Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial.

OBJECTIVES: This study aimed to compare the cost-effectiveness of Botox and anticholinergic (AC) medications for the management of urgency urinary incontinence (UUI). METHODS: Cost and effectiveness data were analyzed from participants in the Anticholinergic versus Botox Comparison randomized trial of daily AC medication versus 100 U of intradetrusor Botox injection. Societal costs included the following: treatment costs, patient costs, and medical and nonmedical utilization during the 6-month trial. Quality-adjusted life-years (QALYs) were calculated based on questionnaire-derived utility measures and annualized based on data collected at baseline through 6 months. We also estimated the average direct costs for each treatment through 9 months - the duration of time when approximately half the Botox participants maintained adequate symptom control. RESULTS: Data were analyzed on the 231 women who completed a 6-month follow-up in the Anticholinergic versus Botox Comparison trial (119 AC and 112 Botox). The mean reduction in UUI episodes per day was not significantly different per group. The cumulative mean direct costs through the first 6 months also were similar: $1339 for the AC group and $1266 for the Botox group with AC costs exceeding Botox costs after 5 months. Both groups had considerable QALY gains. Annualizing the 6-month trial results to a 12-month measure, the AC and Botox groups averaged 0.702 and 0.707 QALYs, respectively. Estimates through 9 months favored Botox, showing that AC participants incurred a higher cost per month of adequate symptoms control ($305) compared with Botox participants ($207). CONCLUSIONS: Botox and AC medications have similar costs and effectiveness in the first 6 months of UUI treatment. If costs and outcomes are considered through 9 months, Botox may have significantly lower costs but similar UUI symptom control as AC.

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

BACKGROUND: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. PURPOSE: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. METHODS: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. RESULTS: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. LIMITATIONS: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. CONCLUSION: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Prevalence, management and impact of urinary incontinence in the workplace.

BACKGROUND: The few prior studies of urinary symptoms in the workplace have been small investigations of women in specific occupations (e.g. nursing) or industries (e.g. pottery manufacture). In this study, the aims were to describe the prevalence, management and impact of urinary incontinence for a large cross-section of employed women in the USA. METHODS: Five-page questionnaires were mailed to 5130 American households selected from the National Family Opinion survey panel during the spring of 2004. Usable questionnaires were returned by 3364 women in the target age range of 18-60 years. RESULTS: About 37% of the 2326 employed respondents reported urine loss during the last 30 days. The most common strategies for managing incontinence at work included frequent bathroom breaks and wearing pads. The use of urine control methods increased with the severity of urine loss. The effect of incontinence on workplace activities also increased with the severity of urine loss: 88% of employed women with the most severe symptoms reported at least some negative impact on concentration, performance of physical activities, self-confidence or the ability to complete tasks without interruption. CONCLUSION: Urinary incontinence is prevalent among employed women. Those who experience severe symptoms report that it has a negative effect on aspects of work. Programs on the prevalence and impact of urinary incontinence would help educate both employers and employees, and may lead to the development of better management techniques in the workplace.

Urologic diseases in America project: urinary incontinence in women-national trends in hospitalizations, office visits, treatment and economic impact.

PURPOSE: We describe temporal trends in hospitalizations, outpatient visits and the treatment of female urinary incontinence (UI), and estimated the costs of incontinence using national databases. MATERIALS AND METHODS: The analytic methods used to generate these results have been described previously. RESULTS: The rate of hospitalization with a primary diagnosis of UI decreased from 51/100,000 women in 1994 to 44/100,000 in 2000 and mean length of stay decreased from 3.1 days to 2.1. In contrast, outpatient visits for UI more than doubled during the same period from 845/100,000 women to 1,845/100,000. Rates of inpatient surgical treatment for UI decreased slightly from 1994 to 2000, while ambulatory surgical center visit rates for Medicare beneficiaries 65 years or older more than doubled from 60/100,000 in 1992 to 142/100,000 in 1998. Medical expenditures for UI increased substantially during the 1990s, almost doubling from 128.1 million dollars in 1992 to 234.4 million dollars in 1998 for Medicare beneficiaries 65 years or older. This increase was due almost entirely to increased outpatient costs, which increased from 25.4 million dollars or 9.1% of total costs in 1992 to 329 million dollars or 27.3% of total costs in 2000 in this group. CONCLUSIONS: While existing national databases generally capture only the minority of incontinent women with UI who seek and receive care for UI, they are useful for documenting treads in service use and surgical treatments, and estimating economic impact. This data can be helpful when formulating public policy and designing observational and clinical studies.

Proceedings of the National Institute of Diabetes and Digestive and Kidney Diseases International Symposium on Epidemiologic Issues in Urinary Incontinence in Women.

The Epidemiologic Issues in Urinary Incontinence: Current Databases and Future Collaborations Symposium included an international group of 29 investigators from 10 countries. The purpose of the symposium was to discuss the current understanding and knowledge gaps of prevalence, incidence, associated risk factors, and treatment outcomes for incontinence in women. During the symposium, investigators identified existing large databases and ongoing studies that provide substantive information on specific incontinence research questions. The investigators were able to form an international collaborative research working group and identify potential collaborative projects to further research on the epidemiology of urinary incontinence and bladder dysfunction.