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.

Impact of the availability of midurethral slings on treatment strategies for stress urinary incontinence: a cost-effectiveness analysis.

OBJECTIVE: To perform a cost-effectiveness analysis for the surgical and non-surgical management of stress urinary incontinence (SUI) with and without the availability of midurethral sling. DESIGN: Cost-effectiveness analysis. SETTING: USA, 2019. POPULATION: Women with stress urinary incontinence. METHODS: We modelled SUI treatment pathways with and without the availability of midurethral slings, including no treatment, incontinence pessary, pelvic floor muscle physical therapy, urethral bulking injection, open and laparoscopic Burch colposuspension, and pubovaginal autologous sling. Time horizon was 2 years after initial treatment. MAIN OUTCOME MEASURES: Costs (2019 US$) included index surgery, surgical retreatment, and complications including urinary retention, de novo urgency and mesh exposure. The incremental cost-effectiveness ratio (ICER) was calculated for non-dominated treatment strategies. RESULTS: The least costly treatment strategies were incontinence pessary, pelvic floor physical therapy, no treatment and midurethral sling, respectively. Midurethral slings had the highest effectiveness. The strategy with the lowest effectiveness was no treatment. The three cost-effective strategies included pessary, pelvic floor muscle physical therapy and midurethral slings. No other surgical options were cost-effective. If midurethral slings were not available, all other surgical options were still dominated by pelvic floor muscle physical therapy. Multiple one-way sensitivity analyses confirmed model robustness. The only reasonable threshold in which outcomes would change, was if urethral bulking costs decreased 12.6%. CONCLUSIONS: The midurethral sling is the most effective SUI treatment and the only cost-effective surgical option. TWEETABLE ABSTRACT: Midurethral sling is the only cost-effective surgical treatment option for stress urinary incontinence.

Cervical pessary vs vaginal progesterone for prevention of preterm birth in women with twin pregnancy and short cervix: economic analysis following randomized controlled trial.

OBJECTIVE: To compare the cost-effectiveness of cervical pessary vs vaginal progesterone to prevent preterm birth and neonatal morbidity in women with twin pregnancy and a short cervix. METHODS: Between 4 March 2016 and 3 June 2017, we performed this economic analysis following a randomized controlled trial (RCT), performed at My Duc Hospital, Ho Chi Minh City, Vietnam, that compared cervical pessary to vaginal progesterone in women with twin pregnancy and cervical length < 38 mm between 16 and 22 weeks of gestation. We used morbidity-free neonatal survival as a measure of effectiveness. Data on pregnancy outcome, maternal morbidity and neonatal complications were collected prospectively from medical files; additional information was obtained via telephone interviews with the patients. The incremental cost-effectiveness ratio was calculated as the incremental cost required to achieve one extra surviving morbidity-free neonate in the pessary group compared with in the progesterone group. Probabilistic and one-way sensitivity analyses were also performed. RESULTS: During the study period, we screened 1113 women with twin pregnancy, of whom 300 fulfilled the inclusion criteria of the RCT and gave informed consent to participate. These women were assigned randomly to receive cervical pessary (n = 150) or vaginal progesterone (n = 150), with two women and one woman, respectively, being lost to follow-up. The rate of morbidity-free neonatal survival was significantly higher in the pessary group compared with the progesterone group (n = 241/296 (81.4%) vs 219/298 (73.5%); relative risk, 1.11 (95% CI, 1.02-1.21), P = 0.02). The mean total cost per woman was 3146 € in the pessary group vs 3570 € in the progesterone group (absolute difference, -424 € (95% CI, -842 to -3 €), P = 0.048). The cost per morbidity-free neonate was significantly lower in the pessary group compared with that in the progesterone group (2492 vs 2639 €; absolute difference, -147 € (95% CI, -284 to 10 €), P = 0.035). CONCLUSION: In women with twin pregnancy and a short cervix, cervical pessary improves significantly the rate of morbidity-free neonatal survival while reducing costs, as compared with vaginal progesterone. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

A Cost-Utility Analysis of Nonsurgical Treatments for Stress Urinary Incontinence in Women.

OBJECTIVE: The objective of this study was to perform a cost-utility analysis of nonsurgical treatments for stress urinary incontinence (SUI) in healthy adult women with a health system perspective over a 1-year time horizon. METHODS: A decision tree model was constructed to evaluate the following nonsurgical treatment options for SUI in a simulated healthy adult female cohort who had failed Kegel exercises: pelvic floor muscle therapy (PFMT), a disposable tampon device (Impressa), a self-fitting intravaginal incontinence device (Uresta), and a traditional incontinence pessary. Published data and consultation with health care providers were used to estimate efficacies and costs. Health utility estimates were derived from existing literature. Deterministic sensitivity analyses were performed as well as Monte Carlo probabilistic sensitivity analysis to account for the impact of parameter uncertainty on costs and efficacies for each treatment. Our primary outcome was the highest net monetary benefit (NMB), which represents the monetary value of the health benefits less the treatment costs. The standard willingness-to-pay threshold of US $50,000 per quality-adjusted life year was used. RESULTS: The utility of SUI in an otherwise healthy patient was 0.81 ± 0.16 and for subjective cure was 0.93 ± 0.08. Using base-case estimates, PFMT was the most cost-effective treatment with an NMB of US $44,098. The Impressa tampon, Uresta, and traditional pessary had NMBs of US $43,970, $43,785, and $42,846, respectively. The probabilistic sensitivity analysis confirmed PFMT to be the most cost-effective treatment option at a willingness to pay of US $50,000 per quality-adjusted life year. CONCLUSIONS: The findings of our cost-utility analysis favor PFMT as the most cost-effective nonsurgical treatment option for SUI. Cost-effectiveness for 1 year of treatment was also favorable for Impressa and Uresta. In jurisdictions where there is no public funding for PFMT, Impressa or Uresta are alternatives for women wishing to avoid surgery.

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.

Cost utility of the treatment of stress urinary incontinence.

OBJECTIVE: We sought to investigate the cost utility of nonsurgical versus surgical treatments for stress urinary incontinence (SUI). METHODS: A decision analysis model was created to compare nonsurgical and surgical treatment options for women with SUI. Decision paths included conservative management, pelvic floor physical therapy (pelvic floor muscle training [PFMT]), PFMT with electrical stimulation, incontinence pessary, and surgical treatment. A Markov model cohort analysis was performed with a cycle length of 1 year starting at age 45 years with a lifetime horizon. Probabilities, success rates, and utilities were obtained from the literature when available or by expert opinion. Cost-utility analysis was performed using US recommendations from a societal perspective. Cost data were obtained from Medicare reimbursement in 2012 US dollars. RESULTS: Incontinence pessary was the most cost-effective treatment option with a cost of $11,411 for 18.9 quality-adjusted life years. At a willingness to pay (WTP) threshold of $50,000, incontinence pessary remained the most cost-effective treatment option. At a WTP threshold of $60,000, surgery became the most cost-effective treatment option. The PFMT and PFMT with electrical stimulation were dominated at any WTP threshold. CONCLUSIONS: Surgical correction is likely the most cost-effective treatment option for young healthy women with SUI. Results are driven by the high success rate of minimally invasive slings. More studies are needed to define utility values for heath states experienced by women with SUI. This will enhance our ability to develop more accurate cost-utility models and offer the best treatment for women affected by incontinence.

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.

Economic analysis of use of pessary to prevent preterm birth in women with multiple pregnancy (ProTWIN trial).

OBJECTIVE: To assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy. METHODS: The study design comprised an economic analysis of data from a randomized clinical trial evaluating cervical pessaries (ProTWIN). Women with a multiple pregnancy were included and an economic evaluation was performed from a societal perspective. Costs were estimated between the time of randomization and 6 weeks postpartum. The prespecified subgroup of women with a cervical length (CL) < 25(th) centile (< 38 mm) was analyzed separately. The primary endpoint was poor perinatal outcome occurring up to 6 weeks postpartum. Direct medical costs and health outcomes were estimated and incremental cost-effectiveness ratios for costs to prevent one poor outcome were calculated. RESULTS: Mean costs in the pessary group (n = 401) were € 21,783 vs € 21,877 in the group in which no pessary was used (n = 407) (difference, -€ 94; 95% CI, -€ 5975 to € 5609). In the prespecified subgroup of women with a CL < 38 mm we demonstrated a significant reduction in poor perinatal outcome (12% vs 29%; RR, 0.40; 95% CI, 0.19-0.83). Mean costs in the pessary group (n = 78) were € 25,141 vs € 30,577 in the no-pessary group (n = 55) (difference, -€ 5436 (95% CI, -€ 11,001 to € 1456). In women with a CL < 38 mm, pessary treatment was the dominant strategy (more effective and less costly) with a probability of 94%. CONCLUSION: Cervical pessaries in women with a multiple pregnancy involve costs comparable to those in women without pessary treatment. However, in women with a CL < 38 mm, treatment with a cervical pessary appears to be highly cost-effective.

Managing a pessary business.

In this final article in a series of three, components of pessary fitting, provision, and follow up are reviewed from a business perspective related to supplies, patient flow, billing, and coding.

Treatment strategies for pelvic organ prolapse: a cost-effectiveness analysis.

INTRODUCTION AND HYPOTHESIS: To compare the relative cost effectiveness of treatment decision alternatives for post-hysterectomy pelvic organ prolapse (POP). METHODS: A Markov decision analysis model was used to assess and compare the relative cost effectiveness of expectant management, use of a pessary, and surgery for obtaining months of quality-adjusted life over 1 year. Sensitivity analysis was conducted to determine whether the results depended on specific estimates of patient utilities for pessary use, probabilities for complications and other events, and estimated costs. RESULTS: Only two treatment alternatives were found to be efficient choices: initial pessary use and vaginal reconstructive surgery (VRS). Pessary use (including patients that eventually transitioned to surgery) achieved 10.4 quality-adjusted months, at a cost of $10,000 per patient, while VRS obtained 11.4 quality-adjusted months, at $15,000 per patient. Sensitivity analysis demonstrated that these baseline results depended on several key estimates in the model. CONCLUSIONS: This analysis indicates that pessary use and VRS are the most cost-effective treatment alternatives for treating post-hysterectomy vaginal prolapse. Additional research is needed to standardize POP outcomes and complications, so that healthcare providers can best utilize cost information in balancing the risks and benefits of their treatment decisions.

Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial.

BACKGROUND: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. METHODS/DESIGN: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. DISCUSSION: This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials: NTR 1858.

The bacteriological changes after re-using a vaginal continence guard.

BACKGROUND: Involuntary loss of urine is a major health care problem, especially in women. The Conveen Continence Guard is a non-surgical treatment of stress incontinence. A possible risk of vaginal devices is introduction of changes in bacteriological flora of the vagina, especially after re-use of the guard. Moreover, vaginal devices can induce magnesium ion deficiency and thereby facilitate growth of Staphylococcus Aureus. This can lead to the production of toxin-1, eventually resulting in toxic shock syndrome. METHODS: The first aim of this study was to investigate the capacity to absorp magnesium ions in an in-vitro study. Secondly, 14 patients with stress incontinence were examined for bacteriological changes in the vagina after re-using the continence guard for four days. After completing this study the patients were asked whether re-using the continence guard was as convenient as single use. RESULTS: The continence guard had no absorption capacity for magnesium ions. The vaginal bacteriological changes after re-use showed in 11% changes in bacterial growth and in 20% increased bacterial growth. Only one patient developed a vaginal colonization with Staphylococcus Aureus but had no symptoms of disease. The continence guard showed itself to be less effective in preventing stress incontinence after re-use. CONCLUSIONS: Although re-use of the continence guard is feasable from a bacteriological point of view, re-use renders the device less effective.

[Analysis of subjective effect, acceptance and costs of conservative treatment of prolapse and incontinence in women]. / Analyse von subjektivem Effekt, Akzeptanz and Kosten der konservativen Behandlung weiblicher Deszensus- und Inkontinenzzustände.

A renaissance of conservative treatment for urinary incontinence and descensus is taking place presently in the German speaking area for pre-surgical improvement of tissue quality as well as for long-term-treatment replacing or postponing surgery. Modern pessaries (shape and material), a more intense and pathophysiological well-founded physiotherapy as well as the support of treatment by electrostimulation and its completion by adequate hormone substitution lead to a successful conservative treatment. "Gesundheitsstrukturreform" (reformatory measures of the German Public Health System), "Fallpauschalen" (flat-rate tariff of treatment by the case) and "Praxisbudgets" (budgets for out-clinic-treatment by the case, also a form of flat-rate tariff) lead to a restriction in prescribing necessary conservative treatment or preventive measures. Assigning the patient to surgical treatment is therefore in large parts favoured (treatment costs are then charged to clinic budgets). On the basis of the presented exemplary cost analysis completed by data on subjective effectiveness, acceptance and evaluation of efforts for patient and doctor we want to show that it is not either method that has to be considered in the treatment but both. Besides we have to treat the patient sequentially-conservative treatment in most cases first, especially in younger women. Conservative treatment thereby offers the possibility to delay or postpone surgery, a very meaningful option offered regarding the relatively poor results of surgery especially in cases of recurrent disease.

Prostaglandin E2 suppositories as a second-trimester abortifacient.

Despite the large number of second-trimester abortions performed each year in the United States through labor induction, the optimal method of inducing labor has not been developed. This study was performed to evaluate the efficacy and safety of vaginal prostaglandin E2 suppositories as an abortifacient. We analyzed the abortions at 14-24 menstrual weeks' gestation performed at Women's Hospital, Los Angeles, in 1985 and 1986. The abortion rate at 24 hours was 90.4%, with a mean induction-to-abortion time of 13.8 hours. Although gastrointestinal side effects were frequent, hemorrhage, infection and live births were infrequent. Prostaglandin E2 suppositories are a simple, effective and safe means of effecting second-trimester abortion that requires little surgical skill.

PIP: As an abortifacient for 2nd trimester pregnancies, prostaglandin E2 vaginal suppositories are safe and effective. However, side effects are likely to occur with this method and live births are possible. As the Los Angeles Women's Hospital, patients who had elected to undergo abortion at 14-24 weeks were identified for the study. Before treatment, each patient was medicated. After premedication, 1 prostaglandin E2 suppository (20 mg) was placed in the posterior vaginal fornix. Successive suppositories were used until the abortion was complete. The success rate for abortion at 24 hours was 90.4%. Pyrexia, or temperature elevation, was experienced by 59% of the patients; 40% of the patients experienced diarrhea, and 32% experienced emesis. Some patients had multiple episodes of diarrhea and/or vomiting. Although this method is simple and relatively inexpensive in terms of drug expense, the side effects are significant and the expense of operating time is greater than other methods available. These factors must be considered when choosing this method for abortion.