Urethral Bulking With Polyacrylamide Hydrogel Compared With Other Treatments for Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.

Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model.

OBJECTIVE: Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse. DESIGN: A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon. SETTING: This model was constructed using TreeAge® software. POPULATION OR SAMPLE: Healthy women undergoing surgery for uterine prolapse were modeled. METHODS: A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY). RESULTS: Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000. CONCLUSION: Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches.

Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year Markov analysis: a cost-effectiveness analysis.

INTRODUCTION AND HYPOTHESIS: To perform a cost-effectiveness analysis of concurrent posterior repair performed at the time of laparoscopic hysterectomy with sacrocolpopexy over a 7-year time period. We hypothesize it is not cost-effective to perform a posterior colporrhaphy. METHODS: We used TreeAge Pro® to construct a decision model with Markov modeling to compare sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. Outcomes included probability and costs associated with prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring reoperation, and postoperative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as ∆ costs /∆ effectiveness and the willingness to pay (WTP) was set at $100,000/QALY. RESULTS: Our model showed that SCP was the dominant strategy, with lower costs (-$ 2681.06) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. In two-way sensitivity analyses, we varied the probability of prolapse recurrence after both strategies. Our conclusions would only change if the probability of recurrence after SCP was at least 29.7% higher than after SCP+PR. When varying the probabilities of dyspareunia for both strategies, SCP+PR only became the dominant strategy if the probability of dyspareunia for SCP+PR was lower than the rate of SCP alone. CONCLUSIONS: In this 7-year Markov cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP+PR costs more with lower effectiveness than SCP alone, due to higher surgical cost of SCP+PR and higher probability of dyspareunia after SCP+PR.

Surgical Correction of the Genital Hiatus at the Time of Sacrocolpopexy-Are Concurrent Posterior Repairs Cost-Effective?

OBJECTIVE: The objective was to perform a cost-effectiveness analysis of posterior repair performed at the time of sacrocolpopexy (SCP). METHODS: We used TreeAge Pro to construct a decision model comparing laparoscopic hysterectomy with SCP with and without concurrent posterior repair (SCP and SCP + PR). Using a time horizon of 1 year, we modeled prolapse recurrence, prolapse retreatment, and complications, including rectal injury, rectovaginal hematoma requiring surgical take-back, and postoperative dyspareunia. Costs included index surgery, surgical retreatment, and complications. We modeled effectiveness as quality-adjusted life years (QALYs). Cost-effectiveness was defined using the incremental cost-effectiveness ratio and willingness to pay of $100,000/QALY. Sensitivity analyses were performed. RESULTS: Sacrocolpopexy was the dominant strategy with a cost of $65,714 and an effectiveness of 0.84. It was cost-effective at willingness to pay threshold less than $100,000/QALY. The SCP + PR costs more ($75,063) with lower effectiveness (0.83). The effectiveness of the 2 strategies was similar, differing only by 0.01 QALY, which is less than the minimally important difference for utilities. Tornado plots showed CEA results were most influenced by the cost of SCP, cost of SCP + PR, and probability of dyspareunia after SCP. In 1-way sensitivity analyses, the model outcome would change only if the cost of SCP was increased by 12.8% or if the cost of SCP + PR decreased by 14.5%. For dyspareunia, our model would only change if the probability of dyspareunia after SCP alone was 75.9% (base case, 18.6%), whereas the probability of dyspareunia after SCP + PR was 26.8%. CONCLUSION: In this cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy.

A cost-effectiveness analysis of vaginal carbon dioxide laser therapy compared with standard medical therapies for genitourinary syndrome of menopause-associated dyspareunia.

BACKGROUND: Topical vaginal estrogen therapy is considered the gold standard treatment for genitourinary syndrome of menopause-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or those who are refractory to vaginal estrogen cream therapy. Although evaluating safety, efficacy, and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared with existing therapies is also critically important but often understudied. OBJECTIVE: We sought to perform a cost-effectiveness analysis of 3 therapies for genitourinary syndrome of menopause, including vaginal estrogen therapy, oral ospemifene therapy, and vaginal CO2 laser therapy and determine if vaginal laser therapy is a cost-effective treatment strategy for dyspareunia associated with genitourinary syndrome of menopause. STUDY DESIGN: An institutional review board-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc, Williamstown, MA) using integrated empirical data from the published literature. Tornado plots and 1-way and 2-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness analysis model. RESULTS: All 3 treatment methods were found to be cost-effective below the willingness-to-pay threshold of $50,000.00 per quality-adjusted life year for moderate dyspareunia. The incremental cost-effectiveness ratio for vaginal CO2 laser therapy was $16,372.01 and the incremental cost-effectiveness ratio for ospemifene therapy was $5711.14. Although all 3 treatment strategies were on the efficient frontier, vaginal CO2 laser therapy was the optimal treatment strategy with the highest effectiveness. In a 1-way sensitivity analysis of treatment adherence, vaginal CO2 laser therapy was no longer cost-effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene therapies remained cost-effective treatment strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene therapy was "dominated" by both vaginal CO2 laser therapy and vaginal estrogen cream therapy. In a 2-way sensitivity analysis of vaginal CO2 laser therapy adherence and vaginal CO2 laser therapy cost, vaginal CO2 laser therapy still remained the optimal treatment strategy at 200% of its current cost ($5554.00) when the adherence was >55%. When the cost fell to 20% of its current cost ($555.40), it was the optimal treatment strategy at all adherence values above 29%. CONCLUSION: This study showed that vaginal fractional CO2 laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM, as are both vaginal estrogen and oral ospemifene therapies. In our model, vaginal CO2 laser therapy is the optimal cost-effective treatment strategy, and insurance coverage should be considered for this treatment option if it is proven to be safe and effective in FDA trials.

Inappropriate oophorectomy at time of benign premenopausal hysterectomy.

OBJECTIVE: We assessed rates of oophorectomy during benign hysterectomy around the release of the American College of Obstetricians and Gynecologists 2008 practice bulletin on prophylactic oophorectomy, and evaluated predictors of inappropriate premenopausal oophorectomy. METHODS: A cross-sectional administrative database analysis was performed utilizing the California Office of Statewide Health Planning Development Patient Discharge Database for years 2005 to 2011. After identifying all premenopausal women undergoing hysterectomy for benign conditions, International Classification of Diseases (ICD)-9 diagnosis codes were reviewed to create a master list of indications for oophorectomy. We defined appropriate oophorectomy as cases with concomitant coding for ovarian cyst, breast cancer susceptibility gene carrier status, and other diagnoses. Using patient demographics and hospital characteristics to predict inappropriate oophorectomy, a logistic regression model was created. RESULTS: We identified 57,776 benign premenopausal hysterectomies with oophorectomies during the period studied. Of the premenopausal oophorectomies, 37.7% (21,783) were deemed "inappropriate" with no documented reason for removal. The total number of premenopausal inpatient hysterectomies with oophorectomy decreased yearly (12,227/y in 2005 to 5,930/y in 2011). However, the percentage of inappropriate oophorectomies remained stable. In multivariate analysis, Hispanic and African American ethnicity/race associated with increased odds of inappropriate oophorectomy (P < 0.001). Urban and at low Medi-Cal utilization hospitals showed increased odds of inappropriate oophorectomy. CONCLUSIONS: In premenopausal women undergoing benign hysterectomy, over one-third undergo oophorectomy without an appropriate indication documented. The rate of inappropriate oophorectomy in California has not changed since the 2008 American College of Obstetricians and Gynecologists guidelines. Whereas the absolute number of inpatient hysterectomies for benign indications has decreased, our work suggests persistent utilization of oophorectomy in premenopausal women, despite well-documented long-term adverse health implications.

An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy.

OBJECTIVES: The aim of the study was to assess the safety and efficacy of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause (GSM). METHODS: Women presenting with GSM and meeting study criteria were enrolled. Examinations at baseline and follow-up (3 mo after final treatment) evaluated dilator tolerance and vaginal pH. Visual analog scales were used to assess pain, vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria; Vaginal Health Index scores were completed before each treatment and at follow-up; Female Sexual Function Index and Short Form 12 questionnaires were also completed. Participant satisfaction was measured on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Women received three laser treatments, 6 weeks apart. RESULTS: Thirty women participated (mean age 58.6 ±â€Š8.8 y). None withdrew or were discontinued due to an adverse event; three were lost to follow-up. Average improvement in visual analog scale scoring was 1.7 ±â€Š3.2 for pain, 1.4 ±â€Š2.9 for burning, 1.4 ±â€Š1.9 for itching, 6.1 ±â€Š2.7 for dryness, 5.1 ±â€Š3.0 for dyspareunia, and 1.0 ±â€Š2.4 for dysuria; improvement in average Vaginal Health Index and Female Sexual Function Index scores were statistically significant (P < 0.001). Twenty-five of 30 participants (83%) showed increase in comfortable dilator size at 3-month follow up. Before the second and third treatments, 86.6% (26 of 30) of women reported they were better or much better than at the previous treatment; 26 of 27 women (96%) were reportedly satisfied or extremely satisfied at follow-up. CONCLUSIONS: In this sample, the data suggest that the fractional CO2 laser is effective and safe for treatment of the symptoms associated with GSM.

Abdominal sacral colpopexy versus sacrospinous ligament fixation: a cost-effectiveness analysis.

INTRODUCTION AND HYPOTHESIS: For the surgical correction of apical prolapse the abdominal approach is associated with better outcomes; however, it is more expensive than the transvaginal approach. This cost-effectiveness analysis compares abdominal sacral colpopexy (ASC) with sacrospinous ligament fixation (SSLF) to determine if the improved outcomes of ASC justify the increased expense. METHODS: A decision-analytic model was created comparing ASC with SSLF using data-modeling software, TreeAge Pro (2013), which included the following outcomes: post-operative stress urinary incontinence (SUI) with possible mid-urethral sling (MUS) placement, prolapse recurrence with possible re-operation, and post-operative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) of less than $50,000 per quality-associated life year (QALY). Base-case, threshold, and one-way sensitivity analyses were performed. RESULTS: At the baseline, ASC is more expensive than SSLF ($13,988 vs $11,950), but is more effective (QALY 1.53 vs 1.45) and is cost-effective (ICER $24,574/QALY) at 2 years. ASC was not cost-effective if the following four thresholds were met: the rate of post-operative SUI was above 36 % after ASC or below 28 % after SSLF; the rate of MUS placement for post-operative SUI was above 60 % after ASC or below 13 % after SSLF; the rate of recurrent prolapse was above 15 % after ASC or below 4 % after SSLF; the rate of post-operative dyspareunia was above 59 % after ASC or below 19 % after SSLF. CONCLUSIONS: Abdominal sacral colpopexy can be cost-effective compared with sacrospinous ligament fixation; however, as the post-operative outcomes of SSLF improve, SSLF can be considered a cost-effective alternative.

A cost-effectiveness analysis of conservative versus surgical management for the initial treatment of stress urinary incontinence.

OBJECTIVE: We sought to determine whether conservative or surgical therapy is more cost effective for the initial treatment of stress urinary incontinence (SUI). STUDY DESIGN: We created a decision tree model to compare costs and cost effectiveness of 3 strategies for the initial treatment of SUI: (1) continence pessary, (2) pelvic floor muscle therapy (PFMT), and (3) midurethral sling (MUS). We identified probabilities of SUI after 12 months of use of a pessary, PFMT, or MUS using published data. Parameter estimates included Health Utility Indices of no incontinence (.93) and persistent incontinence (0.7) after treatment. Morbidities associated with MUS included mesh erosion, retention, de novo urge incontinence, and recurrent SUI. Cost data were derived from Medicare in 2012 US dollars. One- and 2-way sensitivity analysis was used to examine the effect of varying rates of pursuing surgery if conservative management failed and rates of SUI cure with pessaries and PFMT. The primary outcome was an incremental cost-effectiveness ratio threshold <$50,000. RESULTS: Compared to PFMT, initial treatment of SUI with MUS was the more cost-effective strategy with an incremental cost-effectiveness ratio of $32,132/quality-adjusted life year. Initial treatment with PFMT was also acceptable as long as subjective cure was >35%. In 3-way sensitivity analysis, subjective cure would need to be >40.5% for PFMT and 43.5% for a continence pessary for the MUS scenario to not be the preferred strategy. CONCLUSION: At 1 year, MUS is more cost effective than a continence pessary or PFMT for the initial treatment for SUI.

To sling or not to sling at time of abdominal sacrocolpopexy: a cost-effectiveness analysis.

PURPOSE: We compare the cost-effectiveness of 3 strategies for the use of a mid urethral sling to prevent occult stress urinary incontinence in patients undergoing abdominal sacrocolpopexy. MATERIALS AND METHODS: Using decision analysis modeling we compared cost-effectiveness during a 1-year postoperative period of 3 treatment approaches including 1) abdominal sacrocolpopexy alone with deferred option for mid urethral sling, 2) abdominal sacrocolpopexy with universal concomitant mid urethral sling and 3) preoperative urodynamic study for selective mid urethral sling. Using published data we modeled probabilities of stress urinary incontinence after abdominal sacrocolpopexy with or without mid urethral sling, the predictive value of urodynamic study to detect occult stress urinary incontinence and the likelihood of complications after mid urethral sling. Costs were derived from Medicare 2010 reimbursement rates. The main outcome modeled was incremental cost-effectiveness ratio per quality adjusted life-years gained. In addition to base case analysis, 1-way sensitivity analyses were performed. RESULTS: In our model, universally performing mid urethral sling at abdominal sacrocolpopexy was the most cost-effective approach with an incremental cost per quality adjusted life-year gained of $2,867 compared to abdominal sacrocolpopexy alone. Preoperative urodynamic study was more costly and less effective than universally performing intraoperative mid urethral sling. The cost-effectiveness of abdominal sacrocolpopexy plus mid urethral sling was robust to sensitivity analysis with a cost-effectiveness ratio consistently below $20,000 per quality adjusted life-year. CONCLUSIONS: Universal concomitant mid urethral sling is the most cost-effective prophylaxis strategy for occult stress urinary incontinence in women undergoing abdominal sacrocolpopexy. The use of preoperative urodynamic study to guide mid urethral sling placement at abdominal sacrocolpopexy is not cost-effective.

Robot-assisted versus open sacrocolpopexy: a cost-minimization analysis.

PURPOSE: Abdominal sacrocolpopexy is considered a standard of care operation for apical vaginal vault prolapse repair. Using outcomes at our center we evaluated whether the robotic approach to sacrocolpopexy is as cost-effective as the open approach. MATERIALS AND METHODS: After obtaining institutional review board approval we performed cost-minimization analysis in a retrospective cohort of patients who underwent sacrocolpopexy at our institution between 2006 and 2010. Threshold values, that is model variable values at which the most cost effective approach crosses over to an alternative approach, were determined by testing model variables over realistic ranges using sensitivity analysis. Hospital billing data were also evaluated to confirm our findings. RESULTS: Operative time was similar for robotic and open surgery (226 vs 221 minutes) but postoperative length of stay differed significantly (1.0 vs 3.3 days, p <0.001). Base case analysis revealed an overall 10% cost savings for robot-assisted vs open sacrocolpopexy ($10,178 vs $11,307). Tornado analysis suggested that the number of institutional robotic cases done annually, length of stay and cost per hospitalization day in the postoperative period were the largest drivers of cost. Analysis of our hospital billing data showed a similar trend with robotic surgery costing 4.2% less than open surgery. CONCLUSIONS: A robot-assisted approach to sacrocolpopexy can be equally or less costly than an open approach. This depends on a sufficient institutional robotic case volume and a shorter postoperative stay for patients who undergo the robot-assisted procedure.