Financial Toxicity for Female Patients with Urinary Incontinence.

PURPOSE OF REVIEW: Urinary incontinence (UI) is a common global condition that has been noted to disproportionately affect women. In this review, the authors present discussion of factors contributing to cost of care and various modalities of cost-effective care for UI for female patients. RECENT FINDINGS: We found insurance and out-of-pocket (OOP) costs strongly impact of costs for patients. Further, in evaluation of UI, diagnosis can be a costly multi-step process for effective treatment. Treatment can be multimodal, including non-surgical (e.g., pessary, vaginal insert, pelvic floor muscle training, or PFMT), of which PFMT is a cost-effective, effective, and accessible treatment. Pharmacologic management is generally second-line for overactive bladder, but anti-muscarinic drugs and beta-3 agonists are cost-effective depending on willingness-to-pay and the health system in which they are acquired, respectively. Surgical management is considered the most cost-effective treatment as willingness-to-pay increased, with minimally invasive slings being the mainstay. Other relatively novel treatments are also discussed (e.g., EMSELLA) but require further research. Additionally, we discuss systematic barriers in decisions to seek care for urinary incontinence. Urologists are key agents in treating UI for their female patients, and seeking cost-effective options for treatment remains pivotal for quality care.

Eficacia y seguridad de la colocación de un sling masculino ajustable, en comparación con la colocación de un sling masculino fijo en pacientes con incontinencia urinaria de esfuerzo de intensidad leve a moderada post prostatectomía que han fallado al tratamiento conservador / Efficacy and safety of the placement of an adjustable male sling, compared with the placement of a fixed male sling in patients with post-prostatectomy mild to moderate stress urinary incontinence who have failed conservative treatment

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias (ETS), aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de la colocación de un sling masculino (SM) transobturatriz ajustable con puerto de implantación subcutánea, en comparación con la colocación de un SM fijo, en pacientes varones con incontinencia urinaria (IU) de esfuerzo de intensidad leve a moderada, post prostatectomía y que han fallado al tratamiento conservador (ejercicios del piso pélvico). Mediante la Carta N° 056-DU-GQ-HNERM-GRPRESSALUD-2020, los médicos especialistas del servicio de urología general del Hospital Nacional Edgardo Rebagliati Martins (HNERM), a través de la gerencia de la Red Prestacional Rebagliati, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación de la tecnología "Sistema Ajustable Transobturatriz masculino" para evaluar su posible inclusión al listado de material médico disponible en EsSalud para su utilización en el tratamiento de la incontinencia urinaria masculina por esfuerzo. ASPECTOS GENERALES: La IU es una complicación conocida del tratamiento de la próstata que impacta de manera negativa la calidad de vida (Miller et al., 2005). Esta condición predomina después de una prostatectomía radical (PR) debido a cáncer de próstata; pero también puede aparecer después de procedimientos por otras enfermedades prostáticas benignas. La IU después de un tratamiento prostático o IU post prostatectomía (IUPP), se debe principalmente a una función inadecuada del esfínter uretral. Esta deficiencia del esfínter se debe al efecto directo de la cirugía, con el daño al esfínter estriado externo durante la ligadura del complejo venoso dorsal, el daño al musculo liso de la uretra causado por las suturas de anastomosis, y/o denervación debido a la disección de la uretra y próstata. METODOLOGÍA: Se realizó una búsqueda sistemática de información con el objetivo de identificar la mejor evidencia disponible a la fecha sobre la eficacia y seguridad del sling masculino transobturatriz ajustable con puerto de implantación subcutánea. Se realizó una búsqueda bibliográfica avanzada en las bases de datos de PubMed, Cochrane Library y LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud). La búsqueda sistemática fue suplementada con una búsqueda manual en la lista de referencias bibliográficas de los estudios incluidos en la ETS. Además, se realizó una búsqueda de literatura gris en el motor de búsqueda Google, a fin de poder identificar otras publicaciones de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. Asimismo, se realizó una búsqueda dentro de las páginas web pertenecientes a grupos que realizan ETS y GPC, incluyendo, el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), la Haute Autorité de Santé (HAS), el Institut für Qualitát und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), además de la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en: ClinicalTrials.gov. RESULTADOS: No se identificaron estudios aleatorizados ni estudios observacionales con grupos de control para responder a la pregunta de interés. Para sintetizar mejor la evidencia y evaluar los aspectos de seguridad, se incluyeron un total de seis series de casos con al menos 50 participantes en cada estudio. Tres correspondieron al uso de sling masculino transobturatriz fijo (SMTF) y tres al ajustable. Además, inicialmente se incluyeron dos GPC del manejo de la incontinencia urinaria en el hombre. Sin embargo, durante la elaboración del presente dictamen, se publicó una versión actualizada (al 2022) de una de ellas, optando por su inclusión en el documento. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación aprueba el uso del sling masculino transobturatriz fijo en el tratamiento de la incontinencia urinaria de esfuerzo post prostatectomía de intensidad leve a moderada.

Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial.

QUESTION(S): How cost-effective is group-based pelvic floor muscle training (PFMT) for treating urinary incontinence in older women? DESIGN: Economic evaluation conducted alongside an assessor-blinded, multicentre randomised non-inferiority trial with 1-year follow-up. PARTICIPANTS: A total of 362 women aged ≥ 60 years with stress or mixed urinary incontinence. INTERVENTION: Twelve weekly 1-hour PFMT sessions delivered individually (one physiotherapist per woman) or in groups (one physiotherapist per eight women). OUTCOME MEASURES: Urinary incontinence-related costs per woman were estimated from a participant and provider perspective over 1 year in Canadian dollars, 2019. Effectiveness was based on reduction in leakage episodes and quality-adjusted life years. Incremental cost-effectiveness ratios and net monetary benefit were calculated for each of the effectiveness outcomes and perspectives. RESULTS: Both group-based and individual PFMT were effective in reducing leakage and promoting gains in quality-adjusted life years. Furthermore, group-based PFMT was ≥ 60% less costly than individual treatment, regardless of the perspective studied: -$914 (95% CI -970 to -863) from the participant's perspective and -$509 (95% CI -523 to -496) from the provider's perspective. Differences in effects between study arms were minor and negligible. Adherence to treatment was high, with low loss to follow-up and no between-group differences. CONCLUSION: Compared with standard individual PFMT, group-based PFMT was less costly and as clinically effective and widely accepted. These results indicate that patients and healthcare decision-makers should consider group-based PFMT to be a cost-effective first-line treatment option for urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.govNCT02039830.

A mobile app for the treatment of female mixed and urgency incontinence: a cost-effectiveness analysis in Sweden.

INTRODUCTION AND HYPOTHESIS: A previous randomized controlled trial (RCT) demonstrated that the app Tät II, for self-management of mixed urinary incontinence (MUI) and urgency urinary incontinence (UUI), yielded significant, clinically relevant improvements in symptom severity and quality of life (QoL) compared with a control group. We aimed to assess the cost-effectiveness of Tät II. METHODS: A cost-utility analysis with a 1-year societal perspective was carried out, comparing Tät II with an information app. Data were collected alongside an RCT: 122 community-dwelling women aged ≥18 years with MUI or UUI ≥2 times/week were randomized to 3 months of Tät II treatment focused on pelvic floor muscle training (PFMT) and bladder training (BT; n = 60), or to an information app (n = 62). Self-assessed data from validated questionnaires were collected at baseline and at 3-month and 1-year follow-ups. Costs for assessment, treatment delivery, incontinence aids, laundry, and time for PFMT and BT were included. We calculated quality-adjusted life-years (QALYs) using the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life. The incremental cost-effectiveness ratio (ICER) between the groups was our primary outcome. Sensitivity analyses were performed. RESULTS: The mean age was 58.3 (SD = 9.6) years. Annual overall costs were €738.42 in the treatment group and €605.82 in the control group; annual QALY gains were 0.0152 and 0.0037 respectively. The base case ICER was €11,770.52; ICERs in the sensitivity analyses ranged from €-9,303.78 to €22,307.67. CONCLUSIONS: The app Tät II is a cost-effective treatment method for women with MUI and UUI.

Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence.

OBJECTIVE: To describe the characteristics of women with stress or mixed urinary incontinence (SUI/MUI) receiving physical therapy (PT) services, including referral patterns and PT utilization. METHODS: Female patients with claims associated with an SUI or MUI diagnosis (International Classification of Disease-Clinical Modification [ICD-9-CM]: 625.6, 788.33, or ICD-10-CM: N39.3, N39.46) between July 01, 2014 and June 30, 2016 were identified in International business machines (IBM)'s MarketScan Research Database. Inclusion criteria included the absence of pregnancy claims and ≥80% medical and pharmacy enrollment pre- and postindex. First SUI/MUI diagnosis claim determined index. Patients were followed for 2 years, and associated UI-associated PT encounters were identified. Descriptive statistics were calculated for patients with at least one PT visit during the postindex period. RESULTS: In a cohort of 103,813 women with incident SUI or MUI diagnosis, 2.6% (2792/103,813) had at least one PT visit in the 2 years following their diagnosis. Mean age at index PT encounter was 50.55 years. A total of 52.36% (1462/2792) women had one to four PT visits; 21.2% (592/2792) had >8 PT visits. In subanalysis of the PT cohort (1345/2792), women who received PT only had the lowest average 2-year postindex total medical cost (mean: $12,671; SD: $16,346), compared with PT plus medications (mean: $27,394; SD: $64,481), and PT plus surgery (mean: $33,656; SD: $26,245), respectively. Over 40% had their first PT visit ≥3 months after their index date. CONCLUSIONS: The percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women. IMPACT STATEMENT: Our study suggests underutilization of PT among insured women with SUI and MUI in the 2 years following diagnosis. Interventions to improve this gap in first-line care may represent an opportunity for an increased role for PTs in the care of women with UI.

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.

Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation.

INTRODUCTION: Pelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating. AIMS: To evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI. METHODS: Randomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (PeritronTM), questionnaires (Short-Form 6 Dimensions-Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen's d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used. DISCUSSION: This protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4 . Registered on September 3, 2019.

Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.

BACKGROUND: Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries. RESULTS: We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with SUI. When the treatment sequence of pessaries and surgery was compared with surgery alone, the pessaries treatment sequence dominates surgery in the cohort with POP, and in the cohort with SUI pessaries had an incremental cost-effectiveness ratio (ICER) of $1,033 per QALY gained. The annual budget impact of publicly funding vaginal pessaries in Ontario over the next 5 years ranges from $0.3 million in year 1 to $0.5 million in year 5 for POP, and $0.2 million in year 1 to $0.3 million in year 5 for SUI.We included one study in our quantitative evidence review and spoke to 29 people in our direct patient engagement. The evidence indicated that patient preferences vary and that patients accept the risks of their chosen treatment option. The 24 people we spoke with who had direct experience with vaginal pessaries reported that their POP and/or SUI limited their social activities and restricted their activity levels, taking a huge emotional toll. Many were hesitant or even fearful of surgery due to side effects and perceived failure rate of the surgery. Most people reported that pessaries relieved most or all of their symptoms, allowing them to return to their normal daily activities. However, wait times for pessary fittings could be as long as 2 years, and out-of-pocket expenses could be a barrier for people without extended insurance. CONCLUSIONS: For people with SUI, vaginal pessaries may improve symptoms compared with no treatment, but the evidence is very uncertain. Pessaries may result in little to no difference in longer-term improvement of SUI symptoms compared with PFMT. For people with POP, pessaries may improve some longer-term symptoms, as well as sexual function compared with PFMT. For people with symptomatic POP and SUI, vaginal pessaries may be a cost-effective intervention to be used within a stepped care model (a sequence of interventions followed after the current treatment proves ineffective). We estimate that publicly funding vaginal pessaries in Ontario would result in a total 5-year budget impact of $2.0 million for POP and $1.3 million for SUI. People with POP and/or SUI reported pessary use as being an effective treatment option to manage their symptoms.

Developing an Advanced Alternative Payment Model for Stress Urinary Incontinence.

ABSTRACT: Historically, our health care system has been based on a fee-for-service model, which has resulted in high-cost and fragmented care. The Center for Medicare & Medicaid Services is moving toward a paradigm in which health care providers are incentivized to provide cost-effective, coordinated, value-based care in an effort to control costs and ensure high-quality care for all patients. In 2015, the Medicare Access and Children's Health Insurance Program Reauthorization Act repealed the Sustainable Growth Rate and the fee-for-service model, replacing them with a 2-track system: Merit-based Incentive Payment System and the advanced Alternative Payment Model (aAPM) system. In 2016, the American Urogynecologic Society Payment Reform Committee was created and tasked with developing aAPMs for pelvic floor disorders. The purpose of this article is to describe the stress urinary incontinence aAPM framework, the data selected and associated data plan, and some of the challenges considered and encountered during the aAPM development.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Health status, comorbidities and cost-of-illness in females with stress urinary incontinence living in the Canton of Bern.

INTRODUCTION: Two thirds of women suffering from stress urinary incontinence (SUI) reported a negative impact on quality of life (QoL). SUI can also lead to less physical activity and more comorbidities. SUI may result in a substantial economic burden on health care services but numbers are not clear. Therefore, the aim of this study was to estimate the health status, the comorbidities and the health costs of women with SUI living in the Canton of Bern (Switzerland). METHODS: This cost-of-illness (COI) study was embedded in an RCT (n=96) exploring the effect of two pelvic floor muscle training protocols in women with SUI. A prevalence-based COI study with a societal perspective and a bottom-up approach was applied. Baseline demographics, comorbidities and cost data were collected prospectively during 16 weeks. Descriptive statistics, a frequency and a one-way sensitivity analysis were performed. RESULTS: Thirty-seven participants volunteered in this COI study. About 95 % had at least one comorbidity. The most commonly reported problem was back pain (47.6 %). Fifty-one percent consulted a medical doctor, the prevalence of drug consumption was 70 %, 11 % reported less efficiency whilst working and 30 % less physical activity. Mental stress was mentioned by 59.5 % of the participants. The average health costs were CHF 2256. DISCUSSION: This COI study provided data on health status, comorbidities, QoL, health care use, productivity losses and costs of SUI. The high prevalence of comorbidities observed in this study was comparable to obese females of a similar age group. The high economic burden of SUI requires cost-effective preventive actions and clinical treatment concepts.

Economic analysis of Electrical Muscle Stimulator with Multipath technology for the treatment of stress urinary incontinence: a UK-based cost-utility analysis.

Background: Stress urinary incontinence (SUI) is a debilitating and highly prevalent condition in the UK. The condition is associated with a significant economic burden for affected patients and society. Current treatment options for SUI include minimally invasive therapies, medication and surgical intervention for the most serious cases. Electrical Muscle Stimulator with Multipath technology is a recently developed device for the treatment of SUI that relies on neuromuscular external electrical stimulation (NEES) technology. The clinical efficacy of the device has been proven in previous studies, but existing evidence surrounding its economic viability is limited.Objectives: To assess the cost-utility of the Electrical Muscle Stimulator with Multipath technology Therapy device for the treatment of SUI amongst women in a UK setting.Methods: An economic model was developed to consider the cost-utility (cost per quality-adjusted life-year [QALY] gained) of Electrical Muscle Stimulator with Multipath technology compared with current practice. A Markov model was developed, with costs and health effects estimated over the lifetime of the patient in the base-case analysis. The model was developed to reflect the treatment pathways typically followed by patients with SUI in the UK. Parameter uncertainty was explored in deterministic and probabilistic sensitivity analyses.Results: Base-case results indicate that Electrical Muscle Stimulator with Multipath technology results in cost savings and QALY gains over the patient's lifetime. In the "cure" analysis, the intervention is £250 less costly and leads to a 0.03 QALY gain per patient, while in the "improvement analysis", the intervention is £327 less costly and leads to a 0.13 QALY gain per patient. Results from the probabilistic sensitivity analyses show that the likelihood of Electrical Muscle Stimulator with Multipath technology being cost-effective is greater than 74% across all willingness-to-pay thresholds in the two analyses presented.Conclusions: Electrical Muscle Stimulator with Multipath technology is a potentially cost-effective treatment option for patients with SUI who have failed first-line treatment. It could reduce costs to the health care service and improve quality-of-life for selected patients over their lifetime.

Assessment of the Effectiveness of Pelvic Floor Muscle Training (PFMT) and Extracorporeal Magnetic Innervation (ExMI) in Treatment of Stress Urinary Incontinence in Women: A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study is to assess the effectiveness of pelvic floor muscle training and extracorporeal magnetic innervation in treatment of urinary incontinence in women with stress urinary incontinence. METHODS: The randomized controlled trial enrolled 128 women with stress urinary incontinence who were randomly allocated to either one out of two experimental groups (EG1 or EG2) or the control group (CG). Subjects in the experimental group 1 (EG1) received 12 sessions of pelvic floor muscle training, whereas subjects in the experimental group 2 (EG2) received 12 sessions of extracorporeal magnetic innervation. Subjects in the control group (CG) did not receive any therapeutic intervention. The following instruments were used to measure results in all study groups at the initial and final assessments: Revised Urinary Incontinence Scale (RUIS), Beck Depression Inventory (BDI-II), General Self-Efficacy Scale (GSES), and King's Health Questionnaire (KHQ). RESULTS: In both experimental groups, a statistically significant decline in depressive symptoms (BDI-II) and an improvement in urinary incontinence severity (RUIS) and quality of life (KHQ) were found in the following domains: "social limitations," "emotions," "severity measures," and "symptom severity scale." Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2). No statistically significant differences were found between all measured variables in the control group. Comparative analysis of the three study groups showed statistically significant differences at the final assessment in the quality of life in the following domains: "physical limitations," "social limitations," "personal relationships," and "emotions." Conclusion. Pelvic floor muscle training and extracorporeal magnetic innervation proved to be effective treatment methods for stress urinary incontinence in women. The authors observed an improvement in both the physical and psychosocial aspects.

Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.

PURPOSE: The primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC. METHODS: This prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed. RESULTS: Fifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF. CONCLUSION: Significant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.

[Assessment of irisin concentration in women with stress urinary incontinence after using exracorporeal magnetic innervation (EXMI) - pilot study].

OBJECTIVE: Introduction: In Poland, urinary incontinence (UI) is the ninth in frequency of reported health problem, which occurs in 15.4% of women over 60 years of age (data of the Central Statistical Office of 2016). The search for optimal treatment methods for this disease and objective methods for assessing the effectiveness of therapy is a challenge for an interdisciplinary team of specialists. The aim: To examine the effect of Extracorporeal Magnetic Innervation (ExMI) on the Irisin concentration in women with stress urinary incontinence. PATIENTS AND METHODS: Materials and methods: A total of 52 women were included in the analysis: 28 participants were allocated to the experimental group (EG) and 24 to the control group (CG). EG patients completed ExMI therapy, whereas no therapeutic intervention was applied to the CG. Irisin concentration, severity of urinary incontinence (RUIS) were measured in all women at the initial and final assessments. RESULTS: Results: By comparing the initial and final assessment results we have been able to demonstrate a statistically significant differences in the measured variables in the EG. No statistically significant differences in the measured variables were reported for the CG at the initial and final assessments. No correlation was observed between the Irisin concentration results and severity of urinary incontinence in the EG at the final assessment. CONCLUSION: Conclusions: There is a need for further studies of biochemical parameters in the assessment of pelvic floor muscle dysfunction.

Yoga for treating urinary incontinence in women.

BACKGROUND: Urinary incontinence in women is associated with poor quality of life and difficulties in social, psychological and sexual functioning. The condition may affect up to 15% of middle-aged or older women in the general population. Conservative treatments such as lifestyle interventions, bladder training and pelvic floor muscle training (used either alone or in combination with other interventions) are the initial approaches to the management of urinary incontinence. Many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India. OBJECTIVES: To assess the effects of yoga for treating urinary incontinence in women. SEARCH METHODS: We searched the Cochrane Incontinence and Cochrane Complementary Medicine Specialised Registers. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov to identify any ongoing or unpublished studies. We handsearched Proceedings of the International Congress on Complementary Medicine Research and the European Congress for Integrative Medicine. We searched the NHS Economic Evaluation Database for economic studies, and supplemented this search with searches for economics studies in MEDLINE and Embase from 2015 onwards. Database searches are up-to-date as of 21 June 2018. SELECTION CRITERIA: Randomised controlled trials in women diagnosed with urinary incontinence in which one group was allocated to treatment with yoga. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias and evaluated the certainty of the evidence for each reported outcome. Any disagreements were resolved by consensus. We planned to combine clinically comparable studies in Review Manager 5 using random-effects meta-analysis and to carry out sensitivity and subgroup analyses. We planned to create a table listing economic studies on yoga for incontinence but not carry out any analyses on these studies. MAIN RESULTS: We included two studies (involving a total of 49 women). Each study compared yoga to a different comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment.One included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a difference between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean difference (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a difference in the number of women who experienced at least one adverse event (risk difference 0%, 95% CI -38% to 38%; no difference from 222 per 1000, 95% CI 380 fewer to 380 more).The second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the effect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse effects. AUTHORS' CONCLUSIONS: We identified few trials on yoga for incontinence, and the existing trials were small and at high risk of bias. In addition, we did not find any studies of economic outcomes related to yoga for urinary incontinence. Due to the lack of evidence to answer the review question, we are uncertain whether yoga is useful for women with urinary incontinence. Additional, well-conducted trials with larger sample sizes are needed.

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.

Assessment of the long-term outcome of TVT procedure for stress urinary incontinence in a female population: results at 17 years' follow-up.

INTRODUCTION AND HYPOTHESIS: To assess the outcome of the tension-free vaginal tape (TVT) procedure in female patients with urodynamic stress urinary incontinence at 17 years follow-up. METHODS: We carried out a prospective study at the 2nd Department of Obstetrics and Gynecology, Aretaieio Hospital, University of Athens, Greece. Patients who had undergone a TVT procedure 17 years ago. The follow-up assessment included gynecological examination, urinalysis, cough stress test in the lithotomy and/or upright position, filling and voiding cystometry, and uroflow. Also, all patients were required to complete the Patient Satisfaction Questionnaire (PSQ). RESULTS: Out of the 61 initial patients, 56 were available for follow-up. Objective cure rate was 83.9% (47/56) at 17 years follow-up. Subjective cure rate was 78.6% (44/56), subjective improvement was 8.9%, and failure rate was 12.5%. Frequency was present in 39.3% of patients, overactive bladder symptoms were present in 30.3% of patients and urge urinary incontinence was reported by 12.5% of patients. Difficulty emptying the bladder was reported by 10 patients (17.8%) and recurrent urinary tract infection was seen in 3.5% of patients. There was one case of TVT erosion to the vaginal mucosa, which was managed conservatively. CONCLUSIONS: The TVT procedure for the management of stress urinary incontinence in women maintains its efficacy in the long term, having an objective cure rate of 83.9% and a subjective cure rate of 78.6% at 17 years' follow-up, with a very low complications rate.

Cell-based therapy for the treatment of female stress urinary incontinence: an early cost-effectiveness analysis.

AIM: To perform an early cost-effectiveness analysis of in vitro expanded myoblasts (IVM) and minced myofibers versus midurethral slings (MUS) for surgical treatment of female stress urinary incontinence. METHODS: Cost-effectiveness and sensitivity analyses were performed using a decision tree comprising previously published data and expert opinions. RESULTS & CONCLUSION: In the base case scenario, MUS was the cost-effective strategy with a negative incremental cost-effectiveness ratio compared with IVM and a positive incremental cost-effectiveness ratio compared with minced myofibers. However, the sensitivity analysis indicates that IVM may become an alternative providing greater effect at a higher cost. With the possibility of becoming more effective, IVM treatment would be advantageous over MUS given its reduced invasiveness and lower risks of complications.