Long-Term Costs of Minimally Invasive Sacral Colpopexy Compared to Native Tissue Vaginal Repair With Concomitant Hysterectomy.

STUDY OBJECTIVE: To determine the long-term costs of hysterectomy with minimally invasive sacrocolpopexy (MISCP) versus uterosacral ligament suspension (USLS) for primary uterovaginal prolapse repair. DESIGN: A hospital-based decision analysis model was built using TreeAge Pro (TreeAge Software Inc, Williamstown, MA). Those with prolapse were modeled to undergo either vaginal hysterectomy with USLS or minimally invasive total hysterectomy with sacrocolpopexy (MISCP). We modeled the chance of complications of the index procedure, prolapse recurrence with the option for surgical retreatment, complications of the salvage procedure, and possible second prolapse recurrence. The primary outcome was cost of the surgical strategy. The proportion of patients living with prolapse after treatment was the secondary outcome. SETTING: Tertiary center for urogynecology. PATIENTS: Female patients undergoing surgical repair by the same team for primary uterovaginal prolapse. INTERVENTIONS: Comparison analysis of estimated long-term costs was performed. MEASUREMENTS AND MAIN RESULTS: Our primary outcome showed that a strategy of undergoing MISCP as the primary index procedure cost $19 935 and that undergoing USLS as the primary index procedure cost $15 457, a difference of $4478. Furthermore, 21.1% of women in the USLS group will be living with recurrent prolapse compared to 6.2% of MISCP patients. Switching from USLS to MISCP to minimize recurrence risk would cost $30 054 per case of prolapse prevented. Additionally, a surgeon would have to perform 6.7 cases by MISCP instead of USLS in order to prevent 1 patient from having recurrent prolapse. CONCLUSION: The higher initial costs of MISCP compared to USLS persist in the long term after factoring in recurrence and complication rates, though more patients who undergo USLS live with prolapse recurrence.

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.

Financial analysis of minimally invasive sacrocolpopexy compared with native tissue vaginal repair with concomitant hysterectomy.

INTRODUCTION: Minimally invasive sacrocolpopexy (MISCP) is increasingly used for uterovaginal prolapse, but comparative cost data of MISCP versus native tissue vaginal repair (NTR) are lacking. The objective was to determine the cost difference, from a hospital perspective, between MISCP and NTR performed with hysterectomy for uterovaginal prolapse. METHODS: This was a retrospective cohort study at a tertiary care center of women who underwent NTR or MISCP with concomitant hysterectomy in 2021. Hospital charges, direct and indirect costs, and operating margin (revenue minus costs) were obtained from Strata Jazz and compared using SPSS. RESULTS: A total of 82 women were included, 33 MISCP (25 robotic, 8 laparoscopic) versus 49 NTR. Demographic and surgical data were similar, except that MISCP had younger age (50.5 vs 61.1 years, p<0.01). Same-day discharge and estimated blood loss were similar, but operative time was longer for MISCP (204 vs 161 min, p<0.01). MISCP total costs were higher (US$17,422 vs US$13,001, p<0.01). MISCP had higher direct costs (US$12,354 vs US$9,305, p<0.01) and indirect costs (US$5,068 vs US$3,696, p<0.01). Consumable supply costs were higher with MISCP (US$4,429 vs US$2,089, p<0.01), but the cost of operating room time and staff was similar (US$7,926 vs US$7,216, p=0.07). Controlling for same-day discharge, anti-incontinence procedures and smoking, total costs were higher for MISCP (adjusted beta = US$4,262, p<0.01). Mean charges (US$102,060 vs US$97,185, p=0.379), revenue (US$22,214 vs US$22,491, p=0.929), and operating margin (US$8,719 vs US$3,966, p=0.134) were not statistically different. CONCLUSION: Minimally invasive sacrocolpopexy had higher costs than NTR; however, charges, reimbursement, and operating margins were not statistically significantly different between the groups.

Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial.

IMPORTANCE: The relative cost per improvement in quality of life can help guide decisions about adding a midurethral sling at the time of prolapse surgery. OBJECTIVE: This study aimed to assess the cost-effectiveness of prophylactic midurethral slings placed at the time of prolapse surgery to reduce de novo urinary incontinence based on a randomized controlled trial. STUDY DESIGN: Costs and effectiveness were collected as part of a planned secondary analysis from the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial, where 337 women without symptomatic stress urinary incontinence were randomly assigned to a midurethral sling or sham incisions during vaginal prolapse surgery. Within-trial cost-effectiveness analysis was performed from the societal perspective. Effectiveness was measured in quality-adjusted life-years (QALYs) and de novo urinary incontinence. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Within-trial societal costs were higher for the sling group than for the control group ($18,170 [95% confidence interval (CI), $16,420-$19,920] vs $15,700 [95% CI, $14,110-$17300], P = 0.041). The changes in QALY were 0.04 (95% CI, 0.02-0.06) versus 0.03 (95% CI, 0.02-0.05; P = 0.54). The incremental cost-effectiveness ratio for prophylactic sling was $309,620/QALY. This is above the generally accepted range of willingness-to-pay thresholds of $50,000 to $150,000/QALY. At 1 year, urinary incontinence was more common in the control group, and the cost to prevent 1 case was $91. The probability that prophylactic sling is cost-effective is 24%. CONCLUSIONS: Prophylactic sling placed during vaginal prolapse surgery reduced the rate of de novo urinary incontinence, but was not cost-effective.

Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery.

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.

Apical Support Procedures at the Time of Hysterectomy for Benign Indications: A Cost-Effectiveness Analysis.

OBJECTIVE: To assess the cost effectiveness of performing routine concurrent apical support procedures at the time of hysterectomy for benign indications. METHODS: We developed a Markov decision model from the health care sector perspective to compare concurrent apical support (ie, McCall culdoplasty) at the time of hysterectomy for benign indications compared with hysterectomy alone. We modeled Markov transitions between asymptomatic, prolapse without treatment, and treated prolapse states for 3 years. Our primary outcome was incremental cost-effectiveness ratio, defined as the difference between groups in mean cost (2019 U.S. dollars) divided by the difference in mean quality-adjusted life-years (QALYs). Model parameter estimates were taken from the published medical literature. Cost estimates were obtained from Medicare reimbursement rates and the literature. One-way, two-way, and probabilistic sensitivity analyses were performed. RESULTS: We assumed a base-case scenario of 13% posthysterectomy prolapse after hysterectomy alone and 2.1% after concurrent apical support, 5.8% and 0.9% undergoing subsequent surgical treatment for prolapse, respectively. Concurrent apical support at the time of hysterectomy had higher costs ($1,667 vs $1,423) but was more effective (2.34 vs 2.31 QALYs) than hysterectomy alone. Concurrent apical support was cost effective with an incremental cost-effectiveness ratio of $11,988/QALY, compared with general willingness-to-pay ranges of $50,000-150,000/QALY. In sensitivity analyses, concurrent apical support remained cost effective as long as the rate of posthysterectomy prolapse after concurrent apical support remained less than 8.7%. Monte Carlo simulation showed that concurrent apical support was cost effective in more than 60% of the simulated iterations. CONCLUSION: Apical support at the time of hysterectomy for benign indications is cost effective compared with hysterectomy alone from the health care sector perspective at 3 years. Our results suggest that encouraging concurrent apical support procedures at time of hysterectomy is a cost-effective strategy in preventing posthysterectomy vaginal prolapse.

Objective follow-up after transection of uterine round ligament during laparoscopic repair of inguinal hernias in women: assessment of safety and long-term outcomes.

BACKGROUND: Whether to preserve the uterine round ligament during laparoscopic inguinal hernia repair in women is controversial. In this study, we aimed to compare outcomes of uterine round ligament preservation versus transection during such surgery and to explore the impact and long-term outcomes of transecting the round ligament. METHODS: The study cohort comprised 419 women who had undergone laparoscopic inguinal hernia repair in Beijing Chaoyang Hospital and Qilu Hospital from January 2013 to January 2020; 393 (93.8%) of whom were successfully followed up. Patient characteristics and technical details of the operative procedure were collected and analyzed retrospectively. Early and late postoperative follow-up data, complications, especially symptoms related to retroflexed uterus, and fertility outcomes, were collected by a single follow-up nurse who was blinded to the operative procedure. RESULTS: There were 218 women (239 sides) in the uterine round ligament preservation group and 175 (182 sides) in the transection group. The patients in the preservation group were younger (45.9 vs. 53.6 years, p = 0.000), and had lower American Society of Anesthesiologists scores (p = 0.000). The median follow-up times in the preservation and transection groups were 41.8 ± 24.2 and 42.7 ± 24.6 months, respectively (p = 0.692). Compared with the transection group, the preservation group had longer operative times for repair of both primary and recurrent hernias. Intraoperative bleeding, length of hospital stay, development of seromas, recurrence rate, incidence of postoperative pain at the first and third postoperative months, and time of last outpatient visit were similar in the two groups. There were more premenopausal patients in the preservation group; however, we found no evidence that transection of the round ligament affected subsequent pregnancy or childbirth. Moreover, we identified no differences in dyspareunia, dysmenorrhea, chronic pelvic pain, or uterine prolapse. CONCLUSION: Transection of the round ligament during laparoscopic inguinal hernia repair in women does not increase the incidence of dyspareunia, dysmenorrhea, chronic pelvic pain, or uterine prolapse, whereas it has the advantage of reducing the operation time.

Vaginal Complications after Cystectomy: Results from a Medicare Sample.

PURPOSE: Cystectomy with a vaginal-sparing approach may be associated with unique complications specific to the female population. The objective of this study was to estimate the incidence of vaginal complications (defined to include vaginal prolapse, vaginal fistula, dyspareunia and vaginal cuff dehiscence/evisceration) after cystectomy and to determine risk factors for these complications. MATERIALS AND METHODS: Women 65 years or older undergoing cystectomy for any indication were identified by procedural codes in the Medicare Limited Data Set 5% sample from January 1, 2011 to December 31, 2017. Patients experiencing a vaginal complication after cystectomy were compared to those who did not. Demographic and biological factors that could increase likelihood of complications were identified and time to development of complications determined. Cumulative incidence was calculated using cumulative incidence function. Multivariable cause-specific Cox proportional hazards model assessed risk factors for vaginal complications. RESULTS: In all, 481 women undergoing cystectomy were identified during the study period, and 37.2% were younger than 70 years old. The majority (378, 79%) had bladder cancer, and 401 (83.4%) underwent an incontinent conduit or catheterizable channel diversion. Within 2 years of cystectomy, 93 patients (19.5%) had 1 or more complications on record. Vaginal cuff dehiscence had the highest cumulative incidence, occurring in 49 patients (10.2%). Over the entire study period (2011-2017), 102 women (21.2%) were diagnosed with a vaginal complication, and 27 (5.6%) received an intervention. CONCLUSIONS: Among women who undergo cystectomy, vaginal complications occur at rates higher than expected with over 20% of women experiencing a complication and over a quarter of those diagnosed undergoing intervention.

Clinical outcomes and uroflowmetry assessment in patients with apical prolapse after laparoscopic uterosacral ligament suspension.

OBJECTIVE: The aim was to evaluate the voiding function and voiding dysfunction 3 months after laparoscopic uterosacral ligament suspension (LUSLS). We identified risk factors for postoperative voiding dysfunction. STUDY DESIGN: This retrospective study included 57 women with apical prolapse who underwent LUSLS with stage II or greater apical prolapse and without advanced anterior vaginal prolapse (stage III or IV). Data were collected from electronic medical records. Voiding function was assessed by uroflowmetry, PVR examination, and self-report questionnaires (the Pelvic Floor Distress Inventory-20 and the Urinary Impact Questionnaire) at baseline and 3 months after surgery. Voiding dysfunction was defined as an average flow rate (Qave)＜10 ml/s, a maximum flow rate (Qmax)＜15 ml/s, or a postvoid residual volume (PVR)＞50 ml. Statistical analyses were performed using paired-sample t tests, χ2 tests, and multivariate logistic regression. RESULTS: Thirty-five percent of women suffered from voiding dysfunction preoperatively. Uroflowmetry parameters and PVR, objective symptoms including voiding difficulties, incomplete empty, frequency and urinary incontinence didn't show significant improvement postoperatively (all p＞0.05). Low Qave was identified as an independent risk factor of post voiding dysfunction (odds ratio, 0.558; 95 % CI, 0.324-0.963). CONCLUSIONS: Approximately one-third of women suffering from apical prolapse without advanced anterior vaginal wall had evidence of voiding dysfunction preoperatively. LUSLS has no obvious effect on uroflowmetry parameters and clinical symptoms.

Pessaries (mechanical devices) for managing pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.  This is an update of a Cochrane Review first published in 2003 and last published in 2013. OBJECTIVES: To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary. MAIN RESULTS: We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.   The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.

Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs.

BACKGROUND: New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods. OBJECTIVE: To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness. DESIGN: Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1 : 1 ratio), minimised on the need for concomitant anterior and/or posterior procedure, concomitant incontinence procedure, age and surgeon. SETTING: UK hospitals. PARTICIPANTS: Uterine trial - 563 out of 565 randomised women had uterine prolapse surgery. Vault trial - 208 out of 209 randomised women had vault prolapse surgery. INTERVENTIONS: Uterine trial - uterine preservation or vaginal hysterectomy. Vault trial - abdominal or vaginal vault suspension. MAIN OUTCOME MEASURES: The primary outcome measures were women's prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year). RESULTS: Uterine trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference -0.05, 95% confidence interval -0.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was £235 (95% confidence interval £6 to £464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference -0.004, 95% confidence interval -0.026 to 0.019). Vault trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference -0.61, 95% confidence interval -2.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was £570 (95% confidence interval £459 to £682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval -0.031 to 0.041). CONCLUSIONS: Uterine trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach. FUTURE WORK: Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86784244. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 13. See the National Institute for Health Research Journals Library website for further project information.

About 1 in 10 women has pelvic organ prolapse (POP) surgery, and around three of these women require a further operation. The aim of this study was to identify the most appropriate surgery for two different types of POP found in women: (1) when the uterus itself has come down ­ the Uterine trial ­ and (2) when a previous hysterectomy has resulted in the top of the vagina coming down ­ the Vault trial. In the Uterine trial, preserving the uterus was compared with removing it vaginally. In the Vault trial, uplifting and supporting the vault prolapse using an abdominal approach was compared with a vaginal approach. Women were asked about their prolapse and other symptoms affecting their quality of life (QoL). The majority of women reported that their prolapse symptoms and QoL improved after surgery. The women's prolapse was also measured by clinical examination before and 12 months after their operation. All of these results were compared between the different procedures. It was found that all the surgical procedures were successful within the 12-month review period. Abdominal surgery in the Vault trial as well as any that was required in the Uterine trial, was, however, slightly less cost-effective. Serious complications and the need for further prolapse surgery were similar in all groups. A small number of women did require additional surgery for prolapse recurrence or for small mesh exposure when additional or prolapse procedures had involved mesh. Women in both trials will be followed up for at least 6 years to determine longer-term costs and consequences.

Assessment of Electrospun and Ultra-lightweight Polypropylene Meshes in the Sheep Model for Vaginal Surgery.

BACKGROUND: There is an urgent need to develop better materials to provide anatomical support to the pelvic floor without compromising its function. OBJECTIVE: Our aim was to assess outcomes after simulated vaginal prolapse repair in a sheep model using three different materials: (1) ultra-lightweight polypropylene (PP) non-degradable textile (Restorelle) mesh, (2) electrospun biodegradable ureidopyrimidinone-polycarbonate (UPy-PC), and (3) electrospun non-degradable polyurethane (PU) mesh in comparison with simulated native tissue repair (NTR). These implants may reduce implant-related complications and avoid vaginal function loss. DESIGN, SETTING, AND PARTICIPANTS: A controlled trial was performed involving 48 ewes that underwent NTR or mesh repair with PP, UPy-PC, or PU meshes (n=12/group). Explants were examined 60 and 180 d (six per group) post-implantation. INTERVENTION: Posterior rectovaginal dissection, NTR, or mesh repair. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Implant-related complications, vaginal contractility, compliance, and host response were assessed. Power calculation and analysis of variance testing were used to enable comparison between the four groups. RESULTS: There were no visible implant-related complications. None of the implants compromised vaginal wall contractility, and passive biomechanical properties were similar to those after NTR. Shrinkage over the surgery area was around 35% for NTR and all mesh-augmented repairs. All materials were integrated well with similar connective tissue composition, vascularization, and innervation. The inflammatory response was mild with electrospun implants, inducing both more macrophages yet with relatively more type 2 macrophages present at an early stage than the PP mesh. CONCLUSIONS: Three very different materials were all well tolerated in the sheep vagina. Biomechanical findings were similar for all mesh-augmented repair and NTR. Constructs induced slightly different mid-term inflammatory profiles. PATIENT SUMMARY: Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes.

Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale.

OBJECTIVES: To determine intra- and interrater reliability and agreement for ultrasound measurements of pelvic floor muscle contraction and to assess the correlation between ultrasound and vaginal palpation. We also aimed to develop an ultrasound scale for assessment of pelvic floor muscle contraction. METHODS: This was a cross-sectional study of 195 women scheduled for stress urinary incontinence (n = 65) or prolapse (n = 65) surgery or who were primigravid (n = 65). Pelvic floor muscle contraction was assessed by vaginal palpation using the Modified Oxford Scale (MOS) and by two- and three-dimensional (2D/3D) transperineal ultrasound. Proportional change in 2D and 3D levator hiatal anteroposterior (AP) diameter and 3D levator hiatal area between rest and contraction were used as measures of pelvic floor muscle contraction. One rater repeated all ultrasound measurements on stored volumes, which were used for intrarater reliability and agreement analysis, and three independent raters analyzed 60 ultrasound volumes for interrater reliability and agreement analysis. Reliability was assessed using the intraclass correlation coefficient (ICC) and agreement using Bland-Altman analysis. Tomographic ultrasound was used to identify women with major levator injury. Spearman's rank correlation coefficient (rS ) was used to assess the correlation between ultrasound measurements of pelvic floor muscle contraction and MOS score. The proportion of women allocated to each category of muscle contraction (absent, weak, moderate or strong) by palpation was used to determine the cut-offs for the ultrasound scale. RESULTS: Intrarater ICC was 0.81 (95% CI, 0.74-0.85) for proportional change in 2D levator hiatal AP diameter. Interrater ICC was 0.82 (95% CI, 0.72-0.89) for proportional change in 2D AP diameter, 0.80 (95% CI, 0.69-0.88) for proportional change in 3D AP diameter and 0.72 (95% CI, 0.56-0.83) for proportional change in hiatal area. The prevalence of major levator injury was 22.6%. The strength of correlation (rS ) between ultrasound measurements and MOS score was 0.52 for 2D AP diameter, 0.62 for 3D AP diameter and 0.47 for hiatal area (P < 0.001 for all). On the ultrasound contraction scale, proportional change in 2D levator hiatal AP diameter of < 1% corresponds to absent, 2-14% to weak, 15-29% to normal and > 30% to strong contraction. CONCLUSIONS: Ultrasound seems to be an objective and reliable method for evaluation of pelvic floor muscle contraction. Proportional change in 2D levator hiatal AP diameter had the highest ICC and moderate correlation with MOS score assessed by vaginal palpation, and we constructed an ultrasound scale for assessment of pelvic floor muscle contraction based on this measure. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Assessment of Overactive Bladder after Laparoscopic Lateral Suspension for Pelvic Organ Prolapse.

BACKGROUND: Pelvic organ prolapses (POP) and overactive bladder (OAB) may coexist and both negatively impact quality of life in women. The correlation between POP and OAB remains unclear, but these patients may have the OAB resolution after the surgical treatment of POP. Aim of our study was to assess the anatomical results and the effect on OAB symptoms in women who underwent laparoscopic lateral suspension for POP. MATERIALS AND METHODS: This prospective study included all women with apical POP who underwent surgical repair with laparoscopic uterine lateral suspension from January 2016 to December 2017. The baseline and the 1-year follow-up included post-void residual measurement, urinalysis, vaginal examination, OAB symptoms evaluation, and administration of questionnaires (PFDI-20, UDI 6). RESULTS: 64 women underwent laparoscopic lateral suspension for uterine prolapse and 78.1% had concomitant anterior vaginal wall defect. At 1-year follow-up the anatomic success rates were 84.4% for the apical and 76.2% for the anterior compartment. The comparison between OAB symptoms before and after the surgical procedure showed the resolution of OAB in 76% of the women, while de novo OAB was present in 2.6%. With the questionnaires 95.3% (61/64) of our patients were satisfied after the POP repair. We documented a trend in ameliorating of OAB regardless of the POP-Q stage. However, the Pearson test showed this correlation as statistically significant only in women with anterior vaginal wall defect stage III and apical stage II. No patient had vaginal exposure of the polypropylene mesh. CONCLUSION: Our data show how laparoscopic lateral suspension is an effective procedure for apical and anterior vaginal wall defects. This study provides further evidence for the concept that OAB in women with POP >II stage improves after a successful POP surgery. These women may benefit from a resolution of OAB and POP symptoms with the improvement of patient's quality of life.

The Disability Impact and Associated Cost per Disability in Women Who Underwent Surgical Revision of Transvaginal Mesh Kits for Prolapse Repair.

OBJECTIVES: The aim of this study was to investigate disability impact in patients and cost to the families of patients who have had complications of transvaginal prolapse mesh kits and underwent surgical revision. METHODS: Patients who developed complications of transvaginal mesh kits for prolapse and who had undergone vaginal prolapse mesh surgical revision/removal in 2009 to 2014 at a single institution were identified by Current Procedural Terminology codes. The group was invited to complete a phone survey pertaining to the initial vaginal mesh used for prolapse surgery utilizing Sheehan Disability Scale (scale 0-10) and Years of life Lived with Disability (YLDs) questionnaires. The data collected were used to estimate the disability and cost analysis. We used our data to estimate the economic and quality-of-life impact of vaginal mesh complications on patients in the United States RESULTS: Sixty-two patients (62/198 [31.2%]) were consented to participate and completed the questionnaires by phone. Extremely disabled patients were 18 (29%) of 62 of whole cases, and 5 (8%) of 62 reported that they had no disability after vaginal mesh surgery. The median for overall disability score after vaginal mesh procedure was 8 (which reflects marked disability on a scale of 0-10). The majority of patients missed a median of 12 months of their school or work because of their mesh complications. Thirty-seven (59.6%) of 62 did not improve after mesh removal. Twenty-one (33.9%) of 62 stated that their family income dropped because of productivity loss related to mesh complications. The mean time between vaginal mesh surgery and mesh removal procedure was 4.7 years. Sheehan Disability Scale scores are significantly correlated with YLDs outcomes. Patients' overall disability score showed a significant correlation with YLDs scores (P < 0.0001). CONCLUSIONS: Vaginal mesh for prolapse reduction complications had a sustained disability impact that continued despite mesh removal. Likewise, the complications were associated with increased economic burden on the families of the effected individuals and a drop in the family income in more than one third of the families.

[Implants for genital prolapse : Contra mesh surgery]. / Implantate bei Genitalprolaps : Kontra Mesh-Operation.

Alloplastic transvaginal meshes have become very popular in the surgery of pelvic organ prolapse (POP) as did alloplastic suburethral slings in female stress incontinence surgery, but without adequate supporting data. The simplicity of the mesh procedure facilitates its propagation with acceptance of higher revision and complication rates. Since attending physicians do more and more prolapse surgeries without practicing or teaching alternative techniques, expertise in these alternatives, which might be very useful in cases of recurrence, persistence or complications, is permanently lost. It is doubtful that proper and detailed information about alternatives, risks, and benefits of transvaginal alloplastic meshes is provided to every single prolapse patient according to the recommendations of the German POP guidelines, since the number of implanted meshes exceeds the number of properly indicated mesh candidates by far. Although there is no dissent internationally about the available mesh data, thousands of lawsuits in the USA, insolvency of companies due to claims for compensation and unambiguous warnings from foreign urological societies leave German urogynecologists still unimpressed. The existing literature in pelvic organ prolapse exclusively focusses on POP stage and improvement of that stage with surgical therapy. Instead, typical prolapse symptoms should trigger therapy and improvement of these symptoms should be the utmost treatment goal. It is strongly recommended for liability reasons to obtain specific written informed consent.

The Role of the Surgeon on Outcomes of Vaginal Prolapse Surgery With Mesh.

INTRODUCTION: Adverse outcomes after surgery for pelvic organ prolapse (POP) with mesh are often attributed to the mesh material with little attention paid to the influence of surgeon factors. We used a national data set to determine whether surgeon case volume and specialty influenced vaginal prolapse surgery outcomes with mesh. MATERIALS AND METHODS: Public Use File data on a 5% random national sample of female Medicare beneficiaries were obtained from the Centers for Medicare and Medicaid Services. Women with a diagnosis of POP who underwent surgery with mesh between 2007 and 2008 were identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification and Current Procedural Terminology, 4th Edition procedure codes. Outcomes were compared by surgeon case volume and specialty. RESULTS: From 2007 to 2008, 1657 surgeries for POP were performed with mesh. Low-, intermediate-, and high-volume surgeons performed 881 (53%), 408 (25%), and 368 (22%) of the cases with mesh, respectively. The cumulative reoperation rates for low-, intermediate-, and high-volume providers were 6%, 2%, and 3%, respectively. The difference in reoperation rates between low and intermediate and low- and high-volume surgeons was statistically significant (P = 0.007 and 0.003, respectively). There was no significant difference in reoperation rates between gynecologists and urologists when vaginal mesh was implanted for POP surgery. CONCLUSIONS: Low-volume surgeons performed most of the vaginal prolapse repairs with mesh and had significantly higher reoperation rates. Surgeon experience must be a consideration when reporting mesh-related complications of POP surgery.

Evaluation of Sacrospinous Hysteropexy vs. Uterosacral Suspension for the Treatment of Uterine Prolapse: A Retrospective Assessment.

OBJECTIVE: This single-center retrospective study aimed to compare the outcomes of vaginal hysterectomy with utero-sacral suspension (VH/USS) versus sacro-spinous hysteropexy (SSHP) in the management of uterine prolapse at a tertiary care center specializing in Urogynecology. METHODS: The medical records of 50 women with stage 2 or more uterine prolapse treated with VH/USS (n = 26) or SSHP (n = 24) were assessed between January 2006 and December 2012. RESULTS: There were no significant differences between the two groups in terms of body mass index (BMI) and parity P = 0.881 and 0.304, respectively. VH/USS procedure was significantly more successful than SSHP procedure with regard to anatomical success (84.62 vs. 41.67%, P = 0.0028). There was a significantly higher anterior prolapse recurrence with SSHP procedure than with VH/USS (33.3 vs. 7.7%; P = 0.034). SSHP was associated with the lower likelihood of anatomical success and a higher risk of recurrent anterior prolapse in multivariate logistic regression analyzes adjusting for potential confounders. CONCLUSION: The findings of this retrospective study indicate that SSHP appears to be associated with less anatomical objective success and an increased risk of recurrent anterior prolapse in comparison to VH/USS. Further validation of our observations by independent investigators is required.

Evaluating the Impact of Intraoperative Surgical Team Handoffs on Patient Outcomes.

OBJECTIVE: The aim of the study was to assess the impact of intraoperative personnel handoffs on clinical outcomes in patients undergoing minimally invasive sacrocolpopexy (SCP). METHODS: We retrospectively reviewed SCPs performed at an academic center between 2009 and 2014. We analyzed the number of staff handoffs, defined as any instance a scrub technician (tech) or circulating nurse handed off responsibility for a break or shift change. Outcomes included operative (OR) time and composite variables for major complications (conversion to an open procedure, bladder injury, bowel injury, blood transfusion, infection, ileus, bowel obstruction, readmission, or mesh complication) and prolapse recurrence (prolapse at or beyond the hymen or retreatment). Postoperative complications were defined as being within 6 weeks of surgery. Mesh complications and prolapse recurrence were recorded for the entire 68-month study period. RESULTS: Of 814 patients, 97.4% were white, 85.3% postmenopausal, mean (SD) age 59.7 (8.8) years, and mean (SD) body mass index 27.5 (4.5) kg/m. Most had stage 3 prolapse (n = 563, 69.9%). There were 478 (58.7%) laparoscopic and 336 (41.3%) robotic SCPs. The median scrub tech and nurse handoff per case was 1.0 (interquartile range [IQR], 0.0-1.0) and 1.0 (IQR, 1.0-2.0), respectively. Mean (SD) OR time was 204.8 (69.0) minutes. One hundred twenty-nine patients (15.8%) had a major complication and 45 (7.5%) experienced prolapse recurrence over a median follow-up interval of 41.0 weeks (IQR, 12.0-101.0). On multivariable linear regression, each tech and nurse handoff was associated with an increased OR time of 13.6 (P < 0.001) and 9.4 minutes (P < 0.001), respectively. Thus, the median of 1 tech and 1 nurse handoff per case will increase OR time by 23.0 minutes (11.2%). On multivariable logistic regression, staff handoffs were not associated with major complications or prolapse recurrence. CONCLUSIONS: Intraoperative scrub technician and circulating nurse handoffs increased OR time for minimally invasive SCP procedures.