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Dean S. Elterman1, Richard W. Casey2, Thomas J. De los Reyes1, Michael Holloway3.
1Urology, University Health Network, Toronto, ON, Canada; 2The Fe/Male Health Centres, Oakville, ON, Canada; 3Life360 Innovations Inc., Vancouver, BC, Canada
Life360 Innovations Inc. is the Sponsor of this study.
Introduction: Surgical interventions continue to be the mainstay treatment for men with stress urinary incontinence (SUI). For patients with comorbidities that preclude them from surgery or those that are unwilling to undergo invasive therapy, non-surgical options are limited to external compression or collection devices coupled with behavioral modifications. These are often not satisfactory in controlling leakage. The Contino® is a self-administered device placed into the distal urethra to inhibit urine flow, which is then removed prior to urination. This prospective, non-randomized, single-arm trial was used to assess the efficacy of the Contino® device in treating male SUI.
Methods: This multi-site study enrolled 36 men with SUI. Each patient subsequently underwent personalized device sizing and teaching. The primary endpoints of the study were a change from baseline to interim/end of study on the following:
a. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
b. pad weight to assess urine loss
c. adverse events
The trial was 30 days, with data collected at the start, interim and end of study.
Results: A total of 15 participants completed the study (Fig 1). Repeat subjects or with missing data were removed from the statistical analysis completed post hoc by UBC. The use of the device resulted in the reduction of mean scores of ICIQ-SF from baseline (16.5) to day30 (12.2) (Tab 1). Mean pad weight also decreased from baseline (471.4g) to day30 (149.1g) (Tab 2). The t-distribution is assumed for calculating confidence intervals. One-sided 95% confidence intervals were used and gave an upper bound of the estimates (Tab 3 and 4). The adverse events (AE) were primarily mild and non-serious (Fig 2).
Conclusion: The Contino® device resulted in a reduction in urine loss and improved patient perception with urinary incontinence. It is well-tolerated with minimal AE. The Contino® device may serve as an alternative non-invasive option for men with SUI.
Toronto, October 21, 2019 - Today, more than 80 Astellas Pharma Canada ("Astellas") employees will step away from their desks, roll up their sleeves and spend the day volunteering at Variety Village in Scarborough, Ontario as part of the company's annual global day of service, Changing Tomorrow Day (#ChangingTomorrow) – an Astellas employee volunteering initiative dedicated to building stronger communities by giving back.
Celebrating the 10th anniversary of Changing Tomorrow Day this year, Astellas reinforces its longstanding commitment to making a positive, measurable impact in local communities.
“Astellas has a deep-rooted commitment to giving back, and Changing Tomorrow Day reinforces our longstanding vision to making a difference in Canadian communities,” said Steve Sabus, General Manager, Astellas Pharma Canada. “We are thrilled to partner with Variety Village as we live out our corporate culture and values to help change tomorrow and strengthen our community engagement by supporting multiple volunteer activities.”
As part of today’s community development initiative, employees will take part in several volunteer activities at Variety Village, a charitable organization which provides integrated sports and life skills programming for young people with disabilities and those who face developmental barriers to help them achieve their life goals. The volunteer activities that Astellas employees will take part in at Variety Village include gardening and property/facility maintenance activities such as cleaning and painting. Additionally, employees will have the opportunity to participate in Variety Village’s adaptive sports programs to learn more about how the organization is creating an inclusive playing field for people of all abilities.
“Today, Astellas employees are doing well by doing good,” said Karen Stintz, President & CEO of Variety Village. “You are helping Variety’s kids fulfil their potential by helping us focus our efforts on our vision and mission. Your volunteer activities today are saving us much needed funds and we thank you.”
Changing Tomorrow Day is a series of company-sponsored volunteer events for Astellas employees to donate their time to local non-profit organizations to help build a brighter future for patients, people, communities and partners. Over the last four years, Astellas has supported more than 55 non-profit organizations across the Americas as part of Changing Tomorrow Day and on a global basis, last year the company supported nearly 225 locations in approximately 25 countries.
“Volunteerism is so important to the Astellas culture because through unique initiatives like Changing Tomorrow Day, it provides our employees with opportunities to make a difference,” said Adele Zita, Director, Human Resources, Astellas Pharma Canada. “We are proud of our employees’ commitment to demonstrating our shared common purpose and passion for helping patients as they live out our dedication to creating healthier communities.”
In Canada, Astellas employees have volunteered their time on Changing Tomorrow Day with a variety of organizations to make a difference across important causes, by participating in activities to benefit a variety of people in Canadian communities, including patients, people living with disabilities, seniors, and domestic abuse victims; and addressing issues such as food insecurity, homelessness, and the environment.
In 2019, Astellas is celebrating the 10th anniversary of its day of service in the Americas region by recording 80,000 Changing Tomorrow Day volunteer hours in total over the decade. Through this year’s Changing Tomorrow Day, employees will record more than 9,000 hours towards this goal with volunteer events continuing throughout the balance of the year.
Astellas’ commitment to Changing Tomorrow extends globally throughout the company. Each year, Astellas employees around the world support and contribute to their local communities through this initiative. Changing Tomorrow Day is the heart and passion of Astellas employees helping others to live better.
About Astellas Pharma Canada, Inc.:
Astellas Pharma Canada, Inc., headquartered in Markham, Ontario, is a Canadian affiliate of Tokyo-based Astellas Pharma, Inc. In Canada, Astellas has an intense commercial focus on three therapeutic areas – Oncology, Immunology, and Urology. In 2019, the company was featured on the Great Place to Work® Institute’s list of Best Workplaces™ in Canada for the fourth consecutive year, and the lists for Best Workplaces™ for Inclusion; Women; Giving Back; Mental Wellness and Healthcare. For more information about Astellas Pharma Canada, Inc., please visit www.astellas.com/ca. You can also find us on Twitter at @AstellasCA or LinkedIn at Astellas Pharma Canada, Inc.
About Variety – the Children’s Charity and Variety Village:
For over 70 years, Variety has cared for kids, shaped leaders for tomorrow and helped generations of people come together to find support, get healthier and make friends for life. Variety Village has expertise in the following areas: disability, accessibility, integration and inclusion; physical and developmental disabilities and autism spectrum disorder; fitness, rehabilitation and physiotherapy; health, wellness and nutrition; sport and adapted sport for people with disabilities including wheelchair basketball, track, swimming, taekwondo, Volt Hockey, weightlifting and powerlifting; life skills programming for young adults with developmental disabilities; summer camps, leadership skills, life-saving courses. For more information, visit http://www.varietyvillage.ca/.
For further information:
Amanda Mills Sirois Jessica Reynolds
Senior Manager, Product and Corporate Communications Communications Associate
Astellas Pharma Canada, Inc. Astellas Pharma Canada, Inc.
905-940-5752 or 1-833-695-5752