This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.

The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.

The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.

YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants' Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.

YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for "Core 4" elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and "track your progress" brochure; and recipes using bladder-friendly foods.

The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.

The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).

The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating "I'm the boss - not my bladder").

YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to "wait"), daily Toviaz® (always take as directed), and keep track (share with your doctor).

For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).

Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.

YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.

Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.

The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.

YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.

Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).