] (A)
51 (46–60)Cure rate for medical treatment for mixed incontinence [25,26] (B)
0 (0–10)Cure rate for medical treatment for GSI (C)
Other variables
2.5 (0–5)Rate of permanent retention after initial or repeat retropubic bladder suspension [18] (B)
9 (0–15)Rate of recurrent incontinence after urethrolysis [29–32,34] (B)
19 (12–23)Rate of persistent retention after urethrolysis [29–32,34] (B)
30 (12–67)Recurrent urethral hypermobility as cause of recurrent incontinence after retropubic bladder suspension for GSI,  DI or mixed incontinence [4,20,22] (B); [42] (A)
52 (33–53)ISD as aetiology of recurrent incontinence after retropubic bladder suspension for GSI [4,19] (B)
18 (17–33)DI as aetiology of recurrent incontinence after retropubic bladder suspension for GSI [19–21] (B)
20 (10–30)ISD as aetiology of recurrent incontinence after retropubic bladder suspension for DI or mixed incontinence (C)
50 (40–60)DI as aetiology of recurrent incontinence after retropubic bladder suspension for DI or mixed incontinence (C)

Assumptions in the cost-effectiveness analysis

We assumed three types of urinary incontinence in our hypothetical patient population: genuine stress incontinence (GSI), detrusor instability (DI), and mixed incontinence. GSI is defined by the ICS as the involuntary loss of urine occurring when, in the absence of a detrusor contraction, intravesical pressure exceeds maximum urethral pressure [44]. Therefore, by definition, a minimum of dual-channel cystometry is required to confirm the urodynamic diagnosis of GSI (by documenting no detrusor activity preceding urine loss). DI is a urodynamic diagnosis based on the presence of uninhibited detrusor contraction(s), spontaneously or on provocation, during filling [44]. Mixed incontinence is both GSI and DI confirmed by urodynamic testing.

Other (less common) diagnoses of incontinence, e.g. overt neurogenic incontinence and overflow incontinence, were excluded as, by definition (Table 1), all women had a negative neurological history and physical examination, and a normal PVR. We assumed that other diagnoses such as unsuspected neurological disease, urogenital fistula, and ectopic ureter would be so rare as to be negligible in otherwise healthy women with documented transurethral urine loss. Intrinsic sphincter deficiency (ISD) was also excluded as a primary diagnosis. Known risk factors for ISD include advanced age and previous incontinence surgery [4,45], both of which were excluded. However, ISD was included as a category of persistent or recurrent incontinence after failed initial treatment.

The initial therapy for incontinence included medical or surgical treatment, depending on the type of incontinence. Based on the AHCPR Clinical Practice Guideline for the surgical treatment of GSI, retropubic bladder suspension was chosen as the primary surgery [1]. DI was treated with anticholinergic medication. Surgery for DI only occurred with a false-positive diagnosis of GSI. Women with mixed incontinence received medication first, followed by surgery for persistent stress incontinence. GSI was medically treated only with a false-positive diagnosis of mixed incontinence.

In the decision-analysis model, individuals were assigned to one of two groups, i.e. ‘no further studies’ and ‘perform urodynamics’. Women in the first group received no further testing and surgery was undertaken for presumed GSI, based on the positive cough-stress test as part of the minimum evaluation. Assignment to a ‘true’ diagnosis of incontinence was based on published reports to estimate the prevalence of different diagnoses in this patient population. Women in the second group underwent urodynamics, defined as dual-channel subtracted cystometrography, uroflowmetry, pressure-flow voiding study, and an assessment of urethral function by urethral pressure profilometry or leak-point pressure measurement. The results of urodynamic testing were used to assign women to one of the three diagnostic categories of incontinence, and treatment was instituted based on the urodynamic diagnosis.

We included three outcomes after primary and secondary treatment: cure of incontinence, urinary retention and persistent incontinence. Using results from two comprehensive reviews of surgery for stress incontinence, we defined ‘cure’ as sufficient resolution of symptoms that further treatment was not desired or necessary [1,18]. While this includes some women who are not completely continent, it appropriately reflects the cost of subsequent treatment. The duration of the reported follow-up varied but, for the purposes of the model, we assumed that the cure rate was stable for at least 1 year. We included three diagnoses for persistent incontinence after primary surgery: GSI with urethral hypermobility, ISD with no urethral hypermobility, and DI. To simplify the model, other complications of surgery, testing or medical treatment were not considered.

Cost and sensitivity analyses

This study applied the societal perspective in all cost analyses, which has been advocated as the most relevant when considering cost-effectiveness for a population [46]. Costs for all tests and procedures (Table 3) were obtained using data from the 1998 Federal Register based on coding from Medicare Diagnosis-Related Groups and International Classification of Diseases, 9th edition (ICD-9 codes). Costs for hospital services were calculated using Diagnosis-Related Groups case weights multiplied by standard urban rates for labour, non-labour costs, and capital. Costs for physician services were calculated using relative value units for specific tests and procedures multiplied by a standard conversion factor. Costs for outpatient tests and procedures included facility costs and professional reimbursement. The cost of medication was based on twice daily dosing with oxybutynin for 1 year. The range of costs was ±10% of baseline estimates. Because of the difficulty in obtaining reliable estimates, non-medical indirect costs such as days of work lost were not included.

Table 3.  Cost estimates in the cost-effectiveness analyses of preoperative testing for SUI in women
Cost (range), $Definition
445 (401–489)Urodynamic testing
4491 (4042–4940)Initial retropubic bladder suspension
4642 (4178–5106)Repeat retropubic bladder suspension
5012 (4511–5513)Urethrolysis
965 (869–1061)Collagen injection
138 (124–152)Medical treatment for detrusor instability
2680 (2412–2948)Care related to incontinence for one year
2348 (2113–2583)Care related to urinary retention for one year

Cost-effectiveness and sensitivity analyses were performed in two stages. First, we considered all probabilities and costs to be fixed and calculated actual expected mean effectiveness (cure rate of incontinence) and cost per cure for each algorithm. Incremental cost-effectiveness was calculated as the extra cost of one additional cure of incontinence. Second, to estimate the effect of each variable on the results, we conducted a series of one-way sensitivity analyses by systematically changing each variable through its range while holding other variables constant at their baseline values. For each value of the designated variable, mean effectiveness, cost and incremental cost-effectiveness were computed for each testing strategy. Threshold analyses were used to identify the variable's value that would change the results; ranges were extended beyond their original bounds, if necessary, to calculate threshold values. In addition, two-way sensitivity analyses were performed in which the values of two variables were varied while all other variables were held constant at their baseline value. All modelling, calculations, and sensitivity analyses were performed using DATA 3.0 (Tree Age Software Inc., Williamstown, MA), a decision-analysis software program.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

Under baseline assumptions, the effectiveness of treatment was essentially the same for both strategies. For BOA, 96.4% of the hypothetical patient population were cured of incontinence by initial and secondary treatments, whereas 96.5% were cured in the group with urodynamic testing. The average cost of care (including initial and secondary treatments and outcomes) was similar under the two strategies of preoperative testing ($5042 for BOA and $5046 for urodynamic testing). Successful treatment in the BOA strategy cost a mean of $4693 per patient, compared with a higher cost of $4811 for successful treatment in the urodynamic testing strategy. However, unsuccessful treatment was more costly in the BOA strategy, at $5771 vs $5281 per patient unsuccessfully treated in the urodynamic strategy. In the BOA strategy, reduced costs of testing were balanced by increased costs for re-evaluation and re-treatment of patients who failed initial treatment. Using baseline variable estimates, one additional cure of incontinence (incremental cost-effectiveness) using the urodynamic strategy cost $3847, when compared with BOA.

Sensitivity analyses

A series of one-way sensitivity analyses showed that cost-effectiveness was most sensitive to change in the prevalence of types of incontinence (GSI, DI and mixed) in the patient population. When the prevalence of GSI was geqslant R: gt-or-equal, slanted80% the BOA was the more cost-effective strategy. With a prevalence of 80–84%, the addition of urodynamic testing achieved one extra cure of incontinence at costs of $3847–$405 376 (Fig. 2). When the prevalence of GSI was geqslant R: gt-or-equal, slanted85%, the BOA dominated the strategy of urodynamics in that it was both less costly and more effective. When the prevalence of GSI was leqslant R: less-than-or-eq, slant79%, urodynamics was the preferred testing strategy (less costly and more effective).

image

Figure 2. Incremental cost-effectiveness of urodynamic testing compared with BOA, by prevalence of GSI. Incremental cost-effectiveness is defined as the additional cost per extra cure of incontinence achieved by using urodynamic testing vs the BOA strategy. At a prevalence of GSI of leqslant R: less-than-or-eq, slant0.79, the strategy of urodynamic testing dominated the BOA because it is both less costly and more effective. At a prevalence of GSI of geqslant R: gt-or-equal, slanted0.85, the strategy of BOA dominated urodynamic testing.

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As shown in Table 4, the results were influenced by two of the nine cost estimates and three variable estimates related to diagnosis and treatment of mixed incontinence (of a total of 27 other variables estimated). Cost-effectiveness was unaffected by changes in all other variables.

Table 4.  One-way sensitivity analyses in the decision analysis model comparing urodynamics with BOA
VariableUrodynamics*BOA*
  • *

    Estimated value of the variable at which one strategy was favoured over the other.

Prevalence of GSI, %leqslant R: less-than-or-eq, slant 79geqslant R: gt-or-equal, slanted 80
Cost of urodynamics, $leqslant R: less-than-or-eq, slant 446geqslant R: gt-or-equal, slanted 447
Cost of primary surgery, $geqslant R: gt-or-equal, slanted 4475leqslant R: less-than-or-eq, slant 4474
Cure rate of medical treatment for mixed incontinence, %geqslant R: gt-or-equal, slanted 52leqslant R: less-than-or-eq, slant 51
Cure rate of surgery for mixed incontinence, %leqslant R: less-than-or-eq, slant 78geqslant R: gt-or-equal, slanted 79
Sensitivity of urodynamics for mixed incontinencegeqslant R: gt-or-equal, slanted 75leqslant R: less-than-or-eq, slant 74

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

In an evidence-based practice of medicine, diagnostic evaluations would only be used when results influence treatment to improve outcomes. The present findings suggest that, in adult women with SUI symptoms, urodynamic testing provides only a modest improvement in diagnostic accuracy compared with BOA. More importantly, the effectiveness of therapy was similar regardless of which type of preoperative testing was used. The BOA was less costly than urodynamic testing in women likely to have GSI. The cost to obtain one additional cure of urinary incontinence was only $3847 under the baseline assumptions. However, this value should be interpreted cautiously as it was exquisitely sensitive to the prevalence of GSI; as the prevalence of GSI increased by only five percentage points, the incremental cost-effectiveness of urodynamic testing increased exponentially (Fig. 2). When the diagnosis of GSI is more likely to be based on the population prevalence, urodynamics are less likely to provide a benefit by detecting an important competing diagnosis such as DI. This is reflected in the dramatic increase in cost per additional cure of incontinence as the prevalence of GSI increased in the population.

Both professionally and within society, the threshold cost should be determined that is acceptable for the cost-effectiveness of testing and treatment related to urinary incontinence, a chronic condition that may not diminish the quantity of life but that significantly decreases the quality of life. One way to analyse this is by using cost-benefit analyses with outcomes of quality-adjusted life years. Unfortunately, we were unable to use this approach because there is no quantitative information on changes in quality of life with the treatment of urinary incontinence. From the results of these decision analyses, we recommend that randomized trials be conducted to directly compare outcomes of treatment with different levels of testing. Such trials should include an assessment of the effect of successful and unsuccessful treatment on the quality of life. Decisions about the most effective level of testing should not be based solely on cost.

The likelihood that an individual patient fits a particular diagnostic category depends on several factors, which physicians use (formally or informally) in making diagnostic assessments. Previous probability of disease, i.e. the prevalence of different conditions in the population of interest, is subsequently modified by information obtained through the history, physical examination and testing to arrive at a posterior probability of disease, on which treatment is based. We evaluated the effect of diagnostic accuracy, based on two levels of testing, on the outcome of treatment for GSI and other diagnoses of incontinence. Although some reports have examined the influence of preoperative testing on diagnostic accuracy, few have extended their analyses to a potential effect on outcome [2,5–8]. The outcome of importance for a test is not merely diagnostic accuracy; for testing to be worthwhile, it must be accompanied by a clinically important improvement in outcome. Although testing rarely achieves perfect diagnostic accuracy, this is not commonly examined in comparing different evaluations or treatments.

The most important rationale for urodynamics in our study population is the identification of DI (either alone or as mixed incontinence), with the change in management over presumed GSI. There are no controlled studies that directly compare the effectiveness of medication and surgery for mixed incontinence. We included initial medical treatment for mixed incontinence in our models, although we found only two reports on the results of medication before surgery for mixed incontinence [25,26]. As the effectiveness of medical treatment for mixed incontinence was identified as an important variable in the model, it is essential that there is further research to define the optimum evaluation and treatment for mixed incontinence. For example, it is common practice to use a battery of tests, as included in this model. However, if DI is the most important condition in the differential diagnosis, only one test may be needed to limit diagnostic error. Although that hypothesis was not specifically tested in the present study, that would decrease the costs associated with urodynamic testing and could improve cost-effectiveness.

Importantly, the strategy of ‘no further testing’ should not be interpreted to mean no testing at all. History and physical examination findings do not accurately predict the type of incontinence and, alone, are insufficient to recommend surgery for GSI. However, testing need not be complicated or expensive to provide enough diagnostic accuracy to proceed with treatment. The advantages of BOA are clear; it is simple, requires universally available, inexpensive supplies, and is easily carried out by all clinicians caring for women with incontinence.

The limitations of the present study should be acknowledged. Decision analyses involve simulated models rather than real-life events, with several simplifying assumptions; the results are based on averages. These results provide scientific justification for conducting randomized trials that compare the effect of different preoperative testing strategies on outcomes. While we were able to estimate most variables from published reports and sensitivity analyses examined the effect of these variables across ranges of clinical importance, published reports on outcomes after incontinence surgery have been criticised [47]. However, sensitivity analyses showed that the present results were not influenced by variables that estimated the effectiveness of surgery for GSI. Even if ‘true’ outcomes differed significantly from the current literature, this is unlikely to have affected our conclusions. Finally, we focused on a narrowly defined group of women who would be most likely to have GSI and least likely to have other diagnoses, i.e. women least likely to benefit from a diagnostic advantage provided by urodynamic testing. Nevertheless, it is common clinical practice to use urodynamics in all women with incontinence, regardless of the previous probability of GSI.

In conclusion, the results of this decision analysis model show that the routine use of urodynamics before surgery in women likely to have GSI is not cost-effective, and they provide the justification for randomized trials of preoperative testing strategies.

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Authors

  1. Top of page
  2. Abstract
  3. Introduction
  4. Materials and methods
  5. Results
  6. Discussion
  7. Authors

A.M. Weber, MD, MS, Associate Professor.

R.J. Taylor, MD, MS, Assistant Professor.

J.T. Wei, MD, MS, Assistant Professor.

G. Lemack, MD, Assistant Professor.

M.R. Piedmonte, MA, Statistician.

M.D. Walters, MD, Head, Section of Urogynecology and Pelvic Reconstructive Surgery.

Abbreviations
AHCPR

Agency for Health Care Policy and Research

PVR

postvoid residual urine volume

BOA

basic office assessment

SUI

stress urinary incontinence

GSI

genuine stress incontinence

DI

detrusor instability

ISD

intrinsic sphincter deficiency

A.M. Weber, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA 15213, USA. e-mail: aweber@mail.magee.edu