Satisfaction in patients_undergoing_concurrent.5

Satisfaction in Patients Undergoing Concurrent
Pelvic Floor Surgery for Stress Urinary
Incontinence and Pelvic Organ Prolapse
Jeff P. Wolters, MD,* Ashley B. King, MD,* and David E. Rapp, MD*Þ
Objective: Simultaneous repair of stress urinary incontinence (SUI)
and pelvic organ prolapse (POP) is common. In these cases, de-
terminants of patient satisfaction are complicated given that surgical
success may be achieved in one component but not the other. We sought
to assess satisfaction in patients undergoing multiple pelvic surgeries.
Methods: We performed a review of 89 women undergoing concom-
itant POP repair and midurethral sling (MUS) placement. Focus was
placed on patient-reported satisfaction rates. Validated measures were
used to evaluate outcomes after MUS [International Consultation on
Incontinence Questionnaire (ICIQ)-Female Lower Urinary Tract
Symptoms, SUI item; pad use] and POP repair (ICIQ-Vaginal Symp-
toms; POPQ stage).
Results: At 1-year evaluation, 78 (88%) women reported satisfaction.
Assessment identified combined cure of both POP/SUI in 64 (72%)
patients, in contrast to failure of MUS, POP repair, and both repairs in
15 (17%) patients, 9 (10%) patients, and 1 (1%) patient, respectively.
Subset analysis revealed dissatisfaction in 5% (3/64) of patients
achieving complete cure of both SUI and POP. In contrast, 40% (6/15)
were dissatisfied if there was failure to cure SUI, 22% (2/9) if failure to
cure POP, and the patient with failure of both was not dissatisfied. The
ICIQ-Vaginal Symptoms domain score for vaginal bulge was the only
assessed outcome demonstrating a statistical relationship with patient-
reported satisfaction.
Conclusions: Among women achieving cure of both SUI and POP via
concurrent surgical repair, 95% reported satisfaction. Interestingly, a
variety of outcomes measures fail to correlate with satisfaction. Further,
in patients with complete cure of concurrent pelvic surgeries, a per-
centage still report dissatisfaction, highlighting the complicated nature
of patient satisfaction.
Key Words: satisfaction, incontinence, prolapse, concurrent repair
(Female Pelvic Med Reconstr Surg 2014;20: 23Y26)
The comprehensive assessment and treatment of concurrent
pelvic floor pathologies is important. The prevalence of
both urinary incontinence (UI) and pelvic organ prolapse (POP)
is high, with study demonstrating rates as high as 75% and 50%
for stress UI (SUI) and POP, respectively.1,2
Population study
demonstrates concurrent POP and UI in 7% of patients with
pelvic floor pathology.3
In addition, given the significant rate of
de novo SUI associated with POP repair, midurethral sling
(MUS) is also commonly performed concomitantly with POP
repair to prevent the development of SUI.4Y6
Simultaneously, the assessment of outcomes after the sur-
gical repair of incontinence or POP remains difficult. Objective
outcomes markers such as bladder diary variables, urodynamic
parameters, and prolapse staging provide defined information
regarding treatment response. Despite their utility, these in-
struments fail to define the impact that incontinence has on
patients’ daily lives or the patient-perceived benefit of inter-
vention.7
Accordingly, more focus has recently been placed on
the inclusion of patient-reported outcomes (PROs) in related
research.7,8
The importance of using both objective and sub-
jective measures is highlighted by data demonstrating the fail-
ure of objective symptom improvement to correlate with
subjective benefit after incontinence therapies.9,10
Given these issues, the evaluation of outcomes in women
undergoing multiple simultaneous pelvic floor interventions
becomes increasingly complex. Most investigation to date fo-
cuses primarily on incontinence outcomes and/or voiding dys-
function in patients undergoing MUS placement with POP
repair. Indeed, limited study is available that examines the re-
lationship between patient satisfaction and performing con-
comitant SUI/POP repair. Accordingly, the study aim was to
assess satisfaction rates in patients undergoing combined POP
repair and MUS placement. Importantly, we sought to deter-
mine whether patients remained satisfied with surgical success
of 1 procedure given failure of the other. Quite simply, if a pa-
tient undergoes successful surgery for POP but has persistent
SUI after concurrent MUS placement, is she still satisfied?
MATERIALS AND METHODS
This study entailed a review of prospectively collected data
on patients undergoing concomitant surgical repair of POP and
SUI between August 2009 and January 2011. Review inclusion
criteria comprised all patients undergoing repair of POP/SUI
with minimum 1-year clinical and questionnaire follow-up. In
cases of concurrent MUS and POP repair, MUS placement is
performed in both patients with primary symptomatic SUI in
addition to those with occult SUI who have been counseled
regarding risks and benefits of MUS placement. Pelvic organ
prolapse repair is performed for symptomatic POP (POPQ Q
stage II). Virginia Urology Center Institutional Review Board
approval was obtained for study protocol including full patient
consent (#1998-63).
Baseline evaluation comprised full history, general physi-
cal and pelvic examination, urodynamic evaluation, 3-day
bladder diary, and questionnaire evaluation. Follow-up evalua-
tion included abbreviated history, pelvic examination, 3-day
bladder diary, and questionnaire evaluation, performed at
12-month follow-up. Three-day bladder diary was used to assess
daily pad use.
Validated questionnaire evaluation included the Inter-
national Consultation on Incontinence Questionnaire-Vaginal
Symptoms (ICIQ-VS),11
ICIQ-Female Lower Urinary Tract
Symptoms (ICIQ-FLUTS),12
and the Incontinence Impact
ORIGINAL ARTICLE
Female Pelvic Medicine & Reconstructive Surgery & Volume 20, Number 1, January/February 2014 www.fpmrs.net 23
From the *Division of Urology, Virginia Commonwealth University School
of Medicine; and †Virginia Urology Center for Incontinence and Pelvic
Floor Reconstruction, Glen Allen, VA.
Reprints: David E. Rapp, MD, 5829 Ascot Glen Dr, Glen Allen, VA 23059.
E-mail: derapp@yahoo.com.
The authors have declared they have no conflicts of interest.
Copyright * 2013 by Lippincott Williams & Wilkins
DOI: 10.1097/SPV.0000000000000051
Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Questionnaire, Short Form (IIQ-7).13
The ICIQ-VS is a vali-
dated measure assessing impact of vaginal symptoms and as-
sociated sexual matters on quality of life (QOL) and treatment
outcome. The ICIQ-FLUTS is a patient-completed question-
naire for evaluating female lower urinary tract symptoms and
impact on QOL, derived from the Bristol Female Lower Urinary
Tract Symptoms Scored Form. The IIQ-7 is an empirically
validated instrument assessing QOL that is commonly used
in overactive bladder/incontinence research. An additional di-
chotomous (yes/no) (‘‘are you satisfied with the results of your
surgery?’’) questionnaire item was included to assess patient sat-
isfaction. Subjective cure of incontinence was assessed by patient
interview using a dichotomous item.
The primary goal of this study was to assess satisfaction in
patients undergoing both POP and SUI repairs. Accordingly,
primary surgical success was defined as POPQ stage less than 2
and subjective cure of SUI. Data were analyzed to assess for a
statistical relationship between primary surgical success and
patient-reported satisfaction. Secondary measures of surgical
outcomes for POP repair included ICIQ-VS domain items for
‘‘bulge in vagina’’ and ‘‘bulge outside vagina,’’ identified sub-
sequently as ‘‘bulge’’ and ‘‘out.’’ Secondary measures of sur-
gical outcomes for SUI repair included 3-day bladder diary pad
use, as well as ICIQ-FLUTS domain item for SUI. These sec-
ondary measures were also analyzed to assess for a statistical
relationship with patient-reported satisfaction as dependent on
cure, improvement, or worsening of secondary outcome. For the
purpose of this analysis, cure was defined as a validated ques-
tionnaire item score of ‘‘0.’’
Statistical analysis of categorical variables was performed
using a Fisher exact test and Student t test. Data are listed as
mean (SD). A P value of less than 0.05 was used to designate
statistical significance.
RESULTS
Database review identified 89 women undergoing con-
comitant repair with minimum 1-year follow-up. Mean patient
age and parity was 68.3 (12.3) years and 2.5 (1.2), respectively.
Prior hysterectomy, POP surgery, and SUI surgery were
identified in 48 (54%), 15 (17%), and 3 (3%) patients, re-
spectively. Occult SUI was present in 17 (19%) patients with
remaining patients having clinical SUI. Baseline maximum
POPQ stage II, III, and IV defects were treated in 34 (38%),
52 (58%), and 3 (3%) patients, respectively. Surgery types are
detailed in Table 1.
On the basis of the previously described primary definition
of success, combined cure of both POP and SUI was identified
in 64 (72%) patients. In contrast, 15 (17%) and 9 (10%) of
patients had persistent SUI or POP, respectively. An additional 1
(1%) patient had persistent SUI and POP. Statistically signifi-
cant improvements in ICIQ-VS, ICIQ-FLUTS, and IIQ-7 scores
were seen (P G 0.001, all comparisons) (Table 2).
At 1-year follow-up, 78 (88%) patients reported overall
satisfaction. Subset analysis revealed dissatisfaction in 5%
(3/64) of patients achieving complete cure of both SUI and
POP. In contrast, 40% (6/15) were dissatisfied if there was
failure to cure SUI, 22% (2/9) if failure to cure POP, and the
patient with failure of both was not dissatisfied.
Combined cure of prolapse (POPQ stage G2) and SUI
(subjective cure) was associated with satisfaction (P G 0.01).
Analysis assessing for a statistical relationship between out-
comes focused on SUI repair (‘‘stress’’ domain score, 0;
‘‘stress’’ domain score, improved; subjective cure SUI, yes;
PPD, 0; PPD, 0-1) and satisfaction failed to demonstrate a
statistical relationship. Similarly, analysis assessing for a sta-
tistical relationship between outcomes focused on POP repair
(‘‘out’’ domain score, 0; ‘‘bulge’’ or ‘‘out’’ domain score, im-
proved from baseline; POPQ G2) and satisfaction failed to
demonstrate a statistical relationship. Importantly, ICIQ-VS
‘‘bulge’’ domain item score of 0 was the only assessed out-
come demonstrating a statistical relationship with patient-
reported satisfaction (P = 0.002).
COMMENT
Accompanying the Affordable Care Act, Accountable Care
Organizations are established as a new payment model to foster
improved quality and decreased cost of health care. Integral to
this model of health care delivery is the goal of establishing
performance measures, which serve to promote clinical stan-
dards and quality of care. Related opinion calls measurement
systems that capture PRO as central components to this model.14
Indeed, the Patient-Centered Outcomes Research Institute de-
tails the identification of tools for standardizing the measure-
ment of PRO as a significant area of research interest.15
The assessment of such outcomes after the surgical repair
of POP or SUI is complex. Outcome measures comprise both
objective and subjective markers, with more recent focus on
PRO.7,8
Accordingly, numerous instruments have been devel-
oped to assess PRO in the treatment of both UI and POP.7,16
Despite the utility of these instruments, given their variety, the
resultant process of interpreting such information and defining
cure becomes complex. Indeed, previous study has demon-
strated that success rates after repair of POP or SUI are signif-
icantly affected by definition of success.17,18
Given these issues, it can be argued that patient satisfaction
remains the single most important marker of success. However,
given that it serves as a reflection of numerous variables, patient
satisfaction is also one of the most complex measures. Ac-
cordingly, in addition to outcome itself, patient satisfaction is
shown to be influenced by external variables such as age, sex,
TABLE 1. Surgery Type (89 Patients)
Surgeries (n)
Cystocele repair* 73
Rectocele repair 15
Enterocele repair 2
Sacrocolpopexy 7
Colpocleisis 4
MUS 89
Rectocele repair performed with cadaveric fascia; MUS [TVT-O
(Ethicon Inc, Somerville, NJ)].
*Forty-five mesh augmentation, 27 fascial augmentations, and 1
anterior colporrhaphy.
TABLE 2. Outcomes After TVT-O Placement (n = 89)
Baseline 1 y P
ICIQ-FLUTS
F score 5.7 (3.1) 3.3 (2.0) G0.001
V score 3.0 (2.8) 1.3 (1.7) G0.001
I score 7.7 (5.3) 3.6 (4.3) G0.001
ICIQ-VS 19.1 (12.1) 4.1 (6.3) G0.001
IIQ-7 8.3 (6.0) 3.1 (4.5) G0.001
Wolters et al Female Pelvic Medicine & Reconstructive Surgery & Volume 20, Number 1, January/February 2014
24 www.fpmrs.net * 2013 Lippincott Williams & Wilkins

treatment expectation, and physician-patient interaction.19
The
construct of patient satisfaction is even more complex when
assessing concurrent pelvic surgery, given the fact that complete
success may be achieved in 1 surgical component but not the
other. As such, we sought to investigate satisfaction outcomes in
patients undergoing concurrent POP and SUI repair and assess
for a statistical relationship with numerous validated measures
of POP/SUI treatment.
This investigation demonstrates several important findings
that highlight the complexity of assessing patient satisfaction.
First, a small subset of patients achieving combined cure still
report overall dissatisfaction. In contrast, most of the patients
experiencing failure of either POP or SUI surgery remain sat-
isfied. Our data did not allow us to capture the factors under-
lying these results. However, we believe these findings highlight
the previously described external variables that may affect pa-
tient satisfaction.
Second, statistical analysis failed to demonstrate an asso-
ciation with patient-reported satisfaction in most of the numer-
ous validated outcomes measures analyzed. We note this
finding despite the statistically significant improvements ob-
served across all mean validated questionnaire scores. Certainly,
the use of validated questionnaires to capture important sub-
jective information about patient outcomes is well documented.
However, we believe our data reaffirm the previously described
difficulties in determining the construct of patient satisfaction
and its relationship with additional objective or subjective
markers of treatment outcome.19
Despite the presently reported difficulties, identifying
simplified measures that accurately reflect treatment outcome
is of immediate importance. First, the present limitations of
outcome measures inhibit meaningful comparison of multi-
institutional data that are needed to develop treatment stan-
dards. This issue is underscored by numerous examples of
meta-analyses of therapeutic options for UI being limited owing
to discrepancies in outcomes measures.20Y22
Second, as health
care delivery anticipates a shift toward outcomes-based models,
the urogynecologic community is charged with identifying com-
mon measures to facilitate outcomes reporting.
We acknowledge study power and the retrospective, ob-
servational nature of this investigation as study weaknesses.
Future prospective study including comparison cohorts under-
going MUS or POP alone is warranted. In addition, there is
temporal difference between rates of MUS and prolapse repair
failure (early vs delayed, respectively) and that over time the
anticipated increased rate of prolapse recurrence could affect
these data. Follow-up is ongoing to assess this issue. Finally,
our patient population included both those with symptomatic
and occult SUI, which may affect outcomes. Although pa-
tients with occult UI do not have clinical incontinence at
baseline, postoperative incontinence is common even with
concurrent MUS placement. Satisfaction is therefore very
dependent on ‘‘success’’ of MUS placement in preventing the
development of clinical incontinence. Indeed, such patients
with occult SUI who develop clinical incontinence after POP
repair may be more likely to report dissatisfaction than pa-
tients with baseline SUI who report persistent clinical incon-
tinence. Further investigation of outcomes in these distinct
cohorts is necessary.
Importantly, several characteristics contribute to the quality
of these data. Foremost, subjective outcomes assessment in-
cluded 3 comprehensive validated questionnaires assessing
vaginal symptoms, sexual function, lower urinary tract symp-
toms, and QOL. Further, we present minimum 1-year data
consistent with guidelines for study of POP and UI.23
CONCLUSIONS
Among women who achieved cure of both incontinence
and prolapse in a single operation, 95% reported satisfaction
with their clinical outcome. Interestingly, a variety of outcomes
measures fail to correlate with patient satisfaction with the ex-
ception of ICIQ-VS domain score for vaginal bulge. Further, in
patients with complete cure of concurrent pelvic surgeries, a
percentage still report dissatisfaction, highlighting the compli-
cated nature of patient satisfaction.
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* 2013 Lippincott Williams & Wilkins www.fpmrs.net 25

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26 www.fpmrs.net * 2013 Lippincott Williams & Wilkins

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