Background
Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence.
Objective
We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test.
Study Design
We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness.
Results
The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated.
Conclusion
Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sling placement surgery.
Introduction
With the increase in the proportion of elderly Americans, prolapse surgeries are anticipated to rise by nearly 50% by the year 2050. However, it is estimated that 25% to 40% of patients with stress incontinent prolapse will develop de novo stress urinary incontinence (SUI) after their prolapse repair. This is generally believed to be caused by the anatomic unkinking of the urethra with prolapse reduction, which unmasks the underlying SUI. In the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial, with placement of prophylactic midurethral slings (MUS) during vaginal prolapse surgery for women with stress incontinence, there was a 36% reduction in the risk for de novo SUI. However, concomitant MUS placement was also found to be associated with bladder perforations, incomplete bladder emptying symptoms, and urinary tract infections. Based on these data, pelvic reconstructive surgeons’ approaches to prophylactic MUS at the time of vaginal prolapse repair (VPR) for women with stress incontinence vary.
Why was this study conducted?
Pelvic reconstructive surgeons have several options to use to address de novo stress urinary incontinence (SUI) in patients with stress incontinennce undergoing vaginal prolapse repair. Our study assessed the costs and effectiveness of the following 3 distinct approaches in addressing de novo SUI during prolapse surgeries: staged strategy, universal sling placement, and selective sling placement using the prolapse-reduced cough stress test to guide the need for a sling.
Key findings
Compared with a staged strategy, selective sling placement is cost effective and dominated universal sling placement across a wide range of plausible scenarios. Universal sling placement would replace selective sling placement and become the cost-effective strategy if more than 62% of patients experiencing de novo SUI choose to undergo midurethral sling placement as first-line treatment.
What does this add to what is known?
Our findings support the use of a prophylactic selective sling for those with a positive prolapse-reduced cough stress test as a viable option at the time of vaginal prolapse repair.
Although there has not been a uniform approach regarding prophylactic MUS placement at the time of prolapse repair, Richardson et al performed a cost-effectiveness analysis to guide this practice. Their model found universal MUS placement to be the most cost-effective strategy to prevent de novo SUI over both staged and selective strategies. In their model, selective sling placement was assigned to patients with a planned abdominal sacrocolpopexy who underwent urodynamic testing, an intervention the authors noted to have poor sensitivity and specificity to predict de novo SUI. They did not consider the less costly option of a selective approach using the prolapse-reduced cough stress test (CST) as a preoperative assessment. Furthermore, their findings are not generalizable to VPR surgeries, an approach that accounts for more than two-thirds of all prolapse surgeries. In this study, we aimed to compare the cost effectiveness of 3 MUS utilization strategies in preventing de novo SUI 1 year after VPR.
Materials and Methods
We created a decision analysis model to compare the following 3 approaches: (1) staged strategy in which VPR is performed with addition of MUS placement only for de novo SUI; (2) universal sling placement in which VPR is performed with prophylactic MUS placement; and (3) selective sling placement in which VPR is performed with addition of MUS placement for occult SUI based on performance in the preoperative prolapse-reduced CST ( Figure 1 ). Our hypothetical cohort mirrored that of the OPUS trail. We modeled a representative population of women with symptomatic pelvic organ prolapse of at least stage II according to the Pelvic Organ Prolapse Quantification system and without preexisting urinary symptoms. These women had no neurologic abnormality, abnormal postvoid residual, or previous surgical treatments of pelvic organ prolapse or urinary incontinence. In our model, VPR included colpocleisis, apical suspension (via uterosacral or sacrospinous ligament), or anterior colporrhaphy (with or without posterior colporrhaphy). VPR may include a concomitant vaginal hysterectomy although it was not required in this model. We assumed that all VPRs were uncomplicated and successful. As in the OPUS trial, placement of all MUSs in our model was performed by the retropubic approach. Because this study only utilized publicly available data, the study was deemed to not involve human research and received exempt status from the institutional review board at Northwestern University.
We then formulated subsequent treatment pathways if de novo SUI were to occur after index surgery within each of the 3 strategies. We used the 2017 systematic review by van der Ploeg et al to obtain high-quality literature for point estimates of the risk for postoperative SUI. We searched PubMed to identify articles published after this review’s January 2017 cutoff date to include publications relevant to the model. We excluded studies evaluating urodynamics preoperatively, duplicated studies reporting on the same cohorts, abdominal prolapse repairs, and studies without clear definitions of VPR, MUS, or SUI. All base case assumptions can be found in Table 1 .
| Calculated probabilities | Base case | 95% CI | Reference |
|---|---|---|---|
| Universal sling | |||
| De novo SUI after VPR with MUS | 27.3% | 20.6%–34.7% | Wei et al, 2012 |
| Staged strategy | |||
| De novo SUI after VPR alone | 43.0% | 35.5%–50.8% | Wei et al, 2012 |
| Selective sling | |||
| Positive prolapse-reduced CST in continent women | 35.9% | 32.0%–40.1% | Wei et al, 2012 van der Ploeg et al, 2016 |
| De novo SUI after VPR with MUS with positive preoperation CST | 26.0% | 17.6%–36.0% | Wei et al, 2012 van der Ploeg et al, 2016 |
| De novo SUI after VPR alone with negative preoperation CST | 33.6% | 28.7%–38.9% | Wei et al, 2012 Al-Mandeel et al, 2011 van der Ploeg et al, 2016 |
| MUS-related variables | |||
| Occult SUI patients opting for MUS treatment | 21.4% | 15.0%–29.0% | Wei et al, 2012 Al-Mandeel et al, 2011 van der Ploeg et al, 2016 |
| Persistent SUI after staged MUS | 12.8% | 11.6%–14.1% | Ford et al, 2017 |
| Voiding dysfunction requiring sling lysis after MUS | 7.2% | 6.3%–8.2% | Ford et al, 2017 |
| Recurrent SUI after sling lysis | 13.0% | 2.8%–33.6% | Rardin et al, 2002 |
| Mesh exposure requiring excision after MUS | 2.0% | 1.5%–2.7% | Ford et al, 2017 |
| Recurrent SUI after mesh excision | 31.0% | 19.5%–44.5% | Jambusaria et al, 2016 |
| Overactive bladder medication requirement after MUS | 8.2% | 7.1%–9.4% | Ford et al, 2017 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
