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Two-Year Outcomes After Surgery for Stress Urinary Incontinence in Older Compared With Younger Women

Richter, Holly E. PhD, MD1; Goode, Patricia S. MD1,2; Brubaker, Linda MD3; Zyczynski, Halina MD4; Stoddard, Anne M. ScD5; Dandreo, Kimberly J. MSc5; Norton, Peggy A. MD6

doi: 10.1097/AOG.0b013e31818187c2
Original Research
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OBJECTIVE: To estimate whether perioperative and postoperative outcomes after Burch colposuspension or pubovaginal sling for stress urinary incontinence (SUI) differed with age.

METHODS: This study was a prospective secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial. Baseline characteristics, adverse events, and 2-year outcomes of women at least 65 years old were compared with those younger than 65 years using χ2 and t tests. Multivariable analyses were performed, including age and outcomes that differed between age groups on univariable analysis, adjusting for variables that differed by age group at baseline and by surgical treatment group.

RESULTS: Six-hundred fifty-five women were included in analyses of perioperative events and 520 for 2-year outcomes. Mean age (±standard deviation) was 69.7 (±3.7) years in the older group and 49.4 (±8.2) in the younger group. Older women had slightly longer time to normal activities (50 days compared with 42 days, P=.05), but there was no difference in time to normal voiding (14 days compared with 11 days, P=.42). Older women were more likely to have a positive stress test at follow-up (odds ratio [OR] 3.7, 95% confidence interval [CI] 1.70–7.97, P=.001), less subjective improvement in stress (8 point lesser decrease, 95% CI 1.5–14.1, P=.02), and urge incontinence (7 point lesser decrease, 95% CI 1.5–12.2, P=.01) by the Medical and Epidemiologic Social Aspects of Aging questionnaire, and were more likely to undergo surgical retreatment for SUI (OR 3.9, 95% CI 1.30–11.48). Perioperative adverse events and length of stay did not differ between groups.

CONCLUSION: Older women undergoing surgery for stress incontinence can expect to do as well as younger women with respect to perioperative outcomes, but experience 2-year outcomes that are worse.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662

LEVEL OF EVIDENCE: II

Women aged 65 years and older have similar perioperative adverse events and length of stay, but lower subjective and objective cure rates after stress incontinence surgery than younger women.

From the 1University of Alabama at Birmingham, Birmingham, Alabama; 2Birmingham/Atlanta Geriatric Research, Education and Clinical Center, Department of Veteran’s Affairs Medical Center, Birmingham, Alabama; 3Loyola University, Maywood, Illinois; 4Magee-Womens Hospital, Pittsburgh, Pennsylvania; 5New England Research Institute, Watertown, Massachusetts; and 6University of Utah, Salt Lake City, Utah.

Supported by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases, U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, U01 DK60401, and DK068389. Support was also provided by the National Institute of Child Health and Human Development and Office of Research in Women’s Health, National Institutes of Health.

The authors thank Aarthi Balasubramanyam, MS, statistician at the New England Research Institute for her assistance.

Presented at the Society of Gynecological Surgeons, Annual Clinical Meeting, Savannah, Georgia, April 14–16, 2008.

Corresponding author: Holly E. Richter, 618 20th Street South, NHB 219, Birmingham, AL 35322; e-mail: hrichter@uab.edu.

Financial Disclosure Dr. Brubaker has received research funding from Pfizer (New York, NY) and Allergan (Irvine, CA). Dr. Zyczynski has performed research under contract with Johnson & Johnson (New Brunswick, NJ). Dr. Stoddard holds stock in Bristol-Meyers Squibb (New York, NY), Johnson & Johnson, Elan (Dublin, Ireland), Proctor & Gamble (Cincinnati, OH). The other authors have no potential conflicts of interest to disclose.

Pelvic floor disorders, including urinary incontinence, fecal incontinence, and pelvic organ prolapse, increase in prevalence as women age.1 More than 200,000 surgeries are performed each year for the treatment of pelvic floor disorders, with many of these procedures being performed on the older woman.2 With the aging U.S. population, the estimated demand for care of pelvic floor disorders is projected to increase by 45% over the next 30 years.1

Despite a pressing need for data on surgical outcomes in older women, there is a relative paucity of such information in the literature. This may be because older patients are often specifically excluded from clinical trials in this area. For example, Bugeja et al3 reported that one third of original research articles in major medical journals excluded elderly patients without justification.

The data that do exist on surgical outcomes in older patients are somewhat mixed. Previous studies examining risk factors for failure or the effect of age on outcomes for both the Burch colposuspension and fascial sling suggest that cure rates are lower and that there is an increased risk for postoperative storage symptoms, voiding dysfunction, and urinary tract infections in older women.4–10 In a review of medical records on 226 women undergoing surgery for incontinence at a large referral center, women aged older than 70 years had a higher risk of complications when compared with younger women.11 Conversely, a chart review of 267 patients aged older than 75 years who underwent urogynecologic surgery found that the overall perioperative morbidity rate in older women was low.12

The objective of this study was to estimate, in a well-characterized, randomized cohort of women, whether older women differed from younger women with respect to perioperative and postoperative outcomes up to 24 months after undergoing Burch colposuspension or pubovaginal sling for treatment of stress urinary incontinence (SUI).

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MATERIALS AND METHODS

This was a planned analysis of data from the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr).13 Subjects were enrolled from February 2002 to June 2004. Eligibility requirements included documented pure or predominant SUI symptoms for at least 3 months, a positive standardized urinary stress test, and planned SUI surgery. There was no upper age limit in recruitment of adult women for the study. Details of the SISTEr study methods have been published previously14 and are briefly outlined here. All study procedures were approved by the institutional review board of each participating clinical center and the Biostatistical Coordinating Center, with written informed consent obtained from all women before enrollment.

Women were randomly assigned in the operating room after anesthesia induction with the use of a permuted-block randomization schedule with stratification according to clinical site to receive a Burch colposuspension or an autologous rectus fascial sling. Because these procedures are frequently performed in conjunction with pelvic prolapse surgery, abdominal and vaginal approaches for both pelvic prolapse repair and hysterectomy were permitted. Baseline assessment included a complete medical history, physical examination, urodynamic evaluation, and patient symptom survey. Follow-up data were collected by interview and clinical examination preoperatively, and at 6 weeks and 3, 6, 12, 18, and 24 months postoperatively. Factors assessed at baseline included age, race, body mass index (BMI), previous incontinence surgery, number of vaginal deliveries, total number of medications used regularly, menopausal/hormone therapy (HT)/smoking status, pelvic organ prolapse by stage, cotton swab angle, diabetes, and history of frequent urinary tract infections.

Incontinence severity was measured at each visit and included urge and stress symptom scores using the validated Medical Epidemiological and Social Aspects of Aging (MESA) questionnaire,15 number of incontinence episodes on 3-day voiding diary, 24-hour pad test, stress test, and condition-specific quality-of-life scores, including the Urogenital Distress Inventory and Incontinence Impact Questionnaire.16 Urodynamic data were collected at baseline and 24 months after surgery or at the time of surgical retreatment if that occurred before 24 months. Factors measured included: demonstrated stress incontinence, Valsalva leak point pressures, presence of detrusor overactivity, and voiding dysfunction. Sexual function was characterized using the Pelvic Organ Prolapse and Incontinence Sexual Function Questionnaire.17

Perioperative factors measured were length of hospital stay and adverse events, including urinary retention, urinary tract and wound infections, as well as medical complications. Postoperative measures included treated and untreated de novo or persistent urge incontinence as measured by MESA, voiding dysfunction, pelvic organ prolapse, or further pelvic surgery for any reason after Burch or sling.

Overall treatment failure was defined as retreatment for SUI (including behavioral or surgical therapies) at any time, and/or self-report of SUI by the MESA questionnaire (response of “sometimes” or “often”), and/or positive stress test (leakage on examination during cough or Valsalva at a standardized bladder volume of 300 mL or capacity), and/or greater than 15-g pad weight on 24-hour pad test and/or incontinence episodes by 3-day bladder diary any time 6 months after surgery. The primary outcome was determined at 24 months. A total of 655 women were included in the perioperative event analysis, and 520 women were included in the analyses of 2-year follow-up outcomes. The 520 women included 491 who completed 24 months of the study and data from 29 women who underwent surgical retreatment before 24 months. Although we planned to include only women with 24-month follow-up, there were a disproportionate number of older women who had surgical retreatment before 24 months. Exclusion of these women with less successful outcomes would have biased the comparison of 2-year outcomes between age groups in favor of the older women. For women who had received surgical retreatment before the 24-month visit, their last measures before treatment were used.

For factors associated with age we compared women aged younger than 65 years to those 65 years and older. Perioperative and postoperative events and outcomes were evaluated comparing the two age groups. Univariable analyses were carried out using cross-classification and the χ2 test for categorical factors and the t test for comparison of means of continuously measured factors.

To further evaluate postoperative outcomes associated with age group, we used multivariable methods to control for treatment group and other covariables. For stress test, a categorical outcome measure, we used multiple logistic regression analysis. For continuous outcome measures we used least-squares multiple linear regression analysis. For all analyses, we first computed the analysis including age group, treatment group, and their interaction. If the interaction effect was not statistically significant, we removed it from the analysis. We then added covariates that were found to be significant in bivariate analyses and other variables thought possibly to be clinically significant. A 5% significance level was used. Analyses were performed using SAS 9.1 (SAS Institute, Inc. Cary, NC).

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RESULTS

A total of 655 women with an age range of 27–81 years were enrolled and randomly assigned in the SISTEr Trial. Eighty-one women (12%) were aged 65 years or older. Baseline demographic and clinical characteristics and operative data presented by age group are shown in Table 1. The mean (±standard deviation) age of the younger cohort was 49.4±8.2 years, and that of the older cohort was 69.7±3.7 years. The two age groups differed significantly with regard to education, income, number of vaginal deliveries, and smoking status. As expected, the older age group used significantly more medications and a greater percentage were on hormone therapy. A greater percentage of older women had stage 3 or 4 pelvic organ prolapse and had a lower mean straining angle on cotton swab test. The baseline Valsalva leak point pressures were also significantly lower for the women in the older age group. The older age group reported less distress due to urinary symptoms as measured by the Urogenital Distress Inventory and lower incontinence effect as measured by the Incontinence Impact Questionnaire. A lower percentage of the older group was sexually active, but sexually active women in the older group had slightly higher (better) Pelvic Organ Prolapse and Incontinence Sexual Function Questionnaire scores. Women in the older and younger age groups had similar rates of concomitant surgical procedures.

Table 1

Table 1

Table 1

Table 1

After surgery, the two age groups did not differ with respect to length of stay, readmissions within 6 weeks, time to return to normal voiding, or presence of voiding dysfunction (Table 2). Older women had a slightly longer time to return to normal activities, 50 days compared with 42 days (P=.05). Adverse event rates are also shown in Table 2. There were no differences in adverse events rates between age groups.

Table 2

Table 2

Univariable analyses of outcomes are presented in Table 3. Older women were more likely to undergo surgical retreatment for stress incontinence (14%) than younger women (4%). A significantly smaller percentage of older women had a negative stress test at 24-month follow-up (71% compared with 84%). The mean improvement in MESA stress score and Urogenital Distress Inventory score was significantly smaller for women in the older group. Outcome measures that did not differ between age groups included improvement in pad weight, incontinence episodes per day on diary, and MESA urge score. There were no significant differences in urodynamic changes at 24 months compared with baseline including noninvasive uroflowmetry, postvoid residual volume determination, cystometry, and pressure flow studies.

Table 3

Table 3

We computed multivariable analyses for selected outcomes, controlling for treatment group, income, number of prescription medications, number of vaginal deliveries, menopausal/HT status, pelvic organ prolapse stage, and baseline levels of Urogenital Distress Inventory, Incontinence Impact Questionnaire, stress index, and urge index (Table 4). The interaction between age group and treatment group was not statistically significant in any model. When treatment group and other covariables were controlled, the association between older age and a negative stress test and improvement in the MESA stress score remained. Older women were more likely to have a positive stress test at follow-up (odds ratio [OR] 3.7, 95% confidence interval [CI] 1.70–7.97, P=.001), less improvement in stress incontinence (8 point lesser decrease on the MESA, 95% CI 1.5–14.1, P=.02), less improvement in urge incontinence symptoms (7 point lesser decrease on the MESA, 95% CI 1.5–12.2, P=.01) and were more likely to undergo surgical retreatment for SUI (OR 3.9, 95% CI 1.30–11.48). Conversely, the difference between age groups in improvement in Urogenital Distress Inventory was decreased and no longer statistically significant when covariates were controlled (10 point greater decrease, 95% CI –4.6 to 24.0, P=.18). There were no differences in multivariable analyses for all other 24-month outcomes between the two age groups, including satisfaction with treatment.

Table 4

Table 4

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DISCUSSION

Older women did not differ from younger women in most perioperative outcomes after undergoing stress incontinence surgery with or without concomitant prolapse surgery. These outcomes included length of stay, readmissions within 6 weeks, total number of patients with serious adverse events, and number of adverse events, despite the probability of more medical comorbidities in the older women as measured indirectly by their increased number of prescription medications. However, at 24 months postoperatively, older women were more likely to have a positive stress test, less improvement in subjective assessment of stress and urge incontinence symptoms, and a higher rate of surgical retreatment as compared with younger women, whether they had a Burch colposuspension or pubovaginal sling.

We had previously reported that age was not a risk factor for stress-specific or nonstress failure in the SISTEr trial.18 This was based on composite outcomes where stress failure was defined as any self-report of urinary incontinence as measured by the MESA questionnaire and/or a positive stress test and/or retreatment for SUI, and nonstress failure was defined as a positive 24-hour pad test and/or any incontinence episodes on a 3-day voiding diary with none of the three criteria for stress failure. In this current planned secondary analysis, we sought to characterize more fully the individual components of these composite outcome measures as they differ by age group. Other studies of older women have shown that effective detrusor contractility, bladder capacity, ability to withhold voiding, and urethral closure pressure decline with increasing age,5,19 and detrusor hyperactivity with impaired contractile function and irritative bladder symptoms tend to increase,20 thus predisposing older women to the potential risk of adverse surgical outcomes. In our study, the older women overall had lower baseline Valsalva leak point pressures than the younger women, which may have influenced their outcomes, although whether they had a Burch colposuspension or pubovaginal sling did not influence these findings.

Very few studies exist comparing perioperative morbidity between older and younger women in the setting of pelvic floor surgery. In one recent study comparing perioperative morbidity and 12-month outcomes of older (70 years of age or older) and younger (younger than 70 years) women undergoing sacrocolpopexy for pelvic organ prolapse, where roughly one half the subjects received a Burch colposuspension, there were also no significant differences by age group in any perioperative complication rates.21 However, in that study, length of stay was significantly increased in the older women (3.1±1.0 days compared with 2.7±1.5 days, P=.02), whereas in our study there was no significant difference in length of stay. This may reflect more vaginal-only surgery in our study, whereas all subjects in the other report had an abdominal incision.

A recent review of SUI surgery outcomes4 found less improvement in urinary tract symptoms for older women in three studies with the tension-free vaginal tape procedure22–24 as well as decreased satisfaction.24 Our study showed equal satisfaction between the age groups despite lower objective and subjective cure rates in the older women. A prospective cohort study of 196 women after colposuspension also showed outcomes that varied by age group. Continence based on clinical symptomatology, demonstration of stress incontinence, and limited postoperative urodynamics was achieved in 93.1% (162 of 179) of younger women (younger than 70 years) compared with 77.3 % (17 of 179) of older women (older than 70 years), P=.02.8 Postoperative voiding dysfunction after colposuspension as determined by need for prolonged catheterization has also been reported to be increased as women age, affecting 12% of those younger than 50 years of age, 25% of those 50–64 years, and 50% of those 65 years and older.9 This was partially attributed to impaired detrusor function in the older women. Our results differed in not showing a difference by age.

Traditionally, the pubovaginal sling has been associated with high continence rates, but sometimes this success is offset by increased voiding dysfunction, storage symptoms, and need for surgical revision.25–27 Because the older woman has an increased risk of voiding dysfunction, there has been historic reluctance to perform them in this age group.28 In our study, there was no difference in voiding dysfunction between younger and older patients, whether they had a Burch colposuspension or pubovaginal sling. A recent report used Medicare claims data to measure the effect of patient age on outcomes of sling surgery for stress urinary incontinence.6 Women were stratified for analysis at age 75, and multivariable analyses were conducted to identify the independent effects of patient age and comorbidities on outcomes. One year after surgery, overall outcomes in younger women (aged 65–74 years) were significantly better than in older women with respect to postoperative urge incontinence (20.0% compared with 12.6%), treatment failure (10.5% compared with 7.2%), and outlet obstruction (10.5% compared with 6.6%).

Limitations of our study include not having geriatric-specific measures of functional status such as activities of daily living, instrumental activities of daily living, and life space assessment to characterize the potential change in functional status with surgery. Strengths include multiple sites, standardization of surgical techniques, a robust sample size, 24 months of follow-up, subjective characterization of the cohorts using validated questionnaires, as well as objective outcomes. Many other studies have been limited by small numbers of older women and short-term follow-up.11

In conclusion, our findings suggest that women aged older than 65 years contemplating surgery for stress urinary incontinence, with or without concomitant prolapse surgery, can expect to do as well as younger women with respect to their surgical experience, voiding function, and patient satisfaction, but may face somewhat lower subjective and objective cure rates. Whether these findings will be similar in the newer midurethral sling procedures is an area of active interest and research. As the number of older women seeking care for this debilitating condition continues to increase, it is imperative that we are able to counsel them adequately with respect to their risks and benefits of surgery, especially with respect to issues of continued symptoms and need for subsequent treatment.

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