Objective
The purpose of this study was to assess which preoperative and postoperative variables correlated with satisfaction after surgical treatment of urinary incontinence.
Study Design
We conducted a retrospective cohort study of 371 women who underwent rectus fascial or midurethral sling procedure. Satisfaction was defined as a questionnaire response of “completely satisfied.” Incontinence symptoms were based on responses to validated questionnaires. Associations between preoperative and postoperative variables and satisfaction were assessed with the use of logistic regression models.
Results
Increasing patient age (odds ratio [OR], 0.8; P = .002), body mass index (OR, 0.8; P = .003), and an autologous rectus fascial sling (compared with a midurethral sling; OR, 0.5; P = .003) were associated with decreased odds of satisfaction in a multivariate model. Furthermore, patients who required urethrolysis or had severe lower-urinary tract symptoms were significantly less likely to report satisfaction.
Conclusion
Increasing age, body mass index, and type of operation were associated with decreased odds of satisfaction.
Success after urinary incontinence surgery has been assessed traditionally with objective measures of incontinence, such as negative cough stress test, urodynamics, or pad test. Unfortunately, these measurements can vary widely, depending on the definition chosen, and they are not correlated with patient satisfaction. Furthermore, objective continence may be a misleading measure of success when achieved at the expense of de novo, bothersome lower-urinary tract symptoms (eg, urge incontinence, incomplete bladder emptying, the need for sling loosening, lysis).
Information is limited on predictors of patient satisfaction after incontinence surgery. However, there is a growing body of evidence that preoperative and postoperative urge incontinence negatively affects success and satisfaction postprocedure. Mahajan et al prospectively observed 78 patients after prolapse repair and found that urge incontinence was the most commonly reported reason for patient dissatisfaction at follow-up evaluation. Similarly, Barber et al showed that, among women who participated in a randomized trial that compared tension-free vaginal tape and transobturator tape, the women who had concomitant prolapse repairs required preoperative antimuscarinic medications, were older, and had increased risk of treatment failure at 1-year follow-up evaluation.
We hypothesized that additional demographic and postprocedure factors may be associated with satisfaction. However, we believed that, to assess potential associations adequately, a sample large enough to provide sufficient statistical power was required and was not available in previous prospective series on satisfaction. As a planned secondary analysis of a large cohort study of women (n = 428) who had an autologous rectus fascial sling (ARFS) or a polypropylene midurethral sling (MUS), we sought to estimate the association of demographic, preoperative, and postprocedure variables that are thought to affect stress urinary incontinence (SUI) outcome with patient satisfaction.
Materials and Methods
This study was approved by the Mayo Clinic Institutional Review Board. A surgical database was used to identify all women who underwent placement of an ARFS or an MUS with or without concomitant pelvic floor surgery from January 1, 2000, through October 31, 2005. Data about a subset of this cohort (women who had isolated incontinence surgery) have been published previously. We now include women with concomitant surgery to investigate the association between preoperative and postoperative factors and patient satisfaction.
Electronic medical records were used to obtain patient characteristics, operative reports, and postoperative encounters, as previously described. The medical records contained all clinical and surgical encounters and included phone conversations at all Mayo Clinic sites in Rochester, MN. Validated questionnaires were mailed to all identified patients who were asked to participate in the study. Eligible patients were at least 21 years old, had documented urinary incontinence (shown by urodynamic testing or preoperative examination), had undergone surgery for SUI or stress-predominant mixed urinary incontinence (MUI), and had not denied access to their medical records for research purposes. Patients with preexisting neurologic disease (eg, multiple sclerosis, spinal cord injury, Parkinson disease), urethral diverticulectomy, urethral reconstruction, or severe pelvic trauma or fracture were excluded. Patients who did not have preoperative urodynamic evaluation were excluded, unless leakage during a Valsalva or coughing maneuver was documented in the patient’s physical examination.
Surgical procedures and catheter use
In patients with symptomatic pelvic organ prolapse, concomitant repairs included vaginal hysterectomy with or without bilateral oophorectomy, Mayo McCall culdoplasty, traditional suture anterior colporrhaphy, and posterior colpoperineorrhaphy in combination or in isolation, depending on the affected vaginal compartments. In addition, isolated total abdominal and vaginal hysterectomies were performed for nonprolapse indications. All patients underwent a Uretex polypropylene retropubic MUS (Bard Urologic, Covington, GA) or an ARFS procedure as previously described. Use of suprapubic catheters was universal. The catheter aftercare has been described previously.
Data extraction
To standardize comparisons between the groups, we assigned MUI and SUI diagnoses during review of the final clinical note before the index surgery. We used International Continence Society Standardization of Terminology definitions for SUI (complaint of involuntary leakage on effort or exertion or on sneezing or coughing) and MUI (complaint of involuntary leakage associated with urgency and also with exertion, effort, sneezing, or coughing). Patients who reported urgency with or without urge incontinence were classified as having MUI. Urodynamics studies were reviewed to confirm the diagnosis of SUI, but detrusor instability during cystometry was not required for a diagnosis of MUI. Degree of preoperative pelvic organ prolapse was extracted from the electronic medical record and measured with the Baden Walker Halfway Scoring System. A pelvic organ prolapse that was scored grade ≥3 was considered severe. The operative report for each surgery was reviewed to confirm the procedures that were performed.
Outcome assessment
Outcome data were obtained from responses to the validated tools (Incontinence Severity Scale [ISS], Patient Global Impression of Improvement [PGII] Scale, and Urinary Distress Inventory Short Form [UDI-6] ) and from review of the electronic medical records.
Patient satisfaction was defined as a response of completely satisfied on a 5-point Likert scale that ranged from “completely satisfied” to “completely dissatisfied.” Each participant was then asked to elaborate the reasons for satisfaction or dissatisfaction ( Appendix ). Patients were not restricted to answering one or the other question on the basis of the previous response to the question about satisfaction. For example, a patient who answered “somewhat satisfied” on the 5-point Likert scale question had the option to comment on reasons for both satisfaction and dissatisfaction in the following section (Appendix). A composite incontinence outcome was also ascertained: interim treatment for incontinence or reported leakage of urine (ISS score, >0).
Strong improvement of urinary symptoms after surgery was measured with a response of “a great deal better” or “much better” on the PGII Scale (a 7-point Likert scale with responses from “a great deal better” to “a great deal worse”). Patients were considered to have clinically significant frequency, urge incontinence, SUI, or voiding dysfunction at follow-up evaluation if they indicated a score of 2 (moderately) or 3 (greatly) to questions 1 (frequent urination), 2 (urine leakage related to a feeling of urgency), 3 (urine leakage related to activity, coughing, or sneezing), or 5 (difficulty emptying your bladder) on the UDI-6. Finally, patients were considered to have severe incontinence if their ISS score was ≥6.
Statistical analysis
All analyses were performed with SAS software (version 8.2; SAS Institute Inc, Cary, NC). Using logistic regression analysis, we considered the association among demographic, preoperative, and postoperative factors that are believed to influence outcome after incontinence surgery. The following factors were considered: age, body mass index (BMI), preoperative diagnosis (MUI vs SUI), previous incontinence procedures, previous pelvic procedures, presence of intrinsic sphincter deficiency (abdominal leak point pressure, ≤60 cm H 2 O), presence of detrusor contraction on preoperative urodynamic, presence and severity of pelvic organ prolapse, concomitant pelvic surgery, need for reoperation (for either recurrent incontinence or urethrolysis), incontinence, and severity and type of urinary leakage at follow-up evaluation. For each factor, a separate logistic regression model was fit to assess the factor’s association with patient satisfaction, after adjustment for type of surgery (MUS vs ARFS).
Multivariate models were fit with the use of stepwise and backward selection methods to identify preoperative factors that were associated with patient satisfaction after forcing in the type of surgery (MUS vs ARFS). The strength of the associations was summarized through calculating odds ratios (ORs) and 95% confidence intervals (CIs). All calculated probability values were 2-sided, and probability values < .05 were considered statistically significant.
Results
Of the 428 women who were identified, 371 women (86.7%) returned questionnaires and were the subjects of the present study. Of the cohort, 75.7% of the women (n = 281) had an MUS, and 24.3% of the women (n = 90) had an ARFS. Among women who had an MUS, 43.4% (n = 122) had concomitant surgery, and 56.6% (n = 159) had an isolated MUS. Among women who had an ARFS, 87.8% (n = 79) had isolated incontinence surgery, and 12.2% (n = 11) had concomitant pelvic floor surgery.
The demographic characteristics of the cohort are shown in Table 1 . The mean age and BMI were 60.0 years and 29.2 kg/m 2 . Most women were menopausal (73.6%), had had previous pelvic surgery (57.4%), had a preoperative diagnosis of MUI (56.3%), and resided locally (80.6%). Few participants had had incontinence surgery (12.1%), a history of smoking (36.1%), or a diagnosis of intrinsic sphincter deficiency (31.0%).
| Characteristic | Value |
|---|---|
| Age, y a | 60.0 ± 12.6 |
| Body mass index, kg/m 2a | 29.2 ± 5.9 |
| Previous incontinence surgery, n (%) | 45 (12.1) |
| Previous pelvic surgery, n (%) | 213 (57.4) |
| Preoperative diagnosis of mixed urinary incontinence, n (%) | 209 (56.3) |
| Intrinsic sphincter deficiency, n (%) b | 115 (31.0) |
| Menopausal, n (%) | 273 (73.6) |
| Smoker, former or current, n (%) | 134 (36.1) |
| Concomitant surgery, n (%) | 133 (35.8) |
| Local residence, n (%) c | 299 (80.6) |
a Data are given as mean ± SD;
b Leak point pressure ≤60 cm H 2 O;
During a median follow-up period of 2.9 years, 61.0% of the women (225/369; 2 patients did not respond to this question) reported satisfaction (a response of “completely satisfied” in the mailed questionnaire). Complete satisfaction was reported by 65.0% of the 280 women who had an MUS and by 48.3% of the 89 women who had an ARFS. Of the 225 patients reporting satisfaction, 98.7% of the women (n = 222) had perceived improvement in urinary symptoms (a response of “a great deal better” or “much better” on the PGII Scale), compared with 57.6% of patients (83/144) who did not report complete satisfaction ( P < .001). Women who had an MUS were 2 times more likely to report satisfaction than women who had an ARFS (OR, 2.0; 95% CI, 1.2–3.2; P = .01). Consequently, all subsequent analyses were adjusted for type of surgery.
Univariate analysis showed that increasing age (adjusted OR, 0.8; P = .02) and increasing BMI (adjusted OR, 0.8; P = .01) were associated with decreased odds of satisfaction. A history of incontinence or pelvic surgery and concomitant or severe prolapse (defined as apical or anterior compartment prolapse of grade ≥3) was not associated with satisfaction ( Table 2 ). An association existed between a preoperative diagnosis of MUI (adjusted OR, 0.6; P = .048) and patient satisfaction, whereas the association between detrusor instability on preoperative urodynamics (adjusted OR, 0.6; P = .07) and patient satisfaction did not attain statistical significance ( Table 2 ). Backward and stepwise multivariate logistic regression (evaluation of all preoperative variables listed in Table 2 ) identified independent associations between increasing age (OR, 0.8; 95% CI, 0.6–0.9; P = .002), increasing BMI (OR, 0.8; 95% CI, 0.6–0.9; P = .003), and having an ARFS vs an MUS (OR, 0.5; 95% CI, 0.3–0.8; P = .003) with decreased odds of satisfaction.
