Objective
The objective of the study was to evaluate the use of urodynamics to determine the need for incontinence surgery at the time of abdominal sacrocolpopexy (ASC).
Study Design
The records of 441 women undergoing ASC during 2005-2007 were reviewed. Group 1 consisted of 204 women (46.3%) with urodynamic stress incontinence (USI), including occult USI, who underwent incontinence surgery with ASC. Group 2 consisted of 237 women (53.7%) without USI who underwent ASC alone. Primary outcome measures were any complaint of postoperative incontinence (stress or urge) or new-onset urgency/frequency (UF).
Results
At a mean follow-up of 46.6 weeks, the overall rate of incontinence was low and similar for both groups (13.4% in group 1 and 13.3% in group 2 [ P = .967]), as was new-onset UF: 18.6% in group 1 and 11.5% in group 2 ( P = .195).
Conclusion
Urodynamic evaluation appears to be useful in determining the need for incontinence surgery at the time of ASC.
Gynecologic surgeons have long realized that the surgical correction of advanced prolapse will render some continent women incontinent. Gynecologic surgeons also realize that surgical treatment of stress incontinence can cause obstruction or new-onset symptoms of urgency, frequency, urge incontinence, and recurrent urinary tract infection. The goal, of course, is to prevent or treat stress incontinence and not cause obstruction or new-onset symptoms. The ideal method to achieve this goal and manage incontinence in women undergoing surgery for pelvic organ prolapse (POP) remains a subject of debate. Options in this situation range from not treating stress incontinence at the time of prolapse surgery to performing an incontinence procedure during each and every prolapse repair.
See Journal Club, page 403
Almost a decade ago, in an editorial titled, “What is the optimal anti-incontinence procedure in women with advanced prolapse and potential stress incontinence,” Karram commented, “… we have been overaggressive in the surgical correction of these patients specifically regarding the fear of development of stress incontinence.” Most urogynecologists have relied on urodynamic evaluation (UDS) to assess each woman’s lower urinary tract function prior to surgery to determine an individual’s need for an incontinence procedure. The result is a more selective use of incontinence surgery at the time of prolapse surgery.
More recently, Brubaker et al published the results of the Colpopexy and Urinary Reduction Efforts (CARE) trial in which continent women with prolapse undergoing abdominal sacrocolpopexy (ASC) were randomized to undergo Burch or no incontinence procedure. Study enrollment was ended early when significantly more women in the no-Burch group were found to have stress incontinence at 12 weeks postoperatively than those in the Burch group. (44.1% vs 23.8%). Based on their results, they concluded all women should undergo Burch urethropexy at the time of ASC.
This approach represents a significant deviation from the common practice of using UDS to determine the need for incontinence surgery. In an era when patient safety is the most important concern in gynecologic surgery, surgeons and their patients must weigh the risks and benefits of performing prophylactic procedures during reconstructive surgery. The significantly higher rates of incontinence seen in the CARE trial compared with previously published reports also raised questions over whether this approach should be utilized.
The CARE trial was a carefully planned, prospective trial by respected investigators, and it received a great deal of attention in the gynecologic community. Although the authors carefully concluded that their recommendations applied only to the combination of ASC and Burch, in women with advanced POP, without stress incontinence at baseline, many in the gynecologic community quickly adopted the mantra that all women undergoing any type of surgical correction of prolapse must undergo a concomitant incontinence procedure.
Our interpretation of the CARE trial was that it seemed to expose the majority of women to an unnecessary incontinence surgery without any resultant benefit in reducing postoperative stress incontinence compared with published rates. Our current practice is to use urodynamics to determine the need for incontinence surgery, based on our hypothesis that selective use of incontinent procedures in women with demonstrable stress incontinence will result in optimal outcomes in regard to bladder function after prolapse repair. The current study is an analysis of the results of this approach in a similar number of patients studied in the CARE trial.
Materials and Methods
This was a retrospective case series analyzing the subjective bladder function of women who had undergone an ASC during the years 2005-2007. This collaborative endeavor included 11 surgeons from 7 sites. Surgeons were chosen based on their practice pattern of using UDS to diagnose stress incontinence and only performing incontinence surgery at the time of abdominal prolapse repair in women with documented urodynamic stress incontinence (USI). Although a power analysis was not performed, the initial goal was to match the number of patients treated in the CARE trial.
Data collected included baseline information, such as age, and urinary symptoms; preoperative evaluation including the stage of prolapse and urodynamics results; and surgical details, specifically if incontinence surgery was performed and, if so, which procedure.
All patients underwent urodynamic testing preoperatively. Diagnoses of USI, occult USI, detrusor overactivity (DO), mixed incontinence, or no incontinence during testing were noted. Prolapse reduction was performed for patients with advanced prolapse.
The reduction method was determined by the individual centers and included use of large swabs placed at the apices, posterior blade of a bivalve speculum, Sims speculum, or vaginal pessary. This population assumedly included patients with the diagnosis of intrinsic sphincteric deficiency; however, specific urodynamic parameters, such as maximal urethral closure pressure or Valsalva leak point pressure, were not collected in this database. Urgency/frequency was defined as a patient’s perception that she suffered from frequent urination or uncomfortable urgency to void.
Patients diagnosed with urodynamic stress incontinence, either with or without prolapse reduction, underwent incontinence surgery at the time of ASC. The decision to perform a Burch, a retropubic synthetic midurethral sling, or a transobturator synthetic midurethral sling was determined by the individual surgeon. Group 1 consisted of patients with USI who underwent an incontinence procedure at time of ASC. Group 2 consisted of patients with no evidence of USI during testing who did not undergo an incontinence procedure at time of ASC. A subanalysis of the outcomes of Burch with ASC vs synthetic midurethral sling with ASC is the subject of another paper and will not be reported here. The sacrocolpopexies were all performed with a Y-shaped piece of polypropylene mesh including an anterior arm placed along the anterior vaginal wall between bladder and vagina and a posterior mesh arm placed along the posterior vaginal wall.
Because it is our philosophical belief to consider USI and occult USI to be 1 entity, patients demonstrating stress incontinence during urodynamic testing were considered to have urodynamic stress incontinence whether this incontinence occurred only with prolapse reduction, or not and these patients were not analyzed separately. Data regarding time to void after ASC alone or ASC with incontinence procedure were not collected.
The surgeons participating in this study routinely evaluate postoperative patients at 6 weeks and at varying intervals thereafter, so charts were examined to determine patient status at the 6 week postoperative visit and at the last visit recorded for each patient. Although all patients in these practices were asked at each postoperative visit about bladder symptoms, including stress, urge, and frequency, not all practices used the same standardized questionnaires, and the retrospective nature of the study did not allow us to ensure that these questions were asked in the same way for each patient.
It was not always clear when a chart stated “+ incontinence” whether this represented stress or urge or even the frequency or severity of the problem. Therefore, to capture the worst-case scenario, we noted a patient as having incontinence if there was any comment of incontinence on the chart as recorded by any health care practitioner. Similarly, a patient was considered to have urgency/frequency (UF) if she subjectively reported having UF either volunteering the information on intake or responding positively when questioned.
This study was approved by the Advocate Health Care Institutional Review Board (Park Ridge, IL). Data were analyzed through a central data coordinating center utilizing Pearson χ 2 analysis performed with SPSS version 14.0 (SPSS, Inc., Chicago, IL).
Results
The women in this study had a mean age of 59.3 years (range, 29–89 years). The majority of women in this study had stage 3 prolapse by either the Pelvic Organ Prolapse Quantification System or Halfway grading system. Women in group 1 were significantly younger, had a higher percentage of patients with stage 2 prolapse, and were more likely to have undergone concurrent hysterectomy and cystocele repair than group 2. These results are summarized in Table 1 .
| Variable | Group 1, women with preoperative USI (n = 204) | Group 2, women without preoperative USI (n = 237) | Total | P value |
|---|---|---|---|---|
| Age, mean age (y) (range) | 57.65 (32–83) | 60.73 (29–89) | 59.3 (29–89) | < .01 a |
| Stage 2 prolapse |
|
|
| < .01 a |
| Stage 3 prolapse |
|
|
| .440 |
| Stage 4 prolapse |
|
|
| < .01 a |
| Urodynamic diagnoses | ||||
| USI | 122 (59.8%) | 0 | 151 (34.2%) | NA |
| Occult USI | 82 (40.2%) | 0 | 82 (18.6%) | NA |
| DO | 42 (20.7%) | 46 (19.4%) | 88 (20.0%) | .74 |
| PVR >100 mL | 23 (12.6%) | 47 (21.2%) | 70 (15.9%) | .023 a |
| Concomitant surgeries | ||||
| Hysterectomy | 91 (44.8%) | 61 (25.7%) | 152 (34.5%) | < .01 a |
| Cystocele repair | 50 (24.9%) | 29 (12.2%) | 79 (18.0%) | < .01 a |
| Rectocele repair | 54 (26.9%) | 82 (34.6%) | 136 (31.1%) | .08 |
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