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Background: Relapsing multiple sclerosis (RMS) is a chronic, inflammatory disease of the central nervous system. Ublituximab, an anti-CD20 monoclonal antibody (mAb), is indicated for the treatment of RMS. We performed a systematic literature review (SLR) to identify randomized trials reporting the clinical efficacy and tolerability of ublituximab or comparator disease-modifying therapies (DMTs) for treatment of RMS, and assessed their comparative effects using network meta-analysis (NMA). Methods: The SLR involved a comprehensive search across various medical databases to identify relevant studies. Included studies were randomized controlled trials (RCTs) of an adult RMS population, focusing on treatment with at least one of ublituximab, alemtuzumab, natalizumab, ocrelizumab, or ofatumumab. For outcomes included in the NMA (annualized relapse rate (ARR), confirmed disability progression (CDP), and treatment discontinuation rate), rate ratios (RR) or hazard ratios (HR), along with their 95% confidence intervals (CIs), were calculated. We performed NMA using a contrast-based random-effects model within a frequentist framework for all outcomes. Ranking probabilities among comparators, and intervention rankings for the NMA, were estimated using surface under the cumulative ranking curve (SUCRA). Results: We included 15 RCTs in the review. For the ARR outcome, there was no statistically significant difference between ublituximab and the other included mAbs [ofatumumab (RR 1.02 (95% CI 0.64–1.62)), natalizumab (RR 0.99 (0.59–1.65)), alemtuzumab (RR 0.86 (0.51–1.46)), and ocrelizumab (RR 0.75 (0.44–1.28))]. For CDP at 6 months, our results showed no statistically significant difference between ublituximab and the comparator mAbs [ofatumumab (HR 0.97 (0.49–1.92)), natalizumab (HR 1.13 (0.53–2.40)), alemtuzumab (HR 1.25 (0.56–2.81)), and ocrelizumab (HR 1.29 (0.57–2.90))]. For CDP at 3 and 6 months, there was no statistically significant difference between ublituximab and placebo. The all-cause treatment discontinuation rate analysis showed no significant difference between ublituximab and other mAbs, except for alemtuzumab. Conclusions: Results of this SLR-informed NMA showed that there is no statistically significant difference between ublituximab and the other mAbs in terms of clinical efficacy. Additionally, the findings show that there is no statistically significant difference in discontinuation rates with the exception of the comparison with alemtuzumab, which may be attributed to its unique dosing schedule. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the cost-effectiveness of pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) for the treatment of advanced gastric cancer. A Partitioned Survival Model followed by state transition Markov model was developed to estimate the costs and effectiveness of the use of PIPAC C/D versus palliative chemotherapy in the UK. The intervention was assessed at two different levels of care, including upfront therapy (PIPAC C/D plus Oxaliplatin in combination with Capecitabine (XELOX) chemotherapy versus first-line chemotherapy alone) and second-line therapy (PIPAC C/D alone versus second-line chemotherapy (ramucirumab monotherapy)). Data from multiple sources, including published literature and UK-based databases, were used to inform the economic model. For the upfront therapy analysis, the estimated total costs in the intervention and comparator arms were £32,606 (SD: £3877) and £17,844 (SD: £920), respectively. PIPAC C/D plus XELOX led to an increase of 0.46 in quality-adjusted life-years (QALYs) gained. The incremental cost per QALY gained was £31,868. For the second-line therapy analysis, the use of PIPAC C/D led to an increase of 0.19 in QALYs and a £21,474 reduction in costs, meaning the intervention was a dominant strategy. The cost-effectiveness results for the upfront therapy analysis indicate that PIPAC C/D plus chemotherapy is a cost-effective strategy. Additionally, PIPAC C/D alone as a second-line therapy has the potential to reduce costs and improve clinical outcomes for patients with advanced gastric cancer with peritoneal metastasis. [ABSTRACT FROM AUTHOR]

BACKGROUND: Health-related quality of life (HRQOL) evaluation is an important measure of the impact of the disease. As more people with coronary heart disease (CHD) live longer, doctors and researchers want to know how they manage in day to day life. It looked like adults with CHD had a decrease QOL. The aim of this study was to comparison of HRQOL of patients who underwent percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) and to assess its main determinants in the whole sample of coronary artery disease (CAD) patients. METHODS: The study was carried out to estimate HRQOL of 109 patients who underwent invasive coronary revascularization [PCI (n = 75) and CABG (n = 34)]. We applied HRQOL after 6 months and 2 years in both groups and scores were compared. The HRQOL data were obtained using MacNew Heart Disease questionnaire with dimensions emotional, physical and social that estimated. Data entry and analysis were performed by SPSS. RESULTS: A total MacNew scale in CABG and PCI group in 6 months after treatment were 45.32 ± 13.75 and 53.52 ± 15.63, respectively (P = 0.010). After 2 years HRQOL mean changed to 51.176 ± 14.80 and 49.55 ± 16.22, respectively, in CABG and PCI group (P = 0.428). Our results in within-group analysis showed total MacNew scale and its subscales were changed significantly after 2 years in CABG and PCI group's scores were detected. We found in the whole sample of CAD patients those who had a higher level of income and education and were not either overweight or obese experienced better HRQOL. CONCLUSION: Our results showed that patients who underwent PCI experienced significantly higher HRQOL in 6 months after revascularization but over 24 months follow-up no difference was observed between the two groups. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to estimate the economic burden of diabetes mellitus (DM) in Iran from 2009 to 2030. Methods: A Markov micro-simulation (MM) model was developed to predict the DM population size and associated economic burden. Age- and sex-specific prevalence and incidence of diagnosed and undiagnosed DM were derived from national health surveys. A systematic review was performed to identify the cost of diabetes in Iran and the mean annual direct and indirect costs of patients with DM were estimated using a random-effect Bayesian meta-analysis. Face, internal, cross and predictive validity of the MM model were assessed by consulting an expert group, performing sensitivity analysis (SA) and comparing model results with published literature and national survey reports. Sensitivity analysis was also performed to explore the effect of uncertainty in the model. Results: We estimated 3.78 million cases of DM (2.74 million diagnosed and 1.04 million undiagnosed) in Iran in 2009. This number is expected to rise to 9.24 million cases (6.73 million diagnosed and 2.50 million undiagnosed) by 2030. The mean annual direct and indirect costs of patients with DM in 2009 were US$ 556 (posterior standard deviation, 221) and US$ 689 (619), respectively. Total estimated annual cost of DM was $3.64 (2009 US$) billion (including US$1.71 billion direct and US$1.93 billion indirect costs) in 2009 and is predicted to increase to $9.0 (in 2009 US$) billion (including US$4.2 billion direct and US$4.8 billion indirect costs) by 2030. Conclusions: The economic burden of DM in Iran is predicted to increase markedly in the coming decades. Identification and implementation of effective strategies to prevent and manage DM should be considered as a public health priority. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate cost effectiveness of coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI) with stenting from Iran society perspective.Methods: A retrospective study was carried out to estimate the annual cost and health related quality of life (HRQoL) of 109 patients who underwent coronary revascularization (PCI [n = 75] and CABG [n = 34]). A Markov model has been developed to determine the cost effectiveness of CABG compared with PCI. We used the model to calculate lifetime costs, life-years (LYs), and quality-adjusted life-years (QALYs) of each strategy. We also used probabilistic sensitivity analysis to test model robustness.Results: We found that discounted QALY lived per person in CABG versus PCI group in 5 years, 10 years, and lifetime time horizon were (3.8 ± 0.13 versus 3.88 ± 0.14), (6.4 ± 0.23 versus 6.33 ± 0.22), and (8.74 ± 0.29 versus 8.33 ± 0.27), respectively. The estimated medical cost of CABG and PCI per patient in 5 years, 10 years, and lifetime time horizon were (USD 6,819 ± 765 versus 9,011 ± 1,816), (USD 8,852 ± 1,348 versus 12,034 ± 2,375), and (USD 14,037± 4,201 versus 18,798 ± 5,821), respectively. The incremental cost-effectiveness ratio results showed CABG is a dominate alternative in 10 years and lifetime time horizon.Conclusions: This study demonstrated that despite higher initial cost and lower HRQoL, CABG is a cost-effective revascularization strategy compared with PCI for patients with multivessel coronary artery disease in long-term. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to measure health-related quality of life (HRQoL) in Iranian people with Type 2 Diabetes Mellitus using two different measures and examines which socio-demographic and diabetes-related characteristics are associated with better quality of life based on a nationally distributed sample. Methods: A multi-stage cluster sampling method was used to select 3472 subjects as a part of Iranian surveillance of risk factors of non- communicable disease (ISRFNCD). EuroQol-5 Dimensions questionnaire (EQ-5D) and Visual Analog Scale (VAS) were employed to measure HRQoL. Binary logistic and Tobit regression models were used to investigate factors associated with EQ-5D results. Results: The mean age of subjects was 59.4 years (SD= 11.7), 61.3% were female and had 8.08 years (SD = 6.7) known duration of diabetes. The patients reported "some or extreme problems" most frequently in Pain/Discomfort (69.3%) and Anxiety/Depression (56.6%) dimensions of EQ-5D. The mean EQ-5D and VAS score were 0.70 (95% CI 0.69-0.71) and 56.8 (95% CI 56.15-57.5) respectively. Female gender, lower education, unemployment, long duration of diabetes, diabetes- related hospitalization in past years and having nephropathy and lower extremity lesions were associated with higher probabilities of reporting "some or extreme problems" in most dimensions of EQ-5D in binary logistic regression models. The same factors in addition to retinopathy were significantly associated with lower levels of HRQoL in Tobit regression analysis too. Conclusions: The study findings indicate that patients with diabetes in Iran suffer from relatively poor HRQoL. Therefore much more attention should be paid to main determinants of HRQoL to identify and implement appropriate policies for achieving better management of diabetes and ultimately improving the quality of life of diabetic patients in this region. [ABSTRACT FROM AUTHOR]

Introduction Diabetes is a worldwide high prevalence chronic progressive disease that poses a significant challenge to healthcare systems. The aim of this study is to provide a detailed economic burden of diagnosed type 2 diabetes mellitus (T2DM) and its complications in Iran in 2009 year. Methods This is a prevalence-based cost-of-illness study focusing on quantifying direct health care costs by bottom-up approach. Data on inpatient hospital services, outpatient clinic visits, physician services, drugs, laboratory test, education and non-medical cost were collected from two national registries. The human capital approach was used to calculate indirect costs separately in male and female and also among different age groups. Results The total national cost of diagnosed T2DM in 2009 is estimated at 3.78 billion USA dollars (USD) including 2.04±0.28 billion direct (medical and non-medical) costs and indirect costs of 1.73 million. Average direct and indirect cost per capita was 842.6±102 and 864.8 USD respectively. Complications (48.9%) and drugs (23.8%) were main components of direct cost. The largest components of medical expenditures attributed to diabetes's complications are cardiovascular disease (42.3% of total Complications cost), nephropathy (23%) and ophthalmic complications (14%). Indirect costs include temporarily disability (335.7 million), permanent disability (452.4 million) and reduced productivity due to premature mortality (950.3 million). Conclusions T2DM is a costly disease in the Iran healthcare system and consume more than 8.69% of total health expenditure. In addition to these quantified costs, T2DM imposes high intangible costs on society in terms of reduced quality of life. Identification of effective new strategies for the control of diabetes and its complications is a public health priority. [ABSTRACT FROM AUTHOR]

Background: Injecting drug users (IDUs) are a major and most important risk factor for rising hepatitis C virus (HCV) prevalence in Iran. Objectives: The objective of this study was to determine the effectiveness of methadone maintenance treatment (MMT) in prevention of HCV infection transmission among IDUs. Patients and Methods: A mathematical modeling has been used to estimate number of HCV infections averted. The input parameters used in the model were collected by self-reported method from 259 IDUs before registering and one year after MMT. Nonparametric statistical tests have been used to compare risky injecting and sexual behaviors among IDUs before and after participating in MMT program. Deterministic sensitivity analyses were done to show the effects of parameters' uncertainty on outcome. Results: Of the 259 participants, 98.4% (255) were men, the mean age ± SD was 33.1 ± 7.58 years and HCV prevalence was 50%. The studied IDUs reported lower rate of risky injecting and sexual behavior after participation in MMT program. The cumulative incidence of HCV per 100 IDUs due to sharing injection and unsafe sexual contact with MMT program were 13.84 (95% CI: 6.17 -21.51), 0.0003 (0.0001 - 0.0005) and without it 36.48 (25.84 - 47.11) and 0.0004 (0.0002-0.0006) respectively. Conclusions: The MMT program is an effective intervention to prevent HCV infection transmission, although it is essential to compare its effectiveness with other interventions before implementing it in nationwide. [ABSTRACT FROM AUTHOR]

Background: Contrast-associated acute kidney injury (CA-AKI) is an important adverse effect associated with injecting iodinated intra-arterial contrast media (CM) during coronary angiography. The DyeVert™ Contrast Reduction System is a medical device intended to reduce the intra-arterial CM volume (CMV) administered. The aim of this study was to assess DyeVert System clinical effectiveness and safety by implementing a systematic review and meta-analysis of existing evidence., Methods: Systematic electronic literature searches were conducted in MEDLINE, Embase, the Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and the International Clinical Trials Registry Platform database. Relevant data were extracted from included studies and meta-analyses were performed to synthesize evidence across studies., Results: The review included 17 eligible studies involving 1,731 DyeVert System cases and 1,387 control cases (without the use of DyeVert). Meta-analyses demonstrated use of the DyeVert System reduced CMV delivered to the patient by 39.27% (95% CI, 36.10-42.48%, P < 0.001), reduced CMV/baseline renal function ratios (Hedges's g, -0.56; 95% CI, -0.70 to -0.42, P < 0.001) and percentage of cases exceeding the maximum CMV threshold (risk difference -0.31, 95% CI, -0.48 to -0.13, P < 0.001) while maintaining adequate image quality in 98% of cases. DyeVert System cases demonstrated lower CA-AKI incidence vs. controls (absolute risk reduction 5.00% (95% CI, 0.40-9.80%; P = 0.03), relative risk 0.60 (95% CI, 0.40-0.90; P = 0.01) with a pooled estimate of the number needed to treat with the DyeVert System to avoid 1 CA-AKI event of 20., Conclusion: DyeVert System use significantly reduces CMV delivered to the patient, CMV/baseline renal function ratios, and CA-AKI incidence while maintaining image quality. Accordingly, the device may serve as an adjunctive, procedure-based strategy to prevent CA-AKI. Future multi-center studies are needed to further assess effects of minimizing CMV on endpoints such as CA-AKI prevention, incidence of adverse cardiac and renal events, and health care costs., Competing Interests: EM, AM, and MJ were employees of Optimax Access United Kingdom Ltd., and MY was employee of Optimax Access United Kingdom Ltd. and is now an Assistant Professor at Mercer University. AP, CB, and SB were paid consultants for Osprey Medical Corporation. AR and AP received honoraria from GE Healthcare as a consultant. RG has previously received speaker fees from Shockwave Medical Inc. Osprey Medical provided funding for the professional services of Optimax/Device Access, Wendy Mills Writing LLC, and Vita Medical LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Tarantini, Prasad, Rathore, Bansal, Gottfried, Rosenkranz, Briguori, Yaghoubi, Mashayekhi, Javanbakht and Moloney.)

Background: Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities. This Cochrane Review was last updated in 2010., Objectives: To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions., Search Methods: We searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings., Selection Criteria: Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm., Data Collection and Analysis: We independently extracted data from eligible trials, assessed risk of bias and implemented GRADE., Main Results: We included 26 trials involving 2271 women. Thirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias. There is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high-quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low-quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low-quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate-quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. There may be little difference between laparoscopic colposuspension using sutures and tension-free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low-quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low-quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low-quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low-quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low-quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate-quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. No studies reported on bladder perforations. Low-quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low-quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life. We are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low-quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low-quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low-quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low-quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life., Authors' Conclusions: The data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long-term follow-up and measure clinically important outcomes. A brief economic commentary identified three studies. We have not quality-assessed them and they should be interpreted in light of the findings on clinical effectiveness., (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: Recent evidence from prospective cohort studies show a relationship between consumption of dairy foods and cardiovascular diseases (CVDs) and type 2 diabetes mellitus (T2DM). This association highlights the importance of dairy foods consumption in prevention of these diseases and also reduction of associated healthcare costs. The aim of this study was to estimate avoidable healthcare costs of CVD and T2D through adequate dairy foods consumption in Iran., Methods: This was a multistage modelling study. We conducted a systematic literature review in PubMed and EMBASE to identify any association between incidence of CVD and T2DM and dairy foods intake, and also associated relative risks. We obtained age- and sex-specific dairy foods consumption level and healthcare expenditures from national surveys and studies. Patient level simulation Markov models were constructed to predict the disease incidence, patient population size and associated healthcare costs for current and optimal dairy foods consumption at different time horizons (1, 5, 10 and 20 years). All parameters including costs and transition probabilities were defined as statistical distributions in the models, and all analyses were conducted by accounting for first and second order uncertainty., Results: The systematic review results indicated that dairy foods consumption was inversely associated with incidence of T2DM, coronary heart disease (CHD) and stroke. We estimated that the introduction of a diet containing 3 servings of dairy foods per day may produce a $0.43 saving in annual per capita healthcare costs in Iran in the first year due to saving in cost of CVD and T2DM treatment. The estimated savings in per capita healthcare costs were $8.42, $39.97 and $190.25 in 5, 10 and 20-years' time, respectively. Corresponding total aggregated avoidable costs for the entire Iranian population within the study time horizons were $33.83, $661.31, $3,138.21 and $14,934.63 million, respectively., Conclusion: Our analysis demonstrated that increasing dairy foods consumption to recommended levels would be associated with reductions in healthcare costs. Further randomized trial studies are required to investigate the effect of dairy foods intake on cost of CVD and T2DM in the population., (© 2018 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Background: Anterior vaginal repair (anterior colporrhaphy) is an operation traditionally used for moderate or severe stress urinary incontinence (SUI) in women. About a third of adult women experience urinary incontinence. SUI imposes significant health and economic burden to the society and the women affected., Objectives: To determine the effects of anterior vaginal repair (anterior colporrhaphy) on urinary incontinence in comparison with other management options., Search Methods: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 1 September 2009) and the reference lists of relevant articles., Selection Criteria: Randomised or quasi-randomised trials that included anterior vaginal repair for the treatment of urinary incontinence., Data Collection and Analysis: Two review authors independently extracted data and assessed trial quality. Three trial investigators were contacted for additional information., Main Results: Ten trials were identified which included 385 women having an anterior vaginal repair and 627 who received comparison interventions.A single small trial provided insufficient evidence to assess anterior vaginal repair in comparison with physical therapy. The performance of anterior repair in comparison with bladder neck needle suspension appeared similar (risk ratio (RR) for failure after one year 1.16, 95% confidence interval (CI) 0.86 to 1.56), but clinically important differences could not be confidently ruled out. No trials compared anterior repair with suburethral sling operations or laparoscopic colposuspensions, or compared alternative vaginal operations.Anterior vaginal repair was less effective than open abdominal retropubic suspension based on patient-reported cure rates in eight trials both in the medium term (failure rate within one to five years after anterior repair 97/259 (38%) versus 57/327 (17%); RR 2.29, 95% confidence Interval (CI) 1.70 to 3.08) and in the long term (after five years, (49/128 (38%) versus 31/145 (21%); RR 2.02, 95% CI 1.36 to 3.01). There was evidence from three of these trials that this was reflected in a need for more repeat operations for incontinence (25/107 (23%) versus 4/164 (2%); RR 8.87, 95% CI 3.28 to 23.94). These findings held, irrespective of the co-existence of prolapse (pelvic relaxation). Although fewer women had a prolapse after anterior repair (RR 0.24, 95% CI 0.12 to 0.47), later prolapse operation appeared to be equally common after vaginal (3%) or abdominal (4%) operation.In respect of the type of open abdominal retropubic suspension, most data related to comparisons of anterior vaginal repair with Burch colposuspension. The few data describing comparison of anterior repair with the Marshall-Marchetti-Krantz procedure were consistent with those for Burch colposuspension., Authors' Conclusions: There were not enough data to allow comparison of anterior vaginal repair with physical therapy or needle suspension for primary urinary stress incontinence in women. Open abdominal retropubic suspension appeared to be better than anterior vaginal repair judged on subjective cure rates in eight trials, even in women who had prolapse in addition to stress incontinence (six trials). The need for repeat incontinence surgery was also less after the abdominal operation. However, there was not enough information about postoperative complications and morbidity.A Brief Economic Commentary (BEC) identified one study suggesting that vaginoplasty may be more cost-effective compared with tension-free vaginal tape (TVT-O).

Background: Stress urinary incontinence (SUI) imposes significant health and economic burden on society and the women affected. Laparoscopic colposuspension was one of the first minimal access operations for the treatment of women with SUI, with the presumed advantages of avoiding major incisions, shorter hospital stays and quicker return to normal activities., Objectives: To determine the effects of laparoscopic colposuspension for urinary incontinence in women., Search Methods: We searched the Cochrane Incontinence Group Trials Register (searched 2 July 2009), and sought additional trials from other sources and by contacting study authors for unpublished data and trials., Selection Criteria: Randomised or quasi-randomised controlled trials in women with symptomatic or urodynamic diagnosis of stress or mixed incontinence that included laparoscopic surgery as the intervention in at least one arm of the studies., Data Collection and Analysis: The review authors evaluated trials for methodological quality and their appropriateness for inclusion in the review. Two review authors extracted data and another cross checked them. Where appropriate, we calculated a summary statistic., Main Results: We identified 22 eligible trials. Ten involved the comparison of laparoscopic with open colposuspension. Whilst the women's subjective impression of cure seemed similar for both procedures, in the short- and medium-term follow-up, there was some evidence of poorer results of laparoscopic colposuspension on objective outcomes. The results showed trends towards fewer perioperative complications, less postoperative pain and shorter hospital stay for laparoscopic compared with open colposuspension, however, laparoscopic colposuspension was more costly.Eight studies compared laparoscopic colposuspension with newer 'self-fixing' vaginal slings. There were no significant differences in the reported short- and long-term subjective cure rates of the two procedures but objective cure rates at 18 months favoured slings. We observed no significant differences for postoperative voiding dysfunction and perioperative complications. Laparoscopic colposuspension had a significantly longer operation time and hospital stay. We found significantly higher subjective and objective one-year cure rates for women randomised to two paravaginal sutures compared with one suture in a single trial. Three studies compared sutures with mesh and staples for laparoscopic colposuspension and showed a trend towards favouring the use of sutures., Authors' Conclusions: Currently available evidence suggests that laparoscopic colposuspension may be as good as open colposuspension at two years post surgery. However, the newer vaginal sling procedures appear to offer even greater benefits, better objective outcomes in the short term and similar subjective outcomes in the longer term. If laparoscopic colposuspension is performed, the use of two paravaginal sutures appears to be the most effective method. The place of laparoscopic colposuspension in clinical practice should become clearer when there are more data available describing long-term results. A brief economic commentary (BEC) identified three studies suggesting that tension-free vaginal tape (TVT) may be more cost-effective compared with laparoscopic colposuspension but laparoscopic colposuspension may be slightly more cost-effective when compared with open colposuspension after 24 months follow-up.

Background: Bladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of these have moderate or severe symptoms. Stress urinary incontinence (SUI) imposes significant health and economic burdens on society and the women affected., Objectives: To determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options., Search Methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 November 2014), and the reference lists of relevant articles., Selection Criteria: Randomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence., Data Collection and Analysis: At least two authors assessed trials and extracted data independently. Two trial investigators provided additional information., Main Results: We identified 10 trials, which included 375 women having six different types of needle suspension procedures and 489 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension. There was a higher subjective failure rate after the first year (91/313 (29%) failed versus 47/297 (16%) failed after open abdominal retropubic suspension). The risk ratio (RR) was 2.00 (95% confidence interval (CI) 1.47 to 2.72), although the difference in peri-operative complications was not significant (17/75 (23%) versus 12/77 (16%); RR 1.44, 95% CI 0.73 to 2.83). There were no significant differences for the other outcome measures. This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations. Needle suspensions may be as effective as anterior vaginal repair (50/156 (32%) failed after needle suspension versus 64/181 (35%) after anterior repair; RR 0.86, 95% CI 0.64 to 1.16), but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population.No trials compared needle suspensions with conservative management, peri-urethral injections, or sham or laparoscopic surgery., Authors' Conclusions: Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials reviewed. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity. A Brief Economic Commentary (BEC) identified no cost-effectiveness studies comparing bladder neck needle suspension with other surgeries.

Background: Urinary incontinence is a common and potentially debilitating problem. Stress urinary, incontinence as the most common type of incontinence, imposes significant health and economic burdens on society and the women affected. Open retropubic colposuspension is a surgical treatment which involves lifting the tissues near the bladder neck and proximal urethra in the area behind the anterior pubic bones to correct deficient urethral closure to correct stress urinary incontinence., Objectives: The review aimed to determine the effects of open retropubic colposuspension for the treatment of urinary incontinence in women. A secondary aim was to assess the safety of open retropubic colposuspension in terms of adverse events caused by the procedure., Search Methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and the reference lists of relevant articles. We contacted investigators to locate extra studies., Selection Criteria: Randomised or quasi-randomised controlled trials in women with symptoms or urodynamic diagnoses of stress or mixed urinary incontinence that included open retropubic colposuspension surgery in at least one trial group., Data Collection and Analysis: Studies were evaluated for methodological quality or susceptibility to bias and appropriateness for inclusion and data extracted by two of the review authors. Trial data were analysed by intervention. Where appropriate, a summary statistic was calculated., Main Results: This review included 55 trials involving a total of 5417 women.Overall cure rates were 68.9% to 88.0% for open retropubic colposuspension. Two small studies suggested lower incontinence rates after open retropubic colposuspension compared with conservative treatment. Similarly, one trial suggested lower incontinence rates after open retropubic colposuspension compared to anticholinergic treatment. Evidence from six trials showed a lower incontinence rate after open retropubic colposuspension than after anterior colporrhaphy. Such benefit was maintained over time (risk ratio (RR) for incontinence 0.46; 95% CI 0.30 to 0.72 before the first year, RR 0.37; 95% CI 0.27 to 0.51 at one to five years, RR 0.49; 95% CI 0.32 to 0.75 in periods beyond five years).Evidence from 22 trials in comparison with suburethral slings (traditional slings or trans-vaginal tape or transobturator tape) found no overall significant difference in incontinence rates in all time periods evaluated (as assessed subjectively RR 0.90; 95% CI 0.69 to 1.18, within one year of treatment, RR 1.18; 95%CI 1.01 to 1.39 between one and five years, RR 1.11; 95% CI 0.97 to 1.27 at five years and more, and as assessed objectively RR 1.24; 95% CI 0.93 to 1.67 within one year of treatment, RR 1.12; 95% CI 0.82 to 1.54 for one to five years follow up, RR 0.70; 95% CI 0.30 to 1.64 at more than five years). However, subgroup analysis of studies comparing traditional slings and open colposuspension showed better effectiveness with traditional slings in the medium and long term (RR 1.35; 95% CI 1.11 to 1.64 from one to five years follow up, RR 1.19; 95% CI 1.03 to 1.37).In comparison with needle suspension, there was a lower incontinence rate after colposuspension in the first year after surgery (RR 0.66; 95% CI 0.42 to 1.03), after the first year (RR 0.56; 95% CI 0.39 to 0.81), and beyond five years (RR 0.32; 95% CI 15 to 0.71).Patient-reported incontinence rates at short, medium and long-term follow-up showed no significant differences between open and laparoscopic retropubic colposuspension, but with wide confidence intervals. In two trials incontinence was less common after the Burch (RR 0.38; 95% CI 0.18 to 0.76) than after the Marshall Marchetti Krantz procedure at one to five year follow-up. There were few data at any other follow-up times.In general, the evidence available does not show a higher morbidity or complication rate with open retropubic colposuspension compared to the other open surgical techniques, although pelvic organ prolapse is more common than after anterior colporrhaphy and sling procedures. Voiding problems are also more common after sling procedures compared to open colposuspension., Authors' Conclusions: Open retropubic colposuspension is an effective treatment modality for stress urinary incontinence especially in the long term. Within the first year of treatment, the overall continence rate is approximately 85% to 90%. After five years, approximately 70% of women can expect to be dry. Newer minimal access sling procedures look promising in comparison with open colposuspension but their long-term performance is limited and closer monitoring of their adverse event profile must be carried out. Open colposuspension is associated with a higher risk of pelvic organ prolapse compared to sling operations and anterior colporrhaphy, but with a lower risk of voiding dysfunction compared to traditional sling surgery. Laparoscopic colposuspension should allow speedier recovery but its relative safety and long-term effectiveness is not yet known. A Brief Economic Commentary (BEC) identified five studies suggesting that tension-free vaginal tape (TVT) and laparoscopic colposuspension may be more cost-effective compared with open retropubic colposuspension.