Satisfaction in Patients Undergoing ConcurrentPelvic Floor Surgery for Stress Urinary

Incontinence and Pelvic Organ ProlapseJeff 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 surgicalsuccess may be achieved in one component but not the other. We soughtto 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 wasplaced on patient-reported satisfaction rates. Validated measures wereused to evaluate outcomes after MUS [International Consultation onIncontinence Questionnaire (ICIQ)-Female Lower Urinary TractSymptoms, 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 in15 (17%) patients, 9 (10%) patients, and 1 (1%) patient, respectively.Subset analysis revealed dissatisfaction in 5% (3/64) of patientsachieving 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 tocure POP, and the patient with failure of both was not dissatisfied. TheICIQ-Vaginal Symptoms domain score for vaginal bulge was the onlyassessed outcome demonstrating a statistical relationship with patient-reported satisfaction.Conclusions: Among women achieving cure of both SUI and POP viaconcurrent surgical repair, 95% reported satisfaction. Interestingly, avariety 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 natureof patient satisfaction.

Key Words: satisfaction, incontinence, prolapse, concurrent repair

(Female Pelvic Med Reconstr Surg 2014;20: 23Y26)

T he comprehensive assessment and treatment of concurrentpelvic 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 studydemonstrates concurrent POP and UI in 7% of patients withpelvic floor pathology.3 In addition, given the significant rate ofde novo SUI associated with POP repair, midurethral sling(MUS) is also commonly performed concomitantly with POPrepair to prevent the development of SUI.4Y6

Simultaneously, the assessment of outcomes after the sur-gical repair of incontinence or POP remains difficult. Objectiveoutcomes markers such as bladder diary variables, urodynamicparameters, and prolapse staging provide defined informationregarding treatment response. Despite their utility, these in-struments fail to define the impact that incontinence has onpatients’ daily lives or the patient-perceived benefit of inter-vention.7 Accordingly, more focus has recently been placed onthe inclusion of patient-reported outcomes (PROs) in relatedresearch.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 withsubjective benefit after incontinence therapies.9,10

Given these issues, the evaluation of outcomes in womenundergoing multiple simultaneous pelvic floor interventionsbecomes increasingly complex. Most investigation to date fo-cuses primarily on incontinence outcomes and/or voiding dys-function in patients undergoing MUS placement with POPrepair. 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 toassess satisfaction rates in patients undergoing combined POPrepair and MUS placement. Importantly, we sought to deter-mine whether patients remained satisfied with surgical successof 1 procedure given failure of the other. Quite simply, if a pa-tient undergoes successful surgery for POP but has persistentSUI after concurrent MUS placement, is she still satisfied?

MATERIALS AND METHODSThis study entailed a review of prospectively collected data

on patients undergoing concomitant surgical repair of POP andSUI between August 2009 and January 2011. Review inclusioncriteria comprised all patients undergoing repair of POP/SUIwith minimum 1-year clinical and questionnaire follow-up. Incases of concurrent MUS and POP repair, MUS placement isperformed in both patients with primary symptomatic SUI inaddition to those with occult SUI who have been counseledregarding risks and benefits of MUS placement. Pelvic organprolapse repair is performed for symptomatic POP (POPQ Q

stage II). Virginia Urology Center Institutional Review Boardapproval was obtained for study protocol including full patientconsent (#1998-63).

Baseline evaluation comprised full history, general physi-cal and pelvic examination, urodynamic evaluation, 3-daybladder diary, and questionnaire evaluation. Follow-up evalua-tion included abbreviated history, pelvic examination, 3-daybladder diary, and questionnaire evaluation, performed at12-month follow-up. Three-day bladder diary was used to assessdaily pad use.

Validated questionnaire evaluation included the Inter-national Consultation on Incontinence Questionnaire-VaginalSymptoms (ICIQ-VS),11 ICIQ-Female Lower Urinary TractSymptoms (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 Schoolof Medicine; and †Virginia Urology Center for Incontinence and PelvicFloor 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 & WilkinsDOI: 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 treatmentoutcome. The ICIQ-FLUTS is a patient-completed question-naire for evaluating female lower urinary tract symptoms andimpact on QOL, derived from the Bristol Female Lower UrinaryTract Symptoms Scored Form. The IIQ-7 is an empiricallyvalidated instrument assessing QOL that is commonly usedin overactive bladder/incontinence research. An additional di-chotomous (yes/no) (‘‘are you satisfied with the results of yoursurgery?’’) questionnaire item was included to assess patient sat-isfaction. Subjective cure of incontinence was assessed by patientinterview using a dichotomous item.

The primary goal of this study was to assess satisfaction inpatients undergoing both POP and SUI repairs. Accordingly,primary surgical success was defined as POPQ stage less than 2and subjective cure of SUI. Data were analyzed to assess for astatistical relationship between primary surgical success andpatient-reported satisfaction. Secondary measures of surgicaloutcomes 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 paduse, as well as ICIQ-FLUTS domain item for SUI. These sec-ondary measures were also analyzed to assess for a statisticalrelationship with patient-reported satisfaction as dependent oncure, improvement, or worsening of secondary outcome. For thepurpose of this analysis, cure was defined as a validated ques-tionnaire item score of ‘‘0.’’

Statistical analysis of categorical variables was performedusing a Fisher exact test and Student t test. Data are listed asmean (SD). A P value of less than 0.05 was used to designatestatistical significance.

RESULTSDatabase review identified 89 women undergoing con-

comitant repair with minimum 1-year follow-up. Mean patientage and parity was 68.3 (12.3) years and 2.5 (1.2), respectively.Prior hysterectomy, POP surgery, and SUI surgery wereidentified in 48 (54%), 15 (17%), and 3 (3%) patients, re-spectively. Occult SUI was present in 17 (19%) patients withremaining patients having clinical SUI. Baseline maximumPOPQ stage II, III, and IV defects were treated in 34 (38%),52 (58%), and 3 (3%) patients, respectively. Surgery types aredetailed in Table 1.

On the basis of the previously described primary definitionof success, combined cure of both POP and SUI was identifiedin 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 scoreswere seen (P G 0.001, all comparisons) (Table 2).

At 1-year follow-up, 78 (88%) patients reported overallsatisfaction. Subset analysis revealed dissatisfaction in 5%(3/64) of patients achieving complete cure of both SUI andPOP. In contrast, 40% (6/15) were dissatisfied if there wasfailure to cure SUI, 22% (2/9) if failure to cure POP, and thepatient 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 astatistical 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 todemonstrate 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).

COMMENTAccompanying the Affordable Care Act, Accountable Care

Organizations are established as a new payment model to fosterimproved quality and decreased cost of health care. Integral tothis model of health care delivery is the goal of establishingperformance measures, which serve to promote clinical stan-dards and quality of care. Related opinion calls measurementsystems 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 repairof POP or SUI is complex. Outcome measures comprise bothobjective and subjective markers, with more recent focus onPRO.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, theresultant process of interpreting such information and definingcure 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 satisfactionremains the single most important marker of success. However,given that it serves as a reflection of numerous variables, patientsatisfaction is also one of the most complex measures. Ac-cordingly, in addition to outcome itself, patient satisfaction isshown to be influenced by external variables such as age, sex,

TABLE 1. Surgery Type (89 Patients)

Surgeries (n)Cystocele repair* 73Rectocele repair 15Enterocele repair 2Sacrocolpopexy 7Colpocleisis 4MUS 89

Rectocele repair performed with cadaveric fascia; MUS [TVT-O(Ethicon Inc, Somerville, NJ)].

*Forty-five mesh augmentation, 27 fascial augmentations, and 1anterior colporrhaphy.

TABLE 2. Outcomes After TVT-O Placement (n = 89)

Baseline 1 y P

ICIQ-FLUTSF score 5.7 (3.1) 3.3 (2.0) G0.001V score 3.0 (2.8) 1.3 (1.7) G0.001I score 7.7 (5.3) 3.6 (4.3) G0.001

ICIQ-VS 19.1 (12.1) 4.1 (6.3) G0.001IIQ-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

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treatment expectation, and physician-patient interaction.19 Theconstruct of patient satisfaction is even more complex whenassessing concurrent pelvic surgery, given the fact that completesuccess may be achieved in 1 surgical component but not theother. As such, we sought to investigate satisfaction outcomes inpatients undergoing concurrent POP and SUI repair and assessfor a statistical relationship with numerous validated measuresof POP/SUI treatment.

This investigation demonstrates several important findingsthat highlight the complexity of assessing patient satisfaction.First, a small subset of patients achieving combined cure stillreport overall dissatisfaction. In contrast, most of the patientsexperiencing 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 highlightthe 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 thisfinding 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 describeddifficulties in determining the construct of patient satisfactionand its relationship with additional objective or subjectivemarkers of treatment outcome.19

Despite the presently reported difficulties, identifyingsimplified measures that accurately reflect treatment outcomeis of immediate importance. First, the present limitations ofoutcome measures inhibit meaningful comparison of multi-institutional data that are needed to develop treatment stan-dards. This issue is underscored by numerous examples ofmeta-analyses of therapeutic options for UI being limited owingto discrepancies in outcomes measures.20Y22 Second, as healthcare 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 istemporal difference between rates of MUS and prolapse repairfailure (early vs delayed, respectively) and that over time theanticipated increased rate of prolapse recurrence could affectthese data. Follow-up is ongoing to assess this issue. Finally,our patient population included both those with symptomaticand occult SUI, which may affect outcomes. Although pa-tients with occult UI do not have clinical incontinence atbaseline, postoperative incontinence is common even withconcurrent MUS placement. Satisfaction is therefore verydependent on ‘‘success’’ of MUS placement in preventing thedevelopment of clinical incontinence. Indeed, such patientswith occult SUI who develop clinical incontinence after POPrepair 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 distinctcohorts is necessary.

Importantly, several characteristics contribute to the qualityof these data. Foremost, subjective outcomes assessment in-cluded 3 comprehensive validated questionnaires assessingvaginal symptoms, sexual function, lower urinary tract symp-toms, and QOL. Further, we present minimum 1-year dataconsistent with guidelines for study of POP and UI.23

CONCLUSIONSAmong women who achieved cure of both incontinence

and prolapse in a single operation, 95% reported satisfactionwith their clinical outcome. Interestingly, a variety of outcomesmeasures fail to correlate with patient satisfaction with the ex-ception of ICIQ-VS domain score for vaginal bulge. Further, inpatients with complete cure of concurrent pelvic surgeries, apercentage still report dissatisfaction, highlighting the compli-cated nature of patient satisfaction.

REFERENCES

1. Nitti V. The prevalence of urinary incontinence. Rev Urol 2001;3:S2YS6.

2. Olen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgicallymanaged pelvic organ prolapse and urinary incontinence. ObstetGynecol 1997;89:501Y506.

3. Rortveit G, Subak L, Thom D, et al. Urinary incontinence, fecalincontinence and pelvic organ prolapse in a population-based, raciallydiverse cohort: prevalence, risk factors. Female Pelvic Med ReconstructSurg 2010;12:278Y283.

4. Lensen E, Withagen M, Kluivers K, et al. Urinary incontinence aftersurgery for pelvic organ prolapse. Neurourol Urodyn 2013;32:455Y459.

5. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvicorgan prolapse in women. Cochrane Database Syst Rev 2012;4:CD004014.

6. Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduceincontinence after vaginal prolapse repair. N Engl J Med 2012;366:2358Y2367.

7. Brubaker L, Chapple C, Coyne KS, et al. Patient-reported outcomesin overactive bladder: importance for determining clinical effectivenessof treatment. Urology 2007;68(suppl 2A):3Y8.

8. Toozs-Hobson P, Freeman R, Barber M, et al. An InternationalUrogynecological Association (IUGA)/International ContinenceSociety (ICS) joint report on the terminology for reporting outcomesof surgical procedures for pelvic organ prolapse. Neurourol Urodyn2012;31:415Y421.

9. Burgio KL, Locher JL, Roth DL, et al. Psychological improvementsassociated with behavioral and drug treatment of urge incontinence inolder women. J Gerontol B Psychol Sci Soc Sci 2001;56:P46YP51.

10. Franco AV, Lee F, Fynes MM. Is there an alternative to pad tests?Correlation of subjective variables of severity of urinary loss to the 1-hpad test in women with stress urinary incontinence. BJU Int 2008;102;586Y590.

11. Price N, Jackson SR, Avery K, et al. Development and psychometricevaluation of the ICIQ Vaginal Symptoms Questionnaire: the ICIQ-VS.BJOG 2006;113:700Y712.

12. Jackson S, Donovan J, Brookes S, et al. The Bristol Female LowerUrinary Tract Symptoms questionnaire: development and psychometrictesting. Br J Urol 1996;77:805Y812.

13. Uebersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess lifequality and symptom distress for urinary incontinence in women: theIncontinence Impact Questionnaire and the Urogenital DistressInventory. Neurourol Urodyn. 1995;14:131Y139.

14. Fisher ES, Shortell SM. Accountable care organizations: accountablefor what, to whom, and how. JAMA 2010;304:1715Y1716.

15. The Patient-Centered Outcomes Research Institute Web site, ProjectsGrants Program, retrieved from http://pcori.org, December 2012.

16. Coyne KS, Tubaro A, Brubaker L, et al. Development and validationof patient-reported outcomes measures for overactive bladder: a reviewof concepts. Urology 2006;68(suppl 2A):9Y16.

17. Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgeryfor pelvic organ prolapse. Obstet Gynecol 2009;114:600Y609.

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Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

18. Rapp DE, Kobashi KC. Outcomes following sling surgery:

importance of definition of success. J Urol 2008;180:

998Y1002.

19. Marschall-Kehrel D, Roberts RG, Brubaker L. Patient-reported

outcomes in overactive bladder: the influence of perception of condition

and expectation for treatment benefit. Urology 2006;68(suppl 2A):

29Y37.

20. Choi H, Palmer MH, Park J. Meta-analysis of pelvic floor training:

randomized controlled trials in incontinent women. Nurs Res 2007;

56:226Y234.

21. Keegan PE, Atiemo K, Cody J, et al. Periurethral injection therapy forurinary incontinence in women. Cochrane Database Syst Rev 2007;3:CD003881.

22. Duthie J, Wilson DI, Herbison GP, et al. Botulinum toxin injectionsfor adults with overactive bladder syndrome. Cochrane Database SystRev 2007;3:CD005493.

23. Abrams P, Andersson KE, Birder L, et al. Fourth Annual Consultationon Incontinence Recommendations of the International ScientificCommittee: evaluation and treatment of urinary incontinence, pelvicorgan prolapse, and fecal incontinence. Neurourol Urodyn2010;29:213Y240.

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