BJOG: an International Journal of Obstetrics and Gynaecology

March 2003, Vol. 110, pp. 255 262

A costutility analysis of tension-free vaginal tape versus

colposuspension for primary urodynamic stress incontinence
a,* a b,c b,c
Andrea Manca , Mark J. Sculpher , Karen Ward , Paul Hilton
Objective To assess the cost effectiveness of tension-free vaginal tape compared with open Burch
colposuspension as a primary treatment for urodynamic stress incontinence.
Design Cost utility analysis alongside a multicentre randomised comparative trial.
Setting Gynaecology or Urology departments in 14 centres in the UK and Ireland, including University-
associated teaching hospitals and district general hospitals.
Population Women with urodynamic stress incontinence. Exclusion criteria were: (1) detrusor overactivity;
(2) major voiding problems; (3) prolapse; (4) previous surgery for incontinence or prolapse.
Methods Resource use data were collected on all 344 patients in the trial, including length of hospital stay,
time in theatre and management of complications; resource use was costed using UK unit costs at 1999
2000 prices.
Main outcome measures Health outcomes were expressed in terms of quality-adjusted life years (QALYs) between
baseline and six months follow up, based on womens responses to the EQ-5D health questionnaire.
Results Tension-free vaginal tape resulted in a mean cost saving of 243 (95% CI 341 to 201) compared
with colposuspension. Differential mean QALYs per patient (tension-free vaginal tape colposuspension) was
0.01 (95% CI 0.01 to 0.03). The probability of tension-free vaginal tape being, on average, less costly than
colposuspension, was 100%, and the probability of tension-free vaginal tape being more cost effective than
colposuspension was 94.6% if the decision-maker was willing to pay 30,000 per additional QALY.
Conclusion The results from this trial suggest that, over a post-operative period of six months, tension-free
vaginal tape is a cost effective alternative to colposuspension. The results will need to be reassessed on the
basis of longer follow up.

INTRODUCTION than open dissection of the retropubic space. This can be

Urinary incontinence is a significant health problem,
1
with 14% of women reporting the symptoms . Urodynamic
stress incontinence accounts for approximately 50% of
2 well as health outcomes, it is important to assess its cost
urinary incontinence in women presenting to hospital .
Physiotherapy has a cure rate of about 50%
3 5
, and
surgery is recommended for those women who fail to
respond. Colposuspension is the most frequently used form
of primary therapy for urodynamic stress incontinence, but
the morbidity and resource use associated with the proce-
dure are considerable.
A recent development in the treatment of urodynamic
stress incontinence is the use of a prolene tape (tension-free
vaginal tape) inserted using a tunnelling approach rather
a Service perspective.
Centre for Health Economics, University of York, UK
b
Directorate of Womens Services, Royal Victoria
Infirmary, Newcastle upon Tyne, UK
c
Department of Obstetrics and Gynaecology, University of
Newcastle upon Tyne, UK
* Correspondence: Dr A. Manca, Centre for Health Economics,
University of York, Heslington, York, YO 10 5DD, UK.
D RCOG 2003 BJOG: an International Journal of Obstetrics and Gynaecology
doi:10.1016/S1470-0328(03)02915-X
done under local anaesthesia and can be undertaken using
6
day-case admission , allowing more rapid return to normal
activity. Given that the use of tension-free vaginal tape
results in changes in a range of health care resources as
effectiveness relative to standard surgical management
with colposuspension.
A multicentre prospective randomised controlled trial
comparing tension-free vaginal tape and Burch colposus-
pension for primary urodynamic stress incontinence has
7
been undertaken in the UK . As part of the study, patient-
specific resource use and health-related benefits were
prospectively collected during hospitalisation and for a
period of six months after discharge from hospital. This
paper reports the results of a cost utility analysis under-
taken using these data, adopting a UK National Health
METHODS
Full details of the design of the trial have been published
7
elsewhere . Briefly, the clinical study was a prospective
multicentre randomised controlled trial enrolling 344
www.bjog-elsevier.com
256 A. MANCA ET AL.

women diagnosed with primary urodynamic stress incon- Inpatient stay was the number of nights spent in the general
tinence. Patients were recruited to the trial from urogynae- ward by each woman. Post-operative resource use included
cology, general gynaecology and urology outpatient clinics that related to management of complications (e.g. fever,
between May 1998 and August 1999, and were randomised to wound infection, urinary tract infection), additional
either colposuspension (n 169) or tension-free vaginal tape consum-ables (e.g. drains, catheters), post-operative
(n 175). A total of 34 women dropped out from the study, analgesia and any return to theatre during main
28 before surgery (23 colposuspension, 5 tension-free vaginal hospitalisation. Finally, the six-month post-operative visit
tape) and 6 afterwards (4 tension-free vaginal tape, 2 to clinic facilitated the col-lection of data on additional
colposuspension). Of the 23 women who did not undergo surgical procedures, use of concomitant medications, re-
surgery in the colposuspension group, 20 withdrew their hospitalisations, number of outpatient and day-case visits
consent, 2 discontinued the study due to protocol violation and and general practitioner con-tacts since hospital discharge.
1 patient withdrew for other reasons. Of the five women who The differential cost of treating patients in the two arms of
did not have surgery in the tension-free vaginal tape arm, two the trial was estimated by valuing the resource use measured
withdrew their consent, two violated the protocol and one in the study using UK unit costs estimated at 1999 2000
withdrew for other reasons. Of the four women who dropped prices, including value-added tax where appro-priate. Staff
out from the tension-free vaginal tape group after surgery, two time was costed using mid-range salaries uprated for
8 10
had a treatment failure, one did not return for the follow up employers costs . Consumables were costed using
visit and one withdrew for other reasons. Finally, one of the manufacturers list prices, and drug costs were based on those
11
two women who decided not to continue the study after reported in the British National Formulary . Inpatient stay
colposuspension withdrew her consent, while the other did not was costed using an estimated average hotel cost per day in a
return for the follow up visit. gynaecological ward obtained from a survey of three UK
hospitals undertaken in 1995 and uprated for health service
Baseline characteristics and clinical results of the ran- 12
7 inflation . We assumed the hotel cost of a day-case visit to be
domised trial are detailed elsewhere . Women who pre- 13
equal to the cost of an outpatient visit . Finally, the cost of a
sented with urodynamically proven stress incontinence
general practitioner consultation was obtained from published
were invited to participate in the trial. Exclusion criteria 8
were detrusor overactivity, vaginal prolapse requiring treat- estimates . The main unit costs used in the analysis are
reported in Table 1.
ment, previous surgery for prolapse or incontinence, a
major degree of voiding dysfunction, neurological disease The health outcomes of treatment, over six months follow
and allergy to local anaesthetic. In terms of clinical results, up, were expressed in terms of quality-adjusted life years
there was no statistically significant difference between the (QALYs). In order to measure womens health status at
cure rate in the two groups: 115 (66%) women in the various points in time, women were asked to complete the
14
tension-free vaginal tape group and 97 (57%) in the EQ-5D health questionnaire at baseline, at six weeks and six
colposuspension group were objectively cured. Subjective months after hospital discharge. This is a standardised non-
cure of stress incontinence was reported by 103 (59%) and disease specific instrument designed to describe and to
90 (53%) of women in the tension-free vaginal tape and
colposuspension arm, respectively. This economic
Table 1. Key unit costs used in the analysis.
evaluation is conducted on an intention-to-treat basis and
includes only the 316 women who underwent surgery. Item of resource Unit Unit cost () Source
Using case report forms completed by clinical staff, patient- Ward hotel cost Day 103.00 Ref. 12
specific data on resource use were prospectively recorded Theatre
from hospitalisation to six months from discharge. Where
resource use was not expected to vary between patients, Staff (tension-free vaginal tape) Minute 2.24 Refs 8 10
Staff (colposuspension) Minute 2.87 Refs 8 10
estimates based on clinical expert advice were used. Data
Anaesthetic room
were collected on resource use during two study periods: main
hospitalisation and follow up at six months. The former Staff Minute 0.85 Ref. 9
comprised resource use in theatre, inpatient stay and post- Recovery area
operative complications. Theatre resource use included staff
present (in holding bay, anaesthetic room, op-eration theatre Staff Minute 0.20 Ref. 9
Overheads Minute 2.33 Ref. 12
and recovery area) based on clinical advice; consumables (in
theatre and anaesthetic room); and drug use (i.e. Key consumables
thromboprophylactics, anaesthetics and antibiotics). Theatre
resource use included any extra tension-free vaginal tapes. Tension-free vaginal tape Item 359.45 Ethicon
Drugs used for anaesthesia, thromboprophylaxis, se-dation Staple gun Item 113.42 Ethicon
Outpatient and day-case visits Visit 62.00 Ref. 13
and the prophylactic antibiotic regimen were set by the
protocol. Other patient-specific theatre resources com-prised General practitioner visit Visit 15.75 Ref. 8
those associated with intra-operative complications.
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262
 TENSION-FREE VAGINAL TAPE VERSUS COLPOSUSPENSION 257

value health status. Health status is defined in terms of five
dimensions: mobility, self-care, usual activities, pain or
discomfort and anxiety or depression. Each of these dimen-
sions has three levels of severity: no problems, moderate
problems or extreme problems. In completing the EQ-5D, a
patient defines their health state in terms of the five dimen-
sions, which is transformed into a weighted health state index
score or utility. Using values elicited from the UK
15
population , the index typically ranges between 0 (equiva-
lent to death) and 1 (equivalent to good health), although a
small number of health states are valued as worse than death.
EQ-5D scores at baseline, six weeks and six months were
used to calculate patient-specific QALYs, which were esti-
16,17
mated using the area under the curve method . This is
achieved, for each patient, by weighting the time between
the three EQ-5D responses using the health state index
score. Therefore, the QALY seeks to capture the impact of
the alternative treatments in terms of both morbidity and
mor-tality on a single dimension.
18
Statistical analysis was undertaken using STATA 6.0 .
Estimates of mean costs and QALYs for the two treatment
arms were calculated over six months follow up. Costs have
been grouped under four headings: theatre cost, hospital
hotel (i.e. ward) cost, other post-operative complications and
follow up cost at six months. To indicate the pattern of the
health outcomes over the study period, EQ-5D scores at
baseline, six weeks and six months have been reported. Given
that the time horizon of the analysis was less than a year, total
costs and QALYs remain undiscounted.
To account for the skewed nature of the resource use
data, 95% confidence intervals for the differential costs and
QALYs have been calculated using non-parametric boot-
19,20
strap (based on the 2.5th and 97.5th centiles) . In some
patients, resource use data and EQ-5D responses were wholly
or partially missing. Under the assumption that data were
21,22
missing completely at random , those observations where
either length of stay in theatre or one of the EQ-5D
assessments was missing were excluded from the base case
analysis. As a result, 53 observations in the tension-free
vaginal tape group and 49 in the colposuspension group were
excluded from the initial analysis, and the base-case analysis
was conducted on a complete case data set of 214

Table 2. Main resource use measured during the trial based on the complete case analysis. Values are expressed as n (%), mean [SD] or median
{interquartile range}.

Item of resource Tension-free vaginal tape (n 117) Colposuspension (n 97)

Initial hospitalisation
Length of stay in hospital (days) 2.29 [1.9] 6.67 [1.78]
2 {1 3} 6 {5 8}
Time in anaesthetic room (minutes) 15.7 [8.9] 18.6 [8.9]
15 {10 20} 17 {12 25}
Time in theatre (minutes) 39.9 [15.4] 51.7 [22.6]
40 {29 48} 50 {35 60}
Time in recovery area (minutes) 53.4 [41.8] 97.1 [41.2]
45 {31 60} 96 {69 120}
Return to theatre* 1 (0.85)
Minutes in theatre 60
Use of tension-free vaginal tapes
1 tape 110 (94.02)
2 tapes 7 (5.98)
Additional procedures
0 113 (96.59)
1 4 (3.41)
Follow up period

Day case visits

0 112 (95.73) 95 (97.94)
1 5 (4.27) 2 (2.06)
Outpatient visits
0 87 (74.36) 74 (76.29)
12 28 (23.93) 21 (21.65)
34 1 (0.85) 1 (1.03)
56 1 (0.85) 1 (1.03)
General practitioner visits
0 77 (65.81) 57 (58.76)
12 30 (25.64) 28 (28.87)
34 6 (5.13) 9 (9.27)
57 4 (3.41) 3 (3.09)
Re-admissions 2 (1.71) 12 (12.37)
Mean length of stay (min max) 5 (3 7) 2.6 (1 5)

* During initial hospitalisation.

D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262

258 A. MANCA ET AL.

Table 3. Estimates of mean cost of tension-free vaginal tape compared with colposuspension (UK). Unless stated, all costs are based on complete cases.
Values are expressed as mean (median) [interquartile range].

Tension-free vaginal tape (n 117) Colposuspension (n 97)

Costs
Theatre cost 720 (690) [634 to 754] 437 (422) [343 to 518]
Hospital hotel cost 236 (206) [103 to 309] 687 (618) [567 to 824]
Other post-operative cost 28 (0.75) [0 to 4.22] 76 (27) [25 to 30]
Follow up cost at 6 months 74 (46) [0 to 93] 101 (46) [0 to 116]
Total cost per patient 1058 (935) [839 to 1100] 1301 (1195) [1050 to 1449]

Differential costs (tension-free vaginal tape minus colposuspension) 243 [ 341 to 201]*
y
Differential costs (tension-free vaginal tape minus colposuspension) 242 [ 340 to 183]*

y
* 95% non-parametric confidence interval based on 1000 bootstrap replications: lower band 2.5 centile; upper band 97.5 centile.
Based on 316 patients (tension-free vaginal tape 170; colposuspension 146), after multivariate multiple imputation.

patients (117 tension-free vaginal tape, 97 colposuspen-
sion). In the sensitivity analysis, the implications of the
missing completely at random assumption for the results of
the analysis were assessed through the use of an alternative
assumption that data were missing at random. This is
equivalent to saying that cases with incomplete data differ
from cases with complete data, but the missing data pattern
is fully predictable from other variables in the data set. On
this basis, we imputed the incomplete values using a
21 23
multivariate multiple imputation procedure and con-
ducted a new analysis on the entire data set of 316 patients.
The cost effectiveness of tension-free vaginal tape versus
colposuspension was assessed by relating the mean differ-
ential costs per patient of the two forms of surgery, to their
differential effectiveness in terms of mean QALYs per patient
measured over the six-month follow up period. One treatment
can be defined as more cost effective than its comparator if
one of the following conditions apply: (a) it is less costly and
more effective (i.e. it dominates its compar-ator); (b) it is more
costly and more effective, but its ad-ditional cost per extra
QALY is considered worth paying by decision-makers; and (c)
it is less costly and less effective, but the additional cost per
extra QALY of its comparator is not considered worth paying
by decision-makers. The point estimates of mean costs and
effects can be used to identify which of these three conditions
applies. However, these
means are estimated with uncertainty. Therefore, to account
for uncertainty due to sampling variation, we plotted a cost
24 27
effectiveness acceptability curve . Given the data col-
lected within the trial, this curve shows the probability of the
tension-free vaginal tape being more cost effective than colpo-
suspension for different levels that the decision-maker may be
28
willing to pay for an additional QALY . This is a Bayesian
29
approach to the presentation of cost effectiveness data ,
although a full Bayesian analysis has not been undertaken.
RESULTS
Table 2 details the main elements of resource use in the
trial. The mean length of stay in hospital with tension-free
vaginal tape was 2.29 days (interquartile range: 1 to 3), as
opposed to 6.67 days with colposuspension (interquartile
range: 5 to 8). Mean time in theatre with tension-free
vaginal tape was 40 minutes (interquartile range: 29 to 48),
against 52 minutes (interquartile range: 35 to 60) with
colposuspension. Tension-free vaginal tape patients re-
quired a larger number of resources in terms of additional
surgical procedures and outpatient visits. In the colposus-
pension arm, 12 women (12.4%) were readmitted to hos-
pital by six months follow up, whereas two (1.7%) were
readmitted in the tension-free vaginal tape group.

Table 4. Estimates of mean QALYs of tension-free vaginal tape compared with colposuspension. Unless stated, all results are based on complete cases.
Values are expressed as mean (median) [interquartile range].

Tension-free vaginal tape (n 117) Colposuspension (n 97)

EQ-5D values
Baseline 0.778 (0.81) [0.71 to 0.92] 0.785 (0.81) [0.71 to 0.92]
Six weeks 0.788 (0.85) [0.71 to 0.92] 0.754 (0.76) [0.69 to 0.88]
Six months 0.806 (0.85) [0.73 to 0.92] 0.794 (0.85) [0.73 to 0.92]
QALYs 0.397 (0.42) [0.35 to 0.45] 0.387 (0.40) [0.35 to 0.44]

Differential QALYs (tension-free vaginal tape minus colposuspension) 0.010 [ 0.010 to 0.030]*
y
Differential QALYs (tension-free vaginal tape minus colposuspension) 0.012 [ 0.006 to 0.029]*

y
* 95% non-parametric confidence interval based on 1000 bootstrap replications: lower band 2.5 centile; upper band 97.5 centile.
Based on 316 patients (tension-free vaginal tape 170; colposuspension 146), after multivariate multiple imputation.
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262
 TENSION-FREE VAGINAL TAPE VERSUS COLPOSUSPENSION 259

Fig. 1. Bootstrap replications (n 1000) of the mean differences in costs and QALYs generated from the trial data.

Estimated mean costs per patient in the two arms of the
trial are reported in Table 3. Although tension-free vaginal
tape patients had a shorter time in theatre, the associated
cost saving was offset by the cost of tension-free vaginal
tape-specific consumables, which resulted in total theatre
cost being higher in the tension-free vaginal tape arm.
However, when hospital hotel costs are also considered,
tension-free vaginal tape is, on average, less costly, due to the
shorter length of hospital stay associated with its use. This
remains the case when other post-operative and follow up
costs are included. The mean total cost per patient was
estimated to be 1058 (interquartile range: 839 to 1100) in

Fig. 2. Cost effectiveness acceptability curve. CCA complete case analysis (tension-free vaginal tape 117; colposuspension 97); MI multivariate
multiple imputation (tension-free vaginal tape 170; colposuspension 146).
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262
260 A. MANCA ET AL.
the tension-free vaginal tape group and 1301 (interquartile
range: 1050 to 1449) in the colposuspension group.
Mean differential cost of tension-free vaginal tape minus
colpo-suspension was therefore 243 (95% CI: 340 to
201); that is, a cost saving from tension-free vaginal tape.
Table 4 reports the EQ-5D scores at baseline, six weeks
and six months in the two treatment arms. The mean
QALYs per patient were 0.397 (interquartile range: 0.35 to
0.45) for tension-free vaginal tape and 0.387 (interquar-tile
range: 0.35 to 0.44) for colposuspension. The differ-ential
mean QALYs between the two groups was 0.01 (95% CI:
0.01 to 0.03).
On the basis of the point estimates of mean cost and
QALYs presented in Tables 3 and 4, tension-free vaginal
tape dominates colposuspension; that is, over six months, it
generates higher mean QALYs and results in lower mean
health service costs. However, mean costs and QALYs are
estimated with uncertainty. This is evident when looking at
Fig. 1, which provides a graphical representation of the
joint distribution of differential mean costs and QALYs
after 1000 bootstrap replications. A simple visual inspec-
tion shows that the simulations fall completely below the
horizontal dotted line on the cost axis. However, a consid-
erable proportion of the simulations falls to the left of the
vertical dotted line on the QALYs axis. In other words, all
the uncertainty in this comparison relates to the mean
difference in QALYs between the two forms of surgery.
Uncertainty in mean costs and outcomes is reflected in
the cost effectiveness acceptability curve shown in Fig. 2.
The continuous line shows the cost effectiveness accept-
ability curve for tension-free vaginal tape for the base-case
Fig. 3. Impact of differential inpatient hospital stay on the probability of the tension-free vaginal tape being, on average, cost saving and cost effective.
Probability of the tension-free vaginal tape being cost saving as function of the difference in hospital inpatient stay; - - Probability of the tension-free
vaginal tape being cost effective, when the decision-maker is willing to pay 30,000 for an additional QALY, as function of the difference in hospital in
patient stay.
analysis. This indicates that the probability of tension-free
vaginal tape being, on average, less costly than colposus-
pension is 100% this is the point on the curve where the
decision-maker is not willing to pay anything additional for
an extra QALY. The probability of tension-free vaginal tape
being more cost effective than colposuspension is 94.6%
when the decision-maker is willing to pay at least 30,000
per additional QALY. As Fig. 2 shows, even if the decision-
maker is willing to pay up to 100,000 per additional
QALY, the probability that tension-free vaginal tape is cost
effective remains above 85%.
A key determinant of the mean cost saving achieved by
using the tension-free vaginal tape is the difference between
the two procedures in terms of inpatient hospital stay. A
sensitivity analysis was undertaken to investigate the role of
mean differential inpatient stay on (1) the probability for
tension-free vaginal tape of being, on average, cost saving,
and (2) the probability of tension-free vaginal tape being more
cost effective than colposuspension when the decision-maker
is willing to pay 30,000 for an additional QALY. A visual
inspection of Fig. 3 suggests that, all else being equal, the
tension-free vaginal tape is more likely to be cost saving
compared with colposuspension, provided that the difference
in terms of inpatient hospital stay in favour of the tension-free
vaginal tape is not less than two days. Analogously, when the
decision-maker is willing to pay 30,000 for an additional
QALY, the tension-free vaginal tape is more likely to be cost
effective as long as the dif-ferential inpatient length of stay for
women in the tension-free vaginal tape group is no more than
one day higher than for those women undergoing
colposuspension.
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262

Some of the unit costs used in the analysis might not be
representative of those in other UK hospitals. In particular,
the hotel cost per inpatient day in hospital will vary
between centres. In order to explore the robustness of the
results to this unit cost, a sensitivity analysis was
conducted varying this cost between 80 and 250 per day.
Unsurpris-ingly, this had little impact on the cost
effectiveness results. Unit costs greater than the base-case
value (i.e. 103 per day) resulted in an even greater mean
cost saving for the tension-free vaginal tape, being the
intervention with a shorter mean length of stay in hospital.
Similarly, the tension-free vaginal tape is still cost saving
for a hospital hotel cost per day as small as 80.
Finally, a third sensitivity analysis investigated the
impact of missing data on the results of the present study.
The base-case analysis was conducted on the complete case
data set assuming that data were missing completely at
random. An alternative assumption is that data were miss-
ing at random. Under this assumption, multivariate
multiple imputation can be applied to handle the
incomplete data problem. The dotted line in Fig. 2 shows
the cost effective-ness acceptability curve obtained from
the analysis of the entire data set of 316 patients after the
application of multiple imputation. The conclusion of the
analysis, namely, a high probability of the tension-free
vaginal tape being cost effective across a range of
willingness to pay values, remains unaffected.
DISCUSSION
On the basis of the findings presented in this paper over
six months follow up, the tension-free vaginal tape results
in an overall mean cost saving per patient of 243 while
generating a mean improvement in health outcomes of 0.01
QALYs per patient. Although the cost of a tension-free
vaginal tape is markedly higher than the theatre consum-
ables used during colposuspension, this was more than
offset by a reduction in the mean hotel cost of hospital stay.
In this paper, the value for money of the tension-free
vaginal tape was characterised using a cost effectiveness
acceptability curve, which plots the probability of the
tension-free vaginal tape being more cost effective than
colposuspension as a function of the decision-makers
willingness to pay for an additional QALY. If decision-
makers are only interested in costs and do not attach any
value to an improvement in patients health outcomes, the
probability of the tension-free vaginal tape being cost
effective (i.e. cost saving) is 100%. However, any health
service will value health gain and, although a formal value
for an additional QALY has not been stated explicitly in
this context, it is possible to infer a broad range for this
parameter based on decisions previously taken regarding
30,31
what interventions should be funded . Using a wide
range of values for an additional QALY, the probability of
the tension-free vaginal tape being more cost effective than
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262
TENSION-FREE VAGINAL TAPE VERSUS COLPOSUSPENSION 261
colposuspension remains appreciably higher than 80%. The
health service will need to decide whether this level of
certainty is sufficient to justify the widespread use of the
tension-free vaginal tape.
Economic evaluation uses a large number of variables
collected over a period of follow up and, in most trials, a
proportion of data is missing. For the base-case analysis,
only observations with complete data were included (62%).
A sensitivity analysis was conducted to explore the impact
of this decision. This showed that using multiple imputa-
tion rather than complete case analysis had little effect on
the results.
The objective of the analysis was to use unit costs which
are representative of UK hospitals. However, there is con-
siderable variation in some costs, in particular, the hotel cost
13
of an inpatient day in hospital . The sensitivity analysis
showed that variation in this cost between two extreme values
of 80 and 250 per day (compared with a base-case of 103)
had little impact on the cost effectiveness results.
The difference in the mean length of hospital inpatient
stay between the tension-free vaginal tape and colposus-
pension seems to be a crucial variable in the present study,
and the extent to which the measurement of this variable in
the trial is representative of what would emerge in routine
practice needs to be considered. If the period of time
patients remained in hospital was more a reflection of
clinical expectations than patients needs, the estimate of
differential length of stay may be an under- or over-
estimate. Blinding patients and non-surgical clinical staff to
32
the procedure undergone, as in other surgical trials , was
not considered feasible here, in view of the differences in
incision and anaesthetic technique. It is possible that length
of stay for both procedures in the trial will become lower in
routine practice over time. The effect of this de-cline on
clinical success rates is unclear. A key finding in this
analysis is that, as long as average length of stay is at least
two days longer following colposuspension, the tension-
free vaginal tape will remain the less costly procedure.
Given the slight QALY gain with the tension-free vaginal
tape, the threshold that would ensure that the tension-free
vaginal tape is the more cost effective (rather than less
costly) procedure will be still lower. Further observation of
both procedures in routine practice is necessary to
illuminate this issue.
One related issue is that, because the trial from which the
data for this economic analysis are obtained is a pragmatic
one, the colposuspension procedure was not standardised
between surgeons. This lack of standardisation among the 14
units involved with the trial will increase the genera-lisability
of the study findings as this permits variation in clinical
practice to be reflected in the cost effectiveness of the results.
The Burch colposuspension undertaken in this study was open
surgery. Some economic comparisons of this procedure with
33 35
laparoscopic colposuspension have been reported .
However, none of these studies was undertaken alongside a
randomised controlled trial, nor were
262 A. MANCA ET AL.
they full cost utility analyses. Further research is required to
assess whether laparoscopic colposuspension can represent a
more cost effective use of resources than the open form of the
procedure and the tension-free vaginal tape.
The costs and benefits estimated here are based on a
period of follow up of six months. As more time elapses
from the point of initial surgery, some women may require
additional treatments for their urodynamic stress inconti-
nence. Further follow up of patients in this trial is essential
to see whether these longer term events have substantive
effect on the results presented here.
In conclusion, the results from this economic evaluation
suggest that, over a post-operative period of six months,
the tension-free vaginal tape is a cost effective alternative
to colposuspension. The results will need to be reassessed
on the basis of longer follow up.
Acknowledgements
The authors would like to thank the UK and Ireland
TVT Trial Group for recruiting patients into this trial. The
authors also thank the patients, technical, secretarial,
nursing and medical staff of the participating hospitals and
the monitoring staff of Ethicon. Ethicon financially
supported this study. The investigators were given
complete freedom to analyse the data and report the results
as they saw fit. Mark Sculpher is also supported by a
Career Award in Public Health funded by the NHS
Research and Development Programme.
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Accepted 6 November 2002
D RCOG 2003 Br J Obstet Gynaecol 110, pp. 255 262