Abstract
Background
Aging beyond 65 years is associated with increased prevalence of urinary incontinence (UI), frailty, and increased complication rate with UI treatments. To investigate this relationship, we examined frailty as a predictor of procedure-based UI treatment patterns and urologic complications in Medicare-eligible women.
Methods
We identified women undergoing procedures for UI between 2011 and 2018 in the 5% limited Medicare data set. A claims-based frailty index (CFI) using data from the 12 months prior to the index procedure defined frailty (CFI ≥0.25). Urologic complications were assessed during the 12 months following the index procedure. We used unadjusted logistic regression models to calculate odds of having a specific type of UI procedure based on frailty status. Odds of postprocedure urologic complications were examined with logistic regression adjusted for age and race.
Results
We identified 21 783 women who underwent a procedure-based intervention for UI, of whom 3 826 (17.5%) were frail. Frail women with stress UI were 2.6 times more likely to receive periurethral bulking (95% confidence interval [CI] 2.26–2.95), compared to nonfrail. Conversely, frailty was associated with lower odds of receiving a Sling or Burch colposuspension. Among women with urgency UI or overactive bladder, compared to nonfrail, frailty was associated with higher odds of both sacral neuromodulation (odds ratio [OR] = 1.21, 95% CI: 1.11–1.33) and intravesical Botox (OR = 1.16, 95% CI: 1.06–1.28), but lower odds of receiving posterior tibial nerve stimulation. Frailty was associated with higher odds of postprocedure urologic complications (OR = 1.64, 95% CI: 1.47–1.81).
Conclusions
Frailty status may influence treatment choice for treatment of stress or urgency UI symptoms and increase the odds of postprocedural complications in older women.
Keywords: Frailty, Geriatrics, Lower urinary tract symptoms, Urinary incontinence, Urogynecology
Urinary incontinence (UI) is a geriatric syndrome with increasing prevalence with older age and frailty. Frailty is a complex condition that independently increases risk of postprocedure complications due to its impact on an individual’s ability to recover from acute physical and psychological stressors, such as surgery (1). Frailty is prevalent in up to 54% of women with pelvic floor disorder symptoms, including UI. Although most procedure-based treatments for UI are minor surgeries, postprocedure complication rates are higher among women older than 65 years. By 2050, the number of procedures for UI treatment is estimated to increase by up to 47% (2). Unfortunately, with increased numbers of procedures performed on women older than 65 years, we should anticipate more postprocedure complications, potentially due to greater incidence of frailty with aging (3). To date, it is unclear if aging beyond 65 years (chronologic aging) or frailty is most responsible for the observed higher rates of procedure-related complications. We hypothesize that the presence of frailty, not chronological age, increases risk for postprocedure complications.
Frailty may influence the type of anti-incontinence procedures performed for older women with UI symptoms due to perceived elevated risk of postprocedure complications (4). Nevertheless, frailty is not routinely determined prior to procedure-based interventions for UI (5). In fact, in one study, incontinence care providers correctly characterized frailty in only 50% of women seeking care for UI (6). We propose that the relationship between frailty and risks associated with procedure-based treatment for UI in older women may be best studied through large database analyses, as they are rich resources that efficiently answer clinical questions on special and understudied populations, such as frailty in women undergoing treatment for UI symptoms.
We present a retrospective cohort study of Medicare-eligible women to explore associations between frailty and trends in UI treatments and postprocedure urologic complications. We hypothesized that the presence of frailty among older women with UI would influence treatment patterns based on procedures performed to treat UI symptoms. We also hypothesize that frail women may have decreased odds of having an “invasive” procedure for UI symptoms and increased odds of postprocedure urologic complications.
Materials and Methods
Cohort Identification
Women older than 65 years undergoing an incident procedure-based intervention for UI between 2011 and 2018 were identified from the 5% limited data set from the Centers for Medicare and Medicaid Services. Procedure-based interventions for UI were identified using CPT codes detailed below. Women were included in the analytic cohort if they had 12 months of continuous fee-for-service Medicare coverage because this was the period during which we pulled claims to define both the claims-based frailty index (CFI) and comorbid conditions. Participants with a UI procedure during the 12 months prior to the index UI procedure were excluded to ensure that only women who underwent incident UI procedures were included (Figure 1). This study was approved by the Institutional Review Board of Wake Forest and Duke Schools of Medicine.
Figure 1.
Flow chart of the development of the cohort from the 5% limited data set from the Centers for Medicare and Medicaid Services with inclusion criteria of participants, targeted procedures, and allocation to final groups based on claims-based frailty index (cFI) score.
Estimating Frailty in Medicare Data
A validated CFI algorithm was applied to identify participants at risk for frailty using Medicare data from the 12-month period prior to the date of the index UI procedure (7). International Classification of Diseases (ICD) diagnosis and procedure codes, CPT, and Healthcare Common Procedural Coding System codes were extracted from inpatient, outpatient, carrier, home health, hospice, skilled nursing facility, and durable medical equipment tables in the year prior to the index UI procedure date and entered into the CFI algorithm to produce a score for each participant (7–9). CFI scores range from 0 to 1, with higher values indicating greater frailty. The exact calculation of the CFI is available as a SAS program available at http://www.drugepi.org/dope-downloads (7). Consistent with prior studies, we defined frailty as a CFI score of greater than or equal to 0.25 (10).
Demographic and clinical characteristics were abstracted from the master beneficiary summary file, including race/ethnicity and age at index UI procedure. Applying validated coding algorithms, comorbid conditions with high potential to impact on UI treatment chosen or the presence of frailty were abstracted from the impatient, outpatient, and physician carrier claims in the 12 months prior to the index procedure-based UI treatment (11,12).
Outcomes
Standard Common Procedural Terminology (CPT) codes were used to identify UI procedure type, the primary outcome. To treat stress UI symptoms, slings (CPT 57288), periurethral bulking (CPT 51715), and Burch urethropexy (CPT 51841) procedures were included. To treat urgency UI and the overactive bladder (OAB) syndrome symptoms, intravesical BotulinumtoxinA injection (CPT 52287), sacral neuromodulation (CPT 64581, 64590), and percutaneous tibial nerve stimulation (CPT 64566) procedures were included. Invasive procedures were classified as those in which systemic anesthesia or operating room access may be used to complete the procedure, understanding that this may vary based on the clinical practice. For stress UI procedures, this included slings (transobturator, retropubic, single incision, and fascial) and the Burch urethropexy. For urgency UI and OAB procedures, sacral neuromodulation and intravesical Botox were classified as invasive procedures. Thus, periurethral bulking was classified as noninvasive for treatment of stress UI and posterior tibial nerve stimulation was classified as noninvasive treatment for urgency UI and OAB. Details of clinic versus operating room site for procedures were not determined.
Postprocedure urologic complications were evaluated as a secondary outcome. Inpatient, outpatient, and carrier claims were searched within the 12-month period following the index UI procedure date to identify diagnoses that would be clinically deemed a urologic complication. We defined a urologic complication as an ICD-9 or ICD-10 code consistent with: a new diagnosis of urgency UI, urinary tract infection, voiding dysfunction, bladder neck obstruction, urinary retention, bladder trauma, overflow incontinence, slowing urinary stream, diagnosis of pelvic organ prolapse, vaginal mesh exposure/erosion, vesical fistula, urethral fistula, genital pain/dyspareunia, mechanical complication of genitourinary implant, or postprocedure complication in genitourinary system (Supplementary Appendix A).
Data Analysis
Differences in demographic and clinical characteristics between frail and nonfrail women were compared using t tests for continuous variables and chi-square test for categorical variables. Using the CFI as the primary predictor, chi-square tests were applied to compare the proportion of frail and nonfrail women who received different treatments for stress UI and urgency UI or OAB. Logistic regression was performed to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for each UI procedural treatment type by frailty status. Multivariable logistic regression analyses were performed to calculate ORs and 95% CIs for postprocedural urologic complications based upon frailty status adjusted for age and race. Similarly, a decade model examined the association between chronologic aging with age classifications by decade started at 65 years (65–74 and 75–84) with urologic complications. These analyses were not adjusted for comorbid conditions because many are independently associated with the presence of the frailty condition. We did not include region in this model due to low counts in certain sections. All statistical tests were 2-sided, with p < .05 considered statistically significant. All statistical analyses were performed in SAS (version 9.4; SAS Institute, Cary, NC) and R (version 3.5.3; 2019-3-11).
Results
We identified 21 783 older women who underwent a procedure-based intervention for UI between 2011 and 2018. Of these women, 3 826 (17.5%) were classified as frail and 17 957 (81%) were classified as nonfrail (Figure 1). Demographic and clinic characteristics of the analytic cohort are included in Table 1. Overall, the median (interquartile range) age and CFI was 72 (11) years and 0.17 (0.08), respectively. Most women were White (90.5%). Compared to nonfrail women, those with frailty were older and had more comorbid conditions.
Table 1.
Demographic and Clinical Characteristics of the Analytic Cohort Based on Frailty Status
| Cohort (N = 21 783) | Frail (N = 3 826) | Nonfrail (N = 17 957) | P Value | |
|---|---|---|---|---|
| Age, median [IQR] | 72 [11] | 74 [14] | 71 [10] | <.001 |
| Race, N (%) | .01 | |||
| Unknown | 115 (0.53%) | 15 (0.4%) | 100 (0.6%) | |
| White | 19 722 (90.5%) | 3 437 (89.8%) | 16 285 (90%) | |
| Black | 1 034 (4.7%) | 224 (5.8%) | 810 (4.5%) | |
| Other | 225 (1%) | 30 (0.8%) | 195 (1%) | |
| Asian | 198 (0.9%) | 19 (0.5%) | 179 (1%) | |
| Hispanic | 383 (1.8%) | 80 (2%) | 303 (1.7%) | |
| North American Native | 106 (0.4%) | 22 (0.6%) | 84 (0.5%) | |
| Comorbid conditions, N (%) | ||||
| Chronic obstructive pulmonary disease | 6 652 (30.5%) | 2 209 (53%) | 4 623 (25.7%) | <.001 |
| Depression | 6 809 (31%) | 2 254 (59%) | 4 555 (25%) | <.001 |
| Diabetes mellitus | 6 872 (31.5%) | 2 131 (55.6%) | 4 741 (26.5%) | <.001 |
| History of fall within 1 year | 6 755 (31%) | 2 001 (55.2%) | 4 754 (26.4%) | <.001 |
| Alzheimer’s dementia | 456 (2%) | 332 (8.6%) | 124 (0.7%) | <.001 |
| Stroke | 2 283 (10%) | 1 112 (29%) | 1 171 (6.5%) | <.001 |
Note: IQR = interquartile range.
Overall, sling procedures for stress UI were the most common of all procedures performed for older women with UI (n = 9 683, 44%), followed by percutaneous tibial nerve stimulation (n = 3, 513, 16%), sacral neuromodulation (n = 3 304, 15%), intravesical Botox injections (n = 3164, 14%), periurethral bulking (n = 1931, 8.9%), and Burch urethropexy (n = 188, 0.8%). While the total number of procedures performed was greater among nonfrail women, clinically significant differences in the types of procedures performed among frail women were evident. Stress UI treatments were performed in 11, 802 (54%) of the entire cohort. Compared to nonfrail women, older women with frailty were less likely to receive the more invasive procedures of sling (68.4% vs 83.7%; p < .001) or Burch colposuspension (1.7% vs 0.9%; p = .82) for stress UI symptoms. The less invasive procedure of periurethral bulking was performed in 30.7% of frail women versus 14.6% of nonfrail women; p < .001 (Figure 2A). After adjusting for age and race, frail older women were 2.6 times more likely to receive periurethral bulking (95% CI: 2.26–2.95, p < .001) for stress UI (Figure 3). Women with frailty and stress UI also had 42% lower odds of receiving a sling (95% CI: 0.37–0.48) and 51% lower odds of having a Burch colposuspension (95% CI: 0.28–0.94, p < .001).
Figure 2.
Proportion UI procedural treatment types received by older women with (A) stress UI, and (B) urgency UI and overactive bladder, by frailty status. PTNS = posterior tibial nerve stimulation; SNM = sacral neuromodulation; UI = urinary incontinence. p Value for differences between frail and nonfrail women calculated using chi-square test.
Figure 3.
Logistic regression analyses estimating the odds of having a type procedure for treatment of UI based on the type of UI and preexisting frailty. (A) Procedures for stress UI. * Center points represent the OR with error bars representing the 95% CI for each procedure compared to all other procedure performed for stress UI. (B) Procedures for urgency UI. * Center points represent the OR with error bars representing the 95% CI for each procedure compared to all other procedure performed for urgency UI. CI = confidence interval; OR = odds ratio; * PTNS = posterior tibial nerve stimulation; SNM = sacral neuromodulation; UI = urinary incontinence.
Procedures for the treatment of urgency UI and OAB symptoms composed 46% (n = 9 981) of the analytic cohort (Figure 2, panel B). Frailty status was associated with treatment patterns. Compared to nonfrail, frail older women were more likely to receive the more invasive procedure of sacral neuromodulation (36.4% vs 32.0%; p = .03), and less likely to receive percutaneous tibial nerve stimulation (29.5% vs 37.2%; p < .001; Figure 2B). Frail women with urgency UI or OAB symptoms had 30% lower odds of receiving the least invasive procedure of posterior tibial nerve stimulation (OR 0.70, 95% CI: 0.64–0.78, p < .001) compared to nonfrail women. However, frail women had 21% higher odds of sacral neuromodulation (OR = 1.21, 95% CI: 1.11–1.33, p < .01).
Out of the entire cohort, 18 198 (84%) women had a urologic complication after their anti-incontinence procedure. While the majority of women with a urologic complication did not have frailty, women with frailty and a urologic complication made up 18.6% of those with a complication. In unadjusted regression models, women with frailty had 1.63 higher odds of having a urologic complication within 12 months of the index UI procedure (95% CI: 1.47, 1.81, p < .001). When adjusted for age and race, frailty was still associated with higher odds of urologic complication (Table 2). When chronologic aging by decade was examined as a predictor for urologic complication adjusting for race, being frail and aging beyond 65 years per decade did not reveal a significant relationship (Table 2).
Table 2.
Associations of Frailty With Urologic Complications After a Urinary Incontinence (UI) Procedural Treatment
| Frail | |
|---|---|
| Odds Ratio (95% CI) | |
| Adjusted risk of urologic complication based on frailty status† | 1.64 (1.47, 1.81) |
| Adjusted risk of urologic complication based on chronologic aging per decade after ≥65 through <85 years‡ | 0.89 (0.85, 0.93) |
Notes: CI = confidence interval.
†Odds of having a urologic complication within 12 months of the index UI procedure if frail calculated using logistic regression models adjusted for age and race, nonfrail as reference.
‡Odds of having a urologic complication if with aging each decade of life beyond 65 years and before 84 years adjusted for race based on frailty status.
Discussion
We present a retrospective cohort study on a novel cohort of Medicare-eligible women who underwent procedure-based treatments for UI symptoms and had data to support a claims-based frailty risk assessment. From it, we have learned that sling procedures were predominant for treatment of stress UI symptoms in Medicare-eligible women. However, periurethral bulking, known as a less invasive procedure, was predominant among frail women compared to the more invasive procedures of slings and Burch colposuspension that require systemic anesthesia and operating room access. On the contrary, older women who underwent treatment for OAB/urgency UI symptoms with frailty had greater prevalence of sacral neuromodulation, an outpatient surgical procedure that requires operating room access and monitored anesthesia. The office-based approach of percutaneous tibial nerve stimulation was an uncommon procedure among older women with frailty. Preprocedure frailty was an independent predictor of urologic complications in women undergoing procedure-based interventions for the treatment of UI. Chronologic aging after 65 years was associated with a low marginal increase in urologic complications. Our hypothesis that frailty is a stronger predictor of postoperative urologic complications is confirmed.
Studies to assess the impact of frailty on perioperative complications in benign gynecology or urologic surgery are scarce (13). Among females included in the American College of Surgeons National Surgical Quality Improvement Project (NSQIP), frailty was present in 9%–10% undergoing sling procedures and was associated with higher odds of 30-day hospitalization when sling was performed concomitantly with prolapse repair; there was no association between age alone and increased postprocedure morbidity (14). However, Anger and colleagues examined urologic and nonurologic complications after sling procedures in U.S. Medicare-eligible women; age beyond 75 years was associated with greater urologic complications after sling surgery in U.S. Medicare-eligible women (15). Frailty risk was not determined in this cohort, so its association with these findings in comparison to aging alone could not be explored. Suskind and colleagues examined a cohort of women undergoing pelvic organ prolapse surgery and found frailty to be strongly associated with postoperative complications (16). Overall, our findings align with these studies and show that frailty is a strong predictor of postprocedure urologic complications, and this risk increases with aging beyond 75 years. It is highly plausible that frailty is present at higher rates among women older than 75 years; thus, frailty may explain the higher frequency of urologic complications observed after sling and prolapse surgery among the Medicare recipients.
This study suggests that frailty risk as determined by a claims-based frailty assessment may have an undetected influence on procedure selection for Medicare-eligible women undergoing procedure-based treatment for UI. Regarding procedures for treatment of the OAB and urgency UI, the observed trend of more frequent use of sacral neuromodulation among frail women in comparison to the office-based, minimally invasive approach of posterior tibial nerve stimulation may be the result of providers targeting therapies with superior treatment efficacy in reducing UI episodes (17). Secondary data analysis of the ROSETTA trial, a multicentered randomized controlled trial testing the efficacy between intravesical Botox injection and sacral neuromodulation for the treatment of refractory OAB revealed that women younger than 65 years had 3.3 higher odds of having a >75% reduction in urgency UI episodes compared to women older than 65 years. Thus, older women with urgency UI may have less efficacy with sacral neuromodulation and intravesical Botox therapies (18). However, a recent systematic review revealed that all 3 modalities were more efficacious than placebo. Further, in another report that does not account for age beyond 65 years, sacral neuromodulation achieved the greatest reduction in UI episodes in comparison to the other modalities and use of intravesical Botox was associated with the highest risk of complications (urinary retention, urinary tract infection) (19).
Our observations have important clinical implications. Despite mixed UI symptoms being most prevalent in this population of women (20), procedures for stress urinary incontinence were dominant. Among women with frailty and stress UI, the observed treatment trend of utilizing periurethral bulking more commonly than slings and Burch procedures may indicate the likelihood of stress UI being less related to urethral hypermobility in women older than 65 years. In a randomized trial of midurethral slings with and without behavioral therapy to treat women with mixed UI symptoms, aging beyond 65 years was not noted to be a predictor of treatment failure (21). It is plausible that the stress UI treatments chosen for women in this cohort may be a consequence of aiming to treat intrinsic sphincter deficiency featuring poor urethral coaptation rather than urethral hypermobility that is less common in older women with stress UI symptoms (22). It is also plausible that periurethral bulking is appropriately preferred as there were no statistically significant differences in complication rates observed between periurethral bulking and midurethral slings (Relative Risk 1.30, 95% CI: 0.30–5.66, p = .73) in another trial (23). A summation from the data may indicate that it may be prudent to determine frailty status prior to procedure-based treatment of UI symptoms in older women to assess potential risk of urologic complications. The use of an electronic-medical record (EMR) -based frailty assessment may be valuable to the clinician who may be otherwise ill-equipped to identify frailty in their patients.
Strengths and Limitations
This study is strengthened by its design that established the frailty status prior to the index procedure and observed for urologic complications linked specifically to that index procedure. The use of Medicare claims data is a pragmatic mechanism to study procedure-based outcomes of frail women with incontinence as it allows access to a cohort otherwise very difficult and expensive to study prospectively. However, claims-based data analysis does have clinically important limitations; the greatest is the inability to obtain detailed clinical information. Due to this limitation, direct causation for postprocedure complications is not feasible. Further, linking the procedure to the specific UI type and the severity of UI symptoms is also not possible with claims-based data. While having access to the records of a diverse provider/surgeon pool, details of case selection, provider experience or complication rates are not readily available. The primary aim of this paper was to investigate the association of preprocedure frailty on treatment trends and complications after procedure-based treatments for UI symptoms in Medicare-eligible women. Consequently, urologic complications examined in isolation of others such as postprocedure cardiovascular events may not reflect the total risk of postoperative complications; the Clavin–Dindo classifications of complications cannot be determined. We sought to highlight frailty as a predictor for postprocedure complications as a composite outcome; thus, the rate and impact of individual complications are unknown in this cohort.
Conclusion
In summary, clinically important associations with procedure choice for UI treatments were observed with preprocedure frailty status. Postprocedure morbidity as indicated by urologic complications was significantly associated with preprocedure frailty status. While aging is associated with increased risk of frailty, chronological age unlike frailty may not be a significant independent predictor for postprocedure morbidity after treatment of UI in older women. There is a paucity of data that evaluates efficacy and safety of common procedure-based treatments for UI among women older than 65 years. Without these data, clinicians lack evidence-based guidelines to inform treatment decisions for this growing cohort of women with severe and negatively impactful UI symptoms and higher frailty risk. Our data emphasize that specific attention to frailty in the clinical care of incontinent women is important. Consideration of frailty preprocedure may help identify women at increased risk for urologic complications and prioritized application of minimally invasive approaches may be an alternative among frail women with UI.
Supplementary Material
Contributor Information
Candace Y Parker-Autry, Section on Female Pelvic Health, Department of Urology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USA.
Scott Bauer, Department of Medicine and Urology, University of California, San Francisco and Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, California, USA.
Cassie Ford, Biostatistician III, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
W Thomas Gregory, Division of Urogynecology, Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon, USA.
Gopal Badlani, Section on Female Pelvic Health, Department of Urology, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USA.
Charles D Scales, Department of Surgery (Urology), Duke University School of Medicine, Durham, North Carolina, USA.
Lewis A Lipsitz, (Medical Sciences Section).
Funding
This research was supported by grants to C.Y.P.-A. from the National Institute on Aging (R03 AG056460), to S.R.B. (grant numbers 1R03AG067937 and 1K76AG074903), as well as from the R25-HD094667 (PI Amundsen).
Conflict of Interest
None.
Paper Presentation
48th Annual Scientific Meeting of the Society of Gynecologic Surgeons, San Antonio, TX, March 27–30, 2022.
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