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UROGYNECOLOGY
The expectations of patients who undergo
surgery for stress incontinence
Veronica T. Mallett, MD; Linda Brubaker, MD, MS; Anne M. Stoddard, ScD;
Diane Borello-France, PhD; Sharon Tennstedt, PhD; Lynn Hall, RN; Lee Hammontree, MD;
for the Urinary Incontinence Treatment Network
OBJECTIVE: The purpose of this study was to assess patient expectations of surgical outcome after preoperative counseling of surgical procedures in a randomized trial of 655 women in a comparison of the
rectus fascial sling and Burch colposuspension.
STUDY DESIGN: Women who selected surgery for treating stress in-
continence and who consented to this randomized, surgical trial completed a preoperative questionnaire to assess expectations for the postsurgical effects of surgery on urinary incontinence-related symptoms,
limitations, and emotions. Associations of expectations with a range of
preoperative urinary incontinence measures were explored.
(72%), and urgency (70%). Sexual and social limitations were less
frequent (ⱕ44%). Treatment expectations were higher for women who
reported more symptom bother. As expected, most women (98%) had
an expectation that urine leakage would be completely or almost completely eliminated. However, most women (92%) who reported urgency
or frequency (83%) expected significant improvement of these symptoms after surgery.
CONCLUSION: Patients who undergo stress incontinence surgery have
high expectations regarding the outcome of incontinence surgery,
which include the resolution of urgency and frequency.
RESULTS: The most frequent preoperative symptoms were urine leak-
age (98%), embarrassment (88%), frequency (74%), physical activity
Key words: informed consent, patient expectation, surgical outcome
Cite this article as: Mallett VT, Brubaker L, Stoddard AM, et at. The expectations of patients who undergo surgery for stress incontinence. Am J Obstet
Gynecol 2008;198:308.e1-308.e6.
S
urgery is considered to be highly
effective for resolving urodynamic
stress incontinence.1,2 The physician’s
definition of success, however, may not
account for the patient’s entire experience, particularly with complications,
side effects, or new/persistent pelvic
floor symptoms. Previous investigators observed that women who ex-
perience ⬎1 preoperative urinary
symptom may expect that stress incontinence surgery will resolve all urinary
symptoms.3,4 When these symptoms
are not resolved, the patient may consider her surgery to be ineffective or
unsuccessful. Despite efforts to align
physician and patient expectations, all
experienced clinicians recognize that
From the Department of Obstetrics and Gynecology, University of Tennessee Health
Science Center, Memphis, TN (Dr Mallett); the Departments of Obstetrics and Gynecology
and Urology, Loyola University Medical Center, Maywood, IL (Dr Brubaker); New England
Research Institutes, Watertown, MA (Drs Stoddard and Tennstedt); the Department of
Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, PA
(Dr Borello-France); Kaiser Permanente, San Diego, CA (Ms Hall); and the Department of
Urology, University of Alabama at Birmingham School of Medicine, Birmingham, AL (Dr
Hammontree).
Received March 30, 2007; accepted Sept. 2, 2007.
Reprints: Veronica T. Mallett, MD, Department of Obstetrics and Gynecology, University of
Tennessee Health Science Center, Regional Medical Center, 853 Jefferson, Memphis, TN
38138; [email protected].
Supported by cooperative agreements from the National Institute of Diabetes and Digestive and
Kidney Diseases, with additional support from the National Institute of Child Health and Human
Development and the Office of Research on Women’s Health, National Institutes of Health (U01
DK58225, U01 DK58234, U01 DK58229, U01 DK58231, U01 DK60397, U01 DK60401, U01
DK60395, U01 DK60393, U01 DK60380, U01 DK60379)
0002-9378/$34.00 • © 2008 Mosby, Inc. All rights reserved. • doi: 10.1016/j.ajog.2007.09.003
308.e1
American Journal of Obstetrics & Gynecology MARCH 2008
this is an area that needs further
work.5-7
We sought to understand more fully
the patterns of expectations of surgical
patients and to correlate these patterns
with more conventional measures, including validated condition-specific
quality of life questionnaires, with a population of women who participated in a
randomized surgical trial of stress incontinence. Potential variables that were
thought to be related to preoperative expectations included sociodemographic
characteristics, health status, urinary incontinence (UI) type and severity, UI
symptom-related distress, and UI-related quality of life.
M ATERIALS AND M ETHODS
Design
Baseline information from 655 women
who were enrolled in the Stress Incontinence Surgery Efficacy study (SISTEr
trial; a randomized clinical trial to compare the Burch colposuspension and the
rectus fascial sling procedures) was analyzed. Briefly, the SISTEr study enrolled
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women who had predominate stress UI
with symptoms of at least a 3-month duration, evidence of urethral hypermobility, and urine loss on provocative bladder stress test. The study design,
including baseline and follow-up measurements, was published previously.8
All study participants provided written
informed consent for the study. The Institutional Review Board at each participating center reviewed and approved the
study protocol.
Each patient had an informed consent
discussion regarding stress incontinence
surgery with her surgeon as part of her
routine clinical care. The standard components of informed consent include the
purpose, risks, benefits, complications,
and alternatives of the procedure. This
discussion was tailored individually to
each participant, based on her planned
surgery. Each patient made a clinical decision to proceed with stress incontinence surgery on the basis of her individual surgeon’s counseling. Before consent
for stress incontinence surgery, patients
were shown a standard video as part of
their informed consent discussion regarding research participation. This 10minute videotape presented a standard
description of the SISTEr trial that explained the study aims; the similarities
and differences, risks, and success rates
of the 2 surgical procedures; the randomization and informed consent processes, and the schedule and type of evaluations that are associated with study
participation. Before consent for research participation, subjects underwent
a standard baseline expectations assessment that has been described
previously.8
Measures of preoperative
expectations
Preoperative expectations of surgery
were measured with a questionnaire that
was developed specifically for this study,
the Incontinence Surgical Expectations
Questionnaire (ISEQ). The ISEQ includes 9 items across 3 domains: symptoms, activities (physical and social), and
emotions. Four items refer to surgical
expectations for improving UI symptoms; 4 items pertain to activity limita-
tion expectations, and 1 item concerns
emotional expectations. A 5-point Likert-type scale of responses is used to rate
the expectations for each symptom (1
[no better] to 5 [completely better]), activity limitation (1 [no more capable] to
5 [completely capable]), and emotion (1
[no less bothered] to 5 [completely not
bothered]) that are associated with UI.
We also asked which 1 symptom or activity women expected to improve the
most as a result of surgery. The openended responses were postcoded into
categories that reflected the most commonly mentioned responses. To assess
each woman’s overall expectations, we
computed the average of the expectations for the symptoms or limitations
that she identified as problems. The expectation scores were highly skewed,
with most women reporting high expectations. We therefore dichotomized the
expectation scores into 2 categories.
Scores of ⱖ4 were considered “high expectations,” and scores of ⬍4 were considered “low expectations.”
Internal consistency and test-retest reliability for the ISEQ were tested in a
sample of 25 women in a separate pilot
study that was conducted at 1 of the Urinary Incontinence Treatment Network
sites.9 The total scale Cronbach’s alpha
(without the sexual limitation item because of low response frequency) was
high (alpha ⫽ .86), with individual itemtotal correlations ranging from 0.46 to
0.86. Test-retest agreement (mean retest
interval, 6.5 ⫾ 3.7 days) for the presence
or absence of symptoms, limitations,
and emotional bother ranged from 82%94%. Agreement between test and retest
responses ranged from 67% (frequency)
to 82% (urgency) for expectations of
symptom relief and from 67% (physical
activity) to 100% (both social and sexual
activity) for resolution of activity limitations; agreement was 77% for change in
emotions.
Other measures
Symptoms of UI were assessed with the
use of the Medical, Epidemiologic, and
Social Aspects of Aging Questionnaire.10
This measure includes a 9-item subscale
for stress-type symptoms and a 6-item
Research
subscale for urge-type symptoms. An index for each type of symptom converted
the scores to scales that ranged from
0-100. Inclusion criteria for this trial required that the stress index had to exceed
the urge index. Severity of incontinence
was defined by the average number of incontinence episodes per day collected by
a 3-day bladder diary and pad test weight
(grams).11
Demographic data included age,
race/ethnicity, occupation, and socioeconomic status. The Nam-PowersTerrie Occupational Status Score was
used as a measure of socioeconomic
status.12 It measures occupational status on the basis of educational requirements and expected salary. Scores
range from 0-100; a higher score indicates greater status.
Health status data included body mass
index, past treatment or surgery for UI,
and Valsalva leak point pressure. Also included were 2 health status subscales
from the Medical Outcomes Study 36item short-form health survey: the physical function and role-physical subscales.13 The Medical Outcomes Study
36-item short-form health survey is a
measure of health-related quality of life
in chronic disorders. Higher scores indicate fewer physical or role functioning
limitations. Symptom distress/bother
and quality of life related to UI symptoms were measured with the Urogenital
Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ), respectively.14 The UDI contains 19 symptoms (across 3 symptom domains:
irritative, obstructive/discomfort, and
stress) that are associated with lower urinary tract dysfunction. Respondents are
asked to rate the degree of bother that is
associated with each symptom that they
have experienced on a scale from 1 (not
at all) to 4 (greatly). UDI scores range
from 0-300; higher scores indicate
greater symptom-related distress.2 The
IIQ is a 30-item questionnaire that measures the impact of UI on various activities, roles, and emotional states. The
scores range from 0-400; a higher score
indicates poorer perceived UI-related
quality of life.
MARCH 2008 American Journal of Obstetrics & Gynecology
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TABLE 1
Selected characteristics of study participants (n ⴝ 654)
Characteristic
Mean ⴞ SD
Range
Age (y)
51.9 ⫾ 10.3
27-81
Mean body mass index (kg/m )
30.0 ⫾ 6.1
18-54
Occupational status
56.9 ⫾ 24.6
3-99
N
%
..............................................................................................................................................................................................................................................
2
..............................................................................................................................................................................................................................................
a
..............................................................................................................................................................................................................................................
Medical Outcomes Study 36-item short-form health
survey scoreb
..............................................................................................................................................................................................................................................
Physical function
58.1 ⫾ 27.7
0-100
Role: physical
53.5 ⫾ 41.7
0-100
measure that was hypothesized to be associated with expectations. For categoric
explanatory variables, we used crossclassification and the chi-square test of
association. For continuous measures,
we tested the difference of means by the
analysis of variance. All analyses were
conducted with the personal computer
version of SAS Statistical Software (version 9.2; SAS Institute Inc, Cary, NC).
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
Race/ethnicity
.....................................................................................................................................................................................................................................
Hispanic
72
11
480
73
.....................................................................................................................................................................................................................................
Non-Hispanic white
.....................................................................................................................................................................................................................................
Non-Hispanic black
44
7
58
9
..............................................................................................................................................................................................................................................
Other
..............................................................................................................................................................................................................................................
a
Scores range from 0 to 100; a higher score indicates greater status.
b
Higher score indicates fewer physical or role functioning limitations.10
Mallett. Patient expectations of incontinence surgery. Am J Obstet Gynecol 2008.
Analysis
We computed descriptive statistics for
the symptoms and the expectations for
surgical resolution of each symptom that
was reported and the frequency of
women with high and low overall expectations. We then examined the bivariate
associations of expectation with each
R ESULTS
Women in this study were predominantly white (73%), middle-aged (average, 52 years), and socioeconomically diverse (Table 1). On average, they
reported 3.2 incontinent episodes per
day. By design, all women had stress UI,
but most of them (93%) also reported
some degree of urge UI symptoms. The
mean body mass index was 30 kg/m2,
which indicated that the woman was
generally overweight.
Table 2 shows the percentage of
women who reported each symptom
and activity that were limited by incon-
TABLE 2
Frequency of symptoms and related treatment expectations: results from the ISEQ
ISEQ domain and questions
Women who
answered
“yes” (%)
Expectation
(Percent of women
who answered
“yes” and reported
high expectations)9
Symptoms
.......................................................................................................................................................................................................................................................................................................................................................................
Do you currently experience any of the compared with symptoms?
.......................................................................................................................................................................................................................................................................................................................................................................
Urine leakage
98
98
.......................................................................................................................................................................................................................................................................................................................................................................
An urgency to urinate such that you fear not making it to the bathroom in time
70
92
Frequent urination
74
83
Any other symptoms
26
93
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
Activities
.......................................................................................................................................................................................................................................................................................................................................................................
Do you currently limit any of the listed activities because of your bladder?
.......................................................................................................................................................................................................................................................................................................................................................................
Physical activities (eg, housework, yard work, going for a walk, dancing, jogging,
golfing)
72
93
.......................................................................................................................................................................................................................................................................................................................................................................
Social activities (eg, visiting friends, vacationing, going to church or temple)
33
88
Sexual activity
44
87
Any other activities
22
92
.......................................................................................................................................................................................................................................................................................................................................................................
.......................................................................................................................................................................................................................................................................................................................................................................
................................................................................................................................................................................................................................................................................................................................................................................
Emotional
.......................................................................................................................................................................................................................................................................................................................................................................
Are you bothered by feelings of embarrassment, helplessness, frustration, and/or
depression because of your bladder problems?
Mallett. Patient expectations of incontinence surgery. Am J Obstet Gynecol 2008.
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American Journal of Obstetrics & Gynecology MARCH 2008
88
95
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Research
TABLE 3
TABLE 4
Characteristics of incontinence
Symptom expected to improve
the most from surgery
Variable
Mean ⴞ SD
Range
Symptomsa
Symptom or limitation
Percent
Stress subscale percentage
71.6 ⫾ 17.0
15-100
Physical activities
27.0
Urge subscale percentage
36.0 ⫾ 21.7
0-94
Urine leakage
23.5
3.2 ⫾ 2.9
0-26
Bother by negative emotions
17.6
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
Incontinence severity (mean episodes
per day on 3-day diary)
..............................................................................................................................................................................................................................................
b
UDI
..............................................................................................................................................................................................................................................
151.1 ⫾ 48.6
0-290
Obstructive
25.1 ⫾ 21.7
0-97
Irritative
47.8 ⫾ 25.2
0-100
Stress
78.1 ⫾ 21.9
0-100
Total
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
c
IIQ
..............................................................................................................................................................................................................................................
Total
171.1 ⫾ 101.2
..............................................................................................................................................................................................................................................
Activity
45.3 ⫾ 27.8
0-400
Travel
39.3 ⫾ 29.3
0-100
Social
36.4 ⫾ 26.8
Emotional
50.5 ⫾ 28.2
Pad weight (g)
43.5 ⫾ 79.4
...........................................................................................................
...........................................................................................................
...........................................................................................................
Other
...........................................................................................................
Cough, sneeze, laugh
5.6
Use of pads
5.1
Sexual activity
3.7
...........................................................................................................
...........................................................................................................
...........................................................................................................
Other: lifestyle
2.8
Frequency
2.6
Urgency
2.0
Other: prolapse
1.9
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
Social activities
1.7
6.0
0-100
Other: mixed, none,
unknown
0-100
Mallett. Patient expectations of incontinence surgery.
Am J Obstet Gynecol 2008.
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..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
..............................................................................................................................................................................................................................................
...........................................................................................................
..............................................................................................................................................................................................................................................
Mean Valsalva leak point pressure,
unreduced
116.55 ⫾ 37.5
29.7-244.3
..............................................................................................................................................................................................................................................
Ninety-three women (14%) had had previous upper intestinal surgery.
a
Medical, Epidemiologic, and Social Aspects of Aging Questionnaire.6
b
Scores range from 0-300; higher scores indicate greater symptom-related distress.11
c
Scores range from 0-400; a higher score indicates poorer perceived quality of life.
Mallett. Patient expectations of incontinence surgery. Am J Obstet Gynecol 2008.
tinence. The most frequent symptoms
were urine leakage (98%), urinary frequency (74%), and urinary urgency
(70%). Most women reported embarrassment (88%). Limitations on physical
activities (72%) were common, with
44% reporting limitations in sexual and
social activities. Expectations of surgical
outcomes were high. When the responses to the individual items were
combined, the mean and median ISEQ
scores were 4.4 of 5, and 87% of women
had a score of ⱖ4. All women who reported urinary leakage expected near or
complete resolution of this symptom.
However, most of these women also expected relief of symptoms that were not
associated with stress UI. Of the 70% of
patients who reported urgency, nearly all
(92%) expected that the stress incontinence surgery would improve urgency.
Similarly, of the 74% of patients who re-
ported urinary frequency, 83% expected
substantial symptom relief.
Incontinence characteristics included
the average number of incontinent episodes per day based on the 3-day diary,
pad weight, Valsalva leak point pressure,
and previous antiincontinence operative
procedures (Table 3). Based on bivariate
analysis (not shown), there was no relationship between surgical expectation
and any of the incontinence characteristics. Expectations also were not related to
preoperative functional health status,
age, previous antiincontinence surgery,
or physical examination parameters.
When testing the bivariate association
of each of the potential explanatory variables in relation to the level (low vs high)
of overall surgical expectations, we
found that only the UDI stress subscale
and the IIQ travel subscale were associated significantly with surgical expecta-
tions. That is, women with high expectations reported greater UI-related distress
but lower impact of UI on travel. Among
women with low expectations, the mean
UDI stress score was 71.5 ⫾ 23.1; among
women with high expectations, the mean
score was 79.3 ⫾ 21.2 (P ⫽ .002). Regarding the IIQ-travel subscale, women
with low expectations reported a mean
impact of 46.4 ⫾ 28.4, compared with a
mean impact of 38.7 ⫾ 29.3 for women
with high expectations (P ⫽ .02)
The frequencies of the responses to the
open-ended question, “Of all the symptoms, lifestyle restrictions, or emotions
that you experience because of your
bladder problem, which one problem do
you expect to improve the most after you
recover from your surgery?” are shown
in Table 4. The 3 most common responses were problems with physical activities (27%), urine leakage (24%), and
bother from negative emotions (18%).
C OMMENT
Patients had very high expectations for
their individual surgical outcomes, especially those women who reported more
symptom bother. Ninety-eight percent
of respondents indicated that urine leakage was a problem, and 98% of them ex-
MARCH 2008 American Journal of Obstetrics & Gynecology
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Research
Urogynecology
pected to be either completely symptom
free or much better after surgery. This is
an expectation that continence surgeons
find reasonable for an individual
woman, although all continence surgeons are aware of that surgical success
rates are not this high overall for a surgical population. It is understandable that
an individual woman who is planning
surgery expects that she will have a successful outcome. Clearly, if she did not
have this expectation, it would be unreasonable for her to proceed with surgery.
However, continence surgeons generally do not believe that urinary urgency
and/or frequency is a predictable outcome of stress incontinence surgery. It is
assumed that surgeons do not suggest
improvements with urinary urgency
and/or frequency as a result of stress incontinence surgery. Some surgeons are
quite strong in counseling that these
symptoms are quite certain to persist.
Nonetheless, individual surgical patients
do expect resolution of these symptoms
as well. This finding of mismatched expectations has important implications
for preoperative patient counseling.
Clinical counseling (as represented
over 9 clinical sites and 22 surgeons)
seems ineffective in setting clinically reasonable preoperative expectations regarding urgency and frequency. In addition to this routine preoperative clinical
counseling, the patients in our study had
a preoperative consultation that included a videotaped description of the
surgical procedures, the efficacy of both
procedures, and the type of incontinence
that the surgery was designed to address.
Yet, despite preoperative consultation
that included the study-related videotape, patients had high expectations for
the resolution of urinary urgency and
frequency symptoms. Only 2.4% of the
open-ended responses identified frequency as the most important expectation. However, 83% of participants who
reported urgency and frequency on the
ISEQ expected these symptoms to be resolved by the surgical intervention. This
discordance has several possible explanations. Although patients were told
clearly the nature of the antiincontinence surgery, the surgeons failed to educate these patients effectively about the
308.e5
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distinction between irritative symptoms
and symptoms of stress incontinence.
Surgical counseling may include a great
deal of information, including health information, logistical information, and financial information. Unpalatable aspects (such as persistent symptoms) may
be lost selectively to recall. In addition,
patients may not have attended to,
processed, and/or remembered the
information.
Even in the confines of a randomized,
highly standardized clinical trial, ethical
care of research participants requires individualized conversations between a
patient and her surgeon. A limitation of
our findings includes the possibility that
surgeons in this trial may have underemphasized the possibility of persistent
symptoms during counseling of these
procedures. Alternatively, patients may
have understood the nature of their condition and the limitations of the antiincontinence surgeries but rejected the
physician’s prognostic statements regarding irritative symptoms and maintained an optimistic expectation, knowing that their chance of irritative
symptom resolution was low. It has been
suggested that inappropriate expectations can arise from a person’s previous
experiences of surgery, from similar experiences for other successful interventions, or from word of mouth from
friends with whom the patient discussed
the procedure or plans to undergo the
procedure.15
Patient satisfaction is related directly
to patient expectation of treatment outcome.16 Patients with inappropriate
treatment expectations may be at increased risk for dissatisfaction with optimal care. Therefore, it is problematic
when patient and surgeons have discordant expectations. To reduce this discordance, further research will need to identify whether mismatched expectations
are a result of insufficient information,
ineffective counseling methods, or individual characteristics that predispose patients to disregard information. More effective communication is essential.17
The SISTEr trial will also provide information that will allow us to investigate
patient expectations in relation to surgical outcome and patient satisfaction with
American Journal of Obstetrics & Gynecology MARCH 2008
outcome at the conclusion of the study
to determine whether this surgical cohort is similar to others that were reported previously.18
We observed a strong relationship between UI bother and level of treatment
expectation as expected. We found the
relationship between treatment expectation and the IIQ travel score is somewhat
unexpected. We hypothesize that the impact of incontinence on travel is so significant that patients see the ability to return to travel as unrealistic.
Our ability to fully investigate factors
that are related to low expectations is
limited by the skewness of the responses
to the ISEQ scale. The clustering of the
open-ended responses around the established domains for the ISEQ supports
the construct validity of the questionnaire. The skewed range of responses is
problematic when one searches for correlates. This limitation is not a reflection
of the usefulness of the questionnaire but
more likely a reflection of the fact that,
for patients to undergo surgery, they
must expect a positive outcome. In addition, we did not evaluate a patient’s
knowledge of her condition or of the 2
surgeries. We also did not measure selfefficacy (one’s belief that one can exercise control over health and health habits) as a potential predictor or
determinant of expectations. Bandura’s19 social cognitive theory posits
that self-efficacy, outcome expectations,
and perceived facilitators and impediments to change influence the health
goals that an individual establishes and
the behaviors that an individual adopts
and maintains. Self-efficacy has been
shown to affect outcome expectations in
several disease states.19,20 The role of
self-efficacy in a patient’s expectations of
continence surgery must be explored. In
addition, there is a possible selection
bias. Baseline data on the expectations of
women with stress incontinence who
underwent a surgical intervention yet
elected not to participate in the trial are
not available. Women who are willing to
participate in a randomized surgical trial
may have different expectations about
outcomes than a general urogynecology
population. Finally, the predominantly
white study population obviously affects
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the extent to which these data can be
generalized to other populations. Multicentered recruitment in 9 areas of the
country does help support the applicability of the results to a wide portion of
the US female population who will undergo stress incontinence surgery.
The results of this study support the
importance of assessment of the efficacy of a variety of counseling methods
to improve patient recall, comprehension, and ease of understanding. Verifying the patient’s preoperative understanding of the condition, limitations
of surgery, risks, and potential complications should help surgeons modify
unrealistic expectations of treatment
outcome.21,22 In turn, realistic treatment expectations may impact patient
satisfaction directly with the outcome
of surgical intervention.
f
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