Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

Cost-effectiveness of Surgical Treatment Pathways for Prolapse.

OBJECTIVE: To evaluate the cost-effectiveness of surgical treatment pathways for apical prolapse. STUDY DESIGN: We constructed a stochastic Markov model to assess the cost-effectiveness of vaginal apical suspension, laparoscopic sacrocolpopexy, and robotic sacrocolpopexy. We modeled over 5 and 10 years, with 9 pathways accounting for up to 2 separate surgical repairs, recurrence of symptomatic apical prolapse, reoperation, and complications, including mesh excision. We calculated costs from the health care system's perspective. RESULTS: Over 5 years, compared with expectant management, all surgical treatment pathways cost less than the willingness-to-pay threshold of US $50,000 per quality adjusted life-years. However, among surgical treatments, all but 2 pathways were dominated. Of the remaining 2, laparoscopic sacrocolpopexy followed by vaginal repair for apical recurrence was not cost-effective compared with the vaginal-only approach (incremental cost-effectiveness ratio [ICER], >$500,000). Over 10 years, all but the same 2 pathways were dominated. However, starting with the laparoscopic approach in this case was more cost-effective with an ICER of US $6,176. If the laparoscopic approach was not available, starting with the robotic approach similarly became more cost-effective at 10 years (ICER, US $35,479). CONCLUSIONS: All minimally invasive surgical approaches for apical prolapse repair are cost-effective when compared with expectant management. Among surgical treatments, the vaginal-only approach is the only cost-effective option over 5 years. However, over a longer period, starting with a laparoscopic (or robotic) approach becomes cost-effective. These results help inform discussions regarding the surgical approach for prolapse.

Hysterectomy Versus Hysteropexy at the Time of Native Tissue Pelvic Organ Prolapse Repair: A Cost-Effectiveness Analysis.

OBJECTIVE: The aim of the study was to determine whether a hysterectomy at the time of native tissue pelvic organ prolapse repair is cost-effective for the prevention of endometrial cancer. METHODS: We created a decision analysis model using TreeAge Pro. We modeled prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension (TVH-USLS) versus sacrospinous ligament fixation hysteropexy (SSLF-HPXY). We modeled incidence and diagnostic evaluation of postmenopausal bleeding, including risk of endometrial pathology and diagnosis or death from endometrial cancer. Modeled costs included those associated with the index procedure, subsequent prolapse repair, endometrial biopsy, pelvic ultrasound, hysteroscopy, dilation and curettage, and treatment of endometrial cancer. RESULTS: TVH-USLS costs US $587.61 more than SSLF-HPXY per case of prolapse. TVH-USLS prevents 1.1% of women from experiencing postmenopausal bleeding and its diagnostic workup. It prevents 0.95% of women from undergoing subsequent major surgery for the treatment of either prolapse recurrence or suspected endometrial cancer. Using our model, it costs US $2,698,677 to prevent one cancer death by performing TVH-USLS. As this is lower than the value of a statistical life, it is cost-effective to perform TVH-USLS for cancer prevention. Multiple 1-way sensitivity analyses showed that changes to input variables would not significantly change outcomes. CONCLUSIONS: TVH-USLS increased costs but reduced postmenopausal bleeding and subsequent major surgery compared with SSLF-HPXY. Accounting for these differences, TVH-USLS was a cost-effective approach for the prevention of endometrial cancer. Uterine preservation/removal at the time of prolapse repair should be based on the woman's history and treatment priorities, but cancer prevention should be one aspect of this decision.

Primary surgical management of anterior pelvic organ prolapse: a systematic review, network meta-analysis and cost-effectiveness analysis.

BACKGROUND: Anterior compartment prolapse is the most common pelvic organ prolapse (POP) with a range of surgical treatment options available. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of surgical treatments for the repair of anterior POP. METHODS: We conducted a systematic review of randomised controlled trials comparing surgical treatments for women with POP. Network meta-analysis was possible for anterior POP, same-site recurrence outcome. A Markov model was used to compare the cost-utility of surgical treatments for the primary repair of anterior POP from a UK National Health Service perspective. MAIN RESULTS: We identified 27 eligible trials for the network meta-analysis involving eight surgical treatments tested on 3194 women. Synthetic mesh was the most effective in preventing recurrence at the same site. There was no evidence to suggest a difference between synthetic non-absorbable mesh, synthetic partially absorbable mesh, and biological mesh. The cost-utility analysis, which incorporated effectiveness, complications and cost data, found non-mesh repair to have the highest probability of being cost-effective. The conclusions were robust to model inputs including effectiveness, costs and utility values. CONCLUSIONS: Anterior colporrhaphy augmented with mesh appeared to be cost-ineffective in women requiring primary repair of anterior POP. There is a need for further research on long-term effectiveness and the safety of mesh products to establish their relative cost-effectiveness with a greater certainty. TWEETABLE ABSTRACT: New study finds mesh cost-ineffective in women with anterior pelvic organ prolapse.

The effect of diagnosis-related group payment system on the quality of medical care for pelvic organ prolapse in Korean tertiary hospitals.

PURPOSE: To assess changes in clinical practice patterns after implementing diagnosis-related group (DRG) payment system in July 2013 and its effect on the quality of care for pelvic organ prolapse (POP). MATERIALS AND METHODS: Using the 2011-2016 administrative database from National Health Insurance claim data, we reviewed medical information of 7362 patients who underwent hysterectomies for POP in Korean tertiary hospitals. We compared changes in several variables including length of stay, concomitant procedures, outpatient visits and readmission within 30 days after discharge, and retreatment for POP or stress urinary incontinence within postoperative 1 year before and after DRG system. RESULTS: After the introduction of DRG system, the average length of stay decreased (7.74 ± 2.88 to 6.63 ± 2.18 days, p<0.001) without increasing readmission rates. However, the number of outpatient visits increased (2.78±2.33 to 2.98±2.47, p<0.001). Regarding concomitant procedures, the rates of colpopexy and midurethral slings significantly decreased (7.87% and 9.84% to 4.93% and 2.93%, respectively, all p<0.001). Even though there was no difference in the reoperation rates, pessary insertion for recurrent POP significantly increased after the introduction of DRG system (0.10% to 0.38%, p = 0.015). CONCLUSION: The implementation of DRG in Korean tertiary hospitals has led to increase of outpatient visits and reduced surgical management for POP, which indicates that the uniform application of DRG influences the quality of care for POP patients.

Tension-free vaginal mesh surgery versus laparoscopic sacrocolpopexy for pelvic organ prolapse: Analysis of perioperative outcomes using a Japanese national inpatient database.

OBJECTIVE: To compare nationwide outcomes of tension-free vaginal mesh surgery and laparoscopic sacrocolpopexy for the treatment of pelvic organ prolapse in Japan. METHODS: Using the Diagnosis Procedure Combination database, we collected data on female patients who underwent tension-free vaginal mesh surgery or laparoscopic sacrocolpopexy for pelvic organ prolapse from April 2014 to March 2015. We compared the proportion of perioperative adverse events, duration of anesthesia, total costs and postoperative length of stay between the groups. Univariate and multivariate analyses were carried out for age, comorbidity, mesh volume, additional concomitant surgery and hospital volume. RESULTS: We identified 3023 patients, including 2388 who underwent tension-free vaginal mesh surgery, and 635 who underwent laparoscopic sacrocolpopexy. The median age at the time of surgery was significantly higher in the tension-free vaginal mesh group (71 vs 66 years; P < 0.001). The tension-free vaginal mesh group had a higher proportion of all adverse events (7.1% vs 1.8%; P < 0.001) and a higher proportion of genitourinary complications (5.7% vs 1.1%; P < 0.001). The median duration of anesthesia was shorter in the tension-free vaginal mesh group (150 vs 286 min; P < 0.001). The total cost was significantly lower in the tension-free vaginal mesh group. CONCLUSIONS: Both procedures offer favorable results for surgical treatment of pelvic organ prolapse. Overall, the tension-free vaginal mesh procedure seems to represent a good option for high-risk women, such as elderly patients, whereas laparoscopic sacrocolpopexy is useful for younger patients with a higher level of sexual activity.

Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: an activity-based costing analysis.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a common diagnosis that imposes high and ever-growing costs to the healthcare economy. Numerous surgical techniques for the treatment of POP exist, but there is no consensus about which is the ideal technique for treating apical prolapse. The aim of this study was to estimate hospital costs for the most frequently performed operation, vaginal hysterectomy with uterosacral ligament suspension (VH) and the uterus-preserving Manchester-Fothergill procedure (MP), when including costs of postoperative activities. METHODS: The study was based on a historical matched cohort including 590 patients (295 pairs) who underwent VH or MP during 2010-2014 owing to apical prolapse. The patients were matched according to age and preoperative prolapse stage and followed for a minimum of 20 months. Data were collected from four national registries and electronic medical records. Unit costs were obtained from relevant departments, hospital administration, calculated, or estimated by experts. The hospital perspective was applied for costing the resource use. RESULTS: Total costs for the first 20 months after operation were 3,514 € per VH patient versus 2,318 € per MP patient. The cost difference between the techniques was 898 € (95% confidence interval [CI]: 818-982) per patient when analyzing the primary operation only and 1,196 € (CI: 927-1,465) when including subsequent activities within 20 months (p < 0.0001). CONCLUSIONS: The MP is substantially less expensive than the commonly used VH from a 20-month time perspective. Healthcare costs can be reduced by one third if MP is preferred over VH in the treatment of apical prolapse.

Rate of Pelvic Organ Prolapse Surgery Among Privately Insured Women in the United States, 2010-2013.

OBJECTIVE: To analyze utilization of, and payments for, pelvic organ prolapse procedures after the 2011 U.S. Food and Drug Administration (FDA) communication regarding transvaginal mesh. METHODS: This is a retrospective cohort study examining private claims from three insurance providers for inpatient and outpatient prolapse procedures from 2010 to 2013 in the Health Care Cost Institute. Primary outcomes were the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in payments and reimbursements for these procedures. Utilization rates and payments were compared using generalized linear models and interrupted time-series analysis. RESULTS: Utilization of prolapse procedures decreased from 12.3 to 9.7 per 10,000 woman-years (P=.027) with a decrease of 30.7% (3.9 in 2010 to 2.7 in 2013, P=.05) in number of mesh procedures and 16.6% (8.4 in 2010 to 7.0 in 2013, P=.011) for nonmesh procedures. Quarterly utilization of mesh procedures was increasing before the FDA communication and then significantly declined after its release (slope=0.024 vs -0.025, P=.002). Nonmesh procedures, however, were already slightly decreasing before July 2011 and continued to decline at a more rapid pace after that time, although not significantly (slope=-0.004 vs -0.022, P=.47). Inpatient utilization decreased 52.2% (P=.002), whereas outpatient utilization increased 18.5% (P=.132). Payments for individual inpatient procedures, with and without mesh, increased by 12.0% ($8,315 in 2010 to $9,315 in 2013, P=.001) and 15.6% ($7,826 in 2010 to $9,048 in 2013, P=.005), respectively, whereas those for outpatient procedures increased by 41% ($4,961 in 2010 to $6,981 in 2013, P=.006) and 30% ($3,955 in 2010 to $5,149 in 2013, P=.004), respectively. CONCLUSION: Use of prolapse surgery declined during the study period. After the 2011 FDA communication regarding transvaginal mesh, there was a significant decrease in the utilization of procedures with mesh but not for those without mesh. A shift toward outpatient surgeries was observed, and payments for both individual inpatient and outpatient cases increased.

Análisis de costes del tratamiento del prolapso de órganos pélvicos mediante colposacropexia laparoscópica o malla transvaginal / Cost analysis of surgical treatment for pelvic organ prolapse by laparoscopic sacrocolpopexy or transvaginal mesh

Objetivos. El objetivo del estudio es realizar un análisis comparativo de los costes directos de la reparación del prolapso de órganos pélvicos mediante colposacropexia laparoscópica (CL) o malla transvaginal (MTV). La hipótesis inicial es que la corrección del prolapso de órganos pélvicos mediante CL presentaría al menos un coste por procedimiento similar a la corrección mediante MTV. Material y métodos. Análisis retrospectivo comparativo del coste medio por procedimiento de los primeros 69 procedimientos consecutivos de CL frente a los primeros 69 procedimientos consecutivos de MTV. Para cada procedimiento, se determinaron los costes directos: gastos estructurales, personal, ocupación de quirófano, estancia hospitalaria, material fungible e inventariable y el material protésico implantado. Se determinó el coste medio por procedimiento para cada uno de los grupos, con el intervalo de confianza al 95%. Resultados. Mientras que el grupo de CL incurrió en un mayor gasto en relación con un mayor tiempo quirúrgico, ocupación de quirófano y anestesia, el grupo de MTV incurrió en un mayor gasto en relación con una mayor estancia hospitalaria y un coste mayor del material protésico implantado. De forma global, si bien el grupo de CL presentó un coste medio por procedimiento menor que el grupo de MTV (5.985,7 Euros ± 1.550,8 Euros vs. 6.534,3 Euros ± 1.015,5 Euros), esta diferencia no alcanzó la significación estadística. Conclusiones. En nuestro medio, la corrección del prolapso de órganos pélvicos mediante CL presenta al menos, un coste por procedimiento similar a la corrección del mismo mediante MTV (AU)

Objectives. The objective of this study is to compare direct costs of repairing pelvic organ prolapse by laparoscopic sacrocolpopexy (LS) against vaginal mesh (VM). Our hypothesis is the correction of pelvic organ prolapse by LS has a similar cost per procedure compared to VM. Material and methods. We made a retrospective comparative analysis of medium cost per procedure of first 69 consecutive LS versus first 69 consecutive VM surgeries. We calculate direct cost for each procedure: structural outlays, personal, operating room occupation, hospital stay, perishable or inventory material and prosthetic material. Medium cost per procedure were calculated for each group, with a 95% confidence interval. Results. LS group has a higher cost related to a longer length of surgery, higher operating room occupation and anesthesia; VM group has a higher cost due to longer hospital stay and more expensive prosthetic material. Globally, LS has a lower medium cost per procedure in comparison to VM (5,985.7 Euros ± 1,550.8 Euros vs. 6,534.3 Euros ± 1,015.5 Euros), although it did not achieve statistical signification. Conclusions. In our midst, pelvic organ prolapse surgical correction by LS has at least similar cost per procedure compared to VM (AU)

Role of concurrent vaginal hysterectomy in the outcomes of mesh-based vaginal pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Hysterectomy is often performed at the time of pelvic organ prolapse (POP) surgery; yet, there is insufficient evidence regarding the specific effect of hysterectomy on outcomes. We sought to determine the outcomes and associated short-term complications of mesh-based POP surgery with and without concurrent hysterectomy. METHODS: We utilized the New York Statewide Planning and Research Cooperation System (SPARCS) database to identify patients under 55 years of age undergoing surgeries for POP with mesh between 2009 and 2014. Patients who had a hysterectomy at the time of mesh-based POP surgery were compared with those who underwent mesh-based POP surgery without hysterectomy. Outcome measures of the patient groups before and after propensity score matching were compared. We assessed the difference Chi-squared tests and log-rank tests in the entire cohort and Mantel-Haenszel stratified Chi-squared tests and Prentice-Wilcoxon tests in the matched cohort. RESULTS: A total of 1,601 women underwent mesh-based POP surgery. 921 patients underwent concurrent hysterectomy, whereas 680 had mesh-based uterine-preserving POP surgery. After propensity score matching, there was no difference in reintervention rates between groups for up to 3 years. Concurrent hysterectomy with mesh-based POP repair was consistently associated with longer hospitalization (20.0% vs 12.8% stayed longer than 2 days) and higher charges (median charges were $22,689 vs $19,273). CONCLUSIONS: Concurrent hysterectomy during mesh-based POP surgery in patients under 55 years led to more expensive charges and a longer stay compared with uterine-preserving mesh surgery. There was no difference in reintervention rates between groups for up to 3 years.

Effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training in older women with pelvic organ prolapse: 2-year follow-up of a randomized controlled trial in primary care.

OBJECTIVE: We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period. METHODS: Randomized controlled trial with women (≥55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement. RESULTS: There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively. CONCLUSIONS: In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.

Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion.

INTRODUCTION AND HYPOTHESIS: This committee opinion paper summarizes available evidence about recurrent pelvic organ prolapse (POP) to provide guidance on management. METHOD: A working subcommittee from the International Urogynecological Association (IUGA) Research and Development Committee was formed. The literature regarding recurrent POP was reviewed and summarized by individual members of the subcommittee. Recommendations were graded according to the 2009 Oxford Levels of Evidence. The summary was reviewed by the Committee. RESULTS: There is no agreed definition for recurrent POP and evidence in relation to its evaluation and management is limited. CONCLUSION: The assessment of recurrent POP should entail looking for possible reason(s) for failure, including persistent and/or new risk factors, detection of all pelvic floor defects and checking for complications of previous surgery. The management requires individual evaluation of the risks and benefits of different options and appropriate patient counseling. There is an urgent need for an agreed definition and further research into all aspects of recurrent POP.

Trends and Factors Influencing Inpatient Prolapse Surgical Costs and Length of Stay in the United States.

OBJECTIVE: This study aimed to assess trends and factors affecting inpatient hospital costs and length of stay (LOS) in surgical treatment of pelvic organ prolapse in the United States. METHODS: A retrospective cross-sectional study along with longitudinal trend analysis from the 2001 to 2011 National Inpatient Sample included subjects who underwent inpatient prolapse repairs. The primary outcomes were inpatient mean cost per admission and LOS. We compared unadjusted differences in primary outcomes for each patient and hospital characteristic using 2011 data with analysis of variance. Multivariable regression estimated proportional change in cost and LOS associated with each characteristic. RESULTS: Unadjusted analysis revealed increased LOS with age of 80 years or older, African American race, uninsured status, lower income, and lower surgical volume hospitals (≤75%) as well as increased costs in the West and public hospitals. On multivariable analyses, African Americans had 1.09 (95% confidence interval [CI], 1.05-1.13; P < 0.001) times longer LOS compared with Caucasians, and the uninsured had 1.15 (95% CI, 1.01-1.30; P = 0.032) times longer LOS compared with those privately insured. Comorbidities associated with 20% increase in LOS and costs were pulmonary circulation disorders, metastatic cancer, weight loss, coagulopathy, and electrolyte/fluid imbalance (P < 0.001). Congestive heart failure and blood loss/deficiency anemia lead to 20% longer LOS (P < 0.001). In 2001-2011, mean LOS declined from 2.42 days (95% CI, 2.37-2.47) to 1.79 days (95% CI, 1.71-1.87) (P < 0.001), whereas mean total cost increased from $6233 (95% CI, $5859-$6607) to $9035 (95% CI, $8632-$9438) (P < 0.001). CONCLUSIONS: Inpatient surgical costs for prolapse increased despite decreasing LOS. Some patient and hospital characteristics are associated with increased inpatient costs and LOS.

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.

Robotic-assisted laparoscopic surgery for hysterectomy and pelvic organ prolapse repair.

The robotic platform is a tool that has enabled many gynecologic surgeons to perform procedures by minimally invasive route that would have otherwise been performed by laparotomy. Before the widespread use of this technology, a larger percentage of hysterectomies and sacrocolpopexies were completed via the open route because of the lack of training in traditional laparoscopic suturing, knot tying, and retroperitoneal dissection. Additional deterrents of traditional laparoscopic surgery adoption have included the lengthy learning curve associated with development of advanced laparoscopic skills; and surgeon preference for the open route because of surgical ergonomics, decreased operative time, and more experience with laparotomy. Level I evidence regarding robotic-assisted laparoscopy in benign gynecology is sparse, with most of the data supporting robotic surgery comprised of retrospective cohorts. The literature demonstrates the safety and efficacy of robotic-assisted laparoscopy for hysterectomy and pelvic organ prolapse repair; however, most level I data show increased operative time and cost. The true indications for robotic-assisted laparoscopy in benign gynecology have yet to be discerned. A review of the best available evidence is summarized.

Laparoscopic sacrocolpopexy versus transvaginal mesh for recurrent pelvic organ prolapse.

Both expert surgeons agree with the following: (1) Surgical mesh, whether placed laparoscopically or transvaginally, is indicated for pelvic floor reconstruction in cases involving recurrent advanced pelvic organ prolapse. (2) Procedural expertise and experience gained from performing a high volume of cases is fundamentally necessary. Knowledge of outcomes and complications from an individual surgeon's audit of cases is also needed when discussing the risks and benefits of procedures and alternatives. Yet controversy still exists on how best to teach new surgical techniques and optimal ways to efficiently track outcomes, including subjective and objective cure of prolapse as well as perioperative complications. A mesh registry will be useful in providing data needed for surgeons. Cost factors are also a consideration since laparoscopic and especially robotic surgical mesh procedures are generally more costly than transvaginal mesh kits when operative time, extra instrumentation and length of stay are included. Long-term outcomes, particularly for transvaginal mesh procedures, are lacking. In conclusion, all surgery poses risks; however, patients should be made aware of the pros and cons of various routes of surgery as well as the potential risks and benefits of using mesh. Surgeons should provide patients with honest information about their own experience implanting mesh and also their experience dealing with mesh-related complications.

A decision-analytic Markov model to compare the cost-utility of anterior repair augmented with synthetic mesh compared with non-mesh repair in women with surgically treated prolapse.

OBJECTIVES: To assess the cost-effectiveness of a mesh-augmented anterior vaginal wall repair compared with a non-mesh fascial plication repair. DESIGN: Cost-utility analysis. SETTING: Data for outcomes of different surgical techniques were derived from systematic reviews and recent publications. METHODS: A decision-analytic Markov model, developed in TreeAge Pro 2007(®) , was used to compare the cost-utility of mesh and non-mesh anterior vaginal wall repairs. Sensitivity analysis was used to assess the impact of different scenarios and assumptions on results from the model. MAIN OUTCOME MEASURE: Health outcomes were expressed in terms of quality-adjusted life years (QALYs). RESULTS: Under base case assumptions at 5 years, the incremental cost-effectiveness ratio (ICER) for mesh-augmented anterior repairs was £15 million per QALY. Sensitivity analysis found no plausible model inputs that could make a mesh repair cost-effective by conventional criteria. This was mostly because of the extra costs associated with the price of the mesh, treating mesh erosion and difficulty finding data that support a lower reoperation rate for mesh anterior wall repairs. CONCLUSIONS: This model suggests that the use of mesh is not cost-effective.

Midterm prospective comparison of vaginal repair with mesh vs Prolift system devices for prolapse.

OBJECTIVE: To compare midterm clinical outcome using modified pelvic floor reconstructive surgery with mesh (MPFR) vs Prolift devices for the treatment of pelvic organ prolapse (POP). STUDY DESIGN: This prospective observational cohort study involved 223 women with POP stages III-IV who were assigned to either MPFR (n=131) or Prolift device (n=92). Outcomes were analyzed at 6 and 12 months and the last follow-up visit postoperatively. Main outcome measures included pelvic organ prolapse quantification measurement, Short Form-20 Pelvic Floor Distress Inventory (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) questionnaires, perioperative outcomes, complications, and a personal interview about urinary and sexual symptoms. Statistical analysis included comparison of means (Wilcoxon test or Student's t-test) and proportions (Chi-square test). Multivariate analysis was carried out using Cox proportional hazard model. RESULTS: At follow-up (median, 36 months; range, 17-58 months), anatomic success for MPFR and Prolift was 87.07% and 93.41%, respectively (P=0.1339). Both operations significantly improved quality of life, and PFDI-20 scores were lower in the Prolift group than the MPFR group (P=0.03). Complication rates did not differ significantly between the two groups and the prevalence of urinary symptoms decreased postoperatively in both groups. The cost of operation, however, was RMB ¥11,882.86 yuan for MPFR and ¥23,617.59yuan for Prolift (P=0.00). CONCLUSIONS: MPFR and Prolift had comparable anatomic outcomes, Prolift had better functional outcomes than MPFR, but MPFR is much cheaper than Prolift. MPFR is an alternative, cheap and effective surgical treatment option to mesh-kits for the management for POP.

Review of extraperitoneal sacrocolpopexy as a technique for advanced uterine and vault prolapse.

PURPOSE OF REVIEW: This review is aimed to provide an update on the surgical techniques and complications of sacrocolpopexy procedures, and determine the role of minimally invasive techniques based on the most recent evidence. RECENT FINDINGS: The minimally invasive laparoscopic and robot-assisted alternatives to open abdominal sacrocolpopexy offer faster recovery, less complications and better cosmesis. However, this is suggested predominantly by retrospective comparative studies and no high-level evidence is available to date. Robot-assisted sacrocolpopexy (RASC) has enabled surgeons to overcome the steep learning curve associated with laparoscopic sacrocolpopexy at the expense of a higher cost. Recent data, testing its potential advantages of reduced operative time and postoperative pain, have revealed contradictory results. A novel, totally retroperitoneal sacrocolpopexy procedure aimed to eliminate complications associated with transperitoneal access may become an option in patients unsuitable for minimally invasive techniques, but warrants further investigation. SUMMARY: The benefits of RASC must be weighed against the lack of current evidence to prove its superiority over conventional procedures in terms of faster recovery and cost-effectiveness. There is a need for better reporting of complications associated with these novel techniques and for long-term, randomized comparative data.