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Satisfaction in patients_undergoing_concurrent.5
Luis Carlos Murillo Valencia
, GINECOLOGO Y OBSTETRA
Mar 17, 2014
Health & Medicine
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Satisfaction in patients_undergoing_concurrent.5
1. 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: email@example.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 Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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. 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 surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501Y506. 3. Rortveit G, Subak L, Thom D, et al. Urinary incontinence, fecal incontinence and pelvic organ prolapse in a population-based, racially diverse cohort: prevalence, risk factors. Female Pelvic Med Reconstruct Surg 2010;12:278Y283. 4. Lensen E, Withagen M, Kluivers K, et al. Urinary incontinence after surgery for pelvic organ prolapse. Neurourol Urodyn 2013;32:455Y459. 5. Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2012;4: CD004014. 6. Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med 2012;366: 2358Y2367. 7. Brubaker L, Chapple C, Coyne KS, et al. Patient-reported outcomes in overactive bladder: importance for determining clinical effectiveness of treatment. Urology 2007;68(suppl 2A):3Y8. 8. Toozs-Hobson P, Freeman R, Barber M, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn 2012;31:415Y421. 9. Burgio KL, Locher JL, Roth DL, et al. Psychological improvements associated with behavioral and drug treatment of urge incontinence in older 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-h pad test in women with stress urinary incontinence. BJU Int 2008; 102;586Y590. 11. Price N, Jackson SR, Avery K, et al. Development and psychometric evaluation 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 Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol 1996;77:805Y812. 13. Uebersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn. 1995;14:131Y139. 14. Fisher ES, Shortell SM. Accountable care organizations: accountable for what, to whom, and how. JAMA 2010;304:1715Y1716. 15. The Patient-Centered Outcomes Research Institute Web site, Projects Grants Program, retrieved from http://pcori.org, December 2012. 16. Coyne KS, Tubaro A, Brubaker L, et al. Development and validation of patient-reported outcomes measures for overactive bladder: a review of concepts. Urology 2006;68(suppl 2A):9Y16. 17. Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009;114:600Y609. Female Pelvic Medicine & Reconstructive Surgery & Volume 20, Number 1, January/February 2014 Concurrent Surgical Repair for SUI & POP * 2013 Lippincott Williams & Wilkins www.fpmrs.net 25 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 for urinary incontinence in women. Cochrane Database Syst Rev 2007;3: CD003881. 22. Duthie J, Wilson DI, Herbison GP, et al. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev 2007;3:CD005493. 23. Abrams P, Andersson KE, Birder L, et al. Fourth Annual Consultation on Incontinence Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn 2010;29:213Y240. Wolters et al Female Pelvic Medicine & Reconstructive Surgery & Volume 20, Number 1, January/February 2014 26 www.fpmrs.net * 2013 Lippincott Williams & Wilkins Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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